Fennec Pharma Stock Is Trading Higher As Pedmark Is Under FDA Review For Chemo-Induced Toxicity

The FDA has accepted for review Fennec Pharmaceuticals Inc's FENC resubmitted marketing application seeking approval for Pedmark (formulated sodium thiosulfate) to prevent ototoxicity induced by cisplatin chemotherapy.
The application covers patients one month to < 18 years of age with localized, non-metastatic, solid tumors.
The agency's target action date is set for November 27.
If approved, Pedmark stands to be the first FDA-approved therapy to reduce the risk of cisplatin-induced ototoxicity in pediatric patients, the company said.
The FDA has granted Pedmark both Fast Track Designation and Breakthrough Therapy Designation.
The Complete Response Letter received in August 2020 referred to 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 4.83% at $6.95 during the premarket trading session on the last check Tuesday.