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KemPharm Receives Day-74 Letter For KP415 NDA

CELEBRATION, Fla., May 19, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today confirmed that the Company has

Benzinga · 05/19/2020 11:31

CELEBRATION, Fla., May 19, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today confirmed that the Company has received a filing communication from the U.S. Food and Drug Administration (FDA), commonly known as the “Day-74 Letter.”  The Day-74 Letter stated that the New Drug Application (NDA) for KP415 is sufficiently complete to permit a substantive review by the FDA, and that the target goal date under the Prescription Drug User Fee Act (PDUFA) is March 2, 2021.  In addition, the Day-74 Letter indicated that the FDA is not currently planning to hold an advisory committee to discuss the KP415 NDA. 

“As expected, the FDA has set the PDUFA date for March 2, 2021, and we are pleased that the regulatory process is proceeding based on the promulgated timeframes,” said Travis C. Mickle, Ph.D., President and CEO of KemPharm.  “This is another important regulatory milestone for KP415, and we look forward to working together with our partners at GPC and Corium to support the regulatory process and commercial preparation activities needed to facilitate a potential launch in the second half of 2021, if approved.”

KP415 is KemPharm’s investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD), which contains serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH).  In September 2019, KemPharm entered into the License Agreement with an affiliate of Gurnet Point Capital (GPC) for the exclusive worldwide rights to develop, manufacture and commercialize KemPharm’s product candidates containing SDX, including KemPharm’s ADHD product candidates, KP415 and KP484.  GPC’s portfolio company, Corium, Inc., will lead all commercialization activities for KP415.