(RTTNews) - Armata Pharmaceuticals (ARMP) announced the conclusion of an End-of-Phase 2 written response from the FDA and plans to advance the company's intravenously-administered Staphylococcus aureus bacteriophage product candidate, AP-SA02, into a Phase 3 clinical study in complicated S. aureus bacteremia. The Phase 3 study is anticipated to initiate in the second half of 2026.
FDA's Center for Biologics Evaluation and Research division confirmed that the safety and efficacy data from Armata's Phase 2a diSArm study support advancement to Phase 3. Also, the FDA provided critical guidance on key elements of the Phase 3 study design. The company noted that the FDA included recommendations for the future Biologics License Application and is amenable to Armata submitting a request for Qualified Infectious Disease Product Designation for AP-SA02.
In pre-market trading on NYSE American, Armata Pharmaceuticals shares are up 5.9 percent to $7.01.
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