Nektar Therapeutics (NKTR - Free Report) announced that two FDA advisory committees did not give recommendation for approval to its chronic pain candidate, oxycodegol (formerly NKTR-181). The company met Anesthetic and Analgesic Drug Products Advisory Committee, and Drug Safety and Risk Management Advisory Committee to discuss the new drug application (“NDA”) for oxycodegol. The company has withdrawn the NDA for the candidate and decided to stop further development of the candidate following the unfavorable decision.
Shares of Nektar were down 14.9% in pre-market trading on Jan 14, following the unfavorable news. The company’s shares have declined 37.2% in the past year compared with the industry’s decrease of 0.8%.
Please note that the company’s NDA seeking approval for oxycodegol was accepted by the FDA in July 2018. A decision was previously expected in August 2019. However, the FDA postponed product-specific advisory committee meetings to discuss the NDA due to a number of scientific and policy issues relating to opioid analgesics.
The company stated in its recent press release that it had used well-established efficacy, safety and human abuse potential study designs for development of oxycodegol. These study designs had previously led to FDA approval for other opioid-based analgesics.
Meanwhile, the company had raised concerns in its third-quarter earnings report for oxycodegol approval due to substantial uncertainty related to approval of new opioid-based drugs.
Nektar stated that discontinuation of oxycodegol development will help the company to generate cost savings in the range of $75-$125 million in 2020. The savings will be led by reduction in estimated costs related to planned oxycodegol commercialization and post-approval studies.
Meanwhile, Nektar continues to develop its oncology and auto-immune disorder pipeline. The company is developing several immuno-oncology candidates with bempegaldesleukin being its primary candidate. Earlier this month, it expanded its collaboration agreement with Bristol-Myers (BMY - Free Report) to include two new registrational studies. The studies will evaluate bempegaldesleukin plus Bristol-Myers’ Opdivo in adjuvant melanoma and muscle-invasive bladder cancer.
The company is also developing several other candidates across important therapeutic areas including NKTR-358 in autoimmune diseases and NKTR-255 in virology indications. It has collaborations with Eli Lilly (LLY - Free Report) and Gilead Sciences (GILD - Free Report) for development of NKTR-358 and NKTR-255, respectively.
Nektar currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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