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Syndax Pharmaceuticals (SNDX) 5 Nov 24 2024 Q3 Earnings call transcript

AInvestWednesday, Nov 6, 2024 12:43 pm ET
1min read

In the third quarter of 2024, Syndax Pharmaceuticals made remarkable strides in its transition from a development organization to a commercial stage company. The company's robust pipeline, marked by the approval of Niktimvo for chronic graft versus host disease and the anticipated approval of Revumenib for relapsed or refractory KMT2A rearranged acute leukemia, underscores its potential to bring novel medicines to patients and create significant value for investors.

FDA Approval of Niktimvo and Strategic Partnership with Incyte

The approval of Niktimvo, the first and only CSF1R antibody approved for the treatment of chronic graft versus host disease, is a significant milestone for Syndax. This achievement was further strengthened by a $350 million royalty agreement with Royalty Pharma, providing the company with a solid financial foundation for its commercial launches and pipeline expansion. The strategic partnership with Incyte, a leader in the GVHD market, is expected to bring Niktimvo to patients in need and expand its clinical development program in chronic GVHD and other diseases marked by fibrosis and inflammation.

Advancements in Revumenib Clinical Development

The progress of Revumenib, a selective menin inhibitor, is another highlight of Syndax's third quarter. With a PDUFA date of December 26, 2024, and compelling clinical data across the treatment continuum, Revumenib is poised to become a first-in-class and practice-changing therapy for KMT2A and NPM1 acute leukemia. The positive data from the AUGMENT-101 trial and the anticipated approval in relapsed or refractory KMT2A rearranged acute leukemia position Syndax for a strong launch and successful long-term franchise growth across both KMT2A and NPM1 acute leukemias.

Financial Strength and Strategic Priorities

The financial health of Syndax is a testament to its strategic priorities and strong execution. The $399.6 million in cash equivalents and short-term investments, combined with the $350 million from the royalty agreement, provide a strong balance sheet to fund the commercialization of Niktimvo and the anticipated launch of Revumenib. The company's focus on leveraging its first-mover advantage, building a highly experienced commercial organization, and preparing for the launch of both Niktimvo and Revumenib sets a solid foundation for future success.

Conclusion

Syndax Pharmaceuticals' third quarter earnings call showcased the company's transformation into a commercial stage company, backed by a robust pipeline and strategic partnerships. The approval of Niktimvo and the anticipated approval of Revumenib, along with the financial strength provided by the royalty agreement, position Syndax for a promising future in the treatment of chronic graft versus host disease and acute leukemia. With a clear focus on innovation, execution, and commercial success, Syndax is well-positioned to make a major impact on patients and investors alike.

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