Important Biotech Catalysts For September 15, 2022 – End Of The Day Summary
Pfizer (NYSE:PFE) announced positive top-line results from the pivotal Phase 3 trial assessing the safety, tolerability, and immunogenicity…
Important Biotech Catalysts For September 14, 2022 – End Of The Day Summary
The U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of TRACON’s (NASDAQ:TCON)…
Eloxx Shares Plummet As Mid-Stage Cystic Fibrosis Study Results Miss Efficacy Endpoints
Eloxx Pharmaceuticals (NASDAQ: ELOX) announced topline results from the Phase 2 clinical trial of ELX-02 in combination with ivacaftor in Class 1 cystic fibrosis (CF) patients with at least one nonsense mutation.
FDA Grants Orphan Drug Status To Centessa’s Hemophilia B Candidate
Centessa Pharmaceuticals (NASDAQ: CNTA) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to SerpinPC for the treatment of hemophilia B.
A Phase 2a proof-of-concept study evaluated SerpinPC in severe hemophilia A and B patients not on prophylaxis.
Important Biotech Catalysts For September 13, 2022 – End Of The Day Summary
Akero Therapeutics (NASDAQ:AKRO) revealed topline data from HARMONY, a 24-week Phase 2b study evaluating the efficacy and safety…
GENFIT Gets FDA Orphan Drug Status For Liver Disease Candidate
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to GENFIT’s (NASDAQ: GNFT) drug candidate GNS5611 (ezurpimtrostat) for the treatment of cholangiocarcinoma.
Conformis Shares Shoot Higher Following FDA Clearance For Actera Hip System
Conformis (NASDAQ: CFMS) has received 510(k) clearance from the U.S. Food and Drug Administration for its Actera Hip System.
Actera utilizes an advanced tri-taper femur stem design that facilitates direct anterior approach total hip arthroplasties, and provides an additional stem option to orthopedic surgeons.
Syros Shares Soar As FDA Grants Orphan Drug Status To Pancreatic Cancer Candidate
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Syros Pharmaceuticals (NASDAQ: SYRS) lead candidate SY-5609 for the treatment of pancreatic cancer.
Merck Secures Canadian Regulatory Nod For KEYTRUDA In Skin Cancer After Resection
Health Canada has granted approval for Merck’s (NYSE: MRK) KEYTRUDA (pembrolizumab) for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection.