After Two FDA Rejections, Fennec Pharma Lead Drug Scores US Approval For Chemo-Induced Hearing Loss

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  • The FDA approved Fennec Pharmaceuticals Inc's FENC Pedmark to reduce the risk of chemo-induced ototoxicity in pediatric patients.
  • Pedmark is indicated for pediatric patients one month of age, and older who have localized, non-metastatic solid tumors and have been treated with cisplatin infusions.
  • This approval makes Pedmark the first and only treatment approved by the FDA in this area of significant unmet medical need. 
  • The approval comes after receiving two FDA complete response letters, one in August 2020 and another in November 2021.
  • Pedmark is a formulation of sodium thiosulfate. 
  • The latest rejection came as the FDA has indicated that deficiencies have been identified following a recent inspection of the drug product manufacturer's manufacturing facility. 
  • In its Q2 earnings report, the company said it has built out the commercial organization over the past months with key hires in sales, market access, and field-based medical teams.
  • Price Action: FENC shares are up 9.44% at $8.35 on the last check Wednesday.
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