The Manila Times

Opus Genetics Announces FDA Alignment on Phase 3 Registrational Trial Design for OPGx-LCA5 in LCA5-Associated Inherited Retinal Disease

Opus Genetics, Inc. (Nasdaq: IRD) (the "Company” or "Opus Genetics”), a clinical-stage biopharmaceutical company developing gene therapies to restore vision and prevent blindness in patients with ...
Zacks.com on MSN

GALT Jumps 11% on FDA Alignment for Belapectin Phase III Path in MASH

Galectin Therapeutics GALT shares surged 11.4% on Tuesday after the company announced it had reached alignment with the FDA ...
Yahoo Finance

OS Therapies Achieves Global Regulatory Alignment on Design of Phase 3 Trial of OST-HER2 in Fully Resected, Pulmonary Metastatic Osteosarcoma

New York, New York and Rockville, Maryland--(Newsfile Corp. - June 8, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in gene-edited, ...
Mena FN

Nervgen Pharma Announces Successful End-Of-Phase 2 Meeting And FDA Alignment On RESTORE, A Phase 3 Registrational Study Of NVG-291 For Chronic Tetraplegia

Alignment with the FDA across proposed study parameters of RESTORE, a 16-week registrational study evaluating NVG-291 in chronic tetraplegia. Primary endpoint will be the change from baseline in ...
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 ...