Fennec Pharma Refiles Pedmark US Application For Cisplatin-Induced Ototoxicity In Pediatric Patients

Fennec Pharmaceuticals Inc FENC has resubmitted its marketing application to the FDA seeking approval for Pedmark (formulated sodium thiosulfate) for the prevention of ototoxicity (toxic to the ear) induced by cisplatin chemotherapy in patients one month, to less than 18 years, with localized, non-metastatic, solid tumors.
The resubmission follows receipt of final minutes from a Type A meeting with the FDA.
In August 2020, the company received a Complete Response Letter citing deficiencies with the facility of the drug product manufacturer.
No clinical safety or efficacy issues were identified, and there was no requirement for further clinical data.
Price Action: FENC shares are up 6.22% at $7.34 in the premarket session on the last check Friday.