Definium Therapeutics Inc (DFTX)

Phase 3 Data about to drop soon. :)

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

nice breakout coming

Where Psychedelic Treatments Fit in Modern Clinical Care
PAT as specialty care, not a replacement for ongoing therapies.

https://www.psychologytoday.com/us/blog/modern-medicine/202605/where-psychedelic-treatments-fit-in-modern-clinical-care

Key points

PAT may be best understood as a specialty mental health intervention embedded in collaborative care.
Referral pathways mirror a familiar primary-care-to-specialist model used across medicine and psychology.
PAT can help patients become more emotionally flexible and engaged in ongoing therapy.
Ideal integration depends on continuity, communication, and returning patients to their primary providers.

DT-120 for Generalized Anxiety: Addressing the Gap With Optimized LSD Pharmacotherapy
Author(s)Jessica Malberg, PhD, Daniel R. Karlin, MD, MA

https://www.psychiatrictimes.com/view/dt-120-for-generalized-anxiety-addressing-the-gap-with-optimized-lsd-pharmacotherapy

DT-120, an optimized LSD formulation, shows lasting anxiety relief and high remission at 12 weeks, as researchers share detailed phase 2b safety insights.

Jessica Malberg, PhD, and Dan Karlin, MD, shared about DT-120, a pharmaceutically optimized formulation of LSD, and discussed the unmet need driving its development in generalized anxiety disorder and major depressive disorder.1

2026 Annual General and Special Meeting of Shareholders

https://central.virtualshareholdermeeting.com/vsm/web?pvskey=DFTX2026

DEFINIUM THERAPEUTICS, INC. is hosting a Virtual Shareholder Meeting on Thursday, June 11, 2026 at 10:00 A.M. Eastern Time, and shareholders as of the record date will be able to vote and ask questions online during the meeting. If you would like to attend the virtual meeting and have your control number, please log in 15 minutes prior to the start of the meeting.

https://ir.definiumtx.com/news-events/ir-calendar/detail/20260611-2026-annual-general-and-special-meeting-of-shareholders

Is this finally the breakthrough moment for psychedelic therapies?

https://www.rbccm.com/en/insights/2026/05/is-this-finally-the-breakthrough-moment-for-psychedelic-therapies

Psychedelics may finally be close to mainstream medical use, but is the healthcare system prepared for mass delivery to patients?

Hosted By Joseph Coletti
Featuring Brian Abrahams and Leonid Timashev
Published May 22, 2026

Key points

Patient and physician interest and favorable regulation signal an imminent breakthrough for psychedelics to treat mental ill-health.

April’s Presidential order on accelerated research and access for veterans with PTSD is also supportive.

Psychedelics raise challenges for clinical trials, but companies are finding ways to overcome these.

RBC’s research indicates existing clinic infrastructure is equipped to deliver psychedelics with the required clinical supervision.

Awesome day!

Rethinking Psychedelic Treatment for America's Mental Health Crisis



Psychiatry is at an inflection point. And the stakes are high. Mental illness costs the U.S. economy more than $280 billion annually, drives veteran suicide rates, and places mounting strain on everything from emergency rooms to the workforce. Yet many of today’s medicines have not advanced in decades despite the rising prevalence and unmet need.

For the one in five Americans living with a mental health disorder and veterans who face disproportionally high suicide rates and do not respond to conventional treatments, the gap between what medicine promises and what it delivers has never been more consequential.

But change is underway. A new wave of rigorous clinical science is unlocking the therapeutic potential of psychedelic medicines and opening new routes for brain health that could redefine what treatment success looks like.

Psychedelic medicines are advancing through late-stage clinical trials, with several investigational candidates earning FDA Breakthrough Therapy Designation for disorders including anxiety and depression.

Join The Hill, in partnership with Definium Therapeutics, for a timely mental health policy forum convening lawmakers, clinical researchers, and advocates to explore what science tells us, what the regulatory landscape requires, and what actions Congress can take to ensure that patients are not left behind.

Definium Therapeutics | Rethinking Psychedelic Treatment for Mental Health

They are going to get this approved. Excellent data and need

DFTX (prevously MNMD) posted a new Corporate Presentation:

https://www.sec.gov/Archives/edgar/data/1813814/000119312526229657/dftx-ex99_1.htm

Definium Therapeutics Announces First Patient Dosed in Ascend, the Second Phase 3 Pivotal Study of DT120 ODT in Major Depressive Disorder

https://www.businesswire.com/news/home/20260512064160/en/Definium-Therapeutics-Announces-First-Patient-Dosed-in-Ascend-the-Second-Phase-3-Pivotal-Study-of-DT120-ODT-in-Major-Depressive-Disorder

The primary endpoint will measure the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at Week 6 between DT120 Orally Disintegrating Tablet (ODT) 100 µg and placebo

Ascend builds on positive Phase 2b study results in generalized anxiety disorder, which showed the potential antidepressant effects of DT120

Topline data from the 12-week double-blind period is anticipated in 2027

I have an odd feeling that even though it has not been televised (because the revolution will not be) - LSD is making it's way into the VA and they will be the largest clinic for these treatments and the biggest customer of Definium.

Watch May 19th at 8:30AM EST - Rethinking Psychedelic Treatment for America's Mental Health Crisis



Psychiatry is at an inflection point. And the stakes are high. Mental illness costs the U.S. economy more than $280 billion annually, drives veteran suicide rates, and places mounting strain on everything from emergency rooms to the workforce. Yet many of today’s medicines have not advanced in decades despite the rising prevalence and unmet need.

For the one in five Americans living with a mental health disorder and veterans who face disproportionally high suicide rates and do not respond to conventional treatments, the gap between what medicine promises and what it delivers has never been more consequential.

But change is underway. A new wave of rigorous clinical science is unlocking the therapeutic potential of psychedelic medicines and opening new routes for brain health that could redefine what treatment success looks like.

Psychedelic medicines are advancing through late-stage clinical trials, with several investigational candidates earning FDA Breakthrough Therapy Designation for disorders including anxiety and depression.

Join The Hill, in partnership with Definium Therapeutics, for a timely mental health policy forum convening lawmakers, clinical researchers, and advocates to explore what science tells us, what the regulatory landscape requires, and what actions Congress can take to ensure that patients are not left behind.

I'm in until buyout or FDA approval

I'm in until buyout or FDA approval

Nope, this is just recent. I've had a small position in my RH account for awhile. I never saw it trading overnight until yesterday, and I checked my RH holdings almost as much as my Fidelity holdings. Silver and gold etf's, other large cap stocks yes, but never this one until this week. I think it's great but wondering when it happened and what changed for it to be trading overnight? Maybe so whales can accumulate more on the down low before retail starts flooding in? I dunno.?DFTX LOOOOOONG!

I thought it always was while it has been on the NASDAQ since the days of MNMD, but I could be wrong. Either way this is going to be one hell of a year with 3 data readouts. With all three being poised to be stellar based on the 2B trials.

When did DFTX start trading in overnight hours? This is from the little bit I have in my Robinhood account.

The Latest Data on Psychedelic DT120 ODT With Daniel R. Karlin, MD, MA

Videos|April 27, 2026

https://www.psychiatrictimes.com/view/the-latest-data-on-psychedelic-dt120-odt-with-daniel-r-karlin-md-ma

Daniel R. Karlin, MD, MA, the chief medical officer of Definium Therapeutics, shared some more information about the data on DT120 and what separates it from other psychedelics, including the new information shared at their Investor and Analyst Day.

Accelerated FDA Action for Psychedelics: Insights From Daniel R. Karlin, MD, MA
Author(s)Daniel R. Karlin, MD, MA
Definium’s CMO says FDA talks stay aligned with their plans for advancing DT120 ODT for the treatment of depression, anxiety, and now PTSD.

https://www.psychiatrictimes.com/view/accelerated-fda-action-for-psychedelics-insights-from-daniel-r-karlin-md-ma

Definium Therapeutics Highlights DT120 ODT (Lysergide Tartrate) Clinical Advancements and Commercial Strategy at Investor and Analyst Day

April 22, 2026 4:15pm EDT

https://ir.definiumtx.com/news-events/press-releases/detail/223/definium-therapeutics-highlights-dt120-odt-lysergide-tartrate-clinical-advancements-and-commercial-strategy-at-investor-and-analyst-day

MDD: Emerge topline data readout on track for late 2Q 2026; Ascend sites activated with first patient dosing anticipated in 2Q 2026

GAD: Voyage enrollment complete with 214 patients with topline data readout on track for early 3Q 2026; Panorama sample size re-estimation complete and target sample size updated to 200; screening closed with topline readout now expected in late 3Q 2026

PTSD: DT120 ODT program expanded into PTSD with Phase 3 Haven study expected to initiate in 2027

Definium Therapeutics Highlights DT120 ODT (Lysergide Tartrate) Clinical Advancements and Commercial Strategy at Investor and Analyst DayApril 22, 2026 4:15 PM
Business Wire
MDD: Emerge topline data readout on track for late 2Q 2026; Ascend sites activated with first patient dosing anticipated in 2Q 2026


GAD: Voyage enrollment complete with 214 patients with topline data readout on track for early 3Q 2026; Panorama sample size re-estimation complete and target sample size updated to 200; screening closed with topline readout now expected in late 3Q 2026


PTSD: DT120 ODT program expanded into PTSD with Phase 3 Haven study expected to initiate in 2027


Definium Therapeutics, Inc. (Nasdaq: DFTX) (“Definium” or the “Company”), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address the underlying causes of psychiatric and neurological disorders, today highlighted the advancement of its DT120 ODT (lysergide tartrate) clinical program and commercial strategy in major depressive disorder (MDD) and generalized anxiety disorder (GAD), with three anticipated topline readouts in the next six months serving as important near-term catalysts. The Company also announced an expansion of the DT120 ODT program with the planned initiation of the Phase 3 Haven study in posttraumatic stress disorder (PTSD).


“We are building Definium to be a leader in psychiatry, focused on delivering a differentiated, scalable franchise for patients with depression, anxiety, and trauma, anchored by DT120 ODT, which we believe could be a best-in-class therapy,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “With three pivotal readouts expected over the next six months, we are rapidly establishing comprehensive clinical evidence for DT120 ODT. Together, these trial outcomes will inform our regulatory approach, including an expeditious path to a potential NDA submission. We continue to execute with focus and urgency to deliver transformative treatments for patients and sustained value for shareholders.”


The Company is preparing for its next phase of growth with the same rigor and discipline that have underpinned the clinical development of DT120 ODT, which represents a potential multi-billion-dollar commercial opportunity supported by a differentiated therapeutic profile and broad applicability across care settings. Definium is advancing a focused, patient-centric commercial strategy, including a scalable delivery model designed to support efficient adoption and long-term utilization. In parallel, the Company is proactively positioning for access and reimbursement with plans to leverage established and emerging practice patterns and existing administrative pathways to enable timely market uptake.


Clinical Advancements


DT120 ODT (lysergide tartrate) for MDD



Emerge: Fully enrolled with 149 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data on track for late 2Q 2026.



Ascend: Sites activated with first dosing anticipated in 2Q 2026. Study plans to enroll 175 participants randomized 2:1:2 to DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo.



DT120 ODT (lysergide tartrate) for GAD



Voyage: Fully enrolled with 214 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data on track for early 3Q 2026.



Panorama: Blinded sample size re-estimation complete with total target enrollment updated to 200 participants. Current enrollment over 200 participants and screening now closed. Participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. Topline data now anticipated in late 3Q 2026 (updated from 2H 2026).



DT120 ODT (lysergide tartrate) for PTSD



Haven: Phase 3 study in PTSD expected to enroll approximately 200 participants randomized 1:1 to receive DT120 ODT or placebo. Primary endpoint in the study is the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 8. Study initiation expected in 2027.



Today’s Investor and Analyst Day featured Definium’s executive leadership team alongside distinguished expert clinicians, who discussed the evolving treatment landscape in psychiatry, persistent unmet need, and emerging opportunities to improve outcomes for patients, as well as the Company’s clinical progress and commercial strategy. Presentation materials from today’s event are available here.


About DT120 (lysergide tartrate) Orally Disintegrating Tablet (ODT)


DT120 ODT is an ergoline derivative belonging to the group of classic serotonergic psychedelics, which acts as a partial agonist at serotonin-2A (5-HT2A) receptors. DT120 ODT is Definium’s proprietary and pharmaceutically optimized formulation of LSD. DT120 ODT is an advanced formulation incorporating Catalent’s Zydis® ODT fast-dissolve technology, designed to deliver several unique advantages, including faster absorption and onset of transient cognitive, perceptual, and affective changes, improved bioavailability, and a lower incidence of gastrointestinal side effects. Definium is developing DT120 ODT, the tartrate salt form of lysergide, for generalized anxiety disorder (GAD), major depressive disorder (MDD), posttraumatic stress disorder (PTSD), and is exploring its potential applications in other serious brain health disorders. Definium maintains a strong foundation to protect and extend the long-term value of the DT120 ODT franchise through a multi-layered intellectual property strategy spanning composition, formulation, and methods-of-use patents.


About Lysergide (LSD)


Lysergide (LSD) is one of the most extensively studied psychopharmaceuticals in history, with over 1,000 published reports.1 First synthesized in 1938 by Swiss chemist Albert Hofmann in his search for active principles from ergot fungus, its profound psychological effects were discovered in 1943, which transformed psychiatric research.1 LSD, a definitional classic psychedelic, temporarily alters perception, cognition, and emotion, is physiologically safe, non-addictive, and isn’t associated with withdrawal.1 While its precise mechanism of action in the treatment of psychiatric illness is unknown, its acute perceptual, cognitive, and affective effects are mediated by agonism of the serotonin 5-hydroxytryptamine 2A (5-HT2A) receptor, and mechanistic hypotheses suggest that it causes sustained increases in neuroplasticity in a variety of brain regions.2,3


About Definium Therapeutics


The mission of Definium Therapeutics is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Guided by a recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.


Forward-Looking Statements


Certain statements in this news release related to the Company constitute "forward-looking information" within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as "will", "may", "should", "could", "intend", "estimate", "plan", "anticipate", "expect", "believe", "potential" or "continue", or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding the Company’s anticipated topline readout for the Phase 3 Voyage study of DT120 ODT in GAD in early 3Q 2026; the Company’s anticipated topline readout for the Phase 3 Panorama study for DT120 ODT in GAD in late 3Q 2026; the Company’s anticipated topline readout for the Phase 3 Emerge study for DT120 ODT in MDD in late 2Q 2026; the Company’s plans to dose the first patient in the Phase 3 Ascend study of DT120 ODT in MDD in 2Q 2026; the Company’s expectations regarding the enrollment for each of the Panorama and Ascend studies; the Company’s expectation to initiate the Haven study of DT120 ODT in PTSD in 2027; the Company’s expectations regarding enrollment and trial design for the Haven study; the Company’s beliefs regarding potential benefits of its product candidates; the Company's belief that DT120 ODT could be a best-in-class therapy; the Company's regulatory plans, including the timing of any potential NDA submissions; the Company's belief in DT120 ODT’s differentiated therapeutic profile and broad applicability across care settings; the potential market opportunity for DT120 ODT; the Company’s commercial strategy; and patient access to and reimbursement of DT120 ODT. There are numerous risks and uncertainties that could cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; compliance with laws and regulations; legislative and regulatory developments, including decisions by the Drug Enforcement Administration and states to reschedule any of our product candidates, if approved, containing Schedule I controlled substances, before they may be legally marketed in the U.S.; difficulty associated with research and development; risks associated with clinical studies or studies; heightened regulatory scrutiny; early stage product development; clinical study risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; ability to maintain effective patent rights and other intellectual property protection; as well as those risk factors discussed or referred to herein and the risks, uncertainties and other factors described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025 under headings such as "Special Note Regarding Forward-Looking Statements," and "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada, which are available under the Company's profile on SEDAR+ at www.sedarplus.ca, and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.


For more information, visit https://definiumtx.com/ and follow Definium Therapeutics on Instagram, LinkedIn, and X.


References:



Nichols, D. E. (2016). Psychedelics. Pharmacological Reviews, 68(2), 264–355. https://doi.org/10.1124/pr.115.011478



Passie, T., Halpern, J. H., Stichtenoth, D. O., Emrich, H. M., & Hintzen, A. (2008). The pharmacology of lysergic acid diethylamide: A review. CNS Neuroscience & Therapeutics, 14, 295–314. https://doi.org/10.1111/j.1755-5949.2008.00059.x



Liechti, M. E. (2017). Modern clinical research on LSD. Neuropsychopharmacology, 42, 2114–2127. https://doi.org/10.1038/npp.2017.86


View source version on businesswire.com: https://www.businesswire.com/news/home/20260422742468/en/
Investors:

Gitanjali Jain

VP, Head of Investor Relations ir@definiumtx.com


Media:

media@definiumtx.com


Original: Definium Therapeutics Highlights DT120 ODT (Lysergide Tartrate) Clinical Advancements and Commercial Strategy at Investor and Analyst Day

$DFTX - Investor & Analyst Day

Date: Wednesday, April 22, 2026

Time: 10:00 am – 12:00 pm ET

Location: https://definium-therapeutics-investor-analyst-day-2026.open-exchange.net/registration

President Trump’s Landmark Order Advances Breakthrough Mental Health Treatments — Delivering New Hope to Veterans

https://www.whitehouse.gov/releases/2026/04/president-trumps-landmark-order-advances-breakthrough-mental-health-treatments-delivering-new-hope-to-veterans/

--- DFTX Mention ---

Definium Therapeutics CEO Rob Barrow: “Accelerating scientific progress depends on both rigor and urgency, and we thank the Administration and welcome this Executive Order as an important recognition of the persistent unmet treatment needs in serious mental illness. We applaud the Administration’s recognition that psychedelic medicines may represent meaningful new treatment options for patients. We are advancing a comprehensive clinical development program for DT120 (lysergide tartrate) for millions of patients living with conditions including generalized anxiety disorder (GAD) and major depressive disorder (MDD). A science-driven framework that supports rigorous evaluation, responsible access, and faster translation of innovation into care is essential, and the FDA’s evidence-based approval process provides the most effective path to safely delivering these therapies to patients. We commend the Administration’s Executive Order on psychedelic treatment which recognizes the profound urgency of the mental health crisis facing millions of Americans and the potential impact FDA-approved psychedelics could have.”

Definium Therapeutics Announces New Employee Inducement GrantsApril 20, 2026 4:01 PM
Business Wire
Definium Therapeutics, Inc. (“Definium” or the “Company”), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today announced the issuance of inducement grants to five newly hired non-executive employees consisting of options to purchase an aggregate of 70,860 common shares of the Company (the "Options") with effective grant dates of April 6, 2026 and April 20, 2026. The Options have an exercise price equal to the closing price of Definium's common shares on the date of the respective grant, 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 substantially equal monthly increments over the three-year period thereafter, subject to each employee’s continued employment.


The Options were granted as a material inducement to each employee’s employment and were approved by Definium's Compensation Committee on April 3, 2026, in accordance with Rule 5635(c)(4) of The NASDAQ Stock Market LLC. The Options were granted outside Definium's equity incentive plans.


About Definium Therapeutics


The mission of Definium Therapeutics is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Guided by a recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.


For more information, visit https://definiumtx.com/ and follow Definium Therapeutics on Instagram, LinkedIn and X.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260420770097/en/
Investors:

Gitanjali Jain

VP, Head of Investor Relations

ir@definiumtx.com


Media:

media@definiumtx.com


Original: Definium Therapeutics Announces New Employee Inducement Grants

This is going places. The most volume today since the name change and DFTX has been on a tear the last few weeks. Bullish all year long on this one.

Sadly this is getting no volume like the others in this space. I saw last Thursday that someone bought 100 million dollars of these stocks at 10:50am, I’m sure they knew what was coming. Anyone else see those trades?

No way... let this ride!

Nice!! Not selling a share here.

Steady climbs from here to the finish line :)

Oh boy let the party begin!  And this party will gain momentum as we go   Floodgates open!
GLTA

This is it... Monday AM firework show.

#DFTX

ABC News - Trump signs executive order to accelerate research of psychedelic-based drugs

Interview with Martin MaKary

This stock should be on the breakout boards Monday :)

Definium Therapeutics Applauds White House Executive Order to Accelerate Mental Health Innovation and Expand Access to Psychedelic Medical TreatmentsApril 18, 2026 7:38 PM
Business Wire
Definium Therapeutics, Inc. (“Definium” or the “Company”), a late-stage clinical biopharmaceutical company developing a new generation of therapies targeting the underlying causes of psychiatric and neurological disorders, today issued the following statement supporting the newly signed White House Executive Order aimed at accelerating research, development, and responsible access to innovative treatments for serious mental illness, including emerging psychedelic medical treatments:


“Accelerating scientific progress depends on both rigor and urgency, and we thank the Administration and welcome this Executive Order as an important recognition of the persistent unmet treatment needs in serious mental illness,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “We applaud the Administration’s recognition that psychedelic medicines may represent meaningful new treatment options for patients. We are advancing a comprehensive clinical development program for DT120 (lysergide tartrate) for millions of patients living with conditions including generalized anxiety disorder (GAD) and major depressive disorder (MDD). A science-driven framework that supports rigorous evaluation, responsible access, and faster translation of innovation into care is essential, and the FDA’s evidence-based approval process provides the most effective path to safely delivering these therapies to patients.”


The Executive Order directs coordinated federal action to prioritize mental health therapies, streamline regulatory pathways, and expand cross-agency collaboration, consistent with the Administration’s policy to accelerate innovative research models and appropriate drug approvals to increase access to psychedelic medicines that could help save lives and address the serious mental health crisis in America. Definium Therapeutics remains committed to advancing rigorous clinical science to develop safe and effective psychedelic treatments and looks forward to continued collaboration with federal agencies, clinicians, researchers, and patient communities to advance evidence-based solutions for mental health disorders.


About DT120 Orally Disintegrating Tablet (ODT)


DT120 ODT (lysergide tartrate) is an ergoline derivative belonging to the group of classic serotonergic psychedelics which acts as a partial agonist at specific serotonin receptors (human serotonin-2A (5-HT2A) receptors). DT120 ODT is Definium’s proprietary and pharmaceutically optimized formulation of LSD. DT120 ODT is an advanced formulation incorporating Catalent’s Zydis® ODT fast-dissolve technology, designed to deliver several unique advantages, including faster absorption and onset of transient cognitive, perceptual, and affective changes, improved bioavailability, and a lower incidence of gastrointestinal side effects. Definium is developing DT120 ODT, the tartrate salt form of lysergide, for generalized anxiety disorder (GAD), major depressive disorder (MDD), and is exploring its potential applications in other serious brain health disorders.


About Definium Therapeutics


The mission of Definium Therapeutics is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale. Guided by a recognition that patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.


For more information, visit https://definiumtx.com/ and follow Definium Therapeutics on Instagram, LinkedIn and X.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260418158429/en/
Investors:

Gitanjali Jain

VP, Head of Investor Relations

ir@definiumtx.com


Media:

media@definiumtx.com


Original: Definium Therapeutics Applauds White House Executive Order to Accelerate Mental Health Innovation and Expand Access to Psychedelic Medical Treatments

$DFTX Psychedelics Executive Order — News Coverage Roundup
The Washington Post Trump orders more access to psychedelics like LSD, psilocybin and ibogaine https://www.washingtonpost.com/politics/2026/04/17/trump-psychedelics-psylocibin-research/
Pittsburgh Post-Gazette Trump signs order to speed review of psychedelics, including the controversial drug ibogaine https://www.post-gazette.com/news/politics-nation/2026/04/18/trump-psychedelics-drugs-ibogaine-veterans/stories/202604180045
WSAZ President Trump signs executive order encouraging research on psychedelic drugs https://www.wsaz.com/2026/04/18/president-trump-signs-executive-order-encouraging-research-psychedelic-drugs/
CNN Trump accelerates research on psychedelic treatments and asks, ‘Can I have some?’ https://www.cnn.com/2026/04/18/politics/trump-signs-executive-order-urging-more-research-into-psychedelic-ibogaine
MS NOW Trump signs executive order on psychedelic drugs — with Joe Rogan by his side https://www.ms.now/news/trump-executive-order-psychedelic-drugs-joe-rogan
The Guardian Trump announces reforms to accelerate access to psychedelic drug treatments https://www.theguardian.com/us-news/2026/apr/18/trump-psychedelic-drugs-executive-order
USA Today Trump signs order pushing psychedelics research after Joe Rogan call https://www.usatoday.com/story/news/politics/2026/04/18/trump-executive-order-psychedelics-joe-rogan/89676816007/
Reuters Trump signs order to accelerate access to psychedelic drug treatments https://www.reuters.com/world/trump-announces-reforms-accelerate-access-psychedelic-drug-treatments-2026-04-18/
Bloomberg Trump Signs Order on Psychedelics to Ease FDA Restrictions https://www.bloomberg.com/news/articles/2026-04-18/trump-signs-order-easing-restrictions-on-psychedelic-drugs
The Wall Street Journal How Joe Rogan Convinced Trump to Fast-Track Review of Psychedelic Drugs https://www.wsj.com/politics/policy/how-joe-rogan-convinced-trump-to-fast-track-review-of-psychedelic-drugs-3618fd73

They are likely going to be bought out or partnership coming. Lots of data is about to be released, more PRs and also many investor conferences setup. Piper Sandler announced overweight coverage too. This is going BIG!

I interviewed the CEOs of Reddit, Colgate-Palmolive, and 6 other top companies about leading for the long run. Here’s what they said

https://www.fastcompany.com/91517107/i-interviewed-the-ceos-of-reddit-colgate-palmolive-and-6-other-top-companies-about-leading-for-the-long-game-heres-their-advice-business-advice-leadership-long-run

Rob Barrow, CEO of Definium Therapeutics

“The U.S. is facing a profound and worsening mental health crisis, with current treatment options failing millions of people. Our big bet: to usher in a new era of psychiatry with the potential of lysergide tartrate, or LSD, which had its start in systematic research in the 1940s. Through the lens of modern science, our rigorous clinical trials are designed to explore and generate regulatory-grade evidence, and we believe we’re approaching a meaningful shift in what mental health treatment could look like. This will require deep education and collaboration across many stakeholders to create lasting change, but we’re excited and emboldened by the opportunity.”

Thanks. More to come.

Thanks for the great DD as always MOMS

An international mega-analysis of psychedelic drug effects on brain circuit function

https://www.nature.com/articles/s41591-026-04287-9

The recent Nature Medicine mega analysis materially strengthens the mechanistic case for LSD based therapies. Across eleven datasets and multiple psychedelic compounds, LSD consistently demonstrated reliable increases in cross network brain connectivity, selective reductions in rigid network structure, and strong engagement of subcortical gating systems such as the thalamus and striatum.

Importantly, LSD’s effects were highly reproducible and closely aligned with psilocybin, which is the most clinically validated psychedelic to date. This positions LSD as a high confidence and controllable compound rather than an extreme or unpredictable one.

From a generalized anxiety disorder perspective, the implications are compelling because GAD is increasingly understood as a disorder of persistent default mode network driven rumination, impaired top down cognitive control, miscalibrated salience processing, and dysfunctional thalamic filtering.

The network level effects observed with LSD map directly onto these dysfunctions by disrupting entrenched worry loops through reduced within network rigidity, increasing communication between cognitive and emotional systems, recalibrating threat detection, and improving signal filtering across brain regions . This suggests LSD is not simply reducing symptoms but may be addressing the underlying circuit pathology of anxiety. Definium’s DT 120 builds on this foundation by leveraging a well characterized molecule with a validated mechanism and delivering it through an optimized orally disintegrating formulation that improves consistency and usability in a clinical setting. When combined with clinical data showing statistically significant reductions in anxiety scores after a single dose, the broader thesis becomes clear.

LSD does not need to be the most intense psychedelic to win. It needs to be the most reliable and scalable. Based on this paper, LSD sits squarely in that position and represents one of the most credible paths forward for treating GAD.

Going to be good :)

Definium Therapeutics (NASDAQ: DFTX) will host an Investor & Analyst Day in New York on April 22, 2026 from 10 AM–12 PM EDT with presentations and live Q&A from company executives and external key opinion leaders.

Topics include Phase 3 DT120 ODT (lysergide tartrate) clinical program for GAD and MDD, expectations for anticipated 2026 topline data readouts, and market opportunity. In-person attendance is limited; virtual live and archived webcast available on the company investor site for at least 30 days.

Almost 21.00 premarket. Just insane.

What a fantastic day! Way more to come!

Nice close! Broke through $20! There was a battle at $18 though! The RSI is still under 70 so there is still room to hit $22 a share tomorrow or Friday before it hits over-bought territory!

@MomsSpaghetti
Looks like your calculations were correct! According to Fidelity's most recent update the short interest has come down even more! Shorts finally starting to realize they need to start moving on or go long, maybe?

DFTX Loooooong!

New Definium Therapeutics Study Published in the Journal of Mood and Anxiety Disorders Reveals Increasing Prevalence and Burden of Generalized Anxiety Disorder in the United States

https://ir.definiumtx.com/news-events/press-releases/detail/219/new-definium-therapeutics-study-published-in-the-journal-of-mood-and-anxiety-disorders-reveals-increasing-prevalence-and-burden-of-generalized-anxiety-disorder-in-the-united-states

https://www.businesswire.com/news/home/20260331146931/en/

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What they’re showing is that generalized anxiety disorder (GAD) is both larger and growing faster than a lot of people probably assume. According to their study, diagnosed prevalence went from 5.4% in 2020 to 6.6% in 2023, and when you look over a 3-year period, about 10.3% of U.S. adults have been affected. That’s basically 1 in 10 people, which is huge.

On top of that, new cases are still coming in at a steady rate (~2.1–2.3% annually), so this isn’t a static market.

Another important piece they highlight is how messy this condition actually is in the real world. About 67% of diagnosed patients are women, and there’s a high overlap with depression (MDD). That comorbidity matters because it suggests you’re not just treating “anxiety” in isolation, you’re often dealing with more complex, overlapping conditions.

The last new drug approved for GAD was in 2007, and even with current options (SSRIs/SNRIs), something like half of patients don’t get adequate relief or can’t tolerate the side effects long-term. So you’ve got a very large patient pool, with a meaningful percentage essentially underserved by existing treatments.

One subtle but important thing here is that this is based on real-world claims data (Komodo), not just surveys. It reflects actual diagnosed and treated patients, which is the kind of data that resonates more with payers and regulators down the line.

So from a strategy standpoint, this looks like DFTX doing early work on:

Payer/reimbursement positioning
Regulatory narrative (unmet need)
Commercial story for investors

It strengthens the broader thesis: big market, increasing prevalence, and a clear gap in current treatment options.

If DT-120 shows strong efficacy and durability, this kind of data helps support why it could be a meaningful player in the space rather than just another experimental therapy.