Stocktwits on MSN

ONCY stock rallies on second fast track designation for experimental cancer drug

The company said that the designation is supported by clinical data which demonstrates a 33% objective response rate for pelareorep-based therapy. ・According to Oncolytics, there are an estimated 2 ...
TMCnet

Oncolytics Biotech® Receives FDA Fast Track Designation for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer

Strong efficacy signals showing 33% ORR, 16.6-month PFS, and 27-month OS, improving on the SOC by 2-3X in a ...
News Medical

The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development

The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...
Seeking Alpha

Greenwich LifeSciences: Fast Track Designation Does Not Solve Fundamental Issues

Greenwich LifeSciences focuses on developing GLSI-100, a HER2-positive breast cancer vaccine, recently granted FDA Fast Track designation. GLSI's Fast Track status offers regulatory advantages but ...
Nasdaq

Greenwich LifeSciences’ GLSI-100 Granted US FDA Fast Track Designation

STAFFORD, Texas, Sept. 10, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, ...