Key points:
- Veru shares soared around 30% on overwhelming ‘efficacy' of novel Covid-19 drug
- Phase 3 trial was cut short due to evident efficacy and no clear safety concerns
- further talks with the FDA regarding an EUA are to follow
Shares of oncology biopharmaceutical company Veru (NASDAQ: VERU) unsurprisingly soared this morning as investors reacted positively to company news regarding ‘overwhelming’ efficacy of a novel Covid-19 drug. VERU shares are currently trading at a premarket gain of 30.3%. The company is no stranger to a rally, with shares skyrocketing to a price of $20.78, somewhat dwarfing today’s price of $6.00.
The company announced positive efficacy and safety results from its planned interim analysis of a double-blind, randomized, placebo-controlled Phase 3 Covid-19 clinical trial for the drug sabizabulin. The trial was conducted with 150 hospitalized high-risk patients nearing Acute Respiratory Distress Syndrome. In a promising, often unseen turn of events, the Independent Data Safety Monitoring Committee recommended the trial could be stopped early due to evident efficacy, concluding that no safety concerns were present.
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The next steps for the company will involve further talks with the FDA, including a submission of an emergency use authorization. Things should work a little faster than normal for the company, as the FDA already granted Fast Track designation for the sabizabulin Covid-19 clinical program back in January. Since then, Veru has massively scaled-up commercial production to address the potential market.
Mitchell Steiner, Chairman, President and CEO of Veru commented:
“This study represents a significant milestone in the global fight against COVID-19 as sabizabulin is the first drug to demonstrate a clinically and statistically meaningful reduction in deaths in hospitalized patients with moderate to severe COVID-19.”
With Gary Barnette, Chief Scientific Officer of Veru adding:
“What makes these findings more relevant is that the pharmacological activity of sabizabulin is independent of COVID-19 variant type. Pending an upcoming discussion with FDA, this treatment option may be made available soon so we can be ready for when the next clinically important wave of COVID infections comes,”