Nektar Therapeutics (NASDAQ:NKTR) is down 5% premarket on light volume in response to its disclosure that it received a General Advice Letter from the FDA regarding its marketing application for mu-opioid pain med NKTR-181.
Citing its ongoing consideration of scientific and policy issues regarding opioids, the agency is postponing product-specific advisory committee meetings for the time being so its previously scheduled Ad Com review for August 21 has been canceled.
The letter stated that it will continue reviewing the marketing application according to the existing timeline and will request additional information as needed, but did not state whether its action date (PDUFA) of August 29 will change.
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