Neos Therapeutics Inc. (NASDAQ: NEOS) saw its shares dip on Tuesday after the firm reported that it received approval from the U.S. Food and Drug Administration (FDA) for its treatment of attention-deficit/hyperactivity disorder (ADHD). The approval of Cotempla XR-ODT was supported by a Phase 3 clinical trial in children in a laboratory classroom setting for patients in the age of 6 to 17.
Treatment with Cotempla XR-ODT showed a statistically significant improvement in ADHD symptom control compared to placebo across the classroom day. Onset of effect was evident at one hour postdose and lasted through 12 hours.
No serious adverse events were reported during the trial, and the adverse event profile was consistent with the established safety profile for other extended-release methylphenidate products.
Vipin K. Garg, Ph.D., president and CEO of Neos Therapeutics, commented:
We are excited about the FDA approval of Cotempla XR-ODT, which offers patients and caregivers a new treatment option to manage the symptoms commonly associated with ADHD. With this approval, Neos will be the only company to have both a branded methylphenidate and a branded amphetamine product available in an extended-release orally disintegrating tablet dosage form. We look forward to having Cotempla XR-ODT join our Adzenys XR-ODT (amphetamine) extended-release orally disintegrating tablets on the market this fall.
Although the approval is a good sign for the company, shares still slid. Perhaps this news was already priced into the stock as shares have made a significant run in 2017. Excluding Tuesday’s move, Neos has outperformed the market with the stock up 54% year to date. However, over the past 52 weeks the stock is actually down 9%.
Shares of Neos were last seen down nearly 8% at $8.30 on Tuesday, with a consensus analyst price target of $17.83 and a 52-week range of $4.85 to $9.99.