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Teva Reports Positive Phase III Tardive Dyskinesia Data
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Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced encouraging top-line data from the second phase III study (AIM-TD) on SD-809 (deutetrabenazine), which is being evaluated for the treatment of tardive dyskinesia (TD).
The randomized, double-blinded, placebo-controlled, parallel-group, fixed-dose study was conducted in patients with moderate-to-severe TD. Results revealed that all three doses (12 mg/day, 24 mg/day and 36 mg/day) of SD-809 demonstrated statistically significant improvement in Abnormal Involuntary Movement Scale scores – the primary endpoint – compared to placebo. Moreover, the 24 mg and 36 mg dose groups showed a significant change from baseline, based on the modified intent-to-treat population at week 12. In addition, improvement was observed on the Clinical Global Impression of change, indicating a reduction in abnormal movements experienced by patients.
Also, SD-809 demonstrated a favorable safety and tolerability profile over the course of the 12-week treatment. The company intends to present a complete analysis at a future medical meeting.
We are encouraged by the recently reported results from the phase III AIM-TD study, which followed positive data from the first phase III ARM-TD trial that were announced this June. Teva plans to file for FDA approval by the end of 2016.
Per the company press release, TD affects approximately 500,000 people in the U.S. There are currently no FDA-approved treatments for this debilitating hyperkinetic movement disorder, representing significant unmet medical need. Hence, there is ample market opportunity for SD-809, upon a potential approval. We note that SD-809 enjoys Breakthrough Therapy status in the U.S. for the treatment of TD.
Teva’s efforts to gain approval for SD-809 for the treatment of chorea associated with Huntington disease suffered a regulatory setback with the FDA issuing a complete response letter (CRL) in May 2016. Teva expects to submit a response to the CRL shortly.
Meanwhile, Teva also plans to evaluate SD-809 for the treatment of tics associated with Tourette syndrome. SD-809 became part of the company’s pipeline following the May 2015 acquisition of Auspex Pharmaceuticals.
For 2016, Ligand witnessed a 12.13% increase in its earnings estimates over the past 60 days. The company has also posted an average positive earnings surprise of 36.66% over the last four trailing quarters.
In each of the last four trailing quarters, Geron has surpassed expectations, bringing the average positive surprise to 20.78%.
VIVUS has recorded an average positive surprise of 39.88% over the last four trailing quarters.
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Teva Reports Positive Phase III Tardive Dyskinesia Data
Teva Pharmaceutical Industries Ltd. (TEVA - Free Report) announced encouraging top-line data from the second phase III study (AIM-TD) on SD-809 (deutetrabenazine), which is being evaluated for the treatment of tardive dyskinesia (TD).
The randomized, double-blinded, placebo-controlled, parallel-group, fixed-dose study was conducted in patients with moderate-to-severe TD. Results revealed that all three doses (12 mg/day, 24 mg/day and 36 mg/day) of SD-809 demonstrated statistically significant improvement in Abnormal Involuntary Movement Scale scores – the primary endpoint – compared to placebo. Moreover, the 24 mg and 36 mg dose groups showed a significant change from baseline, based on the modified intent-to-treat population at week 12. In addition, improvement was observed on the Clinical Global Impression of change, indicating a reduction in abnormal movements experienced by patients.
Also, SD-809 demonstrated a favorable safety and tolerability profile over the course of the 12-week treatment. The company intends to present a complete analysis at a future medical meeting.
We are encouraged by the recently reported results from the phase III AIM-TD study, which followed positive data from the first phase III ARM-TD trial that were announced this June. Teva plans to file for FDA approval by the end of 2016.
TEVA PHARM ADR Price
TEVA PHARM ADR Price | TEVA PHARM ADR Quote
Per the company press release, TD affects approximately 500,000 people in the U.S. There are currently no FDA-approved treatments for this debilitating hyperkinetic movement disorder, representing significant unmet medical need. Hence, there is ample market opportunity for SD-809, upon a potential approval. We note that SD-809 enjoys Breakthrough Therapy status in the U.S. for the treatment of TD.
Teva’s efforts to gain approval for SD-809 for the treatment of chorea associated with Huntington disease suffered a regulatory setback with the FDA issuing a complete response letter (CRL) in May 2016. Teva expects to submit a response to the CRL shortly.
Meanwhile, Teva also plans to evaluate SD-809 for the treatment of tics associated with Tourette syndrome. SD-809 became part of the company’s pipeline following the May 2015 acquisition of Auspex Pharmaceuticals.
Teva currently carries a Zacks Rank #3 (Hold).
Stocks to Consider
Some better-ranked stocks in the health care sector include Ligand Pharmaceuticals Incorporated (LGND - Free Report) , Geron Corporation (GERN - Free Report) and VIVUS Inc. . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
For 2016, Ligand witnessed a 12.13% increase in its earnings estimates over the past 60 days. The company has also posted an average positive earnings surprise of 36.66% over the last four trailing quarters.
In each of the last four trailing quarters, Geron has surpassed expectations, bringing the average positive surprise to 20.78%.
VIVUS has recorded an average positive surprise of 39.88% over the last four trailing quarters.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>