Xenon Pauses Depression Trials After Safety Signal; Stock Slides
Xenon paused new MDD and BPD enrollment after a psychiatry safety review; X-NOVA2 data expected Q1 2027.
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FDA Approves First Gene Therapy for Kids With Sanfilippo Syndrome Type A
The FDA approved Ultragenyx’s Fayuvi for Sanfilippo syndrome type A following a manufacturing-related delay in 2025. Children ages 2–5 who received the treatment maintained or improved their cognitive scores.
Novo: EU backing for new haemophilia treatment plus $1.4bn oral-drug pact
CHMP recommends FREHEMGO (denecimig) for haemophilia A, with or without inhibitors. Novo and Orbis will develop oral cardiometabolic drugs.
Nuvation Bio’s IBTROZI Label Now Shows More Than Four Years of Response
FDA approved an IBTROZI label update showing 49.7 months median response in TKI-naïve ROS1+ lung cancer. Safety language was unchanged.
Qiagen Sale Speculation: KKR, EQT and the $50 Question
Qiagen reviews options with Goldman and Moelis.
Roth Capital Starts MediciNova at Buy With $6 Target on ALS Drug
Phase 2b/3 ALS data due Q4 2026; cash runway into late 2027.