POTOMAC, MARYLAND / ACCESS Newswire / December 15, 2025 / IGC Pharma, Inc. (NYSE American:IGC) ("IGC" or the "Company"), a clinical-stage biotechnology company leveraging Artificial Intelligence (AI) to develop innovative treatments for Alzheimer's disease, today commented on recent federal policy momentum surrounding the potential reclassification of cannabis to Schedule III and its implications for the regulated cannabinoid pharmaceutical sector.
Recent reports indicating a possible shift in federal scheduling have coincided with renewed market interest across the cannabinoid landscape, reflecting expectations that a clearer federal posture may reduce long-standing friction around research, manufacturing, and financial infrastructure. While such developments would not legalize cannabis or eliminate regulatory oversight, they underscore a broader transition toward recognizing clinically validated cannabinoid medicines as part of the mainstream pharmaceutical ecosystem.
IGC Pharma believes it occupies a distinct position at this inflection point: Unlike consumer-facing cannabis or hemp companies, IGC operates within the FDA-regulated drug-development pathway, with a focused strategy centered on neurological disorders and low-dose cannabinoid formulations designed for therapeutic effect with minimal psychoactivity. The Company's lead candidate, IGC-AD1, is currently being evaluated in a Phase 2 clinical trial for agitation associated with Alzheimer's disease (the CALMA study).
"We built IGC Pharma for this moment," said Ram Mukunda, Chief Executive Officer of IGC Pharma. "As federal policy evolves, the market is beginning to distinguish between unregulated cannabinoid exposure and true pharmaceutical development. We believe IGC stands alone as a publicly traded company focused on FDA-driven, clinically tested cannabinoid therapeutics for Alzheimer's disease, one of the largest and most urgent unmet needs in medicine."
IGC further noted that recent federal signals reflect a willingness to confront long-standing regulatory ambiguity with pragmatic leadership. By encouraging agencies to reassess decades-old assumptions around cannabinoid science, the Administration has opened the door to a more evidence-driven framework, one that prioritizes medical innovation, patient safety, and scientific progress over outdated categorizations.
From regulatory headwinds to structural tailwinds:
Historically, the lack of federal clarity around cannabinoids has created barriers that disproportionately affected companies pursuing legitimate pharmaceutical development, raising costs, limiting clinical site participation, and discouraging institutional engagement. IGC believes emerging policy momentum, including renewed discussion around scheduling and research frameworks, may begin to reverse these dynamics over time. If regulatory conditions continue to mature, the Company expects potential long-term benefits that are particularly relevant to disciplined, patient investors, including:
Expanded participation by major clinical research institutions, supporting trial execution and scalability
More efficient manufacturing and supply-chain planning aligned with pharmaceutical standards
Improved engagement from financial institutions and capital markets, reflecting reduced structural ambiguity around cannabinoid-based medicines
A differentiated long-term thesis:
IGC's strategy has never been oriented toward short-term consumer trends. Instead, the Company has invested years building a patent-protected, data-driven platform grounded in microdosing, safety, and clinical validation. As markets increasingly reward regulatory clarity and durable science, IGC believes this long-horizon approach positions the Company to benefit disproportionately as cannabinoid medicine transitions from regulatory uncertainty to pharmaceutical normalization.
"Developing medicines takes time," Mukunda added. "We recognize the patience our shareholders have shown, and we believe that as policy, science, and capital markets begin to align, the value of that patience may become increasingly apparent."
IGC will continue executing on its clinical roadmap, expanding its intellectual-property portfolio, and engaging responsibly with evolving regulatory frameworks governing cannabinoid therapeutics.
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
igc@imsinvestorrelations.com
(203) 972-9200
SOURCE: IGC Pharma, Inc.
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/igc-pharma-positions-as-a-singular-beneficiary-of-emerging-federal-momentum-toward-sc-1117330
