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

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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