Did you lose money on investments in Veru? If so, please visit Veru Inc. Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or email@example.com to discuss your rights.
NEW YORK, Jan. 31, 2023 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP, a nationally acclaimed investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a securities class action lawsuit that has been filed on behalf of investors who purchased or acquired the common stock of Veru Inc. (“Veru” or the “Company”) (NASDAQ: VERU) between May 11, 2022 and November 9, 2022, inclusive (the “Class Period”). The lawsuit was filed in the United States District Court for the Southern District of Florida and alleges violations of the Securities Exchange Act of 1934.
Veru is primarily an oncology-based biopharmaceutical company that develops drugs for the management of breast and prostate cancers. Veru also develops medicines for COVID-19 and other diseases related to viral and acute respiratory distress syndrome (“ARDS”) and has two FDA-approved products for sexual health.
Veru “opportunistically” developed sabizabulin (VERU-111), an orally administered “microtubule disruptor” (a drug that inhibits a virus’ ability to replicate itself) for the treatment of COVID-19 in hospitalized patients at high risk for ARDS. Veru had originally developed sabizabulin with the intention of using it as a treatment for prostate cancer. In January 2022, however, the FDA granted Veru’s COVID-19 program Fast Track designation. At the time, there was no authorized or approved treatment for hospitalized patients with severe COVID-19 infections.
Plaintiff alleges that Defendants made materially false and misleading statements throughout the Class Period, as well as failed to disclose material adverse facts about the data from the sabizabulin Phase 3 trial and the Company’s interactions with the FDA. Specifically, Veru misled its shareholders to believe that the data from the Phase 3 trial was sufficient to support Emergency Use Authorization (“EUA”) and the submission of a New Drug Application (“NDA”) without any further studies. Thus, VERU’s filings concealed the true risks faced by the Company in gaining approval for its EUA request.
Veru conducted a randomized, double-blind Phase 3 trial of sabizabulin’s effectiveness in treating hospitalized adults with moderate to severe COVID-19 at high risk for ARDS. The Phase 3 study sought to enroll 210 patients and evaluate mortality after 60 days of treatment.
On April 11, 2022, Veru issued a press release announcing that the Company would be terminating sabizabulin’s Phase 3 trial early on the basis of positive interim data, after Veru’s Independent Data Safety Monitoring Committee conducted an interim analysis of the first 150 patients randomized into the study. Veru reported that sabizabulin “resulted in a clinically and statistically meaningful 55% relative reduction in deaths” relative to the placebo group (45% mortality at 60 days for the placebo group vs. 20% mortality for the sabizabulin-treated group).
On an investor call held that same day, Veru’s CEO Mitchell Steiner (“Steiner”) told investors that Veru had been in “constant dialogue with FDA” since receiving the Fast Track designation and that the Company “plan[ned] to meet with FDA to discuss the next steps”, including submitting an application for EUA on the strength of the positive Phase 3 interim results. Steiner also addressed the placebo group’s 45% mortality rate, stating that this death rate “underscores how sick these patients really are.” Veru’s share price more than doubled on April 11, 2022 to close at $12.28 per share.
On May 2, 2022, Veru announced that the FDA had granted the Company a pre-EUA meeting to discuss sabizabulin’s Phase 3 results, to be held on May 10, 2022. Veru issued a press release on May 11, 2022, announcing that in the May 10, 2022 pre-EUA meeting the FDA “agreed that the efficacy and safety data from the completed Phase 3 clinical study in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome are sufficient to support the submission of a request for Emergency Use Authorization (EUA).”
The May 11, 2022 press release further stated that the FDA had “agreed that the current safety data available for sabizabulin is sufficient to support the safety portion of a request for EUA submission” and that “additional safety data that would be collected during the use of sabizabulin under the EUA, if granted, will be sufficient to support an NDA submission, and furthermore, that no additional safety clinical studies are required.”
On June 7, 2022, Veru submitted an EUA request with the FDA for use of sabizabulin to treat COVID-19. On September 7, 2022, the FDA scheduled an October 6, 2022 meeting of the Pulmonary-Allergy Drugs Advisory Committee (“AdCom”) to vote on whether sabizabulin should be granted EUA.
On November 9, 2022, the AdCom voted against granting Veru’s EUA request by an 8-5 margin. One AdCom member who voted against approval explained that there was “no direct evidence to support [sabizabulin’s] antiviral activity.” On this news, Veru’s stock price fell almost 54% to close at $6.97 per share.
If you wish to serve as lead plaintiff, you must move the Court no later than February 6, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.
If you purchased or acquired Veru common stock, and/or would like to discuss your legal rights and options please visit Veru Inc. Shareholder Class Action Lawsuit or contact Peter Allocco at (212) 951-2030 or firstname.lastname@example.org.
Since 1993, Bernstein Liebhard LLP has recovered over $3.5 billion for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal’s “Plaintiffs’ Hot List” thirteen times and listed in The Legal 500 for ten consecutive years.
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