March 29 Quick Takes: Humanigen mAb meets COVID endpoint; plus Merck, Wave, Celldex, Ionis, Orphazyme and uniQure

Humanigen Inc. (NASDAQ:HGEN) shares rose 54% to $21.61 Monday after the company said top-line data showed lenzilumab improved survival without the need for mechanical ventilation in hospitalized patients with COVID-19, meeting the Phase III trial’s primary endpoint. The placebo-controlled survival benefit was 54% ( p=0.0365). The company, which has evaluated the mAb against GM-CSF with the help of the Mayo Clinic, said it plans to seek emergency use authorization for lenzilumab as soon as possible. Humanigen closed Monday’s session with a market cap of more than $1 billion.

FDA wants more TNBC data for Keytruda
Merck & Co. Inc. (NYSE:MRK) received an FDA complete response letter for a Keytruda pembrolizumab sBLA for high-risk early stage triple-negative breast cancer. Data supporting the application — which sought approval for Keytruda in combination with chemotherapy as neoadjuvant treatment and continuation as a single agent after surgery — were based on pathologic complete response (pCR) and early interim event-free survival findings from KEYNOTE-522. The Oncologic Drugs Advisory Committee voted 10-0 in February that FDA should hold off on approval until Merck has more survival data from the trial; the next interim analysis will occur in 3Q. The setback does not affect any indications on Keytruda’s label...