Primärquellen-Eintrag
FDA's written EOP2 response confirms Phase 2a diSArm data support advancement of AP-SA02 to Phase 3. The Company plans to initiate a superiority study versus standard-of-care in complicated S. aureus bacteremia in the second half of 2026, marking the first bacteriophage candidate to reach Phase 3.
EX-99.1 2 tm262898d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Armata Pharmaceuticals Announces End-of-Phase 2 Meeting with FDA and Plans to Advance AP-SA02 to a Phase 3 Superiority Study in Complicated Staphylococcus aureus Bacteremia FDA agreed that data from the Phase 2a diSArm study support advancement of AP-SA02 to a Phase 3 study First bacteriophage company to advance a clinical candidate to Phase 3 LOS ANGELES, Calif., January 13, 2026 -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) (“Armata” or the “Company”), a late clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced the conclusion of an End-of-Phase 2
Armata erhält FDA Breakthrough Therapy Designation für AP-SA02
Armata Pharmaceuticals: AP-SA02 erhält FDA Fast-Track-Status
Armata reicht Phase-3-Protokoll für AP-SA02 ein; Studienstart H2 2026
Armata erhält FDA-Zustimmung zum vereinbarten iPSP für AP-SA02
Armata erhält FDA Fast Track & QIDP für AP-SA02
Armata Pharmaceuticals erhält FDA Fast-Track-Designation für AP-SA02
Armata erhält QIDP-Designation für AP-SA02 bei komplizierter SAB
Armata erhält FDA QIDP-Designation für AP-SA02