VERU - Veru to move forward with studies for COVID therapy despite FDA snub

2023-03-14 16:23:10 ET

• Despite an FDA decision to reject its experimental oral COVID therapy sabizabulin early this month, Veru ( NASDAQ: VERU ) announced Tuesday it would continue to proceed with its studies targeting infectious diseases, including COVID-19.
• Citing remarks from its chief executive Mitchell Steiner, Veru ( VERU ) said it would continue to develop sabizabulin in Phase 3 confirmatory study for moderate to severe COVID-19 patients who are hospitalized and at high risk for acute respiratory disease syndrome (“ARDS”).
• Sabizabulin, which the FDA identified as a new molecular entity (NME) in 2022, will also undergo a Phase 3 trial for hospitalized influenza patients at high risk for ARDS.
• Veru ( VERU ) is ending its Phase 3 VERACITY trial for sabizabulin in prostate cancer as it plans to develop the candidate only for infectious diseases. The company has also decided to pause Phase 2 development of Veru-100 and zuclomiphene.
• Read: Seeking Alpha contributor Terry Chrisomalis reiterated his Strong Buy rating on Veru ( VERU ) despite the FDA rejection of sabizabulin.

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