Small-cap biotech intelligence
Daily commentary on FDA decisions, trial readouts, financings and the stocks reacting to them — plus live market, filings and news trackers.
The Briefing
Market Pulse
Silver and zinc explorers dominated the CSE/TSX-V open on July 23, with back-to-back high-grade drill catalysts (DEF, ZNG, IGO) driving the strongest …
News Wire
Filings Watch
Oncolytics Biotech Inc. (Nasdaq: ONCY) received its third FDA Fast Track designation for pelareorep on July 20, 2026 — this one for pelareorep combined with a checkpoint inhibitor in patients with…
Dyne Therapeutics landed a concrete regulatory milestone on July 20, 2026: the FDA accepted its Biologics License Application for zeleciment rostudirsen — also designated DYNE-251, or z-rostudirsen —…
The FDA accepted Dyne Therapeutics' Biologics License Application for zeleciment rostudirsen on July 20, 2026, assigning a PDUFA target action date of January 21, 2027 — a hard deadline that now…
Nuvation Bio reported updated Phase 2 data for safusidenib in IDH1-mutant glioma, with a 51.9% response rate and a 79.1% three-year progression-free rate.
REGENXBIO reported long-term data showing its AbbVie-partnered gene therapy sura-vec preserved vision and cut injection burden through five years in wet AMD.
4DMT presented two-year Phase 2b PRISM data showing its gene therapy 4D-150 cut anti-VEGF treatment burden by 78% while maintaining vision in wet AMD.
Trevi Therapeutics shares climbed nearly 10% after GSK abandoned its chronic cough candidate camlipixant, removing a leading competitor to Trevi's Haduvio.
Jasper Therapeutics announced an all-stock merger with Kira Pharmaceuticals alongside a roughly $132 million private placement, reshaping its pipeline and balance sheet.
Intensity Therapeutics resumed dosing of INT230-6 in its Phase 2 presurgical triple-negative breast cancer trial under an amended, lower-dose protocol.
Celcuity won FDA approval for REVTORPYK in HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer, marking the company's first commercial product.
Q32 Bio reported 36-week Phase 2a data showing its antibody bempikibart drove meaningful hair regrowth in patients with severe alopecia areata.
Cue Biopharma announced a $50 million private placement led by Cormorant Asset Management to fund clinical development, expected to close on or about July 13, 2026.
One concise briefing. The movers, the filings, the FDA calendar.