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Stock Details
  • PRICE$36.51
  • PRICE CHANGE-$1.50
  • % CHANGE-3.93%
  • TWEETS11
  • CONSENSUSSELL

Trends

Course of Action

SELL

Sentiment (10 days)

  •  Strong Buy
  •  Buy
  •  Hold
  •  Sell
  •  Strong Sell

DAILY PRICE CHANGE VS SENTIMENT

  • BullishBullish
  • BearishBearish
  • SentimentSentiment
  • BarPrice

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NEKTAR THERAPEUTICS (NKTR) News

Nektar Therapeutics Announces Submission of a New Drug Application to the U.S. FDA for NKTR-181, a First-in-Class Investigational Opioid to Treat Chronic Low Back Pain in Adult Patients New to Opioid Therapy

Nektar Therapeutics (Nasdaq: NKTR) today announced submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for NKTR-181, a new molecular entity (NME) and the first analgesic opioid molecule to exhibit a reduced incidence of specific CNS-mediated side effects, such as euphoria, through the targeted alteration of brain-entry kinetics.

"The submission of the NDA for NKTR-181 is an important milestone for Nektar, and we would like to thank our employees, investigators, clinical trial sites and most importantly the patients and families of those living with chronic pain for all of their help in the development of this medicine," said Steve Doberstein, Ph.D., Senior Vice President of Research and Development and Chief Development Officer at Nektar Therapeutics. "This innovative investigational medicine separates analgesic efficacy from the high levels of euphoria that too often lead to the abuse and addiction of traditional opioids."

The NDA is supported by an extensive clinical and nonclinical data package. The clinical data submitted in the NDA comprised 15 studies in 2,234 subjects and includes: a 600-patient efficacy study in patients with chronic low back pain who are new to opioid therapy; a 630-patient long-term 52-week safety study in patients with noncancer pain, who are new to opioid therapy, as well as those who are experienced with opioid therapy; pharmacokinetic/pharmacodynamic studies in over 450 subjects; and two human abuse potential studies evaluating both therapeutic and supratherapeutic doses of NKTR-181 versus an oxycodone control in recreational drug users.

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