Pomerantz Appointed Lead Counsel in Spero Therapeutics Securities Litigation

On September 19, 2022, U.S. Magistrate Judge Roanne L. Mann, of the Eastern District of New York, appointed Pomerantz LLP as Lead Counsel on behalf of Kashif Memon, the Lead Plaintiff, and the class, in In re Spero Therapeutics, Inc. Sec. Litig., 22-cv-3125 (E.D.N.Y.). This securities action alleges that Spero Therapeutics ("Spero" or the "Company") misled the market regarding the regulatory and commercial prospects for Tebipenem Pivoxil Hydrobromide (“Tebipenem HBr”), an oral carbapenem-class antibiotic to treat complicated urinary tract infections, including pyelonephritis for adults.

Spero is a clinical-stage biopharmaceutical company that focuses on identifying, developing, and commercializing treatments for multi-drug resistant (MDR) bacterial infections and rare diseases, including Tebipenem HBr. In October 2021, the Company announced that it had submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections, including Pyelonephritis.

Allegations against Spero include that: (i) the data submitted by the Company in support of its NDA for Tebipenem HBr was insufficient to obtain FDA approval; (ii) accordingly, it was unlikely that the Tebipenem HBr NDA would be approved in its current form; and (iii) the foregoing would require a significant workforce reduction and restructuring of Spero’s operations.

The truth began to emerge on March 31, 2022, when Spero revealed that the FDA had notified it that, as part of its ongoing review of the NDA for Tebipenem HBr, the FDA had “identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.”

On this news, Spero’s share price fell 18.2%.

Then on May 3, 2022, Spero announced that it was immediately deferring “current commercialization activities” for Tebipenem HBr based on feedback from the FDA regarding its NDA. The Company further revealed that review of the NDA “is still ongoing and the FDA has not yet made any final determination regarding approvability,” and that “the discussion suggested that the data package may be insufficient to support approval during this review cycle.” Further, Spero revealed that, as a result of this development, it was “undertaking a reduction in its workforce by approximately 75% and a restructuring of its operations to reduce operating costs and reallocate resources.”

On this news, Spero’s share price fell a further 63.6%.