Shares of CoLucid Pharmaceuticals, Inc. (NASDAQ:CLCD) have been riding high after the company announced positive results from the phase III study, SAMURAI, on its lead candidate, lasmiditan, for the acute treatment of migraine in adults, with or without aura.
Shares of the company hit a new 52-week high of $24.65 on Sep 6, eventually closing a little lower at $23.83. The stock has gained 123.6% on the news.
SAMURAI is the first of two phase III studies on lasmiditan, being conducted under a Special Protocol Assessment (SPA) agreement with the FDA. The study evaluated the safety and efficacy of lasmiditan (100 mg and 200 mg) in comparison to placebo.
CoLucid stated that the study met both the primary and key secondary endpoints with statistical significance. Lasmiditan was generally well tolerated with no significant difference in cardiovascular adverse events between patients dosed with lasmiditan and those on the placebo arm.
Detailed results from the study will be presented at the International Congress of the European Headache and Migraine Trust.
Meanwhile, CoLucid continues to enroll patients in the second phase III study, SPARTAN, on lasmiditan under the SPA agreement. Top-line results from the study are expected in the second half of 2017.
Lasmiditan is also being evaluated in a phase III long-term, open-label study, GLADIATOR. The study will assess the safety and efficacy of the candidate, as well as resource utilization, functional outcomes and disability. Based on the results, the company intends to build a safety database to support a New Drug Application (NDA) for lasmiditan.
As per information provided by the company in its press release, 36 million individuals in the U.S. are estimated to suffer from migraine.
Drugs currently approved to treatment migraine include Topamax, Zomig, Frova and Relpax, among others.
CoLucid currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. (NASDAQ:ANIK) , Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) . All three stocks sport a Zacks Rank #1 (Strong Buy).
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