KemPharm, Inc. (NASDAQ:KMPH) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On May 4, 2020, KemPharm, Inc., or the Company, issued a press release to announce that the Company confirmed that the U.S. Food and Drug Administration, or the FDA, accepted the Company\’s New Drug Application, or NDA, for KP415, the Company\’s investigational product candidate for the treatment of attention deficit hyperactivity disorder. In addition, the Company announced that Corium, Inc., a portfolio company of Gurnet Point Capital, will lead all commercialization activities for KP415, if approved. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained in this Item 7.01, and the press release furnished as Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.
Item 8.01 Other Events.
On May 4, 2020, the Company announced that the FDA accepted the Company’s NDA for KP415. Per the Company’s definitive collaboration and license agreement with an affiliate of Gurnet Point Capital, the Company is entitled to receive a regulatory milestone payment of $5 million following the FDA’s acceptance of the KP415 NDA.
Item 9.01 Financial Statements and Exhibits.
KEMPHARM, INC Exhibit
EX-99.1 2 ex_183564.htm EXHIBIT 99.1 ex_165063.htm Exhibit 99.1 NDA Filing for Potential New ADHD Treatment,…
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About KemPharm, Inc. (NASDAQ:KMPH)
KemPharm, Inc. is a clinical-stage specialty pharmaceutical company. The Company is engaged in the discovery and development of prodrugs. The Company uses its Ligand Activated Therapy (LAT) platform technology to create prodrugs. The Company’s product candidate, KP201/APAP, consists of KP201, its prodrug of hydrocodone, which is combined with acetaminophen (APAP). The Company is developing KP201/APAP as an immediate release (IR), a product candidate for the short-term, or no longer than 14 days for the management of acute pain. The Company has designed KP201/APAP with abuse-deterrent properties to address the epidemic of opioid abuse in the United States. The Company also focuses on developing the pipeline of additional prodrug product candidates that targets pain and attention deficit hyperactivity disorder (ADHD). The Company’s products include KP201/IR (APAP-free), KP511/ER, KP415, KP606/IR and KP746.