Daily Biotech Pulse: Liver Disease-Focused Gene Therapy Pact, Assembly Bio Stops HBV Infection Trial, X4 Pharma Looks For Partners
Here's a roundup of top developments in the biotech space over the last 24 hours:
Olema Oncology Receives FDA Fast Track Designation For OP-1250 For Treatment Of ER+ / HER2- Metastatic Breast Cancer
Olema Pharmaceuticals, Inc. ((&ldquo, Olema&rdquo, or &ldquo, Olema Oncology, &rdquo, NASDAQ:OLMA) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OP-1250, the
Arbutus Biopharma Provides Update On The Phase 2A Combination Trial With AB-729 And A Capsid Inhibitor
Arbutus Biopharma Corporation (NASDAQ:ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, today announced that
Soleno Shares Surge On Regulatory Update For Its Prader-Willi Syndrome Hopeful
Soleno Therapeutics Inc (NASDAQ:SLNO) provided an update following recent communications with the FDA regarding the development of once-daily DCCR (diazoxide choline)…
Merck Provides Update On Phase 3 KEYNOTE-412 Trial In Unresected Locally Advanced Head And Neck Squamous Cell Carcinoma; Trial Did Not Meet Primary Endpoint Of Event-Free Survival
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-412 trial evaluating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, with concurrent
Recap of Tuesday’s Biotech Catalysts – End Of The Day Summary
The U.S. Food and Drug Administration (FDA) has granted tentative approval to Avadel Pharmaceuticals’ (NASDAQ: AVDL) lead candidate LUMRYZ (FT218) for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
Belite Bio Seeks FDA Clearance For Late-Stage Genetic Eye Disease Study
Belite Bio (NASDAQ: BLTE) submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to support Phase 3 development of its lead asset LBS-008 for treatment of Stargardt Disease (STGD1).
Sorrento Shares Gain Following FDA’s Nod for Initial-Stage Covid-19 Study
Sorrento Therapeutics (NASDAQ: SRNE) announced that the U.S. Food and Drug Administration (FDA) has cleared the Phase 1 study of its candidate, STI-1558, in patients with impaired renal and hepatic function.