Syndax Pharmaceuticals and Royalty Pharma Sign $350M Royalty Deal for Niktimvo™

Syndax Pharmaceuticals and Royalty Pharma have unveiled a major $350 million funding agreement that is set to bolster Syndax's financial standing significantly. The deal revolves around the synthetic royalty based on the U.S. net sales of Niktimvo (axatilimab-csfr), a pioneering treatment for chronic graft-versus-host disease (GVHD).

Michael A. Metzger, the CEO of Syndax, expressed optimism about the deal, stating that the funds will support the company's journey towards profitability and enable the launch of two innovative medicines. He emphasized that this injection of capital will allow Syndax to maintain a stake in Niktimvo's profits while benefiting from its future growth potential. Metzger highlighted the role of Royalty Pharma as a partner that shares Syndax's vision for Niktimvo's significant market potential and value creation for GVHD patients.

Pablo Legorreta, the founder and CEO of Royalty Pharma, echoed these sentiments. He expressed excitement about partnering with Syndax, acknowledging the innovative strides Syndax has made in oncology. Legorreta emphasized the critical need for new treatment options for chronic GVHD, a condition with substantial unmet medical needs. He anticipated the upcoming launch of Niktimvo in collaboration with Incyte, which will bring significant relief to patients suffering from this severe condition.

The terms of the agreement include an upfront payment of $350 million from Royalty Pharma to Syndax. In return, Royalty Pharma will receive a 13.8% royalty on U.S. net sales of Niktimvo. The royalty payments will continue until they reach a multiple of 2.35 times the initial payout.

Niktimvo (axatilimab-csfr) is an anti-CSF-1R antibody designed to treat chronic GVHD in patients who have not responded to at least two prior lines of systemic therapy. This therapy is particularly significant for both adult and pediatric patients weighing 40 kg (88.2 lbs) or more. Syndax and Incyte will co-commercialize Niktimvo in the U.S., with Incyte holding exclusive commercialization rights outside the U.S. Syndax plans to launch Niktimvo in the U.S. by early 2025.

Syndax secured the worldwide rights to axatilimab from UCB in 2016. The company later entered a global co-development and co-commercialization agreement with Incyte in 2021. This agreement covers chronic GVHD and other potential future indications. Current clinical development efforts include a Phase 2 trial combining axatilimab with ruxolitinib and a Phase 3 trial combining it with steroids. Additionally, axatilimab is being evaluated in a Phase 2 trial for idiopathic pulmonary fibrosis.

Syndax Pharmaceuticals is a biopharmaceutical company focused on developing cancer therapies. Its pipeline includes Niktimvo and revumenib, a selective menin inhibitor. The company is dedicated to advancing cancer care through continuous innovation and clinical trials.

Founded in 1996, Royalty Pharma is a prominent funder of biopharmaceutical innovation. It collaborates with a diverse range of partners, including academic institutions, research hospitals, and pharmaceutical companies. Royalty Pharma's portfolio features royalties on over 35 commercial products, exemplifying its critical role in the biopharmaceutical industry.

In summary, the $350 million funding agreement between Syndax Pharmaceuticals and Royalty Pharma represents a pivotal moment for both companies. It ensures the financial stability of Syndax and supports the development and launch of groundbreaking treatments for chronic GVHD, with the potential to significantly improve the lives of patients.