KemPharm, Inc. (NASDAQ:KMPH) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On March 2, 2021, KemPharm, Inc., or the Company, issued a press release announcing that the U.S. Food and Drug Administration, or the FDA, approved the New Drug Application, or NDA, for AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), formerly referred to as KP415, a once-daily product for the treatment of attention deficit hyperactivity disorder, or ADHD in patients age six years and older. The Company will conduct a conference call and live audit webcast with slide presentation today, Wednesday, March 3, 2021, at 8:30 a.m. ET.
A copy of the press release and presentation are furnished as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K. The information contained in this Item 7.01, the press release furnished as Exhibit 99.1 and the presentation furnished as Exhibit 99.2, 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 March 2, 2021, the Company announced that the FDA approved the NDA for AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules, for oral use, CII), formerly referred to as KP415, a once-daily product for the treatment of ADHD in patients age six years and older.
Item 9.01 Financial Statements and Exhibits.
| 99.2 | Presentation titled \”AZSTARYS™ FDA Approval\” dated March 3, 2021. |
KEMPHARM, INC Exhibit
EX-99.1 2 ex_231322.htm EXHIBIT 99.1 ex_231322.htm Exhibit 99.1 KemPharm Announces FDA Approval of AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules,…
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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.
