
Amicus Therapeutics, Inc. (FOLD)
Whether directors and officers of Amicus Therapeutics, Inc. (FOLD) breached their fiduciary duties to the company and its shareholders.
Investigation
05/03/2022
Initial Lawsuit
05/26/2022
Lawsuit Progression
07/25/2022
We have opened an investor investigation focused on determining whether Spero communicated the truth about the approval of the Tebipenem HBr New Drug Application (NDA) for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis in its form submitted on October 28, 2021. The U.S. Food and Drug Administration (FDA) recently identified deficiencies precluding discussion of labeling and post-marketing requirements/commitments.
Investors are invited to collaborate, participate and follow the development of the subsequently filed class action lawsuit.
05/03/2022
Spero discloses 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.” The company also announced a 75% workforce reduction and a restructuring of its operations to focus on SPR720 and SPR206.
“In evaluating the efficacy of tebipenem HBr in the Phase 3 (ADAPT-PO) cUTI study, the FDA conducted a separate analysis of the microbiological intent-to-treat (micro-ITT) population, relative to the prespecified analysis as set forth in the previously submitted and reviewed protocol and statistical analysis plan for ADAPT-PO. The effect of this new analysis was to reduce 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. As a result, the FDA considers that the pre-specified non-inferiority (NI) margin of -12.5%, was not met. Spero is continuing its dialogue with the FDA, as the company seeks a pathway forward for potential approval of tebipenem HBr.”
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$1.85 | $5.09 | $-3.24 | -63.65% |
A Spero Therapeutics, Inc. investor filed a federal securities class action lawsuit on behalf of a class consisting of all persons and entities other than defendants that purchased or otherwise acquired Spero securities between October 28, 2021 and May 2, 2022, both dates inclusive.
According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors 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.
The lead plaintiff deadline has passed, we will update this page as the lawsuit progresses.
Last event retrieved on 09/28/2022.
Whether directors and officers of Amicus Therapeutics, Inc. (FOLD) breached their fiduciary duties to the company and its shareholders.
Whether directors and officers of LegalZoom.com, Inc. (LZ) breached their fiduciary duties to the company and its shareholders.
Whether directors and officers of Builders FirstSource, Inc. (BLDR) breached their fiduciary duties to the company and its shareholders.
Whether directors and officers of Kewaunee Scientific Corporation (KEQU) breached their fiduciary duties to the company and its shareholders.
Whether directors and officers of Inari Medical, Inc. (NARI) breached their fiduciary duties to the company and its shareholders.
Confidential investigation: officers & directors’ potential breach of fiduciary duties to investors.