NASDAQ:VERU – VERU INC. shares are trading more than 20% higher on news that the FDA suggested they fast track to Phase 3 clinical trials. The stock is trending

FDA States that Veru Should Submit Request for Emergency Use Authorization (EUA) Based on Positive Efficacy and Safety Data from the Phase 3 Clinical Study of Sabizabulin in Hospitalized COVID-19 Patients

— FDA Agrees that No Additional Efficacy Studies or Safety Data are Required to Support a Request for EUA

— A Request for EUA is Planned for Submission in Calendar 2Q 2022–

–Company Plans to Meet with U.S. and Ex-U.S. Government Officials to Discuss Advance Purchase Agreements

–The Company has a Planned Investors Conference Call at 8:00 AM ET on May 12, 2022 and will Discuss the Outcome of the FDA Meeting and Next Steps

MIAMI, May 11, 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 in a Pre-EUA meeting held May 10, 2022, FDA has agreed that the efficacy and safety data from the completed Phase 3 clinical study in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome are sufficient to support the submission of a request for Emergency Use Authorization (EUA).

Read entire article here: https://www.globenewswire.com/news-release/2022/05/11/2440597/11676/en/FDA-States-that-Veru-Should-Submit-Request-for-Emergency-Use-Authorization-EUA-Based-on-Positive-Efficacy-and-Safety-Data-from-the-Phase-3-Clinical-Study-of-Sabizabulin-in-Hospital.html

RelatedNews

Signup today for free and be the first to get notified of breaking news.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

SIGN UP FOR OUR NEWSLETTER

Sign up for Breaking Alerts, our newsletter putting timely and updated stock and crypto markets news into your hands.

Add New Playlist