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BioWorld - Friday, December 19, 2025
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Home » Ready to Rezurock in GVHD, Syndax/Incyte’s Niktimvo cleared
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Ready to Rezurock in GVHD, Syndax/Incyte’s Niktimvo cleared

Aug. 15, 2024
By Randy Osborne
Wall Street promptly started speculating about the product’s odds in the graft-vs.-host disease (GVHD) marketplace shortly after Syndax Pharmaceuticals Inc. and Incyte Corp. scored U.S. FDA approval – well ahead of the Aug. 29 PDUFA date – of Niktimvo (axatilimab), an anti-CSF-1R antibody for the treatment of chronic disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg (88.2 lbs.).
BioWorld Regulatory Immune Monoclonal antibody U.S. FDA

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