MarketPulse

NDA submission

4 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Gyre Therapeutics Posts 10% Revenue Growth but Guides Lower Amid Strategic Pivot

Gyre Therapeutics posts 10% FY2025 revenue growth to $116.6M, guides 2026 lower due to regulatory prioritization and Cullgen acquisition for TPD expansion.
GYRErevenue guidanceclinical trial
GlobeNewswire Inc.GlobeNewswire Inc.··Na

Cogent Biosciences Presents Expanded SUMMIT Trial Results for Bezuclastinib at 2026 AAAAI Meeting

Cogent Biosciences presented expanded SUMMIT trial data showing bezuclastinib achieved significant symptom reduction and tryptase normalization in systemic mastocytosis patients, supporting its FDA regulatory applications.
COGTdisease modificationclinical results
The Motley FoolThe Motley Fool··Jonathan Ponciano

Major Hedge Fund Exits Protagonist Position Despite 120% Stock Surge

BVF Partners liquidated its $170M Protagonist stake despite 120% gains, likely due to changing risk profile as company awaits FDA decision on blood disorder treatment.
PTGXKYMRRVMDRVMDWclinical-stage biotechhedge fund liquidation
GlobeNewswire Inc.GlobeNewswire Inc.··Clene Inc.

Clene Maps Out 2026 Regulatory Path for ALS Candidate CNM-Au8

Clene outlines 2026 regulatory milestones for ALS drug CNM-Au8, including FDA meeting, NDA submission, and Phase 3 trial, backed by $28 million funding.
CLNNFDA approvalclinical trial