Law Offices of Howard G. Smith announces an investigation on behalf of Spero Therapeutics, Inc. (“Spero” or the “Company”) (NASDAQ: SPRO) investors concerning the Company’s possible violations of federal securities laws.

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.

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 howardsmith@howardsmithlaw.com, 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.

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