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 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
Toggle Summary KemPharm Announces New Additions to Senior Leadership Team
Daniel L. Cohen , global public policy and government relations leader, appointed Executive Vice President, Government and Public Relations Rene A. Braeckman , Ph.D., clinical development expert, appointed Vice President, Clinical Development CORALVILLE, Iowa , April 19, 2016 (GLOBE NEWSWIRE) --
Toggle Summary KemPharm Receives Clearance from FDA to Initiate Human Clinical Trials of KP511, an Investigational Prodrug of Hydromorphone
KemPharm plans to develop KP511 as an abuse-deterrent, extended-release product CORALVILLE, Iowa , March 28, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH) announced today that its Investigational New Drug (IND) application for KP511, KemPharm’s prodrug of hydromorphone, has been accepted by
Toggle Summary KemPharm Receives NDA User Fee Waiver from FDA
CORALVILLE, Iowa , March 24, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration ( FDA ) has granted a fee waiver and has
Toggle Summary KemPharm Announces FDA Advisory Committee Meeting For Lead Abuse-Deterrent Drug Candidate KP201/APAP
CORALVILLE, Iowa , March 14, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH) today announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S.
Toggle Summary KemPharm, Inc. Reports Q4 and Year End 2015 Results
Conference Call and Live Audio Webcast Scheduled for Today at 4:30 p.m. ET Recent Clinical Development & Regulatory Highlights : Submitted New Drug Application (NDA) under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for KP201/APAP to the U.S.
Toggle Summary KemPharm Files IND for KP511, an Investigational Prodrug of Hydromorphone
CORALVILLE, Iowa , March 07, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH) announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration ( FDA ) requesting clearance to begin human clinical trials of KP511, KemPharm’s prodrug of
Toggle Summary FDA Grants Priority Review to KemPharm for KP201/APAP NDA
If Approved, KP201/APAP Could Become the First Immediate-Release Hydrocodone Combination Product With Abuse-Deterrent Properties CORALVILLE, Iowa , Feb. 10, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH) today announced that the New Drug Application (NDA) for KP201/APAP, its investigational
Toggle Summary KemPharm Announces Closing of $86.25 Million 5.50% Senior Convertible Notes Due 2021
CORALVILLE, Iowa , Feb. 09, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH) announced today the closing of $86.25 million aggregate principal amount of 5.50% senior convertible notes due 2021 (the “notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under
Toggle Summary KemPharm Announces Pricing of $75.0 Million 5.50% Senior Convertible Notes Due 2021
CORALVILLE, Iowa , Feb. 04, 2016 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH)  announced today the pricing of $75.0 million aggregate principal amount of 5.50% senior convertible notes due 2021 (the “notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under
Toggle Summary KemPharm Added to NASDAQ Biotechnology Index
CORALVILLE, Iowa , Jan. 07, 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 the company was selected for addition to the NASDAQ Biotechnology Index
Toggle Summary KemPharm, Inc. Expands Pain Therapy Pipeline With Discovery of KP746
Novel Prodrug of Oxymorphone Adds New Asset to KemPharm’s Advancing Abuse-Deterrent Product Portfolio CORALVILLE, Iowa , Dec. 30, 2015 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ:KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary