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KemPharm (KMPH) Soars on FDA Nod for ADHD Treatment, Azstarys

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KemPharm, Inc. (KMPH - Free Report) announced that the FDA has approved its new drug application (“NDA”) for Azstarys a prodrug of methylphenidate for the treatment of attention deficit hyperactivity disorder (“ADHD”) in patients aged six years and above.

Notably, Azstarys [serdexmethylphenidate (“SDX”) and dexmethylphenidate capsules] for oral use was formerly known as KP415. Azstarys consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. Methylphenidate is a stimulant medication used to treat ADHD, the most common mental disorder.

Shares of KemPharm were up 70% in pre-market trading on Wednesday following the announcement of the above news. However, the stock has declined 15.8% so far this year against the industry’s increase of 3.3%.

price chart for KMPH


Please note that KemPharm has definitive collaboration and license agreement with Corium, Inc., a portfolio company of Gurnet Point Capital (“GPC”) for the commercialization of Azstarys. Per the deal, Corium will lead the commercialization of Azstarys which is expected to hit the United States market as early as the second half of this year.

Also, per the licensing agreement with GPC, KemPharm has earned a regulatory milestone payment following the FDA’s approval of Azstarys. The company may be eligible to receive up to $468 million in regulatory and sales-based milestone payments, as well as tiered royalties on the product net sales.

Per the press release, the ADHD market accounted for almost $17.9 billion of revenue in 2019 with a year-over-year prescription growth rate of greater than 4%. Also, the methylphenidate segment of the ADHD market accounted for around 20 million prescriptions and $4.9 billion in sales in 2019. The methylphenidate has seen little innovation in recent year. Accordingly, there is significant unmet need in the market which KemPharm can tap into with the launch of Azstarys.

Zacks Rank Stocks to Consider

KemPharm currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Can-Fite BioPharma Ltd. (CANF - Free Report) , Ono Pharmaceutical Co., Ltd. (OPHLF - Free Report) and Radius Health, Inc. (RDUS - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Can-Fite BioPharma’s loss per share estimates have narrowed 60.8% for 2021 over the past 60 days. The stock has rallied 12.9% year to date.

Ono Pharmaceutical’s earnings estimates have been revised 10.4% upward for 2021 over the past 60 days. The stock has risen 2.4% year to date.

Radius Health’s loss per share estimates have narrowed 43% for 2021 over the past 60 days. The stock has increased 4.5% year to date.

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