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
Gold near US$4,066/oz and silver at US$58.88/oz (+4.45% July 22 surge on geopolitical risk and Fed expectations) are sustaining strong upward pressure…
News Wire
Filings Watch
The FDA granted accelerated approval to Vera Therapeutics' TRUTAKNA (atacicept-vymj) on July 7, 2026. The number that defined the filing: a 46% reduction from baseline in proteinuria, drawn from a…
Crystalys Therapeutics announced on July 22, 2026 a $130 million Series B financing — oversubscribed and closed — less than a year after the company launched with a $205 million Series A announced…
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.
One concise briefing. The movers, the filings, the FDA calendar.