Armata Pharmaceuticals stock price rises due to FDA qualification recognition

Investing.com – Armata Pharmaceuticals Inc (NYSE American:ARMP) stock rose 3.1% in pre-market trading on Monday, after the company announced that the U.S. Food and Drug Administration has granted its Staphylococcus aureus multi-phage candidate product AP-SA02 Qualified Infectious Disease Product designation.

This QIDP designation applies to the intravenous use of AP-SA02 as an adjunct treatment for complicated bacteremia caused by methicillin-sensitive or methicillin-resistant Staphylococcus aureus. The designation provides a five-year market exclusivity period, as well as potential eligibility for fast track and priority review.

QIDP designation makes AP-SA02 eligible for certain incentives under the Generating Antibiotic Incentives Now Act, including an additional five-year extension of Hatch-Waxman market exclusivity. It also qualifies AP-SA02 for fast track status, which offers more frequent meetings and communication with the FDA, priority review, and rolling review, potentially accelerating the approval of its biologics license application.

Armata stated that the company plans to submit an application for fast track designation for AP-SA02 to the FDA. The company also plans to initiate a Phase 3 efficacy study later this year.

To qualify for QIDP designation, the candidate drug must be intended to treat serious or life-threatening infections, especially those caused by bacteria and fungi resistant to treatment, or infections caused by qualified resistant pathogens as determined by the FDA.

Armata is a late-stage biotechnology company focused on developing high-purity, pathogen-specific phage therapies for the treatment of antibiotic-resistant and hard-to-treat bacterial infections.

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