Syndax secures funding from Royalty Pharma for Niktimvo US sales

Syndax Pharmaceuticals has established a synthetic royalty funding agreement with Royalty Pharma, concentrating on the US net sales of Niktimvo (axatilimab-csfr), a treatment aimed at chronic graft-versus-host disease (GVHD). This strategy places Syndax in a favorable position to introduce two new medications and explore additional uses.

As part of this deal, Syndax has secured $350 million upfront in exchange for a 13.8% royalty on Niktimvo's net US sales. These royalty payments to Royalty Pharma will conclude once they amass 2.35 times the initial sum. Syndax's financial and legal guidance was provided by Goldman Sachs & Co and Cooley, while Royalty Pharma received advice from Gibson, Dunn & Crutcher, and Dechert.

Syndax's CEO, Michael Metzger, highlighted that this transaction is expected to sustain the company until it reaches profitability, while allowing them to continue benefiting from Niktimvo's profits and future growth potential.

Niktimvo, an anti-colony stimulating factor 1 receptor (CSF-1R) antibody, has been approved in the US for treating chronic GVHD in both adult and pediatric patients who weigh a minimum of 40 kg and have failed at least two previous systemic treatments. Syndax acquired exclusive global rights to develop and market axatilimab from UCB in 2016. Later, in September 2021, Syndax entered an exclusive global co-development and co-commercialization license agreement with Incyte for axatilimab in chronic GVHD and potential future indications.

Pablo Legorreta, founder and CEO of Royalty Pharma, expressed enthusiasm about partnering with Syndax, acknowledging it as an innovative oncology company with a promising pipeline. He anticipates Syndax and its partner Incyte will soon launch Niktimvo and provide this crucial medication to GVHD patients.

In the US, Niktimvo will be jointly commercialized by Syndax and Incyte, with a launch projected by the first quarter of 2025. Incyte holds exclusive rights for commercialization outside the US. Axatilimab is also being examined in combination studies for chronic GVHD. An active Phase II trial is testing it with ruxolitinib, and a Phase III trial with steroids is in the planning stages. Additionally, axatilimab is undergoing a Phase II trial for idiopathic pulmonary fibrosis.