The company touted that the drug had met both registrational co-primary endpoints in the two trials, and said it plans to file for approval with the Food and Drug Administration in 2019, but it will also have a formidable rival in this drug category, biopharmaceutical company Allergan . Allergan announced positive late-stage results for its migraine drug, ubrogepant, in February, and also expects to file with the FDA in 2019. shares dropped nearly 23% in premarket trade Monday after the company released data from two phase 3 clinical trials for its migraine drug rimegepant.The latest results included higher revenue from Botox, Juvederm, Alloderm and Cool Sculpting and new products, Allergan said, and was partially offset by lower revenues due to patent exclusivity losses and continuing declines for Aczone and Namenda XR.Allergan expects 2018 revenue of $15 billion to $15.3 billion, compared with the Fact Set consensus of $15.33 billion, and a 2018 loss per share of $2.27 to $1.52, compared with the Fact Set consensus of a loss per share of $2.13.Abb Vie shares have surged 24.6% over the last three months, and Neurocrine shares have surged 14%, compared with a 4.5% rise in the S&P 500 .
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Allergan shares have dropped 6.6% over the last three months and Mylan shares have surged 10.9%, compared with a 5.6% rise in the S&P 500 . The therapy, elagolix, combined with low-dose hormone therapy reduced heavy menstrual bleeding in 68.5% of women, compared with 8.7% of women on the placebo.Biohaven expects to release additional results from the trials at scientific meetings this year.In mid-March, Biohaven paid Bristol-Myers Squibb Co.The latest clinical trial data for Biohaven's rimegepant appeared to have no signal of liver toxicity issues, which has been a concern with these oral drugs intended to treat acute symptoms of migraine, said Evercore ISI analyst Umer Raffat, though he noted that one of the studies had a p-value of 0.03 on a measure of freedom from pain at two hours, though the p-value threshold was 0.05.
In addition, Biohaven and Allergan's trials were not designed exactly the same, Raffat said.
The phase 3 trial, ELARIS UF-I, is the first of two late-stage studies, and the Wednesday release was based on topline results from a six-month primary analysis.