Spero Therapeutics Inc

NASDAQ:SPRO   3:49:59 PM EDT
1.04
-0.03 (-2.80%)
Products, Regulatory

Spero Therapeutics Receives Complete Response Letter From U.S. Food And Drug Administration For Tebipenem HBr New Drug Application

Published: 06/27/2022 20:52 GMT
Spero Therapeutics Inc (SPRO) - Spero Therapeutics Receives Complete Response Letter From U.S. Food and Drug Administration for Tebipenem Hbr New Drug Application.
Spero Therapeutics Inc - Intends to Promptly Request a Type a Meeting With FDA.
Spero Therapeutics - in Crl, FDA Communicated That It Had Completed Its Review of NDA and Determined That NDA Could Not Be Approved in Its Present Form.
Spero - in Crl, FDA Ultimately Concluded That Co's Phase 3 Cuti Study of Tebipenem Hbr Was Insufficient to Support Approval.
Spero Therapeutics Inc - Tebipenem Hbr Remains an Important Part of Spero Pipeline.