Company Update (NYSE:TEVA): Teva Pharmaceutical Industries Ltd (ADR) Announces FDA Approval of AUSTEDO for the Treatment of Tardive Dyskinesia in Adults


Teva Pharmaceutical Industries Ltd (ADR) (NYSE:TEVA) announced that the FDA has approved AUSTEDO (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults. AUSTEDO®was previously approved for the treatment of chorea associated with Huntington’s disease in April 2017.

Tardive dyskinesia is a debilitating and often irreversible movement disorder characterized by repetitive and uncontrollable movements of the tongue, lips, face, trunk and extremities. The condition affects about 500,000 people in the United States and can be caused by certain medications used to treat mental health conditions or gastrointestinal conditions.

“We are pleased to bring forward this second indication for AUSTEDO® to treat the underserved tardive dyskinesia population,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We believe physicians treating tardive dyskinesia will appreciate the therapy’s dosing flexibility and the ability to focus on directly treating the movement disorder and not disrupt the ongoing treatment for the underlying condition.”

The approval was based on results from two Phase III randomized, double-blind, placebo-controlled, parallel group studies assessing the efficacy and safety of AUSTEDO® in reducing the severity of abnormal involuntary movements associated with tardive dyskinesia (AIM-TD and ARM-TD).

“Our medical and commercial teams are looking forward to bringing this new treatment to patients and physicians working to manage tardive dyskinesia,” said Rob Koremans, M.D., President and CEO of Global Specialty Medicines at Teva. “The launch of AUSTEDO® demonstrates our continued commitment to the treatment of movement disorders.”

Shares of Teva Pharmaceutical closed today at $15.46, down $0.32 or -2.03%. TEVA has a 1-year high of $52.66 and a 1-year low of $15.32. The stock’s 50-day moving average is $24.51 and its 200-day moving average is $30.08.

On the ratings front, TEVA has been the subject of a number of recent research reports. In a report issued on August 24, Credit Suisse analyst Vamil Divan downgraded TEVA to Sell, with a price target of $13, which represents a potential downside of 18% from where the stock is currently trading. On August 16, Citigroup’s Liav Abraham downgraded the stock to Hold.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Vamil Divan and Liav Abraham have a yearly average loss of -0.2% and a return of 9.1% respectively. Divan has a success rate of 46% and is ranked #3318 out of 4621 analysts, while Abraham has a success rate of 50% and is ranked #1150.

Overall, 3 research analysts have rated the stock with a Sell rating, while 12 analysts have assigned a Hold rating. When considering if perhaps the stock is under or overvalued, the average price target is $26.65 which is 68.5% above where the stock opened today.

Teva engages in the provision of pharmaceutical services. It operates through the following two segments: Generic and Specialty Medicine. The Generic 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 includes several franchises, most significantly core therapeutic areas of CNS medicines.

 

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