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BHVN

Biohaven Pharmaceutical

$40.72

-2.17 (-5.06%)

05:44
12/10/18
12/10
05:44
12/10/18
05:44

Biohaven announces initial 'positive' results from ongoing rimegepant study

Biohaven Pharmaceutical announced initial positive results from its ongoing long-term, open-label safety study of its oral calcitonin gene-related peptide, or CGRP, receptor antagonist, rimegepant, for the acute treatment of migraine. Based upon this interim analysis of Study BHV3000-201 it appears that rimegepant may be safe and well tolerated with long-term dosing in patients with migraine. In this study, patients are allowed to treat migraine attacks of all severities up to once daily for up to a full year. The interim results also include hepatic safety and tolerability data of rimegepant 75 mg in study participants based upon review of both adverse events and regularly scheduled liver function tests. Interim hepatic data were reviewed by an external independent panel of liver experts. The panel provided a consensus opinion based upon the Drug-Induced Liver Injury Network causality assessment. The panel did not assess any liver cases as probably related to study drug and there were no Hy's Law cases identified. The panel concluded that there was no liver safety signal detected through the data analysis cut-off date, including in a subset of patients with near-daily dosing. In aggregate, the panel noted that, compared to placebo arms of other migraine treatments, there was a very low incidence of overall elevations of liver laboratory abnormalities. Subjects will continue to participate in Study 201 with additional data analyses to be submitted to the FDA in connection with the planned filing, including the required 120-day safety update. In addition to the interim safety analysis, preliminary open-label efficacy data from Study 201 suggest that rimegepant may be associated with a reduction in migraine days per month (30 days) compared to the observational lead-in period, suggesting a potential preventive effect. In an exploratory analysis, patients who experienced greater than or equal to 15 migraine days/month (N=172) during the standard of care observation period demonstrated a mean reduction of 4 headache days/month by 12 weeks of intermittent dosing with rimegepant. Approximately 40% of patients who had greater than or equal to 15 headache days/month during the observation period showed at least a 30% or more reduction in their monthly number of headache days by 12 weeks of treatment with rimegepant. Reduction from baseline in the mean number of headache days per month was observed beginning as early as the first month and continued in subsequent months of therapy. Biohaven initiated a double-blind, placebo-controlled trial examining regularly scheduled dosing of rimegepant 75mg for the preventive treatment of migraine in November 2018.

BHVN Biohaven Pharmaceutical
$40.72

-2.17 (-5.06%)

12/03/18
PIPR
12/03/18
NO CHANGE
Target $65
PIPR
Overweight
Piper says buy Biohaven 'aggressively' after 'impressive' data
Biohaven Pharmaceutical (BHVN) this morning reported "impressive" topline data from the Phase III trial testing the Zydis orally dissolving tablet formulation of rimegepant, Piper Jaffray analyst Tyler Van Buren tells investors in a research note. The study not only achieved statistical significance on both co-primary endpoints, "but surprisingly" also demonstrated an "incredibly rapid" 15 minute onset of action, says the analyst. Further, he notes that Biohaven reported pooled safety data from what is now three Phase III rimegepant studies and that the candidate "continues to be safe and well tolerated" with no signal of liver toxicity. Van Buren believes the new data "definitely makes" rimegepant a superior product to Allergan's (AGN) ubrogepant and the "best-in-class" oral calcitonin gene-related peptide. He reiterates an Overweight rating on Biohaven with a $65 price target and recommends that investors buy the stock "aggressively."
11/29/18
PIPR
11/29/18
NO CHANGE
PIPR
Piper Jaffray says 'no good reason' for Biohaven pullback
Piper Jaffray analyst Tyler Van Buren reiterated an Overweight rating on Biohaven after attending the company's R&D day and hosting a fireside chat and investor dinner with company management during the 30th Annual Piper Jaffray Healthcare Conference. The analyst noted that Biohaven shares have experienced a significant pullback, for which he believes there was "no good fundamental reason." Van Buren added that after this week, he has an even higher level on conviction in a "clean 12-month safety update and a successful Phase III ODT study... and therefore rimegepant's $1B+ potential."
11/27/18
CANT
11/27/18
NO CHANGE
Target $55
CANT
Overweight
Cantor reiterates $55 price target on Biohaven after R&D day
Cantor Fitzgerald analyst Charles Duncan reiterates an Overweight rating on Biohaven Pharmaceutical with a $55 price target after attending the company's R&D day. The event was an opportunity to see the breadth of the company's glutamate pipeline, which "is notably broad, but early," Duncan tells investors in a research note. The analyst sees investor focus shifting toward troriluzole and the glutamate platform pending "interpretable, positive data" out of ongoing clinical trials in two indications in 2019.
11/23/18
ADAM
11/23/18
NO CHANGE
Target $46
ADAM
Buy
Biohaven inaugural investor day can be stock moving event, says Canaccord
Canaccord analyst Suman Kulkarni believes the pipeline at Biohaven Pharmaceutical could generate significant value as he sees Biohaven being more than just a migraine drug stock. He believes investors will warm up to its central nervous platform and sees the company's inaugural investor day as both interesting and a stock moving event. Kulkarni reiterated his Buy rating and $46 price target on Biohaven Pharmaceutical shares.

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