Nektar Therapeutics (NASDAQ: NKTR) shares were crushed on Wednesday after the U.S. Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee did not recommend the company’s pain drug.
The committees met to discuss the New Drug Application (NDA) for oxycodegol (formerly NKTR-181), which is a treatment for chronic pain. Ultimately, they decided to not approve the NDA in consideration of updated policies on opioid analgesics.
As a result, Nektar Therapeutics has decided that it will withdraw the NDA for oxycodegol and make no further investment into the program.
The company detailed in a statement:
The Company is disappointed in the Committees’ vote regarding oxycodegol and believes it is also disappointing for patients suffering from chronic pain and the physicians that treat those patients who are currently relying on existing opioid therapies. The Company created oxycodegol specifically to both help these patients and physicians and address the opioid abuse epidemic. For the development of oxycodegol, the Company used well-established efficacy, safety and human abuse potential study designs that have led to many prior FDA approvals of opioid medications. The development program for oxycodegol included over 2,000 patients and volunteers.
Nektar Therapeutics expects to see cost savings of between $75 million to $125 million in 2020, based on its projections of the estimated costs related to commercialization plans and post-approval studies previously discussed with the FDA.
Shares of Nektar Therapeutics were last seen down 15% at $23.82, in a 52-week range of $15.64 to $47.11. The consensus price target is $32.54.