NEW YORK, Feb. 4, 2025 -- Pomerantz LLP announces that a class action lawsuit has been filed against ESSA Pharma Inc. ("ESSA" or the "Company") (NASDAQ: EPIX) and certain officers. The class action, filed in the United States District Court for the Eastern District of Wisconsin, and docketed under 25-cv-00124, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired ESSA securities between December 12, 2023 and October 31, 2024, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the 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 top officials.
If you are an investor who purchased or otherwise acquired ESSA securities during the Class Period, you have until March 25, 2025 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
[Click here for information about joining the class action]
ESSA is a clinical stage pharmaceutical company that focuses on the development of small molecule drugs for the treatment of prostate cancer. At all relevant times the Company's lead product candidate was masofaniten (EPI-7386), an investigational, oral, small molecule inhibitor of the androgen receptor, which plays a pivotal role in the development and progression of prostate cancer, especially castration-resistant prostate cancer ("CRPC").
ESSA was evaluating masofaniten in various clinical trials as a monotherapy and combination therapy for the treatment of prostate cancer. These trials included, among others, EPI-7386-CS-010 (the "M-E Combination Study"), a Phase 1/2 study of masofaniten in combination with enzalutamide compared with enzalutamide alone in patients with metastatic CRPC.
Phase 1 of the M-E Combination Study was a single-arm dose escalation study of masofaniten in combination with a fixed dose of enzalutamide. Based on results from the Phase 1 portion of the M-E Combination Study, ESSA purportedly identified a recommended Phase 2 combination dose of masofaniten 600 mg twice daily combined with enzalutamide 160 mg once daily ("QD"). Phase 2 of the M-E Combination Study compared this recommended combination dose with a 160 mg QD enzalutamide monotherapy—the standard of care for the intended patient population. The primary endpoint of Phase 2 of the M-E Combination Study was the proportion of patients reaching "PSA90," which refers to deep prostate-specific antigen ("PSA") response with a greater than or equal to 90% decline in PSA. PSA90 is an important indicator of a patient's response to prostate cancer treatment.
Because masofaniten was ESSA's lead and most advanced product candidate, establishing its clinical, regulatory, and commercial viability was of central importance to Defendants and investors alike. Indeed, according to ESSA's website, apart from masofaniten, the Company only has two other product candidates, each of which is still in early development at either the research or preclinical stage
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: (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; and (v) as a result, Defendants' public statements were materially false and misleading at all relevant times.
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 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."
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.
Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. 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 in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com.
Attorney advertising. Prior results do not guarantee similar outcomes.
CONTACT:
Danielle Peyton
Pomerantz LLP
dpeyton@pomlaw.com
646-581-9980 ext. 7980
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