Business
Spero Therapeutics Announces Fourth Quarter and Full Year 2021 Operating Results and Provides Business Update
Provides update on ongoing FDA review of Tebipenem HBr NDA Phase 2 trial of SPR720 in nontuberculous mycobacterial-pulmonary disease on track for initiation
About this update from Spero Therapeutics, Inc.
[{"type":"text","content":"Provides update on ongoing FDA review of Tebipenem HBr NDA Phase 2 trial of SPR720 in nontuberculous mycobacterial-pulmonary disease on track for initiation in 2H 2022 following lifting of FDA clinical hold Topline results from Phase 1 bronchoalveolar lavage trial support further development of SPR206 in the setting of hospital-acquired pneumonia and ventilator-associated pneumonia Conference call and live webcast at 4:30 p.m. ET today CAMBRIDGE, Mass., March 31, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced financial results for the fourth quarter and full-year ended December 31, 2021 and provided a business update. The U.S. Food and Drug Administration (FDA) has notified Spero that, as part of its ongoing review of Spero’s New Drug Application (NDA) for tebipenem HBr, it has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review. Spero intends to work with the FDA to seek to resolve the deficiencies expeditiously. The FDA previously assigned a Prescription Drug User Fee Act (PDUFA) goal action date of June 27, 2022, for completion of its review of the NDA, and initially targeted the midpoint of that review period to communicate proposed labeling and, if necessary, any post-marketing requirement and/or commitment requests to Spero. The Company noted that there are three months remaining before the PDUFA goal action date. Spero also has a late cycle review meeting scheduled with the FDA and expects to provide an update on or before its next earnings call in May 2022. “We continue to have an active dialogue with the FDA,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero. “We are focused on doing everything we can to address the deficiencies and, given how early in the review period the labeling discussions were originally scheduled, we believe there would be sufficient time to progress to labeling discussions within the existing PDUFA timeframe. However, we do not yet know the effect of this notification, if any, on our anticipated timelines or on the ultimate approval prospects of tebipenem HBr. We continue to prepare for an anticipated commercial launch of tebipenem HBr in the second half of 2022, as we work with the ...