Supernus Pharmaceuticals, Inc.'s (SUPN - Free Report) shares have dropped almost 10% after the company announced decision to stop evaluating the lower dose option (18 mg) of its pipeline candidate, SPN-810, in two phase III clinical trials. However, the company will carry on with its 36 mg dose of SPN-810 or placebo of similar proportion in both the studies.
Significantly, SPN-810 is being developed as a novel treatment option for impulsive aggression (IA) in patients aged 6-12 years with attention deficit hyperactivity disorder (ADHD).
Supernus’ shares have significantly soared 79.8% so far this year in contrast to the 18.2% decrease of the industry during the period.
The two phase III studies were designed under a Special Protocol Assessment (SPA) by the FDA. The decision taken by the company to terminate the lower dose regime is an outcome of the planned interim analysis from the first phase III clinical trial on SPN-810. The interim analysis was planned when 50% of the patients (n=146) reached randomization in the first trial.
The program was conducted by an independent third-party statistician to evaluate both the doses and provide optimization of the study design. The company believes that chances of achieving a statistically substantial result with the 36 mg dose will be high. Implementation of the suggested changes will be executed immediately.
Notably, enrollment in the first and second trial has already completed 64% and 56%, respectively. The company expects enrollment to continue through mid-2018.
We remind investors that SPN-810 is a key candidate in Supernus’ pipeline, already granted with a fast-track designation from the FDA.
Additionally, Supernus is developing SPN-812 for ADHD treatment.
However, the ADHD market is currently dominated by companies like Shire plc (SHPG - Free Report) . Some drugs approved for this indication are Vyvanse, Adderall XR, Intuniv and Equasym XL.
Zacks Rank & Stocks to Consider
Supernuscurrently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharma sector are Aduro Biotech, Inc. (ADRO - Free Report) and ACADIA Pharmaceuticals Inc. (ACAD - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Aduro Biotech’s loss per share estimates reduced from $1.46 to $1.32 for 2017 and from $1.41 to $1.24 for 2018 over the last 60 days. The company delivered positive surprises in two of the trailing four quarters with an average beat of 2.53%.
ACADIA’s loss per share estimates narrowed from $2.82 to $2.57 for 2017 and from $2.07 to $1.90 for 2018 over the last 60 days. The company came up with positive earnings surprises in two of the last four quarters with an average beat of 7.97%.
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