Shares of CoLucid Pharmaceuticals Inc (NASDAQ:CLCD) ended Friday session in green amid volatile trading. The shares closed up +1.22 points or 5.91% at $21.86 with 4.81 million shares getting traded. Post opening the session at $21.74, the shares hit an intraday low of $21.50 and an intraday high of $23.37 and the price vacillated in this range throughout the day. The company has a market cap of $355.04 million and the numbers of outstanding shares have been calculated to be 15.33 million shares.
CoLucid Pharmaceuticals Inc (CLCD) on September 6, 2016 announced that its Phase 3 pivotal study evaluating lasmiditan, the SAMURAI study, achieved both the primary and key secondary efficacy endpoints with statistical significance (p < 0.001). Lasmiditan was also well tolerated. SAMURAI was a randomized, double-blind, placebo-controlled parallel group study designed to evaluate the efficacy and safety of lasmiditan (100 mg and 200 mg) in comparison to placebo. SAMURAI is the first of two Phase 3 pivotal trials of lasmiditan, each being conducted under a Special Protocol Assessment agreement (“SPA”) with the U.S. Food and Drug Administration (“FDA”).
The primary endpoint of SAMURAI was the efficacy of lasmiditan (100 mg and 200 mg) in comparison to placebo based on freedom from migraine headache pain two hours after dosing. The key secondary endpoint was the efficacy of lasmiditan based on freedom from the most bothersome associated symptom (MBS) of migraine (nausea, phonophobia or photophobia) two hours after dosing. Data from the study were collected using electronic diaries during the treated attack. Beginning pre-dose, patients indicated their degree of headache pain on a 4-point scale: 0, no pain; 1, mild pain; 2, moderate pain; or 3, severe pain. Patients also indicated the presence or absence of nausea, phonophobia or photophobia, and at the pre-dose time point identified the associated symptom present that was “most bothersome.” At each time point assessment, patients were asked to indicate the degree of headache pain and the presence or absence of each associated symptom. The MBS endpoint was patient-centric and measured treatment effect of study drug on associated symptoms. Both the primary and key secondary endpoints of SAMURAI conform to the FDA’s Draft Guidance for Industry, Migraine: Developing Drugs for Acute Treatment, issued in October 2014.
Shares of Express Scripts Holding Company (NASDAQ:ESRX) ended Friday session in red amid volatile trading. The shares closed down -0.98 points or -1.36% at $71.13 with 4.79 million shares getting traded. Post opening the session at $71.63, the shares hit an intraday low of $70.88 and an intraday high of $71.84 and the price vacillated in this range throughout the day. The company has a market cap of $44.83 billion and the numbers of outstanding shares have been calculated to be 630.22 million shares.
Express Scripts Holding Company (ESRX) on Sept. 8, 2016 launched its Inflammatory Conditions Care Value Program℠, a comprehensive approach to control costs and improve care for people with inflammatory conditions like rheumatoid arthritis, psoriasis and Crohn’s Disease.
Through the combination of indication-specific formulary management and refunds for early discontinuation of therapy, this new program is the nation’s most comprehensive approach to better align a drug’s price with the value that drug provides a patient.
“Painful inflammatory conditions like rheumatoid arthritis can cripple patients and obliterate payer budgets,” said Glen Stettin, MD, Senior Vice President and Chief Innovation Officer at Express Scripts. “By finding creative ways to take better care of patients and protect our clients’ budgets, Express Scripts is uniquely tackling one of the biggest health challenges facing our country.”
Approximately ten million Americans live with an inflammatory condition. The biologic medications used to treat these conditions became the country’s costliest therapy class in 2015, representing 9.8 percent of all U.S. pharmacy spending. Express Scripts forecasts that, left unchecked, total U.S. spending on these medications will nearly double from 2015 to 2018.