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Alcobra Stock Down on Poor Late-Stage Data on ADHD Drug
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Shares of Alcobra Ltd. declined 50.7% after the company reported disappointing top-line results from a phase III study, MEASURE, on experimental candidate metadoxine, extended release (MDX) for the treatment of ADHD in adult patients.
Alcobra’s share price has grossly underperformed the Zacks classified Medical-Drugs industry in the last 12 months. The stock has lost 81.3% over this time frame, compared to a decline of 8.8% for the industry.
The results from the trial showed that MDX did not meet the primary endpoint of demonstrating a statistically significant difference from placebo in the change from baseline of the investigator rating of the Conners’ Adult ADHD Rating Scales (CAARS).
This is the second phase III trial on the candidate. We note that the top-line data analysis was conducted on the full set of subjects (n=283) which includes all randomized subjects with at least one post-baseline efficacy assessment.
The company will review the full data set from MEASURE and decide its future course of action.
We note that the candidate was also being evaluated for the treatment of Fragile X Syndrome.
In Sep 2016, the FDA placed a full clinical hold on MDX due to adverse neurological findings in a pre-clinical study. In Dec 2016, the company met with the Division of Psychiatry Products (DPP) of the FDA to discuss their decision to place a full clinical hold on MDX. Earlier in the month, the company received official minutes from its December meeting with the FDA. The FDA agreed to review the data collected so far from the MEASURE study and to modify its full clinical hold to a partial hold.
The news is extremely disappointing for the company. Since MDX was in late-stage trials, a potential approval and successful commercialization would have boosted the company’s growth prospects.
Alcobra currently carries a Zacks Rank #4 (Sell).
We note that Shire plc is a leader in the ADHD market with drugs like Vyvanse and Intuniv.
Biogen’s earnings estimates for 2016 have been stable while estimates for 2017 have gone up by 15 cents in the last 30 days. The company posted a positive surprise in all the four trailing quarters with an average beat of 8.15%.
Intercept Pharma’s loss estimates narrowed by two cents for 2016 in the last 30 days. For 2017, loss estimates have narrowed from $14.03 to $13.86 in the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 3.19%.
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Alcobra Stock Down on Poor Late-Stage Data on ADHD Drug
Shares of Alcobra Ltd. declined 50.7% after the company reported disappointing top-line results from a phase III study, MEASURE, on experimental candidate metadoxine, extended release (MDX) for the treatment of ADHD in adult patients.
Alcobra’s share price has grossly underperformed the Zacks classified Medical-Drugs industry in the last 12 months. The stock has lost 81.3% over this time frame, compared to a decline of 8.8% for the industry.
The results from the trial showed that MDX did not meet the primary endpoint of demonstrating a statistically significant difference from placebo in the change from baseline of the investigator rating of the Conners’ Adult ADHD Rating Scales (CAARS).
This is the second phase III trial on the candidate. We note that the top-line data analysis was conducted on the full set of subjects (n=283) which includes all randomized subjects with at least one post-baseline efficacy assessment.
The company will review the full data set from MEASURE and decide its future course of action.
We note that the candidate was also being evaluated for the treatment of Fragile X Syndrome.
In Sep 2016, the FDA placed a full clinical hold on MDX due to adverse neurological findings in a pre-clinical study. In Dec 2016, the company met with the Division of Psychiatry Products (DPP) of the FDA to discuss their decision to place a full clinical hold on MDX. Earlier in the month, the company received official minutes from its December meeting with the FDA. The FDA agreed to review the data collected so far from the MEASURE study and to modify its full clinical hold to a partial hold.
The news is extremely disappointing for the company. Since MDX was in late-stage trials, a potential approval and successful commercialization would have boosted the company’s growth prospects.
Alcobra currently carries a Zacks Rank #4 (Sell).
We note that Shire plc is a leader in the ADHD market with drugs like Vyvanse and Intuniv.
Alcobra Ltd. Price and Consensus
Alcobra Ltd. Price and Consensus | Alcobra Ltd. Quote
Key Picks:
A couple of better-ranked stocks in the health care sector include Biogen Inc. (BIIB - Free Report) and Intercept Pharmaceuticals .
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biogen’s earnings estimates for 2016 have been stable while estimates for 2017 have gone up by 15 cents in the last 30 days. The company posted a positive surprise in all the four trailing quarters with an average beat of 8.15%.
Intercept Pharma’s loss estimates narrowed by two cents for 2016 in the last 30 days. For 2017, loss estimates have narrowed from $14.03 to $13.86 in the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 3.19%.
Zacks' Top 10 Stocks for 2017
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-hold tickers for the entirety of 2017?
Who wouldn't? As of early December, the 2016 Top 10 produced 5 double-digit winners including oil and natural gas giant Pioneer Natural Resources which racked up a stellar +50% gain. The new list is painstakingly hand-picked from 4,400 companies covered by the Zacks Rank. Be among the very first to see it>>