APLIF - FDA Approval Sends Shares on a Tear

2023-09-25 09:47:15 ET

The morning opened up on a high note for this dually-listed company as it announced U.S. Food and Drug Administration (FDA) approval of its Metronidazole Oral Suspension 500mg/5mL ( ATI-1501 ). Biopharma company %AppiliTherapeutics (TSX: ) (OTCQB: ) focuses on drug development for infectious diseases and biodefense, and announced the approval along with its manufacturing and commercialization partner, Saptalis Pharmaceuticals, LLC in a press release today. The FDA also approved LIKMEZ™ as the brand name for ATI-1501.

The drug is a widely used frontline oral treatment, with over 10 million prescriptions written in the United States every year to help treat parasitic and anaerobic bacterial infections. Currently, the only other approved oral form of metronidazole in the U.S. is a tablet which has a bitter taste and lack of appropriate dosage forms for patients with difficulty swallowing and often presents treatment compliance challenges. Patent coverage provides drug market exclusivity through at least 2039. Canadian shares were trading up at the open.