IGC Pharma Expands Phase 2 CALMA Trial with New Clinical Site at Dominion Medical Associates, a Lightship Network Site, in Richmond, Virginia
Rhea-AI Summary
IGC Pharma (NYSE:IGC) added Dominion Medical Associates, a Lightship network site in Richmond, Virginia, to its Phase 2 CALMA trial of IGC-AD1 for agitation in Alzheimer's disease on January 12, 2026. The site will use Lightship's hybrid access model combining in-clinic, remote, and in-home visits supported by mobile research nurses and validated technology to expand access, reduce participant burden, improve retention, and accelerate enrollment across underserved and rural communities. IGC-AD1 is a cannabinoid-based investigational therapy being studied in a randomized, double-blind, placebo-controlled Phase 2 trial. The expansion aims to strengthen trial execution, participant diversity, and timely study completion while maintaining investigator oversight, protocol adherence, and data integrity.
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News Market Reaction
On the day this news was published, IGC declined 0.13%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
IGC was down 1.54% pre‑headline. Key biotech peers were mixed: CASI -8.33%, ESLA -18.92%, KLTO -3.37%, LSB -20.62%, while LTRN rose 3.56%. Momentum scanner only flagged KAPA up 4.81% with no news, supporting a stock‑specific rather than sector‑wide move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 06 | Fiscal year change | Positive | -1.3% | Shifted fiscal year‑end to Dec 31 to improve reporting comparability. |
| Jan 05 | Capital raise | Neutral | +0.6% | Registered direct offering to fund IGC‑AD1 Phase 2 development. |
| Dec 19 | New patent | Positive | -10.7% | USPTO issued patent for microdose cannabinoid therapy for tics. |
| Dec 15 | Policy positioning | Positive | -3.9% | Outlined strategy around possible Schedule III cannabinoid reclassification. |
| Dec 10 | Analyst coverage | Positive | +14.8% | Analyst raised price target citing potential future clinical catalysts. |
IGC’s positive or strategic news has often seen muted or negative next‑day moves, with the notable exception of an analyst coverage update that coincided with a strong gain.
Over the last two months, IGC reported several milestones. On Dec 10, 2025, an analyst raised its price target, and the stock rose 14.77%. A fiscal year alignment announcement on Jan 6, 2026 and a new patent on Dec 19, 2025 were followed by declines of 1.26% and 10.74%, respectively. Capital raised on Jan 5, 2026 to fund the IGC‑AD1 Phase 2 program saw a modest 0.58% gain. Today’s CALMA site expansion continues this focus on advancing Alzheimer’s trials and operational readiness.
Regulatory & Risk Context
An amended Form S-3/A resale registration filed on Dec 3, 2025 covers up to 978,235 shares held by existing security holders. IGC is not selling shares or receiving proceeds under this shelf but does bear registration costs. A separate 424B5 on Jan 5, 2026 reflects actual usage via a direct stock offering.
Market Pulse Summary
This announcement expands the Phase 2 CALMA trial of IGC‑AD1 through a new hybrid clinical site, aiming to improve access and retention for Alzheimer’s patients, particularly in underserved areas. It follows prior CALMA milestones and broader trial expansion across the U.S. The news underscores IGC’s focus on participant‑centric, flexible trial designs. Investors may watch for future updates on enrollment progress, trial completion timing, and any subsequent regulatory or financing steps linked to advancing IGC‑AD1.
Key Terms
hybrid trial model medical
virtual delivery technical
randomized, double-blind, placebo-controlled medical
cannabinoid medical
Phase 2 clinical trial medical
AI-generated analysis. Not financial advice.
- Hybrid Trial Model Enhances Participant Access, Retention, and Enrollment Efficiency Across Underserved and Rural Communities -
POTOMAC, MD / ACCESS Newswire / January 12, 2026 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage pharmaceutical company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today announced the addition of Dominion Medical Associates, Inc., a Richmond, Virginia-based clinical research site within Lightship's site network, to the Company's Phase 2 CALMA clinical trial evaluating IGC-AD1 for the treatment of agitation in Alzheimer's disease.
Dominion Medical Associates will operate under Lightship's expanded access clinical trial model, combining in-clinic assessments with remote and in-home participant activities as part of a flexible hybrid and virtual delivery approach. This participant-centric approach is designed to expand access, reduce burden, improve retention, and enhance trial efficiency. Dominion Medical Associates is led by Founder and Principal Investigator Dr. Richard Allen Jackson, and Director of Clinical Research Richard "AJ" Jackson.
"The addition of Dominion Medical Associates represents a meaningful step forward in expanding access to our CALMA trial," said Ram Mukunda, CEO of IGC Pharma. "Their hybrid model aligns with our strategy to reach patients in underserved and rural communities while maintaining high-quality clinical oversight and data integrity."
Advancing Enrollment Through Hybrid and Flexible Site-Based Trial Design
Dominion Medical Associates, as part of Lightship's site network, uses a hybrid model that allows certain trial activities to take place in participants' homes. This model offers several key advantages:
Broader participant access, including individuals in more remote locations and those with limited ability to travel.
Improved convenience that supports retention throughout the trial.
Scalability across multiple regions, enabling greater participant diversity and more robust data.
To support the remote components of the trial, Dominion Medical Associates partners with Lightship to deliver hybrid and virtual study visits, supported by trained mobile research nurses, validated technology solutions, and centralized clinical support. Through this approach, remote and in-home study visits are coordinated and conducted with consistent investigator oversight, maintaining protocol adherence, data integrity, and regulatory compliance while extending research participation beyond traditional clinic settings.
"Hybrid clinical trials represent the future of participant-centered research," Mukunda added. "By integrating experienced clinical sites with on-site, hybrid, and virtual visit models, we believe IGC Pharma can accelerate enrollment while maintaining rigorous clinical standards."
Strengthening the CALMA Clinical Network
IGC-AD1 is a cannabinoid-based investigational therapy currently being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial for agitation associated with Alzheimer's disease. The continued expansion of the CALMA clinical network across the United States reflects IGC Pharma's commitment to efficient trial execution, patient diversity, and timely study completion. This approach leverages community-based clinical sites and flexible visit options to extend research participation beyond traditional clinic settings.
To learn more about the trial and participation, visit: 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.
About Lightship
Lightship is a modern clinical trial site organization committed to making research participation possible for all. We collaborate with biopharma and CROs to design and conduct studies that expand access and choice while accelerating new therapies. Through in-clinic, at-home, and mobile research unit visits, we support participants from first contact to completion and deliver shorter timelines, stronger retention, greater diversity, and consistent quality and safety. At Lightship, we redefine what it means to be a clinical trial site.
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
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
View the original press release on ACCESS Newswire
FAQ
What did IGC (NYSE:IGC) announce about the CALMA Phase 2 trial on January 12, 2026?
How will the Dominion Medical Associates site affect patient access for IGC's CALMA trial?
What is IGC-AD1 being tested for in the CALMA Phase 2 trial (IGC)?
Will remote visits in the IGC CALMA trial maintain regulatory and data standards?
Why is IGC using a hybrid site model for the CALMA trial (IGC)?
How can patients learn more or participate in IGC's CALMA Phase 2 trial?
