- The FDA approved Fennec Pharmaceuticals Inc's (NASDAQ: 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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After Two FDA Rejections, Fennec Pharma Lead Drug Scores US Approval For Chemo-Induced Hearing Loss
Published 21/09/2022, 18:05
After Two FDA Rejections, Fennec Pharma Lead Drug Scores US Approval For Chemo-Induced Hearing Loss
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