- Veru Inc. ( NASDAQ: VERU ) shares lost ~14% in the morning hours Monday after the FDA postponed an Advisory Committee meeting the agency scheduled early this month to review the company's marketing application for its oral COVID-19 therapy sabizabulin.
- The FDA has pushed back the meeting of its Pulmonary -Allergy Drugs Advisory Committee by more than a month to Nov. 09 from Oct. 06.
- VERY shares plunged on Sep. 07 after the FDA first scheduled the meeting to discuss the company's emergency use authorization (EUA) application.
- With the EUA, VERU seeks FDA clearance to treat hospitalized patients with moderate to severe COVID-19 who are at risk of developing acute respiratory distress syndrome.
- The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.
For further details see:
Veru FDA AdCom meeting for COVID-19 therapy postponed