Press Releases

KemPharm® is a clinical stage, specialty pharmaceutical company engaged in the development and discovery of proprietary prodrugs that are designed to be improved versions of widely prescribed and FDA approved products.

Press Releases

News Releases

Date Title and Summary
Toggle Summary KemPharm Granted "Fast Track" Designation for KP201/IR
KP201/IR could be the first single entity (APAP-free), IR hydrocodone product for pain analgesia with abuse-deterrent properties CORALVILLE, Iowa , Dec. 20, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and
Toggle Summary KemPharm’s KP415, An Investigational Prodrug of D-Methylphenidate, Completes Phase 1 Proof-of-Concept Trial for the Treatment of ADHD
  Both Early and Extended Release of the Methylphenidate Prodrug was observed in the KP415.101 Study Conference Call and Live Audio Webcast with Dr. Scott Kollins Scheduled for Today at 4:30 p.m., ET CORALVILLE, Iowa , Dec. 14, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc.
Toggle Summary KemPharm Receives Clearance from FDA to Initiate Clinical Program for KP201/IR, a Single-Entity Benzhydrocodone HCl Immediate Release Abuse-Deterrent Prodrug for the Treatment of Acute Pain
KP201/IR could be the first single entity (APAP-free), IR hydrocodone product for pain analgesia with abuse-deterrent properties CORALVILLE, Iowa , Nov. 29, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and
Toggle Summary KemPharm, Inc. Reports Third Quarter 2016 Results
Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today at 5:00 p.m., ET Recent Clinical Development & Regulatory Highlights : Prioritized KP415 and KP201/IR as co-lead product candidates Received clearance from the U.S.
Toggle Summary KemPharm Appeals FDA Complete Response Letter on Apadaz™ by Initiating a Formal Dispute Resolution Process
CORALVILLE, Iowa , Nov. 03, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced it has appealed the Food and Drug Administration's ( FDA ) Complete Response Letter
Toggle Summary KemPharm Files IND for KP201/IR, a Single-Entity Benzhydrocodone HCl Immediate Release Abuse-Deterrent Prodrug for the Treatment of Acute Pain
KP201/IR could be the first single entity (APAP-free), IR hydrocodone product for pain analgesia with abuse-deterrent properties CORALVILLE, Iowa , Oct. 25, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and
Toggle Summary KemPharm Announces Licensing Agreement with Acura Pharmaceuticals for Aversion® Abuse-Deterrent Technology
Agreement focused on KemPharm's current and in-development IR Opioid Pipeline CORALVILLE, Iowa and PALATINE, Ill. , Oct. 18, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, and
Toggle Summary KemPharm Receives Clearance from FDA to Initiate Clinical Program for KP415, an Investigational Prodrug of D-Threo-Methylphenidate for the Treatment of ADHD
KP415, KemPharm’s co-lead product candidate, is designed to be a predictably-dosed, extended release methylphenidate product CORALVILLE, Iowa , Oct. 11, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development
Toggle Summary KemPharm Files IND for KP415 for the Treatment of ADHD, An Investigational Prodrug of D-Threo-Methylphenidate
KP415 is designed to be a predictably-dosed, extended release methylphenidate product CORALVILLE, Iowa , Sept. 19, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today
Toggle Summary KemPharm, Inc. Provides Corporate and Clinical Update
Conference Call and Live Audio Webcast Scheduled for Today at 8:30 a.m. ET KemPharm adjusts product development timelines following full pipeline analysis and positions KP415 and KP201/IR as lead product candidates to capitalize on favorable developmental, regulatory and market conditions Announces
Toggle Summary KemPharm, Inc. Reports Second Quarter 2016 Results
Conference Call and Live Audio Webcast Scheduled for Today at 8:30 a.m. ET Recent Clinical Development & Regulatory Highlights : Completed FDA End of Review meeting for Apadaz™ following receipt of Complete Response Letter Reported results from KP511 Phase 1 Proof-of-Concept Trial; Announces
Toggle Summary KemPharm Completes Key Regulatory Meetings with FDA for KP201/IR and KP415
KemPharm expects to file INDs for both product candidates during second half of 2016 CORALVILLE, Iowa , July 14, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs,  today
Toggle Summary KemPharm’s Prodrug of Hydromorphone, KP511, Demonstrates Comparable Oral Pharmacokinetics to Hydromorphone in Phase 1 Trial
KP511 clinical data consistent with preclinical animal data CORALVILLE, Iowa , June 28, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced results from a Phase 1
Toggle Summary FDA Issues Complete Response Letter for Apadaz™ New Drug Application
CORALVILLE, Iowa , June 13, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration ( FDA ) has issued a Complete Response
Toggle Summary KemPharm Files NDA Amendment Request with FDA for Apadaz™
Discussions On-going with FDA on Potential Apadaz Product Labeling CORALVILLE, Iowa , June 09, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that it has filed
Toggle Summary KemPharm, Inc. to Host Annual Meeting of Stockholders on Tuesday, May 24, 2016 at 9:00 a.m. ET
CORALVILLE, Iowa , May 18, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced today that KemPharm will host its annual meeting of stockholders on Tuesday, May 24, 2016 ,
Toggle Summary KemPharm, Inc. Reports First Quarter 2016 Results
Conference Call and Live Audio Webcast Scheduled for Today at 4:30 p.m. ET Recent Clinical Development & Regulatory Highlights : Introduced Apadaz™ as the proprietary name for KP201/APAP FDA Advisory Committees voted 16 to 4 in support of Apadaz approval; voted 18 to 2 against inclusion of
Toggle Summary KemPharm Receives “Fast Track” Designation for KP511, an Investigational Prodrug of Hydromorphone
KemPharm developing KP511 as an abuse-deterrent, extended-release product candidate – KP511/ER CORALVILLE, Iowa , May 10, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today
Toggle Summary Statement Regarding FDA Advisory Committee Meeting on KemPharm’s Abuse-Deterrent Product Candidate Apadaz™
CORALVILLE, Iowa , May 05, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug
Toggle Summary FDA Advisory Committees To Review KemPharm’s Abuse-Deterrent Drug Candidate Apadaz™
Trading of KMPH Common Stock Halted KemPharm Conference Call Today at 6:15 p.m. ET CORALVILLE, Iowa , May 05, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced