Incyte wins FDA nod for Zynyz to treat rare skin cancer
Grandbrothers
- Incyte (NASDAQ:INCY) announced Wednesday that the FDA cleared its intravenous PD-1 inhibitor Zynyz under the agency’s accelerated approval program for patients with merkel cell carcinoma (MCC), a rare form of skin cancer.
- The decision is based on results about the tumor response rate and duration of response (DOR) linked to Zynyz from the company’s POD1UM-201 trial.
- Continuous approval of Zynyz for this indication is subject to favorable results from confirmatory trials.
- Zynyz, also known as retifanlimab-dlwr, is a partnership between Incyte (INCY) and MacroGenics (NASDAQ:MGNX), which, in a separate release, said that it is on track to receive a $15M milestone payment from Incyte (INCY) following the approval.
- While Wall Street has remained bullish on MacroGenics (MGNX), with an average rating of Buy from analysts compared to Hold ratings from Seeking Alpha Authors, SA’s Quant System, which consistently beats the market, rated MGNX as a Strong Buy.