KemPharm (NASDAQ: KMPH) shares are surging premarket on Tuesday after the company announced that the US Food and Drug Administration has approved the New Drug Application for AZSTARYS.
AZSTARYS is a once-daily product for treating attention-deficit hyperactivity disorder or ADHD in patients age 6 years or older.
Corium Inc, a portfolio company of Gurnet Point Capital, will lead the commercialisation of the drug and expect it to be commercially available in the US as early as the second half of 2021.
As a result of the approval, KemPharm has earned a regulatory milestones payment as provided under the licence agreement with Gurnet and is working with the company to evaluate the related provisions and amounts.
Under the agreement, they may be eligible for up to $468 million in regulatory sales and milestone payments as well as tiered royalty payments.
“The FDA approval of the AZSTARYS NDA is a transformational event for KemPharm and, we believe, an important advancement in the treatment of ADHD,” said Travis C Mickle, President and CEO of KemPharm.
The company shares are trading 95.12% higher premarket at $18.40.