Trevi Therapeutics plans two pivotal phase III trials for IPF-related chronic cough as FDA alignment achieved

Q4 2025 Management View Jennifer Good, CEO, reported that "2025 was a major inflection point for growth at Trevi, driven by our positive data readouts in both the CORAL trial in patients with ...
Business Insider

INmune Bio Announces FDA Alignment on Integrated Phase 2b/3 Registration Pathway for XPro1595 in Early Alzheimer’s Disease

Agency Feedback Provides Regulatory Clarity on Enrichment Strategy and Confirms CDR-SB as Sole Primary Endpoint for Registrational Development Boca Raton, FL, Feb. 12, 2026 (GLOBE NEWSWIRE) -- INmune ...
Nasdaq

Chemomab Therapeutics Announces FDA Alignment on Phase 3 Trial Design for Nebokitug as Potential First Treatment for Primary Sclerosing Cholangitis

Chemomab Therapeutics has announced that it has successfully completed its End-of-Phase 2 meeting with the FDA, aligning on the design of a single Phase 3 trial for its lead product candidate, ...
Seeking Alpha

Cognition Therapeutics Receives End-of-Phase 2 Meeting Minutes Confirming Alignment with U.S. FDA on Registrational Path for Zervimesine (CT1812) in Alzheimer’s Disease

PURCHASE, N.Y., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (CGTX), (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing drugs that treat neurodegenerative ...
Seeking Alpha

Aardvark Therapeutics Announces FDA Alignment on Protocol Amendment Expanding Phase 3 HERO Trial Population for Prader-Willi Syndrome

SAN DIEGO, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-molecule therapeutics to activate innate ...
Nasdaq

IMUNON, Inc. Advances IMNN-001 for Ovarian Cancer with FDA Alignment on CMC Strategy Ahead of Phase 3 Trial

IMUNON announced FDA alignment on CMC strategy for IMNN-001, preparing for a Phase 3 trial in advanced ovarian cancer. IMUNON, Inc. announced a successful Type C Chemistry, Manufacturing, and Controls ...
Becker's ASC

The New Phase of Physician-Hospital Alignment

At the 18th Annual Ambulatory Surgery Centers Conference in Chicago on Oct. 28, Kate Lovrien, senior manager, and Luke Peterson, national director of the strategy group, Kurt Salmon Associates, ...