May 14 Clinical Quick Takes: Myovant, Solid, Minerva, Modus, Zealand

Myovant tumbles after Phase III uterine fibroid data
Myovant Sciences Ltd. (NYSE:MYOV) lost $4.39 (25%) to $12.83 Tuesday despite reporting that relugolix (TAK-385) met the primary endpoint of a better response rate than placebo in the Phase III LIBERTY 1 trial to treat uterine fibroids (73.4% vs. 18.9%, p<0.0001). Relugolix missed the secondary endpoint of reducing uterine fibroid volume vs. placebo, but met six other secondary endpoints. While the once-daily oral GnRH receptor antagonist offers a convenience advantage over oral GnRH receptor antagonist Orilissa elagolix, which is given twice daily, relugolix's response rate compared with 68.5-76.2% rates seen in Phase III trials of Orilissa. AbbVie Inc. (NYSE:ABBV) plans to submit an application to FDA for Orilissa in uterine fibroids mid-year, and Myovant plans an NDA submission in 4Q19 (see "AbbVie's Elagolix Meets in Second Phase III for Uterine Fibroids").

Solid falls on serious adverse event in DMD trial
Solid Biosciences Inc. (NASDAQ:SLDB) lost $2.53 (29%) to $6.32 Tuesday after disclosing in its 1Q19 earnings report that a Duchenne muscular dystrophy patient experienced a treatment-related serious adverse event of transient bilirubin increase greater than twice the upper limit of normal after receiving SGT-001 in the second cohort of the Phase I/II IGNITE DMD trial. SGT-001 is a gene therapy delivered via an adeno-associated viral (AAV) vector designed to stabilize the dystrophin glycoprotein complex by delivering microdystrophin. ...