Presentations to Highlight Corporate, Regulatory and Pipeline Advancements
CELEBRATION, Fla., Sept. 02, 2020 (GLOBE NEWSWIRE) -- KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that its president and chief executive officer, Travis C. Mickle, Ph.D., will present at two investor conferences during the month of September.
During the presentations, Dr. Mickle will provide an overview of KemPharm’s business and highlight recent corporate and regulatory achievements, including the ongoing review of the New Drug Application (NDA) for KP415, KemPharm’s investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD). In a recently completed mid-cycle communication meeting for the KP415 NDA, the FDA did not raise any substantive issues and indicated that no major safety concerns were noted at that point in the review. Additionally, the agency reaffirmed the PDUFA date of March 2, 2021.
Members of KemPharm’s management team will be available to participate in one-on-one virtual meetings with investors who are registered to attend the conferences.
Details of KemPharm's presentations are as follows:
||Virtual Life Science Investor Forum
||Thursday, September 17, 2020
||10:30 AM (ET)
The live webcast of each presentation will available by clicking the provided link or visiting the Investor Relations section of the KemPharm website at http://investors.kempharm.com/.
KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT® (Ligand Activated Therapy) technology. KemPharm utilizes its proprietary LAT® technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder. KemPharm’s co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but have differing duration/effect profiles. In addition, KemPharm has received FDA approval for APADAZ®, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.
Caution Concerning Forward Looking Statements:
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation the Company’s proposed development and commercial timelines, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements, including the timing and probability of potential FDA approval of the KP415 NDA, and the potential commercial launch of KP415. The potential clinical benefits of KP415 or any of our product candidates, are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning KemPharm’s business are described in detail in KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2019, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
Jason Rando/Maureen McEnroe
Tiberend Strategic Advisors, Inc.
(212) 375-2665 / 2664