On Thursday, Syndax Pharmaceuticals (NASDAQ:SNDX) received a reiterated Buy stock rating from TD Cowen, following the recent FDA approval of Niktimvo (axatilimab) for the treatment of third-line or beyond chronic graft versus host disease (cGVHD). The treatment, developed by Syndax, will be co-commercialized in the United States with Incyte (NASDAQ:INCY), with both companies sharing profits equally.
The FDA's approval of Niktimvo was announced on Wednesday, marking a significant milestone for Syndax. The companies are planning to launch Niktimvo in either the fourth quarter of this year or the first quarter of the next, once the optimized two new vial sizes are available. While the Wholesale Acquisition Cost (WAC) was not disclosed, the companies anticipate being able to command premium pricing for the drug, citing its differentiated profile.
The partnership between Syndax and Incyte involves a 50/50 profit share arrangement for the co-commercialization of Niktimvo in the US market. This collaborative approach is expected to leverage the strengths of both companies as they bring the new treatment option to patients suffering from cGVHD.
The optimism surrounding the drug's market potential is reflected in the analyst's comments and the sustained Buy rating. With the planned launch of Niktimvo approaching, Syndax Pharmaceuticals appears poised to enter a new phase of growth as it begins the commercialization of its FDA-approved therapy.
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