Twiggs333
5日前
$CMPS - Compass Pathways Announces Six-Month Data from Second Phase 3 Trial Confirming Rapid and Durable Profile
https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Announces-Six-Month-Data-from-Second-Phase-3-Trial-Confirming-Rapid-and-Durable-Profile/default.aspx
July 7, 2026
New 6-month data supports COMP360’s potential to establish a new standard of care in TRD
Data from positive COMP006 Phase 3 trial demonstrates durable benefit through at least 6 months further validating COMP360’s differentiated profile in highly chronic TRD
Across two highly statistically significant positive Phase 3 trials, COMP360 is the first classic psychedelic¹ to consistently demonstrate rapid onset, significant durability and reproducibility of effect in TRD, one of psychiatry’s most difficult conditions in which to demonstrate efficacy
COMP360 continues to demonstrate a generally well-tolerated and safe profile with no new safety findings
Rolling NDA submission and initial review underway and final submission expected to be completed in Q4
Commercial launch-readiness on track for end of 2026, with launch expected in first half of 2027
Compass continues to progress late-stage PTSD program, where millions of patients are urgently in need of new, effective options
Compass to host a webinar on July 7th at 8:00 am ET
LONDON & NEW YORK--(BUSINESS WIRE)-- Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the 26-week results (Part B) from its second ongoing Phase 3 COMP006 trial of COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD) which confirm COMP360’s rapid onset and durable profile. The 26-week findings in nearly 600 patients build on previously reported results from the first Phase 3 trial, COMP005, which demonstrated rapid onset and durable response to at least 6 months, with a generally well-tolerated and safe profile in people living with TRD.
The COMP360 Phase 3 program participants represent a highly chronic TRD population. In COMP006, participants had current depressive episodes lasting on average over three years and an average of more than six lifetime depressive episodes. Within the context of this severe population, 39% of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS2 (≥ 25%) by week 6, following two fixed doses of COMP360, and maintained durable response at least through Week 26. This compares favorably to the 25% in COMP005 following a single dose, supporting the potential value of a second dose in enhancing clinical benefit for some patients. COMP360 continues to demonstrate a generally well-tolerated and safe profile, with the vast majority of treatment-emergent adverse events (TEAEs) being transient and predominantly occurring on day of dosing.
A rolling New Drug Application (NDA) submission and initial review with the U.S. Food and Drug Administration (FDA) is underway and final submission remains on track to be completed in Q4, 2026. Compass anticipates the launch of COMP360 in the first half of 2027 subject to FDA approval and following Drug Enforcement Administration (DEA) rescheduling.
“The COMP006 data further strengthens our robust clinical package for COMP360 and represents an important step toward completing our NDA submission,” said Kabir Nath, Chief Executive Officer of Compass Pathways. “COMP360 has demonstrated consistent results, with rapid onset and durable benefit for people living with chronic, treatment-resistant depression. We are convinced this profile will lead to a profound shift in mental health care — moving beyond daily or frequent administration towards an option potentially involving just a few treatments in a year that could be life changing for patients. As we advance launch preparations for TRD, we continue to have active interactions with the FDA with our rolling NDA submission underway and on track for final submission in Q4, and launch anticipated in the first half of 2027. We are excited by the data we have generated for COMP360 and thrilled for the millions of patients with TRD who could potentially benefit from our achievements.”
“We are grateful to the hundreds of participants across our Phase 3 program along with the sites, providers and caregivers who have made it possible for us to generate data supporting the safety and efficacy of COMP360. The participants in our Phase 3 program reflect the clinical reality of TRD: people with a chronic, treatment-resistant condition who had already been failed by multiple antidepressant regimens and, in many cases, were in their current depressive episode for nearly four years,” said Dr. Guy Goodwin, Chief Medical Officer of Compass Pathways. “COMP360 has demonstrated rapid, durable and reproducible clinical effects through at least six months — with a consistent safety profile — across two large, well-controlled Phase 3 studies in TRD. Against a high level of chronicity and treatment resistance, this achievement at scale is remarkable in one of psychiatry’s most underserved patient populations. For a condition that places profound burden on patients, families and the healthcare system, COMP360 has the potential to establish a new standard of care and fundamentally change what patients and clinicians can expect from treatment.”
“At Mindful Health Solutions we work with many patients struggling with chronic, severe depression who have failed to respond to standard antidepressants. The latest results from Compass’ COMP006 Part B mark an important step towards bringing a novel class of therapeutics to the many patients in need,” said Tobias Marton MD PhD, CMO of Mindful Health Solutions. “The patients enrolled in Compass’ trial had a high degree of treatment resistance reflected by a current episode length of more than 3 years on average and a history of over 6 lifetime episodes. With 39% of patients achieving a clinically meaningful response after two doses of psilocybin – an effect maintained for an average of six months – and almost 30% of those responders going into remission in the treatment interval, these results are exciting. For us, this represents a significant advancement for psychiatry that will strengthen our ability to reduce the suffering and improve the lives of some of our sickest patients.”
Key findings from COMP006 Part B
Efficacy profile
COMP006 Part A (previously disclosed in February 2026) successfully met its primary endpoint at Week 6, delivering highly statistically significant and clinically meaningful results
Rapid onset of effect was observed, with consistent separation between the 25 mg and the 1 mg arm maintained through the randomized, blinded Part B period to Week 26
39% of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS (≥ 25%) at Week 6, maintaining benefit, on average, through at least Week 26
Retreatment in Part B further enhanced benefit: nearly 30% of participants who achieved a clinically meaningful response at Week 6 later went into remission 3 following retreatment in Part B
Together with COMP005, the COMP006 26-week data confirm a consistent, differentiated profile for COMP360, with rapid onset and durable benefit observed across two large, well-controlled Phase 3 studies in TRD
Safety profile
In a highly chronic TRD population with long-lasting depressive episodes, and consistent with previous studies, COMP360 continues to demonstrate a generally well-tolerated and safe profile with no new safety findings.
Majority of TEAEs were transient and predominantly occurring on day of dosing
Most common adverse events were nausea, headache, anxiety and visual hallucination
Serious adverse events (SAEs) were similar across arms (6.3% in the 1 mg arm and 5.7% in the 25 mg arm) over 26 weeks but low overall across the trial
Live Webcast
Compass management will host a live audio webcast on July 7th at 8:00 am ET. The webcast will be accessible at this link: https://lifescievents.com/event/iwt2n58/
A replay of the webcast will be accessible for 30 days following the event.
About the COMP360 Phase 3 Program
The COMP360 program aims to evaluate the safety and efficacy of COMP360 psilocybin, a synthetic, proprietary formulation of psilocybin under investigation for difficult-to-treat mental health conditions. There are two pivotal Phase 3 trials, COMP005 and COMP006, evaluating the efficacy of COMP360 for treatment-resistant depression (TRD).
The ongoing COMP006 trial, running in parallel to the COMP005 trial, is a randomized, double-blind study with 581 dosed participants across North America and Europe and is comparing the efficacy and safety of two fixed doses, taken three weeks apart, of 25 mg COMP360 to 10 mg COMP360 and 1 mg COMP360 (25 mg: n=296; 10 mg: n=142; 1 mg: n=143). There is a potential for a total of 4 doses of COMP360 across a 52-week period. The trial is comprised of three parts: Part A, which was blinded through 9 weeks, Part B which recently concluded and remained blinded through week 26, and Part C, which contains an open-label treatment part from week 26 to 52.
The COMP005 trial is a randomized, double-blind, placebo-controlled study, with 258 dosed participants across the United States and is assessing the efficacy and safety of a single dose of 25 mg COMP360 versus placebo for reducing symptom severity in TRD (COMP360 25 mg: n=171; placebo: n=87). There is a potential for a total of 3 doses of COMP360 across a 52-week period. The trial is comprised of three parts: Part A, which was blinded through 6 weeks; Part B, which was blinded through week 26; and Part C, which contains an open-label treatment part from week 26 to 52.
About treatment resistant depression (TRD)
Depression, one of the most common mental health disorders, significantly impacts relationships, work performance, overall quality of life, and is associated with an increased risk of suicide. Major depressive disorder (MDD) has been ranked as the third cause of the burden of disease worldwide in 2008 by the World Health Organization (WHO), which has projected that this disease will rank first by 2030.
It is estimated that approximately 4 million patients in the U.S. with MDD live with TRD4. TRD is broadly defined as an inadequate response to two or more appropriate courses of approved medications. TRD has a significantly greater impact on individuals compared to MDD, leading to residual symptoms, poorer quality of life, increased comorbidities, higher mortality, and an increased risk of suicide compared to non-treatment resistant MDD.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
Compass is headquartered in London, UK, with offices in New York in the U.S. We envision a world where mental health means not just the absence of illness but the ability to thrive.
US Market News
5日前
Compass Pathways Announces Six-Month Data from Second Phase 3 Trial Confirming Rapid and Durable ProfileJuly 7, 2026 6:30 AM
Business Wire New 6-month data supports COMP360’s potential to establish a new standard of care in TRD Data from positive COMP006 Phase 3 trial demonstrates durable benefit through at least 6 months further validating COMP360’s differentiated profile in highly chronic TRD Across two highly statistically significant positive Phase 3 trials, COMP360 is the first classic psychedelic¹ to consistently demonstrate rapid onset, significant durability and reproducibility of effect in TRD, one of psychiatry’s most difficult conditions in which to demonstrate efficacy COMP360 continues to demonstrate a generally well-tolerated and safe profile with no new safety findings Rolling NDA submission and initial review underway and final submission expected to be completed in Q4 Commercial launch-readiness on track for end of 2026, with launch expected in first half of 2027 Compass continues to progress late-stage PTSD program, where millions of patients are urgently in need of new, effective options Compass to host a webinar on July 7th at 8:00 am ET Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the 26-week results (Part B) from its second ongoing Phase 3 COMP006 trial of COMP360, a synthetic, proprietary formulation of psilocybin, for treatment-resistant depression (TRD) which confirm COMP360’s rapid onset and durable profile. The 26-week findings in nearly 600 patients build on previously reported results from the first Phase 3 trial, COMP005, which demonstrated rapid onset and durable response to at least 6 months, with a generally well-tolerated and safe profile in people living with TRD. The COMP360 Phase 3 program participants represent a highly chronic TRD population. In COMP006, participants had current depressive episodes lasting on average over three years and an average of more than six lifetime depressive episodes. Within the context of this severe population, 39% of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS2 (≥ 25%) by week 6, following two fixed doses of COMP360, and maintained durable response at least through Week 26. This compares favorably to the 25% in COMP005 following a single dose, supporting the potential value of a second dose in enhancing clinical benefit for some patients. COMP360 continues to demonstrate a generally well-tolerated and safe profile, with the vast majority of treatment-emergent adverse events (TEAEs) being transient and predominantly occurring on day of dosing. A rolling New Drug Application (NDA) submission and initial review with the U.S. Food and Drug Administration (FDA) is underway and final submission remains on track to be completed in Q4, 2026. Compass anticipates the launch of COMP360 in the first half of 2027 subject to FDA approval and following Drug Enforcement Administration (DEA) rescheduling. “The COMP006 data further strengthens our robust clinical package for COMP360 and represents an important step toward completing our NDA submission,” said Kabir Nath, Chief Executive Officer of Compass Pathways. “COMP360 has demonstrated consistent results, with rapid onset and durable benefit for people living with chronic, treatment-resistant depression. We are convinced this profile will lead to a profound shift in mental health care — moving beyond daily or frequent administration towards an option potentially involving just a few treatments in a year that could be life changing for patients. As we advance launch preparations for TRD, we continue to have active interactions with the FDA with our rolling NDA submission underway and on track for final submission in Q4, and launch anticipated in the first half of 2027. We are excited by the data we have generated for COMP360 and thrilled for the millions of patients with TRD who could potentially benefit from our achievements.” “We are grateful to the hundreds of participants across our Phase 3 program along with the sites, providers and caregivers who have made it possible for us to generate data supporting the safety and efficacy of COMP360. The participants in our Phase 3 program reflect the clinical reality of TRD: people with a chronic, treatment-resistant condition who had already been failed by multiple antidepressant regimens and, in many cases, were in their current depressive episode for nearly four years,” said Dr. Guy Goodwin, Chief Medical Officer of Compass Pathways. “COMP360 has demonstrated rapid, durable and reproducible clinical effects through at least six months — with a consistent safety profile — across two large, well-controlled Phase 3 studies in TRD. Against a high level of chronicity and treatment resistance, this achievement at scale is remarkable in one of psychiatry’s most underserved patient populations. For a condition that places profound burden on patients, families and the healthcare system, COMP360 has the potential to establish a new standard of care and fundamentally change what patients and clinicians can expect from treatment.” “At Mindful Health Solutions we work with many patients struggling with chronic, severe depression who have failed to respond to standard antidepressants. The latest results from Compass’ COMP006 Part B mark an important step towards bringing a novel class of therapeutics to the many patients in need,” said Tobias Marton MD PhD, CMO of Mindful Health Solutions. “The patients enrolled in Compass’ trial had a high degree of treatment resistance reflected by a current episode length of more than 3 years on average and a history of over 6 lifetime episodes. With 39% of patients achieving a clinically meaningful response after two doses of psilocybin – an effect maintained for an average of six months – and almost 30% of those responders going into remission in the treatment interval, these results are exciting. For us, this represents a significant advancement for psychiatry that will strengthen our ability to reduce the suffering and improve the lives of some of our sickest patients.” Key findings from COMP006 Part B Efficacy profile COMP006 Part A (previously disclosed in February 2026) successfully met its primary endpoint at Week 6, delivering highly statistically significant and clinically meaningful results Rapid onset of effect was observed, with consistent separation between the 25 mg and the 1 mg arm maintained through the randomized, blinded Part B period to Week 26 39% of participants in the 25 mg arm achieved a clinically meaningful reduction in MADRS (≥ 25%) at Week 6, maintaining benefit, on average, through at least Week 26 Retreatment in Part B further enhanced benefit: nearly 30% of participants who achieved a clinically meaningful response at Week 6 later went into remission3 following retreatment in Part B Together with COMP005, the COMP006 26-week data confirm a consistent, differentiated profile for COMP360, with rapid onset and durable benefit observed across two large, well-controlled Phase 3 studies in TRD Safety profile In a highly chronic TRD population with long-lasting depressive episodes, and consistent with previous studies, COMP360 continues to demonstrate a generally well-tolerated and safe profile with no new safety findings. Majority of TEAEs were transient and predominantly occurring on day of dosing Most common adverse events were nausea, headache, anxiety and visual hallucination Serious adverse events (SAEs) were similar across arms (6.3% in the 1 mg arm and 5.7% in the 25 mg arm) over 26 weeks but low overall across the trial Live Webcast Compass management will host a live audio webcast on July 7th at 8:00 am ET. The webcast will be accessible at this link: https://lifescievents.com/event/iwt2n58/ A replay of the webcast will be accessible for 30 days following the event. About the COMP360 Phase 3 Program The COMP360 program aims to evaluate the safety and efficacy of COMP360 psilocybin, a synthetic, proprietary formulation of psilocybin under investigation for difficult-to-treat mental health conditions. There are two pivotal Phase 3 trials, COMP005 and COMP006, evaluating the efficacy of COMP360 for treatment-resistant depression (TRD). The ongoing COMP006 trial, running in parallel to the COMP005 trial, is a randomized, double-blind study with 581 dosed participants across North America and Europe and is comparing the efficacy and safety of two fixed doses, taken three weeks apart, of 25 mg COMP360 to 10 mg COMP360 and 1 mg COMP360 (25 mg: n=296; 10 mg: n=142; 1 mg: n=143). There is a potential for a total of 4 doses of COMP360 across a 52-week period. The trial is comprised of three parts: Part A, which was blinded through 9 weeks, Part B which recently concluded and remained blinded through week 26, and Part C, which contains an open-label treatment part from week 26 to 52. The COMP005 trial is a randomized, double-blind, placebo-controlled study, with 258 dosed participants across the United States and is assessing the efficacy and safety of a single dose of 25 mg COMP360 versus placebo for reducing symptom severity in TRD (COMP360 25 mg: n=171; placebo: n=87). There is a potential for a total of 3 doses of COMP360 across a 52-week period. The trial is comprised of three parts: Part A, which was blinded through 6 weeks; Part B, which was blinded through week 26; and Part C, which contains an open-label treatment part from week 26 to 52. About treatment resistant depression (TRD) Depression, one of the most common mental health disorders, significantly impacts relationships, work performance, overall quality of life, and is associated with an increased risk of suicide. Major depressive disorder (MDD) has been ranked as the third cause of the burden of disease worldwide in 2008 by the World Health Organization (WHO), which has projected that this disease will rank first by 2030. It is estimated that approximately 4 million patients in the U.S. with MDD live with TRD4. TRD is broadly defined as an inadequate response to two or more appropriate courses of approved medications. TRD has a significantly greater impact on individuals compared to MDD, leading to residual symptoms, poorer quality of life, increased comorbidities, higher mortality, and an increased risk of suicide compared to non-treatment resistant MDD. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York in the U.S. We envision a world where mental health means not just the absence of illness but the ability to thrive. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our business strategy and goals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for TRD or PTSD; our plans and expectations regarding our clinical trials, including our phase 3 trials in TRD and our phase 2b/3 trial in PTSD; any implication that preliminary results will be predictive of full safety and efficacy data from our phase 3 program; our expectations regarding the timing of our rolling submission of a new drug application, or NDA, for COMP360 psilocybin treatment in TRD and the timing of the review by the Food and Drug Administration, or FDA, of such NDA, including potential acceleration due to the grant of rolling review and award of a National Priority Voucher for COMP360 psilocybin treatment in TRD; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our expectations regarding potential commercial launch timelines and our commercial readiness; our efforts and our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained, on our expected, accelerated timeline or at all; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the full results and safety data from our Phase 3 clinical trials in TRD may not be consistent with the preliminary results to date; our need for substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; that the rolling review process and/or the National Priority Voucher pilot program may not actually lead to a faster FDA review or approval process; our efforts to obtain FDA approval, or approval from regulatory authorities in other jurisdictions, for our investigational COMP360 psilocybin treatment on an accelerated basis, or at all, may be unsuccessful; the timing and substance of decisions by the Drug Enforcement Administration and states to reschedule COMP360 psilocybin treatment, if approved by FDA, which contains Schedule I controlled substances and must be rescheduled before commercializing COMP360 psilocybin in the U.S.; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and our ability to manage growth and retain key personnel; and those risks and uncertainties described under the heading “Risk Factors” in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q, and in other reports we have filed with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’s current expectations and speak only as of the date hereof. References For the definition of classic psychedelic, see Vollenweider, F.X. and Smallridge, J.W., 2022. Classic psychedelic drugs: update on biological mechanisms. Pharmacopsychiatry, 55(03), pp.121-138 Montgomery-Åsberg Depression Rating Scale Montgomery-Åsberg Depression Rating Scale ≤12 Wing V, et al. Poster S97 Contemporary Estimate of the National Prevalence of Treatment-Resistant Depression in the United States. Presented at ADAA 2026. View source version on businesswire.com: https://www.businesswire.com/news/home/20260707713443/en/ Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324 Original: Compass Pathways Announces Six-Month Data from Second Phase 3 Trial Confirming Rapid and Durable Profile
US Market News
1週前
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)July 2, 2026 6:30 AM
Business Wire Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to eight newly hired non-executive employees. The equity awards were granted on July 1, 2026 and consisted of options to purchase an aggregate of 63,685 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 30,300 shares. The options have an exercise price per share equal to $13.29, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted share units and nominal cost options will vest in four equal annual installments, subject to each employee’s continued employment. In accordance with NASDAQ Listing Rule 5635(c)(4), the equity awards were approved by the Compensation and Leadership Development Committee of Compass’s Board of Directors and were made as a material inducement to each employee’s employment. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our expectations regarding our business strategy and goals; our expectations and projections about the company’s future cash needs and financial results; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD; our plans and expectations regarding our clinical trials, including our phase 3 trials in TRD and our phase 2b/3 trial in PTSD; our expectations regarding the time period for the release of data from Part B of the COMP006 Phase 3 trial for TRD; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained, on an accelerated timeline or at all; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the full results and safety data from our Phase 3 clinical trials in TRD may not be consistent with the preliminary results to date; our need for additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our acceleration strategies for our NDA submission may not be successful; our efforts to obtain marketing approval from FDA or regulatory authorities in any other jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and our ability to retain key personnel; and those risks and uncertainties described under the heading “Risk Factors” in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’s current expectations and speak only as of the date hereof. View source version on businesswire.com: https://www.businesswire.com/news/home/20260702092582/en/ Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324 Original: Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
US Market News
2週前
A Breakthrough-Designated Depression Drug Is 86% Through Its Phase 3, With Topline Data Due This YearJune 26, 2026 9:30 AM
PR Newswire (US) Issued on behalf of Helus Pharma™Helus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP), the commercial operating name of Cybin Inc., says its APPROACH Phase 3 trial of HLP003 for adjunctive treatment of major depressive disorder has surpassed 86% enrollment, keeping the FDA Breakthrough-designated program on track for a topline data readout in Q4 2026.NEW YORK and TORONTO, June 26, 2026 /PRNewswire/ -- USA News Group News Commentary, In drug development, enrollment is the quiet variable that decides whether a promising therapy ever reaches a data readout on schedule. Late-stage psychiatric trials are notoriously hard to fill, which is why a clean enrollment update is meaningful. On June 24, 2026, Helus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP), the commercial operating name of Cybin Inc., reported that its APPROACH Phase 3 trial of HLP003 for the adjunctive treatment of major depressive disorder has surpassed 86% enrollment and is progressing as planned, keeping the program on course for a topline data readout in the fourth quarter of 2026. Key TakeawaysHelus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP) reported that its APPROACH Phase 3 trial of HLP003 for the adjunctive treatment of major depressive disorder (MDD) has surpassed 86% enrollment and is progressing as planned.HLP003 has previously been granted Breakthrough Therapy Designation by the U.S. FDA, and the Company says it remains on track for a topline data readout in Q4 2026.Company-reported Phase 2 results showed a ~23-point MADRS reduction from baseline at 12 months (after two 16 mg doses three weeks apart), with response/remission rates of 75% at week 18 improving to 100% response and 71% remission at 12 months — figures that have not been evaluated by the FDA.An Enrollment Milestone That Matters"We are pleased with the continued progress of the APPROACH study as we surpass 86% enrollment," said Eric So, Interim Chief Executive Officer of Helus Pharma. "This milestone underscores the execution of our clinical program and brings us closer to the anticipated topline data readout in the fourth quarter of 2026. We remain focused on advancing HLP003 as a potential transformative treatment option for patients living with MDD."APPROACH is one of the Company's Phase 3 studies evaluating HLP003, its lead proprietary novel serotonergic agonist (NSA). The trial sits within a broader Phase 3 program Helus calls PARADIGM, which also includes the EMBRACE study and the EXTEND long-term extension study — a multi-trial structure designed to build the efficacy and safety package required to advance HLP003 toward potential commercialization.What HLP003 Is, and Why 'Breakthrough' Status MattersHelus describes its proprietary NSAs as synthetic molecules designed to activate serotonin pathways that are believed to promote neuroplasticity — the brain's capacity to form new neural connections — with the aim of delivering durable improvements rather than the symptom-by-symptom maintenance of traditional antidepressants. HLP003 is the lead candidate, now in Phase 3 for the adjunctive treatment of MDD; the Company is also developing HLP004, an NSA in Phase 2 for generalized anxiety disorder, alongside a broader portfolio of investigational NSAs.The FDA's Breakthrough Therapy Designation, which HLP003 has received, is granted to investigational therapies intended to treat serious conditions where preliminary clinical evidence suggests a substantial improvement over available options. The designation is meant to expedite development and review through more intensive FDA guidance — it is a signal of regulatory engagement and perceived promise, not a guarantee of approval. For a clinical-stage company, it is among the more meaningful validations a program can carry into late-stage trials.The Phase 2 Data Behind the StoryThe reason HLP003 has drawn attention is the strength of its earlier-stage results. In previously reported Phase 2 data, the Company says HLP003 demonstrated long-term efficacy with an approximately 23-point reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) score compared to baseline at 12 months, following two 16 mg doses administered three weeks apart. The MADRS is the standard clinician-rated instrument for measuring depression severity, and a reduction of that magnitude, if it holds up in a larger controlled trial, would be clinically substantial.The Company further reported that Phase 2 response and remission rates were 75% at week 18, and that by the 12-month mark response and remission rates improved to 100% and 71%, respectively. These are striking figures — but important caveats apply, and Helus Pharma itself flags them: Phase 2 studies are typically small and may lack the controls of a pivotal trial, results from a Phase 2 study may not be predictive of Phase 3 outcomes, and the FDA has not evaluated these results or confirmed any efficacy claims for HLP003. The APPROACH Phase 3 trial exists precisely to test whether the early signal can be reproduced rigorously at larger scale.A Market Hungry for Something NewThe opportunity backdrop is significant. Major depressive disorder affects hundreds of millions of people worldwide and remains a leading cause of disability, yet the workhorse treatments — SSRIs and SNRIs — are built on chemistry that is decades old, can take weeks to work, and leave a large share of patients with inadequate relief. That gap is why the depression field is, in the words of one 2026 industry analysis, undergoing its most significant therapeutic transformation in decades, as mechanistically novel drugs reach the market and late-stage pipeline at the same time.Helus is positioning HLP003 squarely in that opening: a fast-acting, durable, neuroplasticity-oriented option intended to work adjunctively for patients whose depression is not adequately controlled. The thesis is that an adjunctive treatment requiring only periodic dosing could reshape how MDD is managed — if the Phase 3 data deliver. The Company operates across Canada, the United States, the United Kingdom, and Ireland.The Closest ComparisonsA handful of clinical-stage developers are pursuing novel-mechanism therapies for depression using the same pivotal-trial yardstick Helus relies on — the MADRS. Three are worth watching as the most direct points of comparison, though each carries its own risk profile, targets its own patient population, and none is a proxy for Helus. Compass Pathways (NASDAQ: CMPS) is among the most advanced: its synthetic psilocybin candidate, COMP360, is in Phase 3 for treatment-resistant depression, and in early 2026 the company reported achieving the primary endpoint in both of its pivotal Phase 3 trials using the same MADRS-based measurement. It offers the clearest read on how regulators and markets are treating late-stage, novel-mechanism depression programs.Definium Therapeutics (NASDAQ: DFTX), the company formerly known as Mind Medicine (MindMed) and renamed in January 2026, is an especially timely comparison. In June 2026 it reported positive topline results from its Phase 3 Emerge study of DT120 (lysergide) orally disintegrating tablet in MDD: the study met its primary endpoint with a placebo-adjusted MADRS reduction of 8.1 points at week 6 (p
US Market News
1月前
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)June 5, 2026 6:30 AM
Business Wire Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to seventeen newly hired non-executive employees. The equity awards were granted on June 1, 2026 and consisted of options to purchase an aggregate of 157,000 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 74,700 shares. The options have an exercise price per share equal to $14.19, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted share units and nominal cost options will vest in four equal annual installments, subject to each employee’s continued employment. In accordance with NASDAQ Listing Rule 5635(c)(4), the equity awards were approved by the Compensation and Leadership Development Committee of Compass’s Board of Directors and were made as a material inducement to each employee’s employment. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our expectations regarding our business strategy and goals; our expectations and projections about the company’s future cash needs and financial results; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD; our plans and expectations regarding our clinical trials, including our phase 3 trials in TRD and our phase 2b/3 trial in PTSD; our expectations regarding the time period for the release of data from Part B of the COMP006 Phase 3 trial for TRD; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained, on an accelerated timeline or at all; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the full results and safety data from our Phase 3 clinical trials in TRD may not be consistent with the preliminary results to date; our need for additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our acceleration strategies for our NDA submission may not be successful; our efforts to obtain marketing approval from FDA or regulatory authorities in any other jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and our ability to retain key personnel; and those risks and uncertainties described under the heading “Risk Factors” in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’s current expectations and speak only as of the date hereof. View source version on businesswire.com: https://www.businesswire.com/news/home/20260605820093/en/ Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324 Original: Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Twiggs333
1月前
Drugs that change your mind are about to hit the market
https://www.linkedin.com/pulse/drugs-change-your-mind-hit-market-steven-dickman-v5t3e/
Steven Dickman
Owner, CBT Advisors
May 28, 2026
Cambridge, MA, May 28, 2026
In just a few months, LSD and psilocybin, the active ingredient in “magic mushrooms,” will approach the market. Biotech companies developing pharmaceutical versions of these substances are expecting Phase 3 trial readouts in the next few months and, soon after that, physicians will likely be prescribing them to patients with conditions such as generalized anxiety disorder (GAD) and major depressive disorder (MDD). In the United States, generalized anxiety disorder affects roughly 3 to 7% of adults in a given year (on the order of 7 to 15 million people).[1] Major depressive disorder affects well over 10% of US adults.[2] Behind those large-market indications are other significant ones like post-traumatic stress disorder (4%)[3] and substance abuse (16%).[4]
The efficacy of the psychedelic-based drug candidates in Phase 2 clinical trials has been remarkable, showing full remissions for the LSD-based product DT120 in development by Definium Therapeutics (formerly MindMed) in up to 48 per cent of anxiety disorder patients in the optimal dose arm, even when these patients had previously been plagued with severe anxiety. The developers believe, based on the statistically significant results reported in an investigator-initiated trial conducted in MDD with a similar LSD-like molecule, that comparable outcomes might also be achieved in MDD.
There is much that I love about this stunning turn of events:
The astonishing success rates the drugs have had in tough-to-treat disorders;
the companies overcoming regulatory and logistical challenges to bring them closer to the market; and
the delightful unexpectedness of drugs formerly associated with the 1960s counterculture and recreational “trips” becoming a major part of psychiatrists’ arsenals offering the potential to improve health and well-being.
I chaired a panel at a recent life sciences conference, Convergence Forum on Cape Cod, where we heard from three leaders in neuropsychiatric drug discovery working with psychedelics and related drug candidates. Drawing from their comments and my own research, here is how I believe this trend will play out to both patients’ and society’s benefit.
I suggest that, similar to the seismic effect on society of GLP-1s, widespread legal use of psychedelic therapies will impact many more patients than initially being addressed. Furthermore, all of us, not just patients, may well be directly or indirectly impacted. Why am I so convinced of this? Because the drug candidates are:
Mysterious: These drug candidates are both highly efficacious and also somewhat mysterious in their mechanism of action. Once on the market, their use is likely to drive greater understanding of how the brain works.
Differentiated: The candidates are different from any drugs on the market. This includes the ketamine derivative Spravato® from Janssen Pharmaceuticals, a nearly $2 billion drug more limited in its utility and its upside than LSD-based or psilocybin-based drugs are likely to be.
Likely to be prescribed widely, also off-label: Psychedelics are likely to be prescribed both on-label for anxiety and depression and, eventually, off-label for a wide variety of other ailments.
Inspiring to the point of evangelism: Finally, because, once approved and used, they will result in a growing cohort of evangelizing patients talking about their treatment in reverent, even quasi-religious terms
Due to all these factors, I believe that the launch of the first few psychedelic therapies will represent a turning point in the history of the industry and perhaps a bigger one for the rest of us.
Mystery: A Teachable Moment for Neuroscientists
LSD, psilocybin and their psychedelic cousins have been glorified and vilified for decades for their mind-altering powers. But despite the fact that drugs based on these compounds are on the verge of regulatory approval, we still do not know how they work. As panelist Dan Karlin, a practicing psychiatrist and the Chief Medical Officer of Definium Therapeutics, put it, “LSD is an incredibly potent drug. Whether its mechanism is mediated to some extent by the experience, to some extent by downstream signaling and direct drug effects, you don't know the answer to that. We don't really know what's mediating what, and it's not a binary. Nothing in psychiatry, nothing in medicine, is a binary. So at the end of the day, it's not, is it mediated by one or the other? It's which bits of it are mediated by what? But regardless, we do have this really dramatic period of altered consciousness.”
Surprising as this might sound, it is not so different in some ways from aspirin, which, like psilocybin and LSD derivatives, is another synthetic version of a natural product that happened to hit the market in 1899. Expect a wave of scientific discoveries based on post-marketing studies, imaging studies and clinical observations.
Differentiation: Drugs That Bring Novel Benefits Can Earn Outsized Revenues
Primarily because their effect size is so much larger than that of all approved drugs, they are expected to have great commercial success. Panelist Bruce Leuchter, M.D. is CEO of Neurvati Neurosciences, a Blackstone company, and also a practicing psychiatrist. He emphasizes that the drugs modulate the monoamine oxidase enzyme, biology that is understood in terms of other candidates, but that the size of the effect is differentiated. Leuchter said that the members of the first wave of approved psychedelic therapies (assuming positive data and reasonable reimbursement), have potential multibillion-dollar peak sales, with a few variables driving the numbers up or down:
How broadly can they be prescribed? Can they treat GAD and MDD alone or can they also expand into other indications like PTSD?
How durable will their effect be? Can they be “one and done”? (If so, this would limit their commercial attractiveness.)
How scalable is the delivery model? That is, how easily can companies get their products to patients, especially if patients have to be treated under supervision? This could become a key issue.
How flexible will the drug label be, e.g. does it allow for only use as a monotherapy or can it also be used in conjunction with other therapies? Will the potentially powerful effects of these drugs limit their use to supervised or on-label settings?
Importantly, he cautioned, these revenue projections assume that operational constraints—clinic capacity, trained personnel, and payer logistics—are at least partially solved. If a drug company can truly scale its psychedelic sales, he said, there is upside beyond that range. The most “fragile” variables, Leuchter added, are not science or efficacy – those risks are lower now – but rather the delivery risk and the economic risk, which he believes remain underappreciated.
Likely to be Widely Prescribed, Potentially Also Off-Label
Once safety is established in a commercial setting, an admittedly non-trivial hurdle, there are few limits on the indications in which psychedelics, once approved and commercially available, might get tried. For example, cancer: In Michael Pollan’s groundbreaking 2018 book How to Change Your Mind, the psychedelics pioneer Roland Griffiths of Johns Hopkins University cited a study that "found one of the largest treatment effects ever demonstrated for a psychiatric intervention." It reported that the majority of volunteers - all of them cancer patients - who had a mystical experience e.g. induced by psilocybin "reported that their fear of death had either greatly diminished or completely disappeared." [5] This is just one admittedly dramatic example of how approved psilocybin-based and LSD-based drugs might find their way to more patients.
Evangelism: Landing on Fertile Ground
I believe that news of effective psychedelics starting to be used in the initial indications will trigger news coverage and anecdotal reports and hence much wider interest. The initial indications targeted by Definium, generalized anxiety disorder, and by Compass Pathways, treatment-resistant depression, are just the beginning. The ground has been prepared for strong uptake for these drugs based on the decline in the only truly effective alternative for most patients, months or years of talk therapy. While talk therapy is demonstrably effective, it is neither readily reimbursed nor affordable out-of-pocket for most patients. As Karlin put it, “Because of mechanisms of payment, in essence, psychiatry, when it is insurance-supported, has been reduced to only being able to make money through short medical management visits.” Consequently, the need for effective interventions is greater than ever. Definium and other companies have designed their clinical studies accordingly, so that patients are not required to see a psychotherapist for talk therapy in order to be eligible. Indeed, the need for supervised dosing of these drugs, which will be mandated at least initially and perhaps permanently given their powerful effects, can be met by an infrastructure that has already sprung up in response to the approval of Spravato, a ketamine derivative dosed as a nasal spray and prescribed for depression. Spravato, which is considered “dissociative” rather than psychedelic in nature, is generating projected annual revenues of $1.7 billion as of mid-2025.[6]
The ketamine clinics that sprang up to deliver Spravato are a perfect example of what may happen when LSD- and psilocybin-based drugs are approved. When Janssen Pharmaceuticals, a division of Johnson & Johnson, launched Spravato in 2019, Karlin said, “They were aiming at delivering it in emergency rooms and inpatient units. They hadn't even contemplated a world where this could be an outpatient treatment, yet that world came into being because of the existence of the drug.”
Leuchter concurred that there is a vast opportunity for these therapeutics: “Irrespective of regulatory dynamics, irrespective of commercial dynamics, there's a space for anything that can generate this kind of effect size. And it's so obvious when you see it, which is also so atypical for neuroscience. So there are so many things about this space that sort of defy gravity.”
Taking the fun out of the fungi: psychedelics without the trips
As to the future of psychedelics, besides robust uptake of the drugs in this category, there is likely to be an actual broadening of the category itself to encompass drugs that, as panelist Mark Rus put it, “take the fun out of the fungi.” Rus is CEO of Delix Therapeutics, which is working on a category of drugs that is intended to deliver LSD-like or psilocybin-like efficacy but not to trigger a psychedelic or dissociative experience. Delix has generated Phase 1b clinical trial data showing equivalent depression score drops for their lead candidate zalsupindole as compared to hallucinogenic first-generation drug candidates targeting the same receptor. Both Leuchter and Karlin warmly welcomed the development of these so-called “neuroplastogens,” which would conceivably both address lingering concerns about undesired effects of psychedelics and also broaden still further the range of indications that could be addressed with the drugs. Delix was recently granted the go-ahead from FDA to have patients take their pills home during early clinical trials and to take them without in-person medical supervision.
Pollan’s book drew from his prodigious research on a number of psychedelics, including LSD and psilocybin as well as some related drugs, each of which he dutifully consumed in order to properly research their effects and to anticipate how they would affect others. The book, while based in large part on his own experience, was nonetheless as thorough and sensitive a study as I have seen on the way these drugs work and how it feels to take them. Once these powerful new medicines are approved, we will, I believe, move from individuals “changing their minds” to society itself changing for the better, with an accompanying boost in mental health, in fresh thinking and in new insights into how the mind itself works.
NOTE: I invest broadly in the stocks of biotech companies including some of the ones mentioned in this piece.
[1] The prevalence and burden of generalized anxiety disorder in the United States healthcare system: Real-world prevalence and incidence from 2020 to 2023 - ScienceDirect
[2] National Health Statistics Reports, Number 213, November 4, 2024
[3] Important Facts and Statistics About PTSD (Post-Traumatic Stress Disorder)
[4] Alcohol and Drug Abuse Statistics (Facts About Addiction)
[5] Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial - PubMed
[6] Spravato Sales Surge: J&J's Ketamine Nasal Spray Nears Blockbuster
US Market News
1月前
Compass Pathways Elects Kathleen Tregoning to Board of DirectorsMay 28, 2026 6:30 AM
Business Wire Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the election of Kathleen Tregoning to its Board of Directors at the annual general meeting of shareholders. Ms. Tregoning is expected to serve on the Compensation and Leadership Development Committee and the Nominating and Corporate Governance Committee. She brings extensive experience guiding biopharmaceutical companies through periods of growth and transformation, with expertise spanning corporate strategy, external affairs, public policy and patient access. “With two successful Phase 3 trials meeting the primary endpoint, a transformative clinical profile for COMP360, and a rolling NDA submission and review now underway, Compass is strongly positioned to make our goal of securing an FDA approval a reality. Compass is entering a stage where experience in external engagement, public policy, and patient access matters more than ever,” said Kabir Nath, Chief Executive Officer of Compass Pathways. “Kathleen has built and led these functions at scale across multiple biopharma organizations, and she brings the perspective we need as we work to potentially deliver a new treatment option to people living with treatment-resistant depression. We are delighted to welcome her to the Board.” Ms. Tregoning most recently served as Chief Corporate Affairs Officer and Head of Commercial Strategy at Cerevel Therapeutics, where she guided the company through a period of significant growth, culminating in its acquisition by AbbVie in 2024. Previously, she served as Executive Vice President, External Affairs at Sanofi, where she led an integrated organization overseeing global market access, public policy, government affairs, communications, patient advocacy and corporate social responsibility. Prior to Sanofi, Ms. Tregoning spent more than a decade at Biogen in corporate affairs. Earlier in her career, Ms. Tregoning served as a professional staff member in the United States Congress, holding health policy roles across various committees. She currently serves on the Board of Directors of Spero Therapeutics, Inc. (Nasdaq: SPRO). Ms. Tregoning earned a B.A. in International Relations from Stanford University and an M.A. in Public Policy from the Harvard Kennedy School. “COMP360 has the potential to offer a groundbreaking option and renewed hope for people living with treatment-resistant depression, a population that has waited far too long for innovation,” said Kathleen Tregoning. “Compass is laying the groundwork to engage patients, providers, policymakers, and payers. As the company progresses toward regulatory review and potential commercialization, expanding education and access will be as critical as the science itself. At a time when the need for new mental health treatment options is more urgent than ever, I am honored to join the Board and look forward to supporting the team as they work to bring COMP360 to the patients who need it the most.” About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York in the U.S. We envision a world where mental health means not just the absence of illness but the ability to thrive. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our expectations regarding our business strategy and goals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for TRD or PTSD; any implication that past results will be predictive of future results; our plans and expectations regarding our clinical trials, including our ongoing phase 3 trials in TRD and our phase 2b/3 trial in PTSD; our expectations regarding the timing of our rolling submission of a new drug application, or NDA, for COMP360 psilocybin treatment in TRD and the timing of the review by the Food and Drug Administration, or FDA, of such NDA, including potential acceleration due to the grant of rolling review and award of a Commissioner’s National Priority Voucher, or CNPV, for COMP360 psilocybin treatment in TRD; our expectations regarding the potential benefits of being selected for Commissioner's National Priority Voucher pilot program, including without limitation, reduced review timelines following submission of a new drug application; our expectations regarding potential commercial launch timelines and our commercial readiness; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our efforts and our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained, on an accelerated timeline or at all; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; that the full results and safety data from our Phase 3 clinical trials in TRD may not be consistent with the preliminary results to date; that the rolling review process and/or the Commissioner's National Priority Voucher pilot program may not actually lead to a faster FDA review or approval process; that the Commissioner’s National Priority Voucher pilot program does not change the safety and efficacy standards for approval or the quality of evidence necessary to support approval of COMP360 and our efforts to obtain FDA approval, or approval from regulatory authorities in other jurisdictions, for our investigational COMP360 psilocybin treatment may be unsuccessful; that our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; that we may not be able to retain key personnel; and those risks and uncertainties described under the heading “Risk Factors” in Compass’ most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’ current expectations and speak only as of the date hereof. View source version on businesswire.com: https://www.businesswire.com/news/home/20260528330779/en/ Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324 Original: Compass Pathways Elects Kathleen Tregoning to Board of Directors
US Market News
2月前
Compass Pathways Announces First Quarter 2026 Financial Results and Business HighlightsMay 13, 2026 6:30 AM
Business Wire FDA granted Compass NDA rolling submission and review request, based on strength of Phase 3 data CNPV awarded for COMP360 in TRD, further accelerating momentum 26-week (Part B) data from COMP006, expected in early Q3 2026 Final NDA submission on track for Q4, aligned with Company’s previously defined accelerated timing to be launch ready by end of year Successful financing and warrant exercises resulted in strong cash position of $466 million at end of first quarter, providing cash runway well beyond launch and into 2028 Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported first quarter 2026 financial results and business highlights. “With regulatory acceleration unfolding, we are working diligently towards our goal of completing the filing of a robust clinical package by Q4 and securing COMP360 approval,” said Kabir Nath, Chief Executive Officer of Compass Pathways. “COMP360 represents a fundamentally different approach for patients with treatment resistant depression, unlike any other treatment approved today. Its transformative clinical profile has the potential to change what patients can expect in terms of both rapid and durable relief, and we are ready to deliver for those who have waited far too long for better options.” Business Highlights Accelerated regulatory path Approval timelines are tracking to Compass’ fastest projected expectations, supported by regulatory acceleration including a rolling New Drug Application (NDA) submission and the Commissioner’s National Priority Review Voucher (CNPV). NDA rolling submission underway: FDA granted Compass NDA rolling submission and review request, based on strength of positive Phase 3 data. Rolling submission and review are underway, with sections of the NDA already submitted. 26-week (Part B) data from COMP006, expected in early Q3 2026. The final NDA submission remains on track for Q4, aligned with the Company’s previously defined accelerated timing. Post-NDA filing momentum: CNPV awarded for COMP360, Compass’ proprietary formulation of synthetic psilocybin for TRD, which has the potential to accelerate filing review time to be completed within 1-2 months. White House Executive Order on psychedelics treatments directs the Drug Enforcement Administration (DEA) to initiate and complete review of psychedelic treatment that has successfully completed Phase 3 trials so that rescheduling may proceed as quickly as possible. Advancing toward commercial launch Launch readiness: Compass will be launch ready by the end of the year and has assembled a highly experienced commercial leadership team. The team is advancing comprehensive launch preparedness efforts, including KOL and HCP education, payer engagement, and ongoing initiatives to support a timely federal and state rescheduling process. Delivery infrastructure readiness: COMP360 is expected to fit seamlessly across diverse healthcare settings within the current infrastructure of over 7,300 centers1 offering multi-hour treatments Treatment centers are growing rapidly, and existing centers are already scaling in anticipation of a COMP360 launch and additional multi-hour psychedelic treatments coming to market. COMP360’s transformative clinical profile COMP360 has the potential to offer a highly differentiated, transformative clinical profile and is expected to be a blockbuster opportunity. COMP360 is the first classic psychedelic2 to consistently achieve a highly statistically significant result and clinically meaningful effect in 3 large late-stage trials involving more than 1,000 participants living with TRD, with a generally well-tolerated and safe profile. COMP360 demonstrates effects as quickly as within one day after administration with durability lasting at least through 6 months for those who achieve a clinically meaningful response after one or two doses. Financial Highlights Research and development expenses were $26.5 million for the three months ended March 31, 2026, compared with $30.9 million during the same period in 2025. The decrease was primarily driven by lower development expenses, reflecting reduced clinical trial costs as our Phase 3 program for COMP360 psilocybin therapy in TRD progresses toward completion, as well reduced discovery program expenses following the termination of certain programs in connection with the reorganization that took place in the fourth quarter of 2024 and the related contract terminations in 2025. General and administrative expenses were $16.4 million for the three months ended March 31, 2026, compared with $18.7 million during the same period in 2025. The decrease was primarily due to lower legal and professional fees, driven by higher financing-related costs in 2025, including those associated with warrant issuances, which were expensed as incurred, whereas a greater portion of such costs in 2026 were capitalized. This decrease was partially offset by increased consulting and legal advisory expenses. Net income for the three months ended March 31, 2026, was $91.2 million, or $0.71 net income per share (basic) and $0.30 net loss per share (diluted), compared with a net loss of $17.9 million, or $0.20 net loss per share (basic) and $0.24 net loss per share (diluted), during the same period in 2025. The increase in net income was primarily driven by a $130.9 million non-cash gain on fair value adjustment related to our warrants, compared with $19.5 million during the same period in 2025. As the fair value of the warrants fluctuates with our share price, this adjustment can result in significant variability in our reported net income or net loss. Cash and cash equivalents were $466.0 million as of March 31, 2026, compared with $149.6 million as of December 31, 2025. Debt was $50.5 million as of March 31, 2026, compared with $31.6 million as of December 31, 2025. Financial Guidance The current cash position is expected to be sufficient to fund operating expenses and capital expenditure requirements into 2028. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our expectations regarding our financial guidance; our business strategy and goals; our expectations and projections about the company’s future cash needs and financial results; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD; our plans and expectations regarding our clinical trials, including our phase 3 trials in TRD and our phase 2b/3 trial in PTSD; our expectations regarding the time periods for the release of data from Part B of the COMP006 Phase 3 trial for TRD; any implication that past results will be predictive of future results; our expectations regarding the timing of our rolling submission of a new drug application, or NDA, for COMP360 psilocybin treatment in TRD and the timing of the review by the Food and Drug Administration, or FDA, of such NDA, including potential acceleration due to the grant of rolling review and award of a Commissioner’s National Priority Voucher, or CNPV, for COMP360 psilocybin treatment in TRD; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our expectations regarding potential commercial launch timelines and our commercial readiness; our efforts and our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained, on an accelerated timeline or at all; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the full results and safety data from our Phase 3 clinical trials in TRD may not be consistent with the preliminary results to date; our need for additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; that the rolling review process and/or the Commissioner's National Priority Voucher pilot program may not actually lead to a faster FDA review or approval process; our efforts to obtain FDA approval, or approval from regulatory authorities in other jurisdictions, for our investigational COMP360 psilocybin treatment on an accelerated basis, or at all, may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that our strategic collaborations will not continue or will not be successful; and our ability to retain key personnel; and those risks and uncertainties described under the heading “Risk Factors” in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q, the prospectus supplement related to the proposed public offering we plan to file and in other reports we have filed with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’s current expectations and speak only as of the date hereof. References Data on file For the definition of classic psychedelic, see Vollenweider, F.X. and Smallridge, J.W., 2022. Classic psychedelic drugs: update on biological mechanisms. Pharmacopsychiatry, 55(03), pp.121-138 Enquiries Media: Dana Sultan-Rothman, media@compasspathways.com Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324 COMPASS PATHWAYS PLC Condensed Consolidated Balance Sheets (unaudited) (in thousands, except share and per share amounts) (expressed in U.S. Dollars, unless otherwise stated) March 31, December 31, 2026 2025 ASSETS CURRENT ASSETS: Cash and cash equivalents $466,010 $149,608 Restricted cash 379 379 Prepaid expenses and other current assets 44,478 41,503 Total current assets 510,867 191,490 NON-CURRENT ASSETS: Operating lease right-of-use assets 2,861 3,424 Deferred tax assets 4,098 3,751 Long-term prepaid expenses and other assets 13,913 11,684 Total assets $531,739 $210,349 LIABILITIES AND SHAREHOLDERS' EQUITY/(DEFICIT) CURRENT LIABILITIES: Accounts payable $10,877 $15,222 Accrued expenses and other liabilities 8,984 9,214 Debt, current portion — 17,523 Operating lease liabilities - current 2,054 2,110 Warrant liabilities 131,882 203,726 Total current liabilities 153,797 247,795 NON-CURRENT LIABILITIES: Debt, non-current portion 50,476 14,110 Operating lease liabilities - non-current 779 1,292 Total liabilities $205,052 $263,197 SHAREHOLDERS' EQUITY/(DEFICIT): Ordinary shares, £0.008 par value; 134,923,295 and 96,085,785 shares authorized, issued and outstanding at March 31, 2026 and December 31, 2025, respectively 1,393 973 Additional paid-in capital 1,071,481 783,562 Accumulated other comprehensive loss (14,795) (14,789) Accumulated deficit (731,392) (822,594) Total shareholders' equity/(deficit) 326,687 (52,848) Total liabilities and shareholders' equity/(deficit) $531,739 $210,349 COMPASS PATHWAYS PLC Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands, except share and per share amounts) (expressed in U.S. Dollars, unless otherwise stated) Three Months ended March 31, 2026 2025 OPERATING EXPENSES: Research and development $26,480 $30,880 General and administrative 16,424 18,736 Total operating expenses 42,904 49,616 Loss from operations: (42,904) (49,616) OTHER INCOME (EXPENSE), NET: Fair value change of warrant liabilities 130,916 19,460 Benefit from R&D tax credit 2,477 8,448 Interest income 2,419 2,386 Interest expense (1,465) (1,124) Foreign exchange (losses) gains (736) 2,133 Other income 484 803 Total other income, net 134,095 32,106 Income (loss) before income taxes 91,191 (17,510) Income tax benefit (expense) 11 (354) Net income (loss) $91,202 $(17,864) Net income (loss) per share attributable to ordinary shareholders: basic $0.71 $(0.20) Weighted average ordinary shares outstanding: basic 110,064,581 89,192,252 Net loss per share attributable to ordinary shareholders: diluted $(0.30) $(0.24) Weighted average ordinary shares outstanding: diluted 130,266,693 98,641,623 Net income (loss) $91,202 $(17,864) Other comprehensive income (loss): Foreign exchange translation adjustment (6) (117) Comprehensive income (loss) $91,196 $(17,981) View source version on businesswire.com: https://www.businesswire.com/news/home/20260513826535/en/ Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324 Original: Compass Pathways Announces First Quarter 2026 Financial Results and Business Highlights
US Market News
2月前
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)May 6, 2026 6:25 AM
Business Wire Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to thirteen newly hired non-executive employees. The equity awards were granted on May 1, 2026 and consisted of options to purchase an aggregate of 125,335 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 59,625 shares. The options have an exercise price per share equal to $9.01, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted share units and nominal cost options will vest in four equal annual installments, subject to each employee’s continued employment. In accordance with NASDAQ Listing Rule 5635(c)(4), the equity awards were approved by the Compensation and Leadership Development Committee of Compass’s Board of Directors and were made as a material inducement to each employee’s employment. About Compass Pathways Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). Compass is headquartered in London, UK, with offices in New York in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive. Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our expectations regarding our business strategy and goals; our expectations and projections about the company’s future cash needs and financial results; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD; our plans and expectations regarding our clinical trials, including our phase 3 trials in TRD and our phase 2b/3 trial in PTSD; our expectations regarding the time period for the release of data from Part B of the COMP006 Phase 3 trial for TRD; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained, on an accelerated timeline or at all; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment, including as a treatment of TRD or PTSD. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the full results and safety data from our Phase 3 clinical trials in TRD may not be consistent with the preliminary results to date; our need for additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our clinical trials; our acceleration strategies for our NDA submission may not be successful; our efforts to obtain marketing approval from FDA or regulatory authorities in any other jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and our ability to retain key personnel; and those risks and uncertainties described under the heading “Risk Factors” in Compass’s most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’s current expectations and speak only as of the date hereof. View source version on businesswire.com: https://www.businesswire.com/news/home/20260506806833/en/ Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324 Original: Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
US Market News
3月前
Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's National Priority VoucherApril 24, 2026 10:37 AM
Business Wire
Compass is the most advanced company in classic psychedelics and has generated positive data from two ongoing large, well controlled Phase 3 clinical trials, designed to uphold the highest regulatory standards
FDA grants Compass NDA rolling submission and review request, based on Phase 3 data
CNPV awarded for COMP360, Compass’ proprietary formulation of synthetic psilocybin, for treatment-resistant depression (TRD)
CNPV further accelerates momentum and Compass is confident and ready to deliver for patients
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced the U.S. Food and Drug Administration (FDA) granted Compass NDA rolling review request and selected COMP360, Compass’ proprietary formulation of synthetic psilocybin, for the Commissioner's National Priority Voucher (CNPV) program for treatment-resistant depression (TRD). Companies selected for the voucher program will be entitled to benefits including enhanced communications and a shortened 1-2 month review time following filing of a New Drug Application (NDA), while maintaining FDA’s rigorous safety and efficacy standards.
“We are honored and grateful to be selected for the CNPV which is a clear validation of both the urgent unmet need facing millions of people living with treatment resistant depression and the innovative science of COMP360,” said Kabir Nath, Chief Executive Officer of Compass Pathways. “As the most advanced company in the classic psychedelics field, Compass has generated positive data from two large, well controlled Phase 3 clinical trials. Based on the strength of our data, the FDA granted us a rolling NDA submission and review. Importantly, while the CNPV may provide process efficiencies and accelerated review timelines, an NDA submission must still meet FDA’s established standards of clinical evidence, scientific rigor, and regulatory compliance. We are confident we meet these standards.”
Nath continued, “Patients with TRD often endure years of persistent suffering with limited options, and the need for meaningful innovation for these patients has never been more urgent. We are well advanced in our commercial preparations and the CNPV could further accelerate momentum toward bringing our transformative treatment, if approved, to patients who have been waiting far too long.”
COMP360’s transformative clinical profile
COMP360 is the first classic psychedelic1 to consistently achieve a highly statistically significant result and clinically meaningful effect in two phase 3 studies, with a generally well-tolerated and safe profile. With data generated across more than 1,000 participants living with TRD, COMP360’s transformative clinical profile is redefining rapidity and durability for TRD patients. Unlike any other approved treatment available for this patient population today, COMP360 may demonstrate effects as quickly as within one day after administration with durability lasting at least through 6 months for those who achieve a clinically meaningful response after one or two doses. With respect to COMP360’s safety profile, a significant majority of treatment-emergent adverse events (TEAEs) are mild or moderate in severity, and the vast majority resolve within 24 hours.
About treatment resistant depression (TRD)
Depression, one of the most common mental health disorders, significantly impacts relationships, work performance, overall quality of life, and is associated with an increased risk of suicide. Major depressive disorder (MDD) has been ranked as the third cause of the burden of disease worldwide in 2008 by the World Health Organization (WHO), which has projected that this disease will rank first by 2030.
It is estimated that approximately 4 million patients in the U.S. with MDD live with TRD2. TRD is broadly defined as an inadequate response to two or more appropriate courses of approved medications. TRD has a significantly greater impact on individuals compared to MDD, leading to residual symptoms, poorer quality of life, increased comorbidities, higher mortality, and an increased risk of suicide compared to non-treatment resistant MDD.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
Compass is headquartered in London, UK, with offices in New York in the U.S. We envision a world where mental health means not just the absence of illness but the ability to thrive.
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, statements regarding our expectations regarding our business strategy and goals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for TRD or PTSD; any implication that past results will be predictive of future results; our plans and expectations regarding our clinical trials, including our ongoing phase 3 trials in TRD and our phase 2b/3 trial in PTSD; our expectations regarding discussions with the FDA, including discussions regarding rolling NDA submission and review for COMP360 psilocybin treatment in TRD; our expectations regarding the potential benefits of being selected for Commissioner's National Priority Voucher pilot program, including without limitation, reduced review timelines following submission of a new drug application; our expectations regarding potential commercial launch timelines and our commercial readiness; the potential for the pivotal phase 3 program in TRD to support regulatory filings and approvals on an accelerated basis or at all; our efforts and our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained, on an accelerated timeline or at all; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; that the full results and safety data from our Phase 3 clinical trials in TRD may not be consistent with the preliminary results to date; that the Commissioner's National Priority Voucher pilot program may not actually lead to a faster FDA review or approval process; that the Commissioner’s National Priority Voucher pilot program does not change the safety and efficacy standards for approval or the quality of evidence necessary to support approval of COMP360 and our efforts to obtain FDA approval, or approval from regulatory authorities in other jurisdictions, for our investigational COMP360 psilocybin treatment may be unsuccessful; that our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; and those risks and uncertainties described under the heading “Risk Factors” in Compass’ most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass’ current expectations and speak only as of the date hereof.
References
1. For the definition of classic psychedelic, see Vollenweider, F.X. and Smallridge, J.W., 2022. Classic psychedelic drugs: update on biological mechanisms. Pharmacopsychiatry, 55(03), pp.121-138
2. Wing V, et al. Contemporary Estimate of the National Prevalence of Treatment-Resistant Depression in the United States. ADAA Annual Meeting 2026, April 9 – 11, Chicago, IL.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260424121830/en/
Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
Original: Compass Pathways Announces FDA Granted NDA Rolling Review Request and Awarded Commissioner's National Priority Voucher
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