Nektar Therapeutics (NKTR) Stock Tumbles On FDA Rejection

Nektar Therapeutics NKTR Stock News

We told you about Nektar Therapeutics’ (NASDAQ: NKTR) FDA advisory committee last week. As expected the meeting took place yesterday. Unfortunately, the advisory committee voted to reject the drug and the stock is down more than 10% in the premarket as a result.

What’s the deal with NKTR and how does this set the stage for other FDA events this week? Here’s what you need to know!

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NKTR Stock Tumbles On Advisory Committee Rejection

In an after-hours press release yesterday, Nektar Therapeutics announced that it met with¬† the FDA’s Anasthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee.

The meeting was to discuss the NDA surrounding oxycodegel, a pain killer under review at the FDA. Unfortunately, in the release, NKTR said that the Committees voted to reject the New Drug Application.

The company said that as a result of the vote at the meeting, it has decided to withdraw the NDA for oxycodegol. Moreover, the company will be making no further investments into the oxycodegol program.

NKTR said that dropping the program will save the company between $75 million and $125 million in 2020. These figures were based on its projections of estimated costs related to commercialization and post-approval studies discussed with the FDA.

With the rejection by the Advisory Committee in mind and the company’s decision to no longer invest in the program surrounding the drug, the bleeding stops. However, the investments made previously have proven to be for nothing, upsetting investors.

Does This Set The Stage For Other FDA Events This Week?

As mentioned in our Biotech Watch post this week, both IntelliPharmaceuitics International (OTCMKTS: IPCIF) and Durect Corporation (NASDAQ: DRRX) have advisory committee meetings today. IPCIF will be meeting today and DRRX will be meeting tomorrow.

Importantly, both advisory committee meetings surround pain killing drugs that have been rejected by the FDA in the past. However, while the drug applicatication for IPCIF surrounds an opiod, the application for DRRX does not.

With the recent uproar surrounding the opiod epidemic in the United States, the Advisory Committees at the FDA are likely taking a stance against opioids, likely having to do with the rejection of the NKTR NDA. Considering this, I believe that there’s a strong chance for a vote against IPCIF’s candidate today.

However, considering that the DRRX candidate is non-opioid, if the company has addressed all issues mentioned in the previous Complete Response Letter from the FDA, the drug has a stronger chance of being seen in a positive light by the FDA. This could be why the stock is up more than 3% this morning.

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