San Diego, CA -- (SBWire) -- 06/09/2022 --An investor, who purchased shares of Spero Therapeutics, Inc. (NASDAQ: SPRO), filed a lawsuit in the over alleged Securities Laws violations by Spero Therapeutics, Inc. in connection with certain allegedly false and misleading statements.
Investors who purchased shares of Spero Therapeutics, Inc. (NASDAQ: SPRO) have certain options and for certain investors are short and strict deadlines running. Deadline: July 25, 2022. NASDAQ: SPRO investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.
Cambridge, MA based Spero Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on identifying, developing, and commercializing treatments for multi-drug resistant (MDR) bacterial infections and rare diseases in the United States. On October 28, 2021, Spero Therapeutics, Inc. 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").
On March 31, 2022, Spero Therapeutics, Inc. announced 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."
Then on May 3, 2022, Spero Therapeutics, Inc. announced "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."
Shares of Spero Therapeutics, Inc. (NASDAQ: SPRO) declined from $19.87 on September 28, 2021, to as low as $1.00 per share on June 6, 2022.
The plaintiff claims that between October 28, 2021 and May 2, 2022, the 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, that accordingly, it was unlikely that the FDA would approve the Tebipenem HBr NDA in its current form, that the foregoing would necessitate a significant workforce reduction and restructuring of Spero's operations, and that as a result, the Company's public statements were materially false and misleading at all relevant times.
Those who purchased shares of Spero Therapeutics, Inc. (NASDAQ: SPRO) have certain options and should contact the Shareholders Foundation.
Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com
About The Shareholders Foundation
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.
NASDAQ:SPRO Investor Notice: Lawsuit Alleges Misleading Statements by Spero Therapeutics, Inc.
A lawsuit was filed on behalf of investors in Spero Therapeutics, Inc. (NASDAQ:SPRO) shares over alleged securities laws violations.