Maxim Group initiated coverage of Fennec Pharmaceuticals (NASDAQ:FENC) with a “buy” rating and price target of $12. The stock closed at $6.27 on April 16.
Fennec is developing PEDMARK, a unique formulation of sodium thiosulfate, for the prevention of cisplatin-induced ototoxicity, or hearing loss, in pediatric patients. PEDMARK has two positive Phase 3 studies to support regulatory approval.
Analyst Naureen Quibria, Ph.D., writes that Fennec first filed an NDA for PEDMARK in February 2020, but received a complete response letter in August, related to manufacturing issues.
“In our view, 2021 will be a ‘do-over’ year for Fennec,” Dr. Quibria said, with the company set to resubmit the NDA in the second quarter of 2021. “We expect approval in the second half of 2021, transforming the company from a clinical development company to a commercial one,” she added.
“We believe the manufacturing issues will be fully addressed and the risk/reward scenario is attractive,” Dr. Quibria said. “We would be buyers of Fennec shares ahead of the regulatory outcome.”