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.
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