Analysis focus: BHVN
Biohaven Pharmaceuticals (NYSE:BHVN) is a CNS-focused company with a strong pipeline with multiple drug candidates in late stage trials. The company recently announced a number of updates for its pipeline. For its lead candidate, rimegepant from the CGRP receptor antagonist platform, the company will report initial results from a long-term safety study in Q4 2018. In Q4 2018, the company will also produce top-line results from a Phase 3 rimegepant Zydis ODT trial. In 2019, the company will submit an NDA for rimegepant, on the basis of positive topline data from its first two pivotal phase 3 trials. From BHV-3500, its other product candidate in this platform, there will be an IND and the start of a phase 1 trial for the acute treatment and prevention of migraine.
Its other platform is the Glutamate modulator platform, which has three candidates in various mid and early stage trials. The company will complete enrollment in a Phase 2 trial evaluating trigriluzole in OCD in 2018. There is also a phase 3 extension trial, for trigriluzole in spinocerebellar ataxia, which will report topline results by end-2018. The same drug candidate will begin a phase 2 trial in Alzheimer’s disease by Q2 2018. Most importantly, the company will submit an NDA to the FDA via the 505(b)(2) pathway for BHV-0223 in patients with ALS in the second half of 2018. This pathway helps a drug get quicker approval through a bioequivalence study, which, if successful, lets it use data from previous trials and accelerate the approval process.
BHVN is a $1+bn company with a decent cash runway and an excellent management team. The migraine market, its primary focus, has limited treatment options, and although a number of players are developing therapies in the space, opportunity exists for BHVN with their CGRP platform. More than one tenth of all Americans suffer from migraine, and this is a multi-billion dollar therapeutic space with few proper treatment options.
Stocks in News: Analysis of MEIP, GILD
MEI Pharma secures $75M capital raise
Discussion: MEI Pharma (NASDAQ:MEIP) is up on the news that it secured $75mn from institutional investors through a direct sale of common stock and warrants. As a subscriber of Total Pharma Tracker pointed out, Verastem (NASDAQ:VSTM) is down, on the same day, after raising money through a secondary offering. The difference is quite possibly because although dilutive, MEIPs fund raising comes from institutional investors which includes warrants at 1/2 of a share of common stock at $2.54, which indicates that smart money likes the company, specifically its lymphoma candidate MEI-401.
Kite Pharma continues buildout for cell therapy manufacture
Discussion: Gilead (NASDAQ:GILD) is quietly but quickly developing the infrastructure it needs to facilitate the process of CAR-T therapy in various geographies. It leased a 177K square-foot facility in the Netherlands for manufacturing cell therapies in Europe, and the plant, which will employ 300 people, will be fully operational in 2020. The Netherlands, being a transport hub for the entire Europe, will make it very easy to process and deliver CAR-T therapy, where, as we know, logistics is a key concern. The company has also developed R&D units in California and in Maryland.
In other news
Celyad (NASDAQ:CYAD) has announced a 1.8M-unit offering in the form of American Depositary Shares in the U.S., Canada and certain other non-European countries, and ordinary shares in Europe and certain other non-North American countries.
The FDA has approved expanded use of Gilead’s Truvada to adolscents; previously it was approved only as HIV pre-exposure prophylaxis for adults.
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