Nektar takes a hit as the FDA swerves away from opioid reviews — leaving NKTR-181 in limbo
Nektar Therapeutics took another hit on Thursday after the biotech reported that its opioid pain drug NKTR-181 was being put on hold at the FDA.
In an SEC filing the company reported that the agency “continues to consider a number of scientific and policy issues relating to this class of drugs” and would be postponing their planned AdComm next month. Their August 29 PDUFA date? Well, the FDA might not meet that.
The stock $NKTR was hurt, ending the day down 7%, as investors reacted to the buzz.
For Nektar, which had spun this drug off into subsidiary operation — after initially looking hard for a partner to come in and pick it up — it was another blow for a drug that they have billed as a blockbuster-in-the-making.
Analysts, though, have come up with a wide range of peak sales figures for this drug — ranging from paltry to huge. But just about all of them agree it’s a bit of a sideshow compared to NKTR-214, which has had its own problems.
Jefferies’ David Steinberg says he now expects a 1-year delay for the entry of the drug and lop off 30% of its peak revenue — trimming that to $350 million.
Importantly, there is no indication that the FDA will no longer approve opioids for pain management at this point – although that always remains a possibility given the severity of the current crisis. And we continue to view NKTR-181 as a meaningful, safer treatment option for patients suffering from chronic pain…