We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Supernus Drops SPN-810's Lower Dose Test in Phase III Trials
Read MoreHide Full Article
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 . Some drugs approved for this indication are Vyvanse, Adderall XR, Intuniv and Equasym XL.
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%.
4 Promising Stock Picks to Keep an Eye On
With news stories about computer hacking and identity theft becoming increasingly commonplace, the cybersecurity industry looks like a promising investment opportunity. But which stocks should you buy? Zacks just released Cybersecurity: An Investor’s Guide to Locking Down Profits to help answer this question.
This new Special Report gives you the information you need to make well-informed investment choices in this space. More importantly, it also highlights 4 cybersecurity picks with strong profit potential.
Image: Bigstock
Supernus Drops SPN-810's Lower Dose Test in Phase III Trials
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 . Some drugs approved for this indication are Vyvanse, Adderall XR, Intuniv and Equasym XL.
Supernus Pharmaceuticals, Inc. Price
Supernus Pharmaceuticals, Inc. Price | Supernus Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Supernuscurrently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharma sector are Aduro Biotech, Inc. 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%.
4 Promising Stock Picks to Keep an Eye On
With news stories about computer hacking and identity theft becoming increasingly commonplace, the cybersecurity industry looks like a promising investment opportunity. But which stocks should you buy? Zacks just released Cybersecurity: An Investor’s Guide to Locking Down Profits to help answer this question.
This new Special Report gives you the information you need to make well-informed investment choices in this space. More importantly, it also highlights 4 cybersecurity picks with strong profit potential.
Get the new Investing Guide now>>