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

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Fulcrum Therapeutics, Evofem Biosciences Drug Candidates Receive FDA Fast Track Designation
  • The FDA has granted Fast Track designation to Fulcrum Therapeutics Inc's (NASDAQ: 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 (NYSE: GSK).
  • Evofem Biosciences Inc's (NASDAQ: 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.
 

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