Shareholder rights law firm Robbins LLP is investigating Spero Therapeutics, Inc. (NASDAQ: SPRO) and its officers and directors to determine whether they breached fiduciary duties or violated securities laws in making misstatements regarding FDA approval of one of its lead product candidates.

Spero is clinical-stage biopharmaceutical company that focuses on developing treatments for multi-drug resistant (MDR) bacterial infections and rare diseases in the United States. The Company's product candidates include Tebipenem Pivoxil Hydrobromide (HBr), an oral carbapenem-class antibiotic to treat complicated urinary tract infections.

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What is this Case About: According to a complaint filed against Spero, between October 28, 2021 and May 2, 2022, defendants failed to disclose that the data submitted in support of the Tebipenem HBr NDA were insufficient to obtain FDA approval and therefore, it was unlikely that the FDA would approve the Tebipenem HBr NDA in its current form. The failure to obtain FDA approval necessitated a significant workforce reduction and restructuring of Spero’s operations, and as a result, the Company’s public statements were materially false and misleading.

On March 31, 2022, Spero announced the Company's fourth quarter and full year 2021 financial results, disclosing that the FDA "has notified Spero that, as part of its ongoing review of Spero’s New Drug Application (NDA) for tebipenem HBr, it has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.” On this news, Spero’s stock price fell $1.59 per share, 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 (LCM) with the U.S. Food and Drug Administration (FDA) regarding Spero’s New Drug Application (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.” Specifically, the FDA advised the Company, in relevant part, that the FDA’s separate analysis of the relevant study population had “reduce[d] the number of evaluable patients in the primary analysis population compared with those resulting from the trial’s pre-specified micro-ITT population as outlined in the statistical analysis plan” and [a]s a result, the FDA considers that the pre-specified non-inferiority margin of -12.5% was not met.” Further, the press release advised that, “[i]n connection with this development, Spero announced that it is 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 price fell $3.24 per share, or 63.65%, to close at $1.85 per share on May 3, 2022.

Next Steps: If you acquired shares of Spero Therapeutics, Inc. (SPRO) securities between October 28, 2021 and May 2, 2022, you have legal options. Contact Robbins LLP for more information.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.

Contact us to learn more:

Aaron Dumas

(800) 350-6003

adumas@robbinsllp.com

Shareholder Information Form

About Robbins LLP: A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LLP have been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002. To be notified if a class action against Spero Therapeutics, Inc. settles or to receive free alerts when corporate executives engage in wrongdoing, sign up for Stock Watch today.

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