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

Acurx signals progress in Phase 3 ibezapolstat program with $12M credit line following regulatory alignment

Luci indicated the company is focused on securing additional funding opportunities to support the Phase 3 ibezapolstat clinical trial program and expects further updates on funding initiatives in ...
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, ...
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 ...
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 ...
manilatimes

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 ...