IGC Pharma (NYSE American: IGC) added the Icahn School of Medicine at Mount Sinai in New York as a clinical site in its Phase 2 CALMA trial of IGC-AD1 for agitation in Alzheimer's disease. About 80% of targeted participants have completed participation, and the study is progressing toward database lock and topline analysis.
Loading...
Loading translation...
Positive
Icahn School of Medicine at Mount Sinai added as CALMA Phase 2 clinical site
Approximately 80% of targeted CALMA trial participants have completed participation
In the Jun 2 session, IGC declined 1.69%, reflecting a mild negative market reaction.
Argus tracked a peak move of +3.6% during that session.
Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility.
Trading volume was above average at 2.0x the daily average, suggesting increased trading activity.
This announcement adds the Icahn School of Medicine at Mount Sinai as a new site for the Phase 2 CAL...
Analysis
This announcement adds the Icahn School of Medicine at Mount Sinai as a new site for the Phase 2 CALMA trial of IGC-AD1, with approximately 80% of targeted participants having completed participation. It underscores continued operational focus on site quality, patient access, and data integrity as the study moves toward database lock and topline analysis. Investors may watch for future updates on completion timing, data readout, and any related financing or regulatory developments.
Key Figures
Trial completion status:Approximately 80% of targeted participants completedTrial phase:Phase 2
Visionary Investigators Network added with ~70% of planned enrollment done.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Pattern Detected
Clinical-trial CALMA updates have mostly seen positive price reactions, with one notable negative divergence despite constructive progress messaging.
Recent Company History
Over recent months, IGC has repeatedly highlighted progress in its Phase 2 CALMA trial of IGC-AD1. Prior updates marked milestones like 70% and 80% enrollment and the activation of new U.S. clinical sites to expand reach and data quality. These clinical-trial announcements, tagged as clinical trial news, often produced modest positive moves, with occasional pullbacks. Today’s Mount Sinai site addition continues this pattern of incremental CALMA execution toward database lock and topline analysis.
Key Terms
phase 2, randomized, double-blind, placebo-controlled, +4 more
8 terms
phase 2medical
"as a clinical site in the Company's Phase 2 CALMA trial evaluating IGC-AD1"
Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.
randomizedmedical
"being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial"
Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.
double-blindmedical
"being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial"
A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.
placebo-controlledmedical
"being evaluated in a randomized, double-blind, placebo-controlled Phase 2 clinical trial"
"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.
database locktechnical
"strengthening momentum toward database lock and topline analysis"
A database lock is the point in a clinical trial when the collected study data are finalized and no further changes or corrections are allowed, so analysts can run the official statistical tests. For investors this matters because it usually precedes public results or regulatory filings—think of it like sealing and signing off an exam before grading: once locked, the timing and content of the readout become clearer and uncertainty about last-minute data edits is reduced.
topline analysistechnical
"toward database lock and topline analysis"
A topline analysis is a high-level review of a company's most important headline numbers—typically sales (revenue), profit margins and other primary results—meant to show whether the business is growing or shrinking. It matters to investors because it provides a quick snapshot of performance and momentum, helping decide whether to investigate further or adjust valuations, much like glancing at a car’s speedometer to judge whether you need to slow down or speed up.
clinical-stage biotechnologymedical
"a clinical-stage biotechnology company developing therapeutics for Alzheimer's disease"
Clinical-stage biotechnology refers to biotechnology companies that are in the process of testing new medical treatments or drugs in human trials. This stage is crucial because it indicates that these treatments have shown enough promise in earlier research to be evaluated for safety and effectiveness in people. For investors, it signals a key phase where potential breakthroughs are being tested, but also involves higher risk since the outcomes are still uncertain.
agitationmedical
"trial evaluating IGC-AD1 for agitation associated with Alzheimer's disease"
Agitation is a clinical state of increased restlessness, irritability, and physical or emotional distress that is more intense than a person’s normal behavior and commonly occurs with psychiatric, neurological, or medical conditions. It matters to investors because reducing or managing agitation is a frequent goal of drug trials, medical devices, and hospital care; therapies that succeed can change treatment guidelines, regulatory approvals, patient demand, and healthcare costs, similar to how fixing a noisy engine part can prevent bigger breakdowns.
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.
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.
What did IGC Pharma (IGC) announce about the CALMA Phase 2 trial on June 2, 2026?
IGC Pharma announced adding Mount Sinai in New York as a clinical site for its Phase 2 CALMA trial. According to IGC Pharma, roughly 80% of targeted participants have completed participation, and the study is moving toward database lock and topline analysis.
How advanced is IGC Pharma's CALMA Phase 2 trial for agitation in Alzheimer's disease?
The CALMA Phase 2 trial has approximately 80% of targeted participants who have completed participation. According to IGC Pharma, this supports momentum toward final trial activities, including database lock and topline analysis for IGC-AD1 in agitation associated with Alzheimer's disease.
What role does Mount Sinai play in IGC Pharma's CALMA trial of IGC-AD1 (IGC)?
Mount Sinai serves as a newly added clinical site for the Phase 2 CALMA trial of IGC-AD1. According to IGC Pharma, the site in New York expands presence in a major research center and supports access to a diverse patient population and trial execution.
Who is leading the Mount Sinai clinical site in IGC Pharma's CALMA Phase 2 trial?
The Mount Sinai site is led by Dr. Rachel Fremont, MD, PhD, Assistant Professor of Psychiatry. According to IGC Pharma, she is board-certified in Adult and Geriatric Psychiatry, focusing on psychiatric symptoms in neurodegenerative disorders, including Alzheimer's disease and related dementias.
What is IGC-AD1, the drug in IGC Pharma's CALMA Phase 2 trial (IGC)?
IGC-AD1 is the investigational therapy being evaluated in the randomized, double-blind, placebo-controlled Phase 2 CALMA trial. According to IGC Pharma, the study assesses safety and efficacy in Alzheimer's patients experiencing agitation, a challenging neuropsychiatric symptom of the disease.
What are the next operational milestones for IGC Pharma's CALMA trial of IGC-AD1?
Next milestones include completing remaining study activities and advancing to database lock and topline analysis. According to IGC Pharma, the company is focusing on site performance, patient engagement, and disciplined clinical execution as approximately 80% of participants have finished the trial.
