FDA Approves Incyte/Syndax Partnered Drug For Chronic Graft-Versus-Host Disease, A Post-Transplant Complication
Portfolio Pulse from Vandana Singh
The FDA has approved Incyte Corporation (NASDAQ: INCY) and Syndax Pharmaceuticals Inc’s (NASDAQ: SNDX) drug Niktimvo for chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy. This approval is based on the AGAVE-201 study, which showed a 75% overall response rate within the first six months of treatment. Niktimvo will be co-commercialized by Incyte and Syndax in the U.S., with Incyte holding exclusive commercialization rights outside the U.S. The companies plan to launch smaller vial sizes by early Q1 2025.
August 15, 2024 | 2:11 pm
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POSITIVE IMPACT
The FDA approval of Niktimvo, co-developed with Syndax, for chronic GVHD is a significant milestone for Incyte. The drug showed a 75% response rate in trials and will be co-commercialized in the U.S. This approval could boost Incyte's revenue and market position.
The FDA approval of Niktimvo is a major development for Incyte, as it is their second approved treatment for chronic GVHD. The high response rate in trials and the co-commercialization strategy in the U.S. are likely to positively impact Incyte's revenue and market position.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100
POSITIVE IMPACT
Syndax Pharmaceuticals, in partnership with Incyte, received FDA approval for Niktimvo for chronic GVHD. The drug demonstrated a 75% response rate in trials. This approval is expected to enhance Syndax's market presence and revenue.
The FDA approval of Niktimvo is a significant achievement for Syndax Pharmaceuticals. The drug's high response rate in trials and the co-commercialization agreement with Incyte in the U.S. are likely to positively impact Syndax's market presence and revenue.
CONFIDENCE 90
IMPORTANCE 85
RELEVANCE 100