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BHVN

Biohaven Pharmaceutical

$55.07

2.57 (4.90%)

07:33
12/17/19
12/17
07:33
12/17/19
07:33

Biohaven reports 'positive' results from Phase 2/3 study of vazegepant

Biohaven Pharmaceutical announced positive topline results from its randomized, dose ranging, placebo controlled, pivotal Phase 2/3 clinical trial evaluating the efficacy and tolerability of intranasal vazegepant 5, 10 and 20 mg versus placebo in 1,673 patients for the acute treatment of migraine. Vazegepant 10 and 20 mg was statistically superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptom at 2 hours using a single dose. The benefits of vazegepant were durable and sustained without rescue medication through 48 hours, including: sustained pain freedom 2 to 24 hours; sustained pain freedom 2 to 48 hours; sustained pain relief 2 to 24 hours; and sustained pain relief 2 to 48 hours. Additional results from this study are anticipated to be presented at upcoming scientific meetings in 2020. Vazegepant was also superior to placebo on multiple secondary endpoints demonstrating early activity. Vazegepant had rapid onset with pain relief at 15 minutes, and return to normal function as early as 30 minutes. The 10 and 20 mg vazegepant doses showed therapeutic benefits on both pain relief and return to normal function at 2 hours. Intranasal vazegepant was well tolerated in this single dose trial. Individual adverse events greater than 5% were: dysgeusia and nasal discomfort. The majority of AEs were mild in intensity. There was no signal of hepatoxicity as no subjects had AST or ALT greater than 3x ULN, or total bilirubin greater than 2x ULN, in any treatment arm.

BHVN Biohaven Pharmaceutical
$55.07

2.57 (4.90%)

12/06/19
PIPR
12/06/19
NO CHANGE
Target $100
PIPR
Overweight
Biohaven should be owned ahead of pivotal readouts, says Piper Jaffray
Piper Jaffray analyst Tyler Van Buren recommends continuing to own shares of Biohaven Pharmaceutical ahead of give near-term pivotal data readouts. After hosting a dinner with management, the analyst has a "high level of confidence" in the impending Phase III rimegepant prevention and vazegepant acute readouts, and the ultimate approval of rimegepant in the acute setting in Q1. Moreover, the company's glutamate platform is "severely underappreciated," Van Buren tells investors in a research note. He believes Biohaven will likely soon have three viable CGRP products for the acute treatment and prevention of migraine. The analyst keeps an Overweight rating on the shares with a $100 price target.
12/06/19
OPCO
12/06/19
NO CHANGE
Target $67
OPCO
Outperform
Oppenheimer keeps Outperform on Biohaven after Alzheimer's drug passes futility
Oppenheimer analyst Esther Rajavelu said the fact that troriluzole's Phase 2/3 clinical trial in Alzheimer's disease will continue after passing an interim futility analysis is an important milestone for Biohaven Pharmaceuticals and she keeps an Outperform rating and $67 price target on the stock following this morning's announcement. She estimates the U.S. market potential for Alzheimer's to be $4B+ and her current price target assumes 25% probability for commercial revenues based on a potential launch of troriluzole by year-end 2021 and a co-commercialization model.
12/06/19
PIPR
12/06/19
NO CHANGE
Target $100
PIPR
Overweight
Biohaven models should start adding value for Alzheimer's, says Piper Jaffray
Biohaven Pharmaceutical's "potentially superior" glutamate drug troriluzole passed the Alzheimer's Phase II/III interim futility analysis at six months, Piper Jaffray analyst Tyler Van Buren tells investors in a research note. While no details of the data were disclosed, the analyst believes the bar for futility was relatively high. Troriluzole is demonstrating meaningful efficacy on top of placebo, the probability of the study ultimately succeeding has increased, and it is likely time to add some value for this potentially "very large" Alzheimer's opportunity, says the analyst. He keeps an Overweight rating on Biohaven shares with a $100 price target. The stock in morning trading is up 5%, or $2.48, to $56.24.
12/06/19
LEER
12/06/19
NO CHANGE
Target $64
LEER
Outperform
Biohaven price target raised to $64 from $62 at SVB Leerink
SVB Leerink analyst Marc Goodman maintained an Outperform rating on Biohaven Pharmaceutical and raised his price target on the shares to $64 from $62 after the company announced that troriluzole successfully passed the interim futility analysis for the 48-week pivotal Phase 2/3 Alzheimer's disease study, noting that the study should now continue on to completion. Goodman said that this is good news for Biohaven as AD is a high unmet need disease with few products approve, and also it begins to validate the glutamate platform in light of many investors being "solely focused" on th lead migraine asset rimegepant. The analyst added that he is now increasing probability of success for troriluzole in AD to 35% from 20% on this "positive" result.

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