NEW YORK, May 30, 2022 /PRNewswire/ — Pomerantz LLP announces that a class action lawsuit has been filed against Spero Therapeutics, Inc. (“Spero” or the “Company”) (NASDAQ: SPRO) and certain of its officers. The class action, filed in United States District Court for the Eastern District of New Yorkand registered under number 22-cv-03125, is on behalf of a class consisting of all persons and entities other than defendants who purchased or otherwise acquired Spero securities between October 28, 2021 and May 2, 2022both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of federal securities laws and to pursue remedies under Sections 10(b) and 20(a). ) of the Securities Exchange Act of 1934 (the “Exchange Act”) and rule 10b-5 promulgated thereunder, against the Company and certain of its principal officers.
If you are a shareholder who purchased or otherwise acquired Spero securities during the Class Period, you have until July 25, 2022 ask the court to name you as the lead plaintiff for the class. A copy of the complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those making inquiries by email are encouraged to include their mailing address, phone number and number of shares purchased.
Spero, a clinical-stage biopharmaceutical company, is focused on identifying, developing and commercializing treatments for multidrug-resistant bacterial infections and rare diseases in United States. The Company’s product candidates include Tebipenem Pivoxil Hydrobromide (HBr), an oral carbapenem antibiotic for treating complicated urinary tract infections, including pyelonephritis in adults.
On October 28, 2021Spero announced that it has 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 “NDA Tebipenem HBr”).
The Complaint alleges that, throughout the Class Period, the Defendants made materially false and misleading statements regarding the company’s business, operations and prospects. Specifically, the defendants made false and/or misleading statements and/or failed to disclose that: (i) the data submitted in support of the Tebipenem HBr NDA was insufficient to obtain FDA approval; (ii) as a result, it was unlikely that the FDA would approve the NDA Tebipenem HBr in its current form; (iii) the foregoing would require significant downsizing and restructuring of Spero’s business; and (iv) as a result, the Company’s public statements were materially false and misleading at all material 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 revealed that “[t]The U.S. Food and Drug Administration (FDA) has informed Spero that, in its ongoing review of Spero’s New Drug Application (NDA) for tebipenem HBr, it has identified deficiencies that prevent discussion labeling and post-marketing requirements/commitments at this stage. time.”
At this news, Spero’s share price plummeted. $1.59 per share, or 18.27%, to close at $7.11 per share on First of April2022.
Then on May 3, 2022Spero issued a press release announcing “it will immediately postpone current commercialization activities for tebipenem HBr based on feedback from a recent end-of-cycle meeting with the U.S. Food and Drug Administration (FDA) regarding Spero’s new drug application (NDA) for tebipenem HBr[,]” and that, “[a]Although the review is still ongoing and the FDA has not yet made a final decision regarding approval, the discussion suggested that the data set may be insufficient to support approval in this cycle. of examination. Specifically, the FDA advised the company, in relevant part, that the FDA’s separate analysis of the relevant study population had “reduced[d] the number of evaluable patients in the primary analysis population compared to those resulting from the pre-specified micro-ITT population of the trial, as indicated in the statistical analysis plan and [a]Accordingly, the FDA considers that the pre-specified non-inferiority margin of -12.5% was not met.” Further, the press release stated that, “[i]As part of this development, Spero has announced that it is undertaking a workforce reduction of approximately 75% and a restructuring of its operations to reduce operating costs and reallocate resources.”
At this news, Spero’s share price plummeted. $3.24 per share, i.e. 63.65%, to close at $1.85 per share on May 3, 2022.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Parisand Tel Aviv, is recognized as one of the leading law firms in the areas of corporate litigation, securities and antitrust. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues the tradition he established, fighting for the rights of victims of securities fraud, breaches of fiduciary duty and corporate misconduct. The firm recovered numerous multimillion-dollar damages on behalf of class members. See www.pomlaw.com
Robert S. Willoughby
888-476-6529 ext. 7980
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SOURCE Pomerantz LLP