UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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| Item 8.01 | Other Events |
On December 5, 2019, the U.S. Food and Drug Administration (“FDA”) announced a forthcoming public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee (collectively, the “Committees”) to be held on January 14, 2020 from 8 a.m. to 5:30 p.m. Eastern Time. The official notice was published in the Federal Register on December 6, 2019. The FDA noted that the Committees will discuss the new drug application (NDA) for oxycodegol (also known as NKTR-181), a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The Committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product. As previously disclosed by Nektar, the FDA did not meet the PDUFA goal date of August 29, 2019 for the oxycodegol NDA.
SIGNATURES
Pursuant to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| By: | /s/ Mark A. Wilson | |
| Mark A. Wilson | ||
| General Counsel and Secretary | ||
| Date: | December 6, 2019 |