PR Newswire·Mar 19, 2026, 7:00 AM ET

Armata Pharmaceuticals Delays Announcement of Fourth Quarter and Full-Year 2025 Results and Provides Corporate Update

ARMP

Armata Pharmaceuticals announced a delay in releasing financial results for the fourth quarter and full year ended December 31, 2025, with the Form 10-K filing expected by March 31, 2026.
The FDA granted Qualified Infectious Disease Product (QIDP) designation to AP-SA02, a multi-phage candidate for treating complicated Staphylococcus aureus bacteremia (SAB), making it eligible for a five-year market exclusivity extension under the GAIN Act.
Armata submitted a request for Fast Track Designation for AP-SA02 to facilitate potential accelerated approval of its Biologics License Application (BLA).
Following an End-of-Phase 2 meeting, the FDA confirmed that Phase 2a diSArm study data supports advancing AP-SA02 into a Phase 3 superiority trial against the current standard of care, anticipated to start in the second half of 2026.
The company's Los Angeles cGMP manufacturing facility has been formally commissioned with completed production runs to support future clinical trials & commercialization.
Positive Phase 2a diSArm study results showed AP-SA02 combined with Best Available Antibiotic Therapy achieved higher cure rates & 100% response without relapse compared to placebo, alongside trends toward rapid normalization of mortality predictors.
Armata hosted a Key Opinion Leader webinar on redefining the standard of care for complicated S. aureus bacteremia & continued collaborations to advance phage biology understanding.
CEO Dr. Deborah Birx expressed gratitude to Innoviva & the U.S. Department of Defense for their continued support in advancing the company's phage product pipeline.