Spero Therapeutics, Inc.

On October 28, 2021, Spero announced that it had submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for its urinary tract infection treatments, tebipenem HBr.

On March 31, 2022, Spero released its fourth quarter and full year 2021 financial results, disclosing that the FDA had notified the Company that it had “identified deficiencies” in the NDA “that preclude discussion of labeling and post-marketing requirements/commitments.”

On this news, Spero’s stock fell $1.59, or 18.27%, to close at $7.11 per share on April 1, 2022.

Then, on May 3, 2022, Spero issued a press release announcing “that it will immediately defer current commercialization activities for tebipenem HBr based on feedback from a recent Late Cycle Meeting with the [FDA] regarding Spero’s [NDA] for tebipenem HBr[,]” and that, “[a]lthough the review is still ongoing and the FDA has not yet made any final determination regarding approvability, the discussion suggested that the data package may be insufficient to support approval during this review cycle.” Spero also disclosed that it would be “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 stock fell $3.25, or 63.65%, to close at $1.85 per share on May 3, 2022, thereby injuring investors further.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) the data submitted in support of the Tebipenem HBr NDA were insufficient to obtain FDA approval; (2) accordingly, it was unlikely that the FDA would approve the Tebipenem HBr NDA in its current form; (3) the foregoing would necessitate a significant workforce reduction and restructuring of Spero’s operations; and (4) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.