Stock of Veru Inc. (NASDAQ: VERU) fell -55.56% to $6.67 on Thursday following the rejection of its medicine.
Which authorization has VERU been unable to secure?
The U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) met yesterday to review sabizabulin for Emergency Use Authorization (EUA) in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS), according to Veru Inc. (VERU), which released the outcomes of the meeting. By an 8–5 margin, the advisory committee decided that sabizabulin’s known and prospective advantages do not exceed its known and possible disadvantages when used to treat adult patients hospitalized with COVID-19 who are at high risk of developing ARDS.
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However, there was also further debate on the clinical trial design elements of a prospective post-authorization necessity for another clinical study. The FDA will take the advisory committee’s suggestions into account while reviewing the EUA and making a determination on the Emergency Use Authorization. With its unique ability to disrupt microtubules and reduce viral replication regardless of virus strain, sabizabulin has great potential.
Sabizabulin decreased absolute mortality at 60 days by 20.5% in a newly published well-executed double-blind placebo-controlled study of patients with respiratory impairment and at high risk of developing ARDS, as opposed to a reduction of 0-6% for all other medications. There has never been a medicine that demonstrated such a pronounced level of protection in the lengthy history of pharmacological trials conducted for patients with severe respiratory failure over many decades.
International regulatory activities:
On July 25, 2022, VERU was notified by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) that the sabizabulin marketing authorization application will undergo a speedier assessment. Sabizabulin therapy for hospitalized COVID-19 patients for emergency usage in European Union nations is now being reviewed, according to The European Medicines Agency’s Emergency Task Force, which started its evaluation on July 27, 2022. Sabizabulin therapy in hospitalized COVID-19 patients at high risk for ARDS qualifies for an accelerated, provisional registration regulatory pathway, according to a ruling made on August 22, 2022, by Australia’s Therapeutic Goods Administration (TGA).
How will VERU evolve going forward?
Veru Inc (VERU) will keep collaborating with the FDA in order to make sure that this medicine is made promptly accessible to patients. VERU urged that there is an urgent need for newer therapies with much greater effectiveness than what is currently available in the still-evolving COVID-19 pandemic that claims the lives of over 300 U.S. citizens every day and with the threat of new virus variants looming that may not be as easily treated with the constrained array of presently used therapies.