IGC Pharma expands regulatory, AI data science capabilities ahead of Phase 2 CALMA readout

Reuters2026/08/11 12:32

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IGC Pharma is strengthening its regulatory, biostatistics, AI-enabled data science, and pharmaceutical development capabilities as it approaches enrollment closure for its Phase 2 CALMA Alzheimer’s trial, with topline results expected in Q4 2026.
CALMA has randomized 160 participants, with up to eight additional randomizations planned before enrollment closes to bolster the dataset.
The company engaged Italy-based contract research organization OPIS Research to support regulatory interactions with the European Medicines Agency.
The buildout is intended to support data quality work, regulatory readiness for potential FDA and EMA engagement, and preparation for partner discussions following the Phase 2 readout.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. IGC Pharma Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 202608110830ACCESSWRNAPR_____1206025) on August 11, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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IGC Pharma expands regulatory, AI data science capabilities ahead of Phase 2 CALMA readout

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