Small Cap Losers: RVNC, OMER, MNKD
3:02 pm Monday, October 18th, 2021
Revance Therapeutics Inc (NASDAQ:RVNC) received a Complete Response Letter from the FDA for its BLA for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines. The FDA indicated that there are deficiencies related to the FDA’s onsite inspection at co’s manufacturing facility. Co intends to request a Type A meeting with the FDA. At 52-week lows.
Omeros Corporation (NASDAQ:OMER) received a Complete Response Letter from the FDA for its BLA for narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. The FDA, in the letter, expressed difficulty in estimating the treatment effect of narsoplimab in the indication and asserted that additional information will be needed to support regulatory approval. Co plans to request a Type A meeting with the FDA. Drops to multi-year lows.
MannKind Corporation (NASDAQ:MNKD): The FDA issued a complete response to United Therapeutics (UTHR) regarding the New Drug Application for Tyvaso DPI for the treatment of pulmonary arterial hypertension and PH-ILD. United Therapeutics developed Tyvaso DPI through a collaboration and license agreement with co. The complete response did not pertain to co; no issues were cited by the FDA as it relates to co’s facility in Connecticut for manufacture, testing, and packaging of finished Tyvaso DPI, including its associated device.
