Supernus' ADHD Candidate Positive in 4th Phase III Study

Shares of Supernus Pharmaceuticals, Inc. SUPN inched up 2.1% after the company announced top-line data from the phase III study on SPN-812 for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged from 12 to 17 years.

The P304 study evaluated the two doses of SPN-812 (400 mg/600 mg). The lower dose reached a statistical significance for the primary endpoint, showing a clinically meaningful reduction in the symptoms of ADHD as, compared to placebo. However, the higher dose narrowly missed the statistical significance in the primary endpoint.

Notably, last December, the company presented positive data from the previous three (P301, P302 and P303) studies on SPN-812. P304 is the fourth study on the SPN-812 phase III program.

Data from the study was consistent with the first three studies. Patients who received the 400 mg dose of SPN-812 daily, demonstrated a statistically significant improvement in ADHD rating scale 5 compared with placebo, which was the primary endpoint. Moreover, the 400 mg dose met the Clinical Global Impression-Improvement, the key secondary endpoint.

The safety and tolerability profile of SPN-812 was consistent with the previous phase III studies. Overall, the candidate was well tolerated with a few treatment-related adverse events and low discontinuation rates reported.

Supernus now has substantial data on SPN-812 for different dosages — 100 mg, 200 mg and 400 mg — for treating children and adolescent patients with ADHD. The company is on track to submit a new drug application (NDA) for SPN-812 during the second half of this year. If approved, the company plans to launch SPN-812 in the second half of 2020.

Shares of Supernus have gained 5.4% so far this year, underperforming the industry’s increase of 9.6%.


Another similar candidate in Supernus’ portfolio is SPN-810. It is initially being evaluated in a phase III study for treating impulsive aggression (IA) in children and adolescents, who are diagnosed with ADHD. The company also plans to develop SPN-810 for the treatment of IA in patients with autism, post-traumatic stress disorder (PTSD), bipolar disorder, schizophrenia and other forms of dementia.

Zacks Rank & Stocks to Consider

Supernus currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include Mallinckrodt plc MNK, Dr. Reddy's Laboratories Ltd. RDY and Sol-Gel Technologies Ltd. SLGL. While Mallinckrodt sports a Zacks Rank #1(Strong Buy), Dr. Reddy's and Sol-Gel Technologies carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Mallinckrodt’s earnings estimates have been revised 10.5% upward for 2019 and 6.6% for 2020 over the past 60 days. The stock has surged 39.7% in the year so far.

Dr. Reddy's earnings estimates have moved 10.1% north for 2019 and 1.5% for 2020 over the past 60 days. The stock has gained 8.7% so far this year.

Sol-Gel Technologies’ loss per share estimates have been narrowed 2.9% for 2019 and 21.5% for 2020 in the last 60 days. The stock has rallied 21% year to date.

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