Nektar Therapeutics (NASDAQ:NKTR) is up 5% premarket on light volume in reaction to U.S. Breakthrough Therapy designation for bempegaldesleukin (NKTR-214), combined with Bristol-Myers Squibb’s (NYSE:BMY) Opdivo (nivolumab), for previously untreated patients with unresectable/metastatic melanoma.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
A Phase 1/2 study, PIVOT-02, is ongoing.
Bempegaldesleukin is a CD122-preferential IL-2 pathway agonist designed to activate and proliferate certain cancer-killing immune cells.
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