- Spero Therapeutics, Inc. ( NASDAQ: SPRO ) surged ~64% Tuesday after the clinical-stage biotech announced that the FDA agreed to review results from a single additional Phase 3 trial to support a potential marketing approval for its investigational UTI antibiotic tebipenem HBr.
- Previously, the FDA declined to approve tebipenem HBr as a treatment for adults with certain bacterial microorganisms that cause complicated urinary tract infections (cUTI), including pyelonephritis.
- In the Complete Response Letter, the agency noted that the data from SPRO’s Phase 3 cUTI clinical trial, ADAPT-PO, was inadequate to support its approval.
- However, at a subsequent Type A meeting the FDA had indicated that data from an additional Phase 3 clinical trial and confirmatory nonclinical evidence could support the approval of tebipenem HBr for a limited use indication. The company and the FDA have agreed to the main components of a design for a future Phase 3 study.
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The update clarifying the late-stage advancement for tebipenem HBr comes at a time when SPRO shares have lost more than 92% this year, as shown in this graph.
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Spero jumps 64% as FDA clarifies future regulatory path for UTI candidate