Share of Veru Inc. (VERU) plunged 31.0% toward a 2 1/2-year low in premarket Friday, after the U.S. Food and Drug Administration turned down the biopharmaceutical company's request for Emergency Use Authorization (EUA) for sabizabulin, its treatment for hospitalized patients with COVID-19 who are at high risk for Acute Respiratory Distress Syndrome (ARDS). The company said that although the FDA declined the EUA request, "the FDA remains committed to working with the company for the development of sabizabulin." Separately, the company expects to soon provide details of the timing and design of a proposed confirmatory Phase 3 study it submitted, that could support a new EUA authorization. The stock has already tumbled 31.3% over the past three months through Thursday, while the iShares Biotechnology exchange-traded fund (IBB) has shed 7.3% and the S&P 500 has slipped 2.2%.
Veru Provides FDA Update on Request for Emergency Use Authorization for Sabizabulin for Hospitalized COVID-19 Patients at High Risk for ARDS
MIAMI, FL, March 02, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced that the U.S. Food and Drug Administration (FDA) has declined to grant at this time the Company's request for Emergency Use Authorization (EUA) for sabizabulin, Veru's novel microtubule disruptor, to treat hospitalized adult patients with moderate to severe COVID-19 who are at high risk for Acute Respiratory Distress Syndrome (ARDS).
In communicating its decision, the FDA stated that despite the FDA declining to issue an EUA for sabizabulin at this time, the FDA remains committed to working with the Company for the development of sabizabulin.
Separately, the FDA also provided comments on a proposed confirmatory Phase 3 study protocol submitted by the Company for hospitalized moderate to severe COVID-19 patients at risk for ARDS and death that could support a new EUA authorization and/or NDA approval. FDA stated that in the potential confirmatory Phase 3 clinical study design: "strong consideration should be given to appropriate time frames for interim analyses so that -- should a strong efficacy signal again be observed -- the trial could be stopped in an efficient time frame." Veru expects to communicate the details of the design and timing of this potential Phase 3 confirmatory study soon. It should be noted that in the U.S. Department of Health and Human Services' (HHS) fact sheet published on February 9, 2023, HHS and FDA made clear that FDA's ability to continue authorizing new COVID-19 therapeutics for emergency use is not impacted by the ending of the declaration of the U.S. public health emergency on May 11, 2023.
"Our team has applied its scientific rigor and clinical expertise to expeditiously investigate sabizabulin, a microtubule disruptor, for the treatment of hospitalized critically ill COVID-19 patients during the pandemic," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "We are disappointed in the FDA's decision to decline the request for an EUA because of the possibility of unknown influences, or uncertainties that may have affected the study as FDA agreed upon its review that our Phase 3 study met its primary endpoint and could not be invalidated by any known influences(1) , and we followed the unanimous recommendation of the Independent Data Monitoring Committee to stop the Phase 3 study because of clear clinical benefit. During our May 10, 2022 pre-EUA meeting with the FDA, the Agency indicated that our clinical data package was sufficient to support an EUA submission. Unfortunately, COVID-19 remains a serious threat as the third leading cause of death in the U.S. with over 250,000 lives lost in 2022. We lost 510 Americans to COVID-19 just yesterday despite existing FDA authorized and approved standard of care treatments. We reaffirm our strategy to deliver sabizabulin, a potentially life-saving treatment, to this vulnerable patient population facing inadequate therapeutic options to address the threat of ARDS and death from COVID-19. To that end, we will work closely with the FDA to gain clarity on advancing our sabizabulin program toward a potential new request for an EUA and an NDA submission."
Sabizabulin for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for ARDS is currently under regulatory review for potential emergency authorization by other regulatory agencies outside the U.S. |
