Syndax Pharmaceuticals

Syndax Pharmaceuticals and Royalty Pharma announce a $350 million synthetic royalty funding agreement for Niktimvo™ (axatilimab-csfr), expected to fund Syndax through profitability with proforma cash approaching $800 million as of June 30. The agreement involves a 13.8% royalty on U.S. net sales of Niktimvo, with royalty payments ceasing upon reaching 2.35x the upfront payment. Niktimvo is a first-in-class anti-CSF-1R antibody approved for chronic graft-versus-host disease (GVHD) in the U.S., co-commercialized by Syndax and Incyte, with a planned U.S. launch by early Q1 2025.

Syndax Pharmaceuticals and Royalty Pharma announce a $350 million synthetic royalty funding agreement for Niktimvo™ (axatilimab-csfr), expected to fund Syndax through profitability and support upcoming launches and development of Niktimvo and revumenib.

Royalty Pharma enters $350 million synthetic royalty funding agreement with Syndax Pharmaceuticals for Niktimvo's U.S. net sales, receiving a 13.8% royalty until a 2.35x multiple is reached. The funding supports Niktimvo's launches and development, with Syndax's proforma cash nearing $800 million as of June 30. Niktimvo targets chronic graft-versus-host disease (GVHD).

Royalty Pharma plc and Syndax Pharmaceuticals announce a $350 million synthetic royalty funding agreement for Niktimvo (axatilimab-csfr), a first-in-class treatment for chronic graft-versus-host disease (GVHD). The agreement includes a 13.8% royalty on U.S. net sales of Niktimvo, with payments ceasing upon reaching a 2.35x multiple. The funds are expected to support Syndax through profitability and the launch of Niktimvo in the U.S. by early 2025.

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Syndax Pharmaceuticals, a biotech company focused on cancer therapies, is at a pivotal juncture with recent FDA approvals and upcoming product launches. Key developments include the approval of Niktimvo for cGVHD and the extended PDUFA date for revumenib in AML. The company's financial outlook is stable, with a strong cash position and a cash runway through 2026. Syndax's product pipeline, anchored by Niktimvo and revumenib, shows potential for expansion into new indications like CRC. Analysts maintain a positive outlook, with a consensus price target of $33.00, reflecting optimism about the company's growth trajectory.

Niktimvo™ (axatilimab-csfr) met primary endpoint in AGAVE-201 trial, showing 74% response rate in 0.3 mg/kg dose cohort for chronic graft-versus-host disease (GVHD). FDA approved Niktimvo for GVHD treatment after two prior therapies, and it's added to NCCN Guidelines as a category 2A recommendation.

NIKTIMVO™ (axatilimab), a first-in-class anti-CSF-1R antibody, treats chronic graft-versus-host disease (cGvHD) in adults and pediatric patients weighing ≥40kg with at least two failed systemic therapies. FDA approved in August 2024, NIKTIMVO targets inflammation and fibrosis drivers in cGvHD, supplied as a 50mg/ml solution in single-dose vials for IV administration. Clinical trial AGAVE-201 showed 75% ORR within six months, with sustained response in 60% at 12 months.

Incyte and Syndax Pharmaceuticals secure FDA approval for Niktimvo, a treatment for chronic graft-versus-host disease, with potential sales of $650 million.