Teva Pharmaceutical Industries Ltd (ADR) (TEVA) Submits Biologics License Application to the FDA for Migraine Treatment


TEVA logoTeva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine.

TEVA Chief Scientific Officer Michael Hayden commented, “The BLA submission for fremanezumab marks a very important milestone for the migraine community […] There have been few therapeutic innovations for migraine patients in over 25 years. If approved, fremanezumab will be among the first to enter the market in a new class of drugs for the preventive treatment of migraine. We are immensely proud of the progress we have made in the fremanezumab development program, and look forward to the potential to make this therapy available to the millions of people around the world who live with the debilitating effects of migraine.”

Ernesto Aycardi, Vice President, Therapeutic Area Head, Migraine & Headache at Teva, added “Phase III clinical studies of fremanezumab demonstrated a significant reduction in the number of migraine and headache days, acute medication use and disability, in addition to demonstrating improvement in quality of life in patients living with episodic and chronic migraine […] We are very excited to have submitted the BLA to the FDA as an important step in being able to introduce a new therapy that may help to address a significant need in the migraine community for targeted, preventive treatment options.”

The BLA includes data from the HALO clinical trial program, which enrolled more than 2,000 patients with episodic migraine (EM) and chronic migraine (CM), evaluating both monthly and quarterly dose regimens of fremanezumab. Results from these trials were recently presented at the Congress of the International Headache Society (IHC) in September and will be published in future peer-reviewed publications. The most common adverse events reported in clinical trials include injection site induration, erythema, and pruritis.

Shares of Teva closed yesterday at $14.71, down $0.27 or -1.80%. TEVA has a 1-year high of $44.42 and a 1-year low of $14.30. The stock’s 50-day moving average is $16.68 and its 200-day moving average is $25.92.

On the ratings front, TEVA stock has been the subject of a number of recent research reports. In a report issued on October 6, Piper Jaffray analyst David Amsellem reiterated a Hold rating on TEVA, with a price target of $23, which represents a potential upside of 56% from where the stock is currently trading. Even worse, on October 5, Morgan Stanley’s David Risinger maintained a Sell rating on the stock and has a price target of $15.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, David Amsellem and David Risinger have a yearly average loss of -1.0% and -9.6% respectively. Amsellem has a success rate of 49% and is ranked #3851 out of 4697 analysts, while Risinger has a success rate of 42% and is ranked #4508.

Overall, 3 research analysts have rated the stock with a Sell rating, 12 research analysts have assigned a Hold rating and 2 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $20.88 which is 41.9% above where the stock closed yesterday.

Teva Pharmaceutical is a global pharmaceutical company, which provides patient-centric healthcare solutions. It operates through two segments: Generic Medicines and Specialty Medicines. The Generic Medicines segment includes chemical and therapeutic equivalents of originator medicines in a variety of dosage forms, including tablets, capsules, injectables, inhalants, liquids, ointments and creams. The Specialty Medicine segment engages in the provision of core therapeutic areas of central nervous system medicines. 

 

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