Teva Migraine Candidate Succeeds In Second Phase III Study

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced that its experimental migraine prevention drug, fremanezumab, met all the primary and secondary endpoints in a second late-stage study.

Pivotal data from the second phase III HALO study in episodic migraine prevention showed that patients who were treated with monthly as well as quarterly dosing regimens of fremanezumab experienced clinically and statistically significant improvements in all endpoints and 12 pre-specified analyses.

Teva’s shares have lost 20.7% so far this year compared with the Zacks classified Medical-Generics Drug industry’s decline of 7.0%.

Coming back to fremanezumab, it is an anti-calcitonin gene-related peptide (CGRP) subcutaneous injection developed for the prevention of episodic and chronic migraine.

Last week, Teva presented positive results from another HALO late-stage study in chronic migraine which also showed that the monthly and quarterly dosing regimens of fremanezumab met all primary and secondary endpoints.

Detailed findings from both the studies will be presented at future medical meetings.

Teva intends to seek FDA approval for fremanezumab later this year based on the HALO studies for both episodic and chronic migraine and expects approval in the second half of next year.

Given the limited treatment options, fremanezumab represents significant commercial potential. According to Teva’s press release, more than a billion people suffer from migraine across the world including 38 million in the U.S.

We remind investors that Teva is not the only company working on a migraine drug. Amgen, Inc. (NASDAQ:AMGN) and partner Novartis AG (NYSE:NVS) recently filed for FDA approval of their CGRP receptor, erenumab, for the prevention of migraine. Meanwhile, Eli Lilly & Company (NYSE:LLY) plans to file for FDA approval of its investigational migraine drug, galcanezumab, in the second half of the year.

Teva carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

3 Top Picks to Ride the Hottest Tech Trend

Zacks just released a Special Report to guide you through a space that has already begun to transform our entire economy...

Last year, it was generating $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce ""the world's first trillionaires,"" but that should still leave plenty of money for those who make the right trades early. Download Report with 3 Top Tech Stocks >>