$VERU Phase 3 Green Flag News on Sabizabulin

Earlier in this week, $VERU got some great news, and yet the stock finished down for the week:

UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) Supports Expedited Review of Marketing Authorization Application for Sabizabulin Treatment in Hospitalized COVID-19 Patients
Veru Inc.
Mon, July 25, 2022 at 7:30 AM


MIAMI, July 25, 2022 (GLOBE NEWSWIRE) – Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers, today announced that the United Kingdom’s (UK’s) Medicines and Healthcare Products Regulatory Agency (MHRA) considers that the currently available safety and efficacy data will support an expedited review of the marketing authorization application for the Company’s sabizabulin treatment in hospitalized COVID-19 patients at high risk for Acute Respiratory Distress Syndrome (ARDS) when the application is submitted.

“We are pleased that the MHRA has agreed to support the expedited review of our sabizabulin UK marketing authorization submission. With this decision, we plan to proceed toward the submission of our application as soon as possible,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “COVID infections are sharply rising in the UK. Unfortunately, the death rate in hospitalized patients with moderate to severe COVID-19 who are at risk for ARDS remains unacceptably high with current standard of care. By reducing deaths in hospitalized COVID-19 patients, sabizabulin has great potential to play a critical role in the battle against COVID-19 in the UK and elsewhere.”


The Company has completed a positive Phase 3 COVID-19 study in hospitalized moderate to severe COVID-19 patients at high risk for ARDS.

A double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial was conducted in approximately 210 hospitalized COVID-19 patients with moderate to severe COVID (= WHO 4-supplemental oxygen) at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Based on a planned interim analysis of the first 150 patients randomized, the Independent Data Monitoring Committee unanimously halted the study for overwhelming efficacy and safety. Treatment with sabizabulin 9mg once daily, an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and antiviral properties, resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths. On June 7, 2022, the Company submitted a request for emergency use authorization to FDA. On July 6, 2022, the Company announced the publication of the Phase 3 COVID-19 trial results evaluating the efficacy and safety of oral sabizabulin in The New England Journal of Medicine Evidence®.

$VERU daily chart is setting up nicely way down at the bottom of the chart with the Slow Stochastic (5,1) about to turn positive in the BUY ZONE. (See green circle on study.)


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