BENSALEM, Pa.–(BUSINESS WIRE)–Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Spero Therapeutics, Inc. (“Spero” or the “Company”) (NASDAQ: SPRO) securities between October 28, 2021 and May 2, 2022, inclusive (the “Class Period”). Spero investors have until July 25, 2022 to file a lead plaintiff motion.
Investors suffering losses on their Spero investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to [email protected]
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.
If you purchased Spero securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to [email protected], or visit our website at www.howardsmithlaw.com.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.