15.01.2020 05:16:32
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Nektar To Withdraw NDA For Oxycodegol
(RTTNews) - Nektar Therapeutics (NKTR) said that it has decided to withdraw the New Drug Application or NDA for oxycodegol and to make no further investment into the program. Earlier, the U.S. Food and Drug Administration' Committees did not recommend approval of oxycodegol.
The company estimates that this will afford its cost savings of between $75 million to $125 million in 2020 based upon its projections of the estimated costs related to commercialization plans and post-approval studies previously discussed with the FDA.
The company said it 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.
NKTR closed Tuesday trading at $27.96, up $0.56 or 2.04%. But, in the after-hours, the stock dropped $4.28 or 15.31 percent.
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