NEW YORK, Jan. 27, 2025 (GLOBE NEWSWIRE) — Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Eastern District of Wisconsin on behalf of all persons or entities who purchased or otherwise acquired ESSA Pharma Inc. (“ESSA” or the “Company”) (NASDAQ: EPIX) securities between December 12, 2023 and October 31, 2024, inclusive (the “Class Period”). The lawsuit seeks to recover damages for the Company’s investors under the federal securities laws.
The Complaint alleges that 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, the Complaint alleges that the Defendants failed to disclose to investors that: (i) masofaniten in combination with enzalutamide had no clear efficacy benefit over enzalutamide alone; (ii) accordingly, masofaniten in combination with enzalutamide was less effective in treating prostate cancer than Defendants had led investors to believe; (iii) the M-E Combination Study was unlikely to meet its prespecified Phase 2 primary endpoint; (iv) accordingly, Defendants had overstated masofaniten’s clinical, regulatory, and commercial prospects.
The Complaint alleges that, on October 31, 2024, during after-market hours, ESSA issued a press release announcing its decision to terminate Phase 2 of the M-E Combination Study, citing “a protocol-specified interim review of the safety, PK [pharmacokinetics] and efficacy data, which showed a much higher rate of PSA90 response in patients treated with enzalutamide monotherapy . . . than were expected based upon historical data” and “no clear efficacy benefit seen with the combination of masofaniten plus enzalutamide compared to enzalutamide single agent.” The Complaint alleges that the Company further advised that “a futility analysis determined a low likelihood of meeting the prespecified primary endpoint of the study” and that, “[a]s part of the effort to focus its resources,” it was “planning to terminate the other remaining company-sponsored and investigator-sponsored clinical studies evaluating masofaniten either as a monotherapy or in combination with other agents.”
According to the Complaint, on this news, ESSA’s stock price fell $3.80 per share, or 73.08%, to close at $1.40 per share on November 1, 2024.
Investors who purchased or otherwise acquired shares of Regeneron should contact the Firm prior to the March 25, 2025 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 [email protected] or [email protected].
Please visit our website at http://www.gme-law.com for more information about the firm.