Recap Of Friday’s Biotech Catalysts – End Of The Day Summary
Bristol Myers Squibb (NYSE:BMY) received European Medicines Agency (EMA) Positive CHMP Opinion recommending approval for Opdualag (nivolumab and…
Recursion Gains European Commission Orphan Drug Status For Rare Tumor Candidate
Recursion (NASDAQ: RXRX) received Orphan Drug Designation for REC-4881 from the European Commission towards the potential treatment of familial adenomatous polyposis (FAP).
Aytu BioPharma Commences Late-Stage Genetic Disorder Study
Aytu BioPharma (NASDAQ: AYTU) has initiated the global Phase 3 PREVEnt clinical trial of Enzastaurin (AR101) for the treatment of patients with COL3A1-positive Vascular Ehlers-Danlos Syndrome (VEDS).
Rhythm Shares Shoot Higher Following Pre-marketing Authorization From French Regulatory For Multisystem Disorder Candidate
The French National Agency for Medicines and Health Products Safety (ANSM) and Haute Autorité de santé (HAS) have granted pre-marketing authorization AP1 (early access authorization), for Rhythm Pharmaceuticals’ (NASDAQ: RYTM) lead candidate IMCIVREE (setmelanotide) in patients with genetically-conf
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.
Impel Commences Mid-Stage Autism Spectrum Disorder Study
Impel Pharmaceuticals (NASDAQ: IMPL) has dosed the first patient in a Phase 2a proof-of-concept study of INP105, nasal olanzapine, a widely used atypical, second-generation antipsychotic.
Apellis Shares Climb As FDA Accepts Geographic Atrophy Candidate Submission Under Priority Review
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation for Apellis Pharmaceuticals’ (NASDAQ: APLS) New Drug Application (NDA) for the intravitreal pegcetacoplan.
The regulatory agency has assigned target action date of November 26, 2022.