NEW YORK, May 31, 2022 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a class action lawsuit has been filed against Spero Therapeutics, Inc. (“Spero” or the “Company”) (NASDAQ: SPRO) in the United States District Court for the Eastern District of New York on behalf of investors who purchased Spero stock between October 28, 2021 and May 2, 2022, inclusive (the “Class Period”).
On October 28, 20212, Spero 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 (the “Tebipenem HBr NDA”).
The Complaint alleges that Defendants made false and/or misleading statements and/or failed to disclose that: (i) the data submitted in support of the Tebipenem HBr NDA were insufficient to obtain FDA approval; (ii) accordingly, it was unlikely that the FDA would approve the Tebipenem HBr NDA in its current form; (iii) the foregoing would necessitate a significant workforce reduction and restructuring of Spero’s operations; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.
On March 31, 2022, Spero issued a press release announcing the Company’s fourth quarter and full year 2021 financial results. In the press release, Spero disclosed that “[t]he U.S. Food and Drug Administration (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 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.
Investors who purchased or otherwise acquired shares of Spero should contact the Firm prior to the July 25, 2022 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.
Please visit our website at http://www.gme-law.com for more information about the firm.
