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Biotech Stocks Facing FDA Decision In August 2020

Fennec Pharmaceuticals
Fennec Pharmaceuticals

Cisplatin is the standard of care for pediatric solid tumors and is often associated with ototoxicity. It is estimated that about 60% of children on Cisplatin therapy develop irreversible ototoxicity, which manifests itself as hearing loss, sometimes accompanied by tinnitus.

Fennec Pharmaceuticals Inc. (FENC) has developed a drug for the prevention of ototoxicity induced by Cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic, solid tumors.

The drug candidate named Pedmark is under FDA priority review, with a decision expected on August 10, 2020.

There is currently no established preventive agent for this hearing loss due to chemotherapy and only expensive, technically difficult and sub-optimal cochlear (inner ear) implants have been shown to provide some benefit. If approved, Pedmark has the potential to prevent chemotherapy-induced hearing loss and be the first available agent approved for this condition.

FENC closed Friday’s (Jul.24, 2020) trading at $8.68, down 0.91%.