Spero Therapeutics Shares Jump After Upbeat FDA Feedback For Tebipenem HBr Program

Spero Therapeutics Inc SPRO received minutes from a recent Type A meeting with the FDA, discussing steps required to resubmit the marketing application for tebipenem HBr for complicated urinary tract infection (cUTI).
During the Type A meeting, the FDA indicated that positive results from an additional Phase 3 trial supported by confirmatory nonclinical efficacy evidence could be sufficient to support the approval of tebipenem HBr for cUTI, including pyelonephritis for a limited use indication.
Spero and the FDA also aligned the key components of the proposed pivotal Phase 3 trial design, which may be the subject of a Special Protocol Assessment request, to be confirmed once the clinical protocol is finalized.
Spero received a Complete Response Letter from the FDA in June 2022, citing data from Spero's initial Phase 3 cUTI clinical trial, ADAPT-PO, that were insufficient to support approval.
Also read: FDA Identifies Review Issues For Spero's Tebipenem Application, Shares Plunge.
Spero plans to advance tebipenem HBr's clinical development and potential commercialization through external partnership.
If approved, tebipenem HBr would be the first oral carbapenem antibiotic to receive FDA approval.
Price Action: SPRO shares are up 10.50% at $0.80 on the last check Tuesday.