March 3 Quick Takes: Praxis aims to start Phase III essential tremor study despite Phase II miss 

Praxis Precision Medicines Inc. (NASDAQ:PRAX) will meet with FDA about starting a Phase III trial of ulixacaltamide (PRAX-944) next half despite a miss on the primary endpoint in a Phase II study to treat essential tremor. Although ulixacaltamide failed to reach significance compared with placebo on the primary endpoint measuring modified Activities of Daily Living scores (p=0.126), with a numerical trend toward improvement, the small molecule inhibitor of T-type calcium channels did show significance on an unmodified version of the scale (p=0.026). Praxis fell $1.92 (66%) to $1 on Friday.

Incyte Corp. (NASDAQ:INCY) is discontinuing the Phase III LIMBER-304 study of Jakafi ruxolitinib and parsaclisib to treat myelofibrosis in patients who have an inadequate response to Jakafi alone after an IDMC said the trial was unlikely to meet its primary endpoint. The trial was the most advanced of the company’s Jakafi myelofibrosis combination studies; behind it are Phase II trials for Jakafi in combination with BET inhibitor INCB57643 and in combination with ALK2 inhibitor INCB00928. Incyte engineered parsaclisib, a PI3K inhibitor, to avoid the toxicities that have plagued the class, and added that the decision to stop LIMBER-304 was not related to safety. ...