Incyte-partnered Niktimvo wins Australia approval for chronic graft-versus-host disease

Incyte Corporation

Incyte Corporation

INCY

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  • Incyte-partnered NIKTIMVO (axatilimab) cleared by Australia TGA under Priority Review for chronic graft-versus-host disease in patients aged 6+ weighing at least 40 kg who failed at least two prior systemic therapies.
  • Specialised Therapeutics holds exclusive rights to commercialize drug in Australia, New Zealand, Singapore under June 2025 agreement with Incyte.
  • Approval supported by Phase 2 AGAVE-201 data showing 74% overall response rate at 0.3 mg/kg every two weeks.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Incyte Corporation published the original content used to generate this news brief via PR Newswire (Ref. ID: 202605031200PR_NEWS_USPR_____CN48940) on May 03, 2026, and is solely responsible for the information contained therein.