Biotech Values

[DewDiligence]

NKTR -7%—possible delay to NKTR-181 NDA:

https://www.sec.gov/Archives/edgar/data/906709/000121390019013563/f8k072319_nektartherap.htm

On July 23, 2019, Nektar Therapeutics…received a General Advice letter (“Letter”) from the U.S. Food and Drug Administration (“FDA”) regarding Nektar’s New Drug Application (“NDA”) for NKTR-181…

In the Letter, the FDA stated that it is postponing product-specific advisory committee meetings for opioid analgesics, including the one previously scheduled for August 21, 2019 to discuss the NDA for the NKTR-181 product, while the agency continues to consider a number of scientific and policy issues relating to this class of drugs.

The Letter stated that the FDA’s reason for postponing the advisory committee meeting for NKTR-181 is not unique to the NKTR-181 product. The Letter further stated that the FDA will continue to review the NDA for NKTR-181 according to the existing Prescription Drug User Fee Act (“PDUFA”) timeline and will request additional information from Nektar, as needed. However, the FDA did indicate in the Letter that it is possible the agency may not be able to meet the PDUFA goal date of August 29, 2019, due to the postponement of the advisory committee meeting.