Armata Pharmaceuticals, Inc. (ARMP) on Thursday said the U.S. Food and Drug Administration has granted Fast Track designation to AP-SA02 for the adjunct treatment of complicated bacteremia caused by methicillin-sensitive and methicillin-resistant S. aureus.
The company's shares were more than 9% up in pre-market trading.
The company said the designation allows more frequent interactions with the FDA and permits rolling review of the biologics license application, potentially speeding up the approval process.
Armata had previously reported positive results from its Phase 2a diSArm study. It now plans to advance AP-SA02 into a Phase 3 superiority study in complicated S. aureus bacteremia, with initiation expected in the second half of 2026.
Armata stock closed at $9.06 on Wednesday, down 3.21%.
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