March 7 Quick Takes: Clinical hold weighs on Alpine
Plus Xhance meets in sinusitis and updates from Lava, Acer, Maverick and more
Shares of Alpine Immune Sciences Inc. (NASDAQ:ALPN) fell $0.68 to $6.98 Monday after FDA placed a partial clinical hold on the company’s NEON-2 trial of davoceticept (ALPN-202) in combination with pembrolizumab to treat advanced malignancies in adults following the death of a patient. Davoceticept is a CD80 variant protein engineered to conditionally co-stimulate CD28 and block PD-L1 and CTLA-4. The partial clinical hold does not affect the NEON-1 monotherapy trial.
OptiNose Inc. (NASDAQ:OPTN) said that Xhance intranasal fluticasone propionate met both co-primary endpoints of composite symptom score and objective measure of disease in the sinus cavities in the ReOpen1 Phase III trial for chronic sinusitis. The company expects to report top-line results from ReOpen2, the second Phase III trial for Xhance in 2Q22. FDA approved Xhance to treat nasal polyposis in 2017. ...