Business Insider

FDA Grants Fast Track Status to Amplyx Pharmaceuticals for IV and Oral Formulations of Fosmanogepix (APX001) for Seven Different Indications

SAN DIEGO, Sept. 9, 2019 /PRNewswire/ -- Amplyx Pharmaceuticals, a biotech company dedicated to developing innovative therapies for debilitating and life-threatening diseases in patients with ...
Nasdaq

Polaryx Therapeutics Receives U.S. FDA Fast Track Designations for All Four Indications to be Evaluated in the SOTERIA Basket Trial

PARAMUS, N.J., April 21, 2026 (GLOBE NEWSWIRE) -- Polaryx Therapeutics, Inc. (Nasdaq: PLYX), a clinical-stage biotechnology company developing disease-modifying therapies for rare pediatric LSDs, ...
Nasdaq

Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial ...

The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development program to date and will provide extensive data from nearly 50,000 patients, ...