KemPharm Inc. (NASDAQ: KMPH) shares made a solid gain on Tuesday following an U.S. Food and Drug Administration (FDA) approval. Essentially, the company announced that its Investigational New Drug (IND) application for KP415 has been accepted by the FDA.
As we have said time and time again, clinical trials and FDA decisions have the potential to make or break companies in this industry. For the month of October, a few of these companies have been on the move, and a few more are expecting results or decisions later this quarter.
For some quick background: KP415 is KemPharm’s co-lead product candidate. It is an extended release d-threo-methylphenidate (d-MPH) prodrug for the treatment of attention deficit hyperactivity disorder (ADHD).
Going forward, KemPharm expects to commence and complete proof of concept human trials prior to the end of 2016, with additional human clinical trials initiating during the first half of 2017. Also the company anticipates submitting a New Drug Application (NDA) submission for KP415 as early as 2018.
Travis C. Mickle, Ph.D., president and CEO of KemPharm, commented:
We are very pleased that the FDA accepted our IND request for KP415, our co-lead product candidate, and expect to advance this program through proof-of-concept before year-end and into human clinical trials. Based on our estimates, in 2015, methylphenidate accounted for approximately 19.7 million prescriptions and $4.2 billion in sales in the ADHD market.
However, patent expiration in the ADHD space is eroding the revenues of branded products. We believe KP415 offers the opportunity to address this market dynamic with a prodrug technology that, in pre-clinical studies, has demonstrated both extended release properties and a pharmacokinetic profile that could enable a more predictable therapy compared with currently available, immediate-release d-MPH products.
Shares of KemPharm were last seen up 9% at $4.80, with a consensus analyst price target of $25.33 and a 52-week trading range of $3.52 to $21.30.