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4日前
IGC Pharma Adds Mount Sinai Clinical Site as CALMA Trial Advances Toward Completion and Topline Analysis
https://www.accessnewswire.com/newsroom/en/biotechnology/igc-pharma-adds-mount-sinai-clinical-site-as-calma-trial-advances-toward-completion-a-1172698
Approximately 80% of target participants have completed trial participation, strengthening momentum toward database lock and topline analysis
POTOMAC, MD / ACCESS Newswire / June 2, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company developing therapeutics for Alzheimer's disease, today announced the addition of the Icahn School of Medicine at Mount Sinai in New York as a clinical site in the Company's Phase 2 CALMA trial evaluating IGC-AD1 for agitation associated with Alzheimer's disease.
The addition of Mount Sinai comes as CALMA advances toward completion, with approximately 80% of targeted participants having completed trial participation. The Company believes the continued addition of world-class clinical sites supports final-stage execution, patient access, and data integrity as the program progresses toward database lock and topline analysis.
The trial, at Mount Sinai, is led by Dr. Rachel Fremont, MD, PhD, Assistant Professor of Psychiatry at the Icahn School of Medicine at Mount Sinai, and is board-certified in Adult and Geriatric Psychiatry. Her work focuses on the clinical and biological characterization of psychiatric symptoms in neurodegenerative disorders, including Alzheimer's disease and related dementias.
The study will be coordinated locally by Katherine Keller, Clinical Research Coordinator, at Mount Sinai's campus located at 1468 Madison Avenue, New York, NY 10029.
"Adding Mount Sinai at this stage of CALMA reflects our continued focus on disciplined execution, site quality, and data integrity as the trial advances toward completion," said Ram Mukunda, CEO of IGC Pharma. "With approximately 80% of targeted participants having completed trial participation, our focus is on completing the remaining study activities efficiently while maintaining the clinical rigor needed for a meaningful data readout."
IGC believes the inclusion of Mount Sinai expands the Company's presence in a major metropolitan research center and enhances access to a diverse patient population. The Company continues to focus on site performance, patient engagement, and disciplined clinical execution towards its next operational milestones.
IGC-AD1 is currently being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial designed to assess safety and efficacy in patients with Alzheimer's disease experiencing agitation, one of the most challenging neuropsychiatric symptoms associated with Alzheimer's disease.
US Market News
3週前
IGC Pharma Reports First Quarter 2026 Financial Results with CALMA Phase 2 in the final stage, with 80% EnrollmentMay 19, 2026 5:30 PM
ACCESS Newswire- Continued Advancement of CALMA Phase 2 Trial -POTOMAC, MD / ACCESS Newswire / May 19, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company developing therapeutics and artificial intelligence ("AI-enabled") tools for Alzheimer's disease ("AD"), today announced the filing of its Quarterly Report on Form 10-Q with the U.S. Securities and Exchange Commission ("SEC") for the quarter ended March 31, 2026. "During the first quarter, we continued to execute against our core priorities by advancing CALMA, expanding our clinical site network, and strengthening the AI and intellectual property components of our Alzheimer's strategy with disciplined capital allocation," said Ram Mukunda, CEO of IGC Pharma. "Our near-term focus remains on completing CALMA and deploying capital toward programs that we believe may support long-term value creation for patients and shareholders. As with all clinical-stage programs, there can be no assurance regarding trial timing, clinical outcomes, regulatory approval, or commercialization."Clinical & Strategic Highlights (three months ended March 31, 2026)CALMA Clinical Progress: Continued advancement of the Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation associated with Alzheimer's disease. The CALMA trial remains ongoing, with a target enrollment of 146 patients. Subsequent to March 2026, the Company reported approximately 80% patient enrollment in the Phase 2 CALMA clinical trial.Clinical Site Expansion: Added clinical research sites to the CALMA trial, including Dominion Medical Associates, Inc. within Lightship's site network, Integrative Clinical Trials, LLC in Brooklyn, New York, and Visionary Investigators Network ("VIN").AHA Intellectual Property: Filed utility patent applications covering the architectural framework of AHA, the Company's internally developed AI-based data harmonization system.IGC-AD1 Intellectual Property: Announced that the Canadian Intellectual Property Office ("CIPO") issued a Notice of Allowance covering the proprietary composition underlying IGC-AD1, the Company's Phase 2 clinical-stage program for agitation associated with AD.Financial Summary: Focused Investment in Clinical and AI Execution (three months ended March 31, 2026)Accelerated Research and Development ("R&D"): R&D expenses were approximately $1.3 million, compared to approximately $997 thousand in the prior-year period. The increase was primarily attributable to the progression of the CALMA trial for IGC-AD1.Revenue: Revenue was $317 thousand for the three months ended March 31, 2026, compared to $330 thousand for the three months ended March 31, 2025. Revenue in both quarters was primarily derived from the Company's Life Sciences segment, encompassing the sale of our formulations as white-labeled manufactured products, among others.Selling, General and Administrative Expenses ("SG&A"): SG&A expenses were approximately $1.2 million, compared to approximately $570 thousand in the prior-year period. The increase was primarily attributable to the absence of a $700 thousand credit recognized in the prior-year period related to the conversion of accrued cash bonuses into performance-based compensation by the Board of Directors, partially offset by decreases in certain operating expenses.Net Loss: Net loss attributable to common stockholders was approximately $2.4 million for the three months ended March 31, 2026, compared to $1.2 million for the three months ended March 31, 2025. Basic and diluted net loss per share was $0.02 for both periods.Liquidity and Capital Resources: As of March 31, 2026, the Company had total outstanding debt of approximately $917 thousand. Subsequent to the quarter, the Company raised additional debt of approximately $585 thousand. The Company also maintained access to an undrawn $12 million O-Bank credit facility, subject to its terms and conditions. The Company continues to evaluate financing alternatives, including potential equity and debt transactions, to support its clinical development programs and operations.Investors and stakeholders may access the filing at www.sec.gov or through the Investor Relations section of IGC Pharma's website at www.investor.igcpharma.com.About IGC Pharma (dba IGC):IGC Pharma (NYSE American: IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.Forward-Looking Statements:This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially, including risks related to the Company's ability to complete enrollment in its Phase 2 CALMA trial within anticipated timeframes, demonstrate safety and efficacy, the timing of data readouts, regulatory approvals, and other factors discussed in the Company's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-KT. The Company undertakes no obligation to update these statements.Contact Information:Andres Sanchez
Investor Relations
US Market News
1月前
IGC Pharma Advances Caregiver Engagement as Phase 2 CALMA Trial Advances Final Enrollment PhaseApril 28, 2026 12:15 PM
ACCESS NewswireOutreach initiative supports awareness of agitation and patient engagement as enrollment approaches completionPOTOMAC, MD / ACCESS Newswire / April 28, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company developing therapeutics for Alzheimer's disease, today announced its participation in the caregiver-focused podcast Autumn Is Here, as part of its broader effort to increase awareness of agitation associated with Alzheimer's disease and support patient engagement in its ongoing Phase 2 CALMA clinical trial, which has recently reached approximately 80% patient enrollment and is advancing toward completion. The episode featured Margarita Venegas, Psychometric Training Manager, and Barbara Forero, Clinical Neuropsychologist & Recruitment Coordinator at IGC Pharma, in a discussion focused on recognizing agitation as a distinct and clinically significant symptom of Alzheimer's disease. The conversation was hosted by Francine Crawford, creator of Autumn Is Here, who brings a personal caregiving perspective.Supporting Clinical Progress Through AwarenessAs the CALMA trial advances toward its final phase of enrollment, increasing awareness of agitation remains an important component of both patient care and clinical trial participation. The Company believes that caregiver education can support earlier recognition of symptoms and improve engagement in clinical studies evaluating potential treatment options.During the episode, participants discussed how agitation may present in patients, how it differs from other behavioral symptoms, and why it is often under-recognized despite its significant impact on patients and caregivers.Connecting Research and the Caregiver Community"Engaging with caregivers is an important part of advancing Alzheimer's research," said Ram Mukunda, Chief Executive Officer of IGC Pharma. "As CALMA progresses toward enrollment completion, outreach and education play a role in supporting awareness of agitation and the importance of continued research in this area."The Company continues to prioritize outreach efforts that connect clinical research with patients, caregivers, and healthcare professionals as it advances the CALMA clinical trial toward completion.The full podcast episode is available here: Link.About IGC Pharma (dba IGC):IGC Pharma?(NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize?clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.Forward-Looking Statements:This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially, including risks related to the Company's ability to complete enrollment in its Phase 2 CALMA trial within anticipated timeframes, demonstrate safety and efficacy, the timing of data readouts, regulatory approvals, and other factors discussed in the Company's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-KT. The Company undertakes no obligation to update these statements.Contact Information:Walter Frank / John Nesbett
IMS Investor Relations
US Market News
2月前
IGC Pharma Secures Psilocybin Research Authorization, Expanding Focus on Neuropsychiatric Symptoms in DementiaApril 20, 2026 8:30 AM
ACCESS NewswireAuthorization provides regulated capability to evaluate emerging therapeutic approaches alongside Phase 2 CALMA trial approaching completionPOTOMAC, MD / ACCESS Newswire / April 20, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company developing therapeutics for Alzheimer's disease, today announced that on April 9, 2026, it received authorization in Colombia to synthesize, formulate, and conduct development activities involving psilocybin at its research and development facility in Bogotá. The authorization, granted under the oversight of the Fondo Nacional de Estupefacientes (FNE), provides IGC Pharma with a regulated capability to work with psilocybin, positioning the Company within an expanding area of scientific and investor interest. The Company believes it is among a limited number of organizations in Colombia with this type of authorization.This capability allows the Company to evaluate potential applications of psilocybin, for example in neuropsychiatric symptoms (NPS) associated with dementia, including depression and anxiety, conditions affecting a large portion of Alzheimer's patients and representing a significant and underserved market opportunity.Potential Engine of GrowthNeuropsychiatric symptoms affect about 80% of Alzheimer's patients and broad and heterogeneous, including agitation, depression, anxiety, and mood-related conditions. While IGC Pharma's lead candidate, IGC-AD1, is advancing through a Phase 2 clinical trial targeting agitation, additional symptom domains such as depression and anxiety represent a substantial and largely unaddressed segment of the disease burden. The Company believes that differentiated mechanisms may be required across these symptom clusters, creating the potential for multiple therapeutic pathways.Strategic Positioning in a High-Growth AreaThe psilocybin authorization provides IGC Pharma with a capital-efficient platform to evaluate emerging therapeutic approaches in neuropsychiatric disorders. Compared to traditional drug development pathways, this capability allows for earlier-stage evaluation with greater flexibility and lower cost. This authorization also positions the Company within a rapidly evolving global landscape, where regulatory, scientific, and investor interest in novel neuropsychiatric therapies continues to expand. Early access to regulated development environments may provide a strategic advantage as this field matures.Complementary to CALMA Clinical ProgramThe Company continues to prioritize the advancement of its lead program, IGC-AD1, currently being evaluated in the Phase 2 CALMA clinical trial for agitation associated with Alzheimer's disease, which has recently reached approximately 80% patient enrollment and is advancing toward completion."IGC-AD1 and CALMA remains our primary near-term focus as we advance toward data readout," said Ram Mukunda, CEO of IGC Pharma. "At the same time, we are not just targeting agitation, we are building a multi-pronged approach to the $1 trillion Alzheimer's crisis. This authorization allows us to build additional assets in Alzheimer's disease using differentiated mechanisms in a capital-efficient manner."About IGC Pharma (dba IGC):IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.Forward-Looking Statements:This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially, including risks related to the Company's ability to complete enrollment in its Phase 2 CALMA trial within anticipated timeframes, demonstrate safety and efficacy, the timing of data readouts, regulatory approvals, and other factors discussed in the Company's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-KT. The Company undertakes no obligation to update these statements.Contact Information:Walter Frank / John Nesbett
IMS Investor Relations
US Market News
2月前
IGC Pharma Reaches 80% Enrollment in Phase 2 CALMA Trial, Entering Final Phase Ahead of Enrollment Completion and Data ReadoutApril 14, 2026 8:30 AM
ACCESS NewswirePOTOMAC, MD / ACCESS Newswire / April 14, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company") today announced that it has approximately 80% patient enrollment in its Phase 2 CALMA clinical trial evaluating IGC-AD1 for agitation associated with Alzheimer's disease. This milestone represents a significant step in advancing the program toward enrollment completion, expected in mid-2026, and positions the Company to progress toward database lock and topline results. Enrollment progress across the Company's US and Canadian clinical network continues to support consistent execution as the study enters its final phase.Approaching a Defined Clinical Catalyst
"Reaching 80% enrollment marks an important milestone as we advance toward completion of the CALMA trial," said Ram Mukunda, CEO of IGC Pharma. "We have entered the final phase of recruitment with strong momentum. Every patient enrolled brings us one step closer to evaluating the full potential of IGC-AD1. Our focus is now on 100% enrollment and preparing for the data readout that could potentially redefine the treatment landscape for Alzheimer's disease."Enrollment completion represents the primary operational gating step ahead of clinical data readout. As a randomized, double-blind, placebo-controlled study, efficacy outcomes are not analyzed on an ongoing interim basis in order to preserve trial integrity.Final Phase of Execution
As the trial progresses through the final phase of recruitment, the Company continues to benefit from:Sustained enrollment momentum across a diversified US and Canadian clinical networkImminent Catalyst: Completion of enrollment in mid-2026 sets the stage for the highly anticipated Phase 2 topline results.Unmet Need: While the first medication for agitation was recently approved, the market remains largely underserved. With agitation affecting up to 76% of Alzheimer's patients, IGC is positioning as a Next-Generation Disruptor in a multi-billion-dollar CNS market where the demand for diverse and safer treatment options remains critical.Advancing Toward a Defined Clinical Catalyst
IGC-AD1 is an investigational therapy being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial designed to assess both safety and efficacy in patients with Alzheimer's disease experiencing agitation.Agitation is a devastating neuropsychiatric symptom that often leads to premature institutionalization and severe caregiver burnout. Each successive enrollment reduces operational risk and supports IGC's progression toward a defined clinical data catalyst that could help transform the lives of patients and caregivers worldwide. With enrollment now at approximately 80%, the Company believes the CALMA trial is entering its final operational phase ahead of a defined clinical readout.About IGC Pharma (dba IGC):
IGC Pharma?(NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize?clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially, including risks related to the Company's ability to complete enrollment in its Phase 2 CALMA trial within anticipated timeframes, demonstrate safety and efficacy, the timing of data readouts, regulatory approvals, and other factors discussed in the Company's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Annual Report on Form 10-KT. The Company undertakes no obligation to update these statements.Contact Information:
Walter Frank / John Nesbett
IMS Investor Relations
US Market News
2月前
Ascendiant Capital Markets Raises IGC Pharma Price Target to $5.25, Citing Clinical Progress and Upcoming CatalystsApril 8, 2026 12:45 PM
ACCESS NewswirePOTOMAC, MD / ACCESS Newswire / April 8, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company with its lead program currently in a Phase 2 CALMA clinical trial evaluating IGC-AD1 for Alzheimer's-related agitation today announced that Ascendiant Capital Markets has issued an updated equity research report on the Company, raising its price target to $5.25 per share.The research report entitled, "Reports Q3. We believe more positive clinical data and progress in 2026 to be strong catalysts for stock. Raising P/T to $5.25" can be obtained directly from Ascendiant Capital Markets Link.All reports on IGC Pharma prepared by analysts represent the views of those analysts and are not necessarily those of IGC Pharma. IGC is not responsible for the content, accuracy, or timelines provided by analysts. By referring to these analysts or distributing their opinions, IGC does not in any way commit itself to the validity of such information, conclusions, or recommendations.About IGC Pharma (dba IGC):IGC Pharma?(NYSE American: IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize?clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.Forward-Looking Statements:This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.Contact Information:
Walter Frank / John Nesbett
IMS Investor Relations
US Market News
3月前
IGC Pharma to Showcase AI Platform with Alzheimer's Disease Data Initiative at ADPD 2026March 18, 2026 9:00 AM
ACCESS NewswirePOTOMAC, MD / ACCESS Newswire / March 18, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company developing therapeutics for Alzheimer's disease, today announced it will demonstrate its Agentic Harmonization Assistant ("AHA"), an artificial intelligence platform designed to automate the integration and analysis of complex biomedical datasets, at the Alzheimer's & Parkinson's Diseases Conference (ADPD) 2026. The demonstration will take place in collaboration with the Alzheimer's Disease Data Initiative (ADDI), a global data-sharing platform supported by Gates Ventures and leading research institutions focused on accelerating discoveries in neurodegenerative disease.AHA is an agent-based AI platform designed to harmonize fragmented datasets across multiple studies, including clinical trial data, imaging, and other biomedical information. Data harmonization remains one of the most time-consuming steps in Alzheimer's research, often requiring months of manual preparation before meaningful analysis can begin. By automating this process, AHA is designed to significantly reduce the time required to prepare large datasets for analysis."Artificial intelligence is becoming an increasingly important component of modern biomedical research," said Ram Mukunda, CEO of IGC Pharma. "Demonstrating AHA within the ADDI ecosystem at ADPD provides an opportunity to showcase how AI-driven data integration can accelerate insights from complex datasets while strengthening our in-house analytical capabilities and advancing our clinical programs toward key milestones." Advanced data integration capabilities such as AHA may enhance analysis of complex clinical datasets and support the continued development of the Company's lead drug candidate, IGC-AD1, currently being evaluated in the ongoing Phase 2 CALMA clinical trial for agitation associated with Alzheimer's disease.The Company also believes that scalable platforms capable of harmonizing large biomedical datasets may create future monetization opportunities to support pharmaceutical companies and global research collaborations working with complex neurodegenerative disease datasets.Participation in ADPD reflects the Company's broader strategy of integrating artificial intelligence, advanced data analytics, and therapeutic development to accelerate innovation in Alzheimer's disease.About IGC Pharma (dba IGC):
IGC Pharma?(NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize?clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.Forward-Looking Statements:
This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, and on Forms 10-Q filed with the SEC on August 14, 2025, and on November 14, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.Contact Information:
Walter Frank / John Nesbett
IMS Investor Relations
US Market News
3月前
IGC Pharma Files Utility Patent Applications Covering AI-Based Data Harmonization Architecture Supporting Alzheimer's ResearchFebruary 26, 2026 8:30 AM
ACCESS NewswirePOTOMAC, MD / ACCESS Newswire / February 26, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company developing therapeutics for Alzheimer's disease, today announced the filing of utility patent applications covering the architectural framework of its Agentic Harmonization Assistant ("AHA"), an internally developed AI-based data harmonization system. IGC is developing AHA to support the standardization of heterogeneous Alzheimer's disease datasets, which often vary significantly in schema definitions, variable encodings, and data structures. These inconsistencies can limit cross-cohort analysis and slow both clinical research and AI model development. AHA is being designed as a structured, multi-stage agentic architecture intended to automate dataset alignment and validation across diverse Alzheimer's datasets. The Company has harmonized 15 Alzheimer's-related datasets for internal development purposes and continues to refine the system architecture.Earlier this year, AHA advanced to the semi-final round of a competitive AI research evaluation program. The Company plans to present additional details regarding AHA's development roadmap at the upcoming ADPD conference.The filed utility patent applications are intended to protect key elements of AHA's architectural design and harmonization methodologies. IGC believes that scalable dataset harmonization infrastructure may become increasingly important in Alzheimer's research as multi-cohort AI-driven analysis expands."While our primary focus remains the completion of the CALMA clinical trial, we believe scalable data harmonization and internal AI capabilities are essential to modern Alzheimer's research," said Ram Mukunda, CEO of IGC Pharma. "AHA is being developed to support research initiatives and, over time, may support potential collaborations, integrations, or licensing opportunities."About IGC Pharma (dba IGC):IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.Forward-Looking Statements:This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, and on Forms 10-Q filed with the SEC on August 14, 2025, and on November 14, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.Contact Information:Rosalyn Christian / John Nesbett
IMS Investor Relations
US Market News
3月前
IGC Pharma Adds Visionary Investigators Network as Clinical Site to Phase 2 CALMA TrialFebruary 23, 2026 8:30 AM
ACCESS Newswire- Practice integrated neurology network expands enrollment capacity -POTOMAC, MARYLAND / ACCESS Newswire / February 23, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), today announced the addition of Visionary Investigators Network ("VIN") as a clinical research site participating in the Company's Phase 2 CALMA trial evaluating IGC-AD1 for the treatment of agitation associated with Alzheimer's disease dementia. VIN operates clinical research programs embedded within established private neurology practices, providing access to well-characterized patient populations while maintaining continuity of clinical care. IGC Pharma believes this practice-integrated model supports efficient enrollment, sustained patient engagement, and consistent protocol adherence as the CALMA trial advances. The Company recently reported approximately 70% of planned enrollment is completed."The CALMA trial continues as designed, and our focus is execution through enrollment completion," said Ram Mukunda, CEO of IGC Pharma. "VIN brings an experienced, practice-integrated research model that aligns well with our Phase 2 execution priorities and supports continued enrollment momentum.VIN - Coconut Grove location is led by Dr. Andrew Lerman, a neurologist with more than ten years of experience in Central Nervous System disorders and a history of serving as Principal Investigator on over 20 neurodegenerative-focused clinical trials, including studies in Alzheimer's disease and mild cognitive impairment. The CALMA trial will be conducted at VIN's Coconut Grove location in Miami, Florida, supported by Clinical Trial Coordinator Susan Gonzalez.CALMA is a randomized, double blind, placebo-controlled Phase 2 clinical trial designed to assess the safety and efficacy of IGC-AD1, a proprietary cannabinoid-based investigational therapy, for associated with Alzheimer's disease.About Visionary Investigators Network:VIN is a multi-site, neurology-focused clinical research organization operating across South Florida. VIN conducts clinical trials embedded within established private neurology practices, supporting continuity of care while enabling access to well-characterized patient populations.The network specializes in neurodegenerative and central nervous system disorders, including Alzheimer's disease and related dementias, and is supported by experienced physician investigators, dedicated research teams, and centralized regulatory and quality management infrastructure. VIN operates at multiple sites, but given the research strengths of the Coconut Grove Site, this location was chosen for the development and advancement of the CALMA Program.About IGC Pharma (dba IGC):IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.Forward-Looking Statements:This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, and on Forms 10-Q filed with the SEC on August 14, 2025, and on November 14, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.Contact Information:Rosalyn Christian / John Nesbett
IMS Investor Relations
US Market News
4月前
IGC Pharma to Participate in Fireside Chat With Ascendiant Capital MarketsFebruary 12, 2026 8:30 AM
ACCESS NewswirePOTOMAC, MD / ACCESS Newswire / February 12, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), today announced that CEO Ram Mukunda and CCO Claudia Grimaldi will be participating in a fireside chat hosted by Ascendiant Capital Markets on Wednesday, February 18, 2026, at 1:00 p.m. ET. IGC Pharma's management will discuss recent clinical progress in its Phase 2 CALMA trial evaluating IGC-AD1 for agitation associated with Alzheimer's disease, including enrollment momentum and regulatory developments. The discussion will also cover advancements in the Company's AI-driven precision medicine platform and progress across its broader pipeline of disease-modifying Alzheimer's candidates. Management will provide perspective on upcoming milestones and strategic priorities for fiscal 2026.To register for the fireside chat, please visit: LinkAbout IGC Pharma (dba IGC):IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.Forward-Looking Statements:This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, and on Forms 10-Q filed with the SEC on August 14, 2025, and on November 14, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.Contact Information:
Rosalyn Christian / John Nesbett
IMS Investor Relations
US Market News
4月前
IGC Pharma Announces Equity Research Update by Alliance Global PartnersFebruary 10, 2026 8:30 AM
ACCESS NewswirePOTOMAC, MARYLAND / ACCESS Newswire / February 10, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), today announced that Alliance Global Partners ("AGP") has published an updated equity research report covering the Company. The report reiterates a Buy rating and includes a price target of $3.00 per share. All statements, opinions, estimates, projections, and conclusions contained in analyst reports represent the views of the respective analysts and are not those of IGC Pharma. IGC does not endorse, adopt, or guarantee the accuracy or completeness of any analyst report and undertakes no obligation to update or correct the information.A copy of the report may be obtained from AGP: Link.About IGC Pharma (dba IGC):IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.Forward-Looking Statements:This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.Contact Information:Rosalyn Christian / John Nesbett
IMS Investor Relations
US Market News
4月前
IGC Pharma Expands Phase 2 CALMA Trial into Colombia's Premier Alzheimer's Research CenterFebruary 9, 2026 8:30 AM
ACCESS Newswire- Adds world renowned GNA site to broaden genetic diversity and strengthen path toward 2026 data catalyst -POTOMAC, MARYLAND / ACCESS Newswire / February 9, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company") today announced the expansion of its Phase 2 CALMA trial for IGC-AD1 into Colombia, South America, through the addition of Grupo de Neurociencias de Antioquia ("GNA"). This expansion marks a pivotal operational milestone as IGC enters a region internationally recognized for its unique, genetically linked Alzheimer's population. The GNA site is the latest addition to a clinical network that now spans 23 active sites across 26 locations in the United States and Canada.CALMA is a randomized, double-blind, placebo-controlled Phase 2 study that has now reached approximately 70% of planned enrollment. IGC expects to complete enrollment by mid-2026, the primary operational gating step ahead of database lock and topline results.GNA is internationally recognized for its long-running research into genetically linked Alzheimer's disease and related neurodegenerative conditions, including longitudinal cohorts and biomarker's research. For the Colombia site, Dr. Claudia Ramos, a psychiatrist at GNA with a PhD in Clinical Medicine, will serve as Principal Investigator and lead the project alongside a multidisciplinary team, including Sub-PI and General Coordinator of the GNA Dr. David Aguillón and an experienced group of neuropsychiatrists and medical researchers."GNA's deep expertise in longitudinal Alzheimer's cohorts and biomarkers provides us with a high caliber research environment that broadens access to participation, and strengthens the diversity of our clinical program," said Ram Mukunda, CEO of IGC Pharma.Honoring a global Alzheimer's pioneer.IGC also recognized the legacy of Dr. Francisco Lopera, founder of GNA and a globally respected Alzheimer's researcher, who passed away in September 2024. "Dr. Lopera's work elevated Alzheimer's research across Latin America and helped reshape the field's understanding of inherited Alzheimer's," Mukunda added. "We are honored to collaborate with the team Dr. Lopera built and inspired, and to advance Alzheimer's research in Colombia with the scientific rigor he championed."About IGC Pharma (dba IGC):IGC Pharma (NYSE American:IGC) is a clinical-stage biotechnology company leveraging AI to develop innovative treatments for Alzheimer's and metabolic disorders. Our lead asset, IGC-AD1, is a cannabinoid-based therapy currently in a Phase 2 trial (CALMA) for agitation in Alzheimer's dementia. Our pipeline includes TGR-63, targeting amyloid plaques, and early-stage programs focused on neurodegeneration, tau proteins, and metabolic dysfunctions. We integrate AI to accelerate drug discovery, optimize clinical trials, and enhance patient targeting. With a complete patent portfolio and a commitment to innovation, IGC Pharma is advancing breakthrough therapies.Forward-Looking Statements:This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma's expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company's failure or inability to commercialize one or more of the Company's products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA's general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma's U.S. Securities and Exchange Commission ("SEC") filings. IGC incorporates by reference its Annual Report on Form 10-K filed with the SEC on June 27, 2025, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur. IGC Pharma, Inc. assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events, or developments.Contact Information:Rosalyn Christian / John Nesbett
IMS Investor Relations
georgie18
1年前
IGC...4138...🥳Off the 3897 Alert...
georgie18
Member Level
Re: None
Wednesday, December 11, 2024 1:17:54 PM
Post#
667553
of 667765
IGC...3897...🥳Scaling in here... New trials to evaluate IGC-AD1's potential impact on amyloid plaque, tau tangles, and cognitive decline in Alzheimer's diseaseExpanded research positions IGC-AD1 as a potential treatment targeting the underlying disease pathology of Alzheimer's
POTOMAC, MARYLAND / ACCESSWIRE / December 2, 2024 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") announced today an expansion of its clinical research program for IGC-AD1, an investigational treatment for Alzheimer's disease. Building on Phase 2 interim results demonstrating reductions in agitation and cognitive improvement, the Company is initiating new trials to evaluate IGC-AD1's potential as a disease-modifying therapy.
The expanded research will explore how IGC-AD1's dual-action mechanism-combining anti-neuroinflammatory properties with amyloid- and tau-targeting effects-may slow the progression of Alzheimer's disease. These trials will evaluate critical outcomes, including cognitive function and biological markers associated with Alzheimer's, such as amyloid and tau levels, at multiple time points. Building on previously announced preclinical data showing IGC-AD1's impact on amyloid plaques and spatial memory, these investigations aim to explore its potential to influence key pathological features of Alzheimer's disease.
"We plan to initiate a new Phase 2 clinical trial for IGC-AD1 in 2025," said Ram Mukunda, CEO of IGC Pharma. "The trial underscores our commitment to advancing IGC-AD1 as a potential disease-modifying therapy for Alzheimer's. Cognitive decline is one of the most devastating aspects of Alzheimer's, severely impacting patients' memory, attention, and reasoning. By focusing on cognitive outcomes and underlying disease mechanisms such as amyloid plaques and tau tangles, we aim to address the critical unmet needs of patients and caregivers. This subsequent research phase is a significant step forward in delivering innovative treatments to those who need them most.
These new trials represent a pivotal step in advancing IGC-AD1 as a transformative Alzheimer's treatment. By exploring its potential as a disease-modifying therapy, we aim to create opportunities for strategic partnerships and licensing with major pharmaceutical companies. Our vision is to deliver innovative therapies that address the immense challenges faced by patients and caregivers while generating substantial value for our investors."
georgie18
1年前
IGC...3897...🥳Scaling in here... New trials to evaluate IGC-AD1's potential impact on amyloid plaque, tau tangles, and cognitive decline in Alzheimer's diseaseExpanded research positions IGC-AD1 as a potential treatment targeting the underlying disease pathology of Alzheimer's
POTOMAC, MARYLAND / ACCESSWIRE / December 2, 2024 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC Pharma" or the "Company") announced today an expansion of its clinical research program for IGC-AD1, an investigational treatment for Alzheimer's disease. Building on Phase 2 interim results demonstrating reductions in agitation and cognitive improvement, the Company is initiating new trials to evaluate IGC-AD1's potential as a disease-modifying therapy.
The expanded research will explore how IGC-AD1's dual-action mechanism-combining anti-neuroinflammatory properties with amyloid- and tau-targeting effects-may slow the progression of Alzheimer's disease. These trials will evaluate critical outcomes, including cognitive function and biological markers associated with Alzheimer's, such as amyloid and tau levels, at multiple time points. Building on previously announced preclinical data showing IGC-AD1's impact on amyloid plaques and spatial memory, these investigations aim to explore its potential to influence key pathological features of Alzheimer's disease.
"We plan to initiate a new Phase 2 clinical trial for IGC-AD1 in 2025," said Ram Mukunda, CEO of IGC Pharma. "The trial underscores our commitment to advancing IGC-AD1 as a potential disease-modifying therapy for Alzheimer's. Cognitive decline is one of the most devastating aspects of Alzheimer's, severely impacting patients' memory, attention, and reasoning. By focusing on cognitive outcomes and underlying disease mechanisms such as amyloid plaques and tau tangles, we aim to address the critical unmet needs of patients and caregivers. This subsequent research phase is a significant step forward in delivering innovative treatments to those who need them most.
These new trials represent a pivotal step in advancing IGC-AD1 as a transformative Alzheimer's treatment. By exploring its potential as a disease-modifying therapy, we aim to create opportunities for strategic partnerships and licensing with major pharmaceutical companies. Our vision is to deliver innovative therapies that address the immense challenges faced by patients and caregivers while generating substantial value for our investors."
Smilin_B
2年前
Looks like Bradbury is unleashing some of its shares into the market
On March 22, 2024, the Company entered into a Share Purchase Agreement (the "SPA") with Bradbury, subject to the terms and subject to the conditions set forth in the SPA. The investment is for approximately $3 million in gross proceeds at the March 21, 2024, closing price of $0.34. The funds will support general corporate purposes and the Company's advancement of its investigational medicines including IGC-AD1.
The completion of the private placement is subject to customary closing conditions, including approval by the NYSE. Under the terms of the SPA, IGC will issue 8,823,529 shares of common stock. The shares are unregistered and are not immediately tradable.
ErnieBilco
2年前
– Interim Data: Study Achieves Primary End Point Demonstrating Clinical and Statistically Significant Reductions Compared to Placebo in Agitation Associated with Dementia Due to Alzheimer’s Disease –
Potomac, MD, March 20, 2024 – IGC Pharma, Inc. (“IGC Pharma”, “IGC”, or the “Company”) (NYSE American: IGC) today announced the results of an interim analysis of its ongoing Phase 2 trial investigating IGC-AD1 as a treatment for Agitation in dementia from Alzheimer’s Disease (“AAD”).
The interim data demonstrates a clinical and statistically significant reduction in agitation compared to placebo in patients with Alzheimer’s disease, indicating strong therapeutic potential for IGC-AD1.
The study’s primary goal is to assess the change in AAD after six weeks using a standard scale, the Cohen Mansfield Agitation Inventory (“CMAI”). Based on interim data, patients taking IGC-AD1, on average, experienced a more significant reduction in agitation scores compared to those on placebo, and the positive effects were observed as early as week two of the trial.