LEAD PLAINTIFF DEADLINE IS JULY 25, 2022
NEW YORK, June 9, 2022 /PRNewswire/ --Wolf Haldenstein Adler Freeman & Herz LLP reminds investors that a federal securities 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 a class consisting of those that purchased or otherwise acquired Spero securities between October 28, 2021 and May 2, 2022,
All investors who purchased the shares of Spero Therapeutics, Inc. and incurred losses are advised to contact the firm immediately at classmember@whafh.com or (800) 575-0735 or (212) 545-4774. You may obtain additional information concerning the action or join the case on our website, www.whafh.com.
If you have incurred losses in Spero Therapeutics, Inc., you may, no later than July 25, 2022, request that the Court appoint you lead plaintiff of the proposed class. Please contact Wolf Haldenstein to learn more about your rights as an investor in Spero Therapeutics, Inc.
PLEASE CLICK HERE TO JOIN THE CASE
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 Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis (the "Tebipenem HBr NDA").
The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that:
- the data submitted in support of the Tebipenem HBr NDA were insufficient to obtain FDA approval;
- it was unlikely that the FDA would approve the Tebipenem HBr NDA in its current form; and
- the foregoing would necessitate a significant workforce reduction and restructuring of Spero's operations.
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.
Wolf Haldenstein has extensive experience in the prosecution of securities class actions and derivative litigation in state and federal trial and appellate courts across the country. The firm has attorneys in various practice areas; and offices in New York, Chicago and San Diego. The reputation and expertise of this firm in shareholder and other class litigation has been repeatedly recognized by the courts, which have appointed it to major positions in complex securities multi-district and consolidated litigation.
If you wish to discuss this action or have any questions regarding your rights and interests in this case, please immediately contact Wolf Haldenstein by telephone at (800) 575-0735 or via e-mail at classmember@whafh.com
Contact:
Wolf Haldenstein Adler Freeman & Herz LLP
Patrick Donovan, Esq.
Gregory Stone, Director of Case and Financial Analysis
Email: gstone@whafh.com, donovan@whafh.com or classmember@whafh.com
Tel: (800) 575-0735 or (212) 545-4774
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
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SOURCE Wolf Haldenstein Adler Freeman & Herz LLP
