Fulcrum Therapeutics, Evofem Biosciences Drug Candidates Receive FDA Fast Track Designation

  • The FDA has granted Fast Track designation to Fulcrum Therapeutics Inc's FULC losmapimod for the potential treatment of facioscapulohumeral muscular dystrophy (FSHD).
  • Fulcrum is on track to report full data from the ReDUX4 Phase 2b trial at the virtual FSHD International Research Congress to be held next month.
  • Losmapimod previously received Orphan Drug Designation for FSHD.
  • Losmapimod is a selective p38α/β mitogen-activated protein kinase (MAPK) inhibitor exclusively in-licensed from GlaxoSmithKline plc GSK.
  • Evofem Biosciences Inc's EVFM EVO100 to prevent urogenital gonorrhea in women also received the Fast Track tag from the FDA.
  • Phase 3 trial of EVO100 for prevention of chlamydia and gonorrhea in women is currently enrolling.
  • The Company expects to complete enrollment by year-end 2021 and to report top-line data in mid-2022, with potential marketing application submission by the end of 2022.
  • EVO100 previously received the FDA Fast Track designation for the prevention of chlamydia in women. It was also designated as a Qualified Infectious Disease Product for the prevention of gonorrhea in women.
  • Price Action: FULC shares closed 0.38% lower at $10.40, while EVFM shares closed 0.81% higher at $1.25 on Wednesday.
Market News and Data brought to you by Benzinga APIs
Posted In: BiotechNewsPenny StocksHealth CareSmall CapFDAGeneralBriefsFast Track DesignationFDA Fast Trackmuscular dystrophy
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!