Incyte (recently entered into an exclusive worldwide collaboration and license agreement with INCY Quick Quote INCY - Free Report) Syndax Pharmaceuticals, Inc. ( SNDX Quick Quote SNDX - Free Report) to develop and commercialize the latter’s axatilimab, an anti-CSF-1R monoclonal antibody.
Per the terms, Incyte will lead global commercial activities for axatilimab across all indications. Both the companies will share profits equally in the United States and Syndax will receive double-digit royalties on sales outside the country. Syndax will retain the option to co-promote axatilimab for any approved indications in the United States. In exchange, Syndax will receive an upfront payment of $117 million and a $35 million equity investment, which will be purchased at $24.62 per share, a 30% premium to the volume-weighted average price over the 10 days prior to Sep 24, 2021. Syndax is also entitled to receive up to an additional $450 million in milestone payments.
Both the companies will share development costs related to the studies being conducted globally and in the United States for all agreed upon trials at a rate of 55% (Incyte) and 45% (Syndax). Incyte will be solely responsible for future development costs for trials that are specific to ex-U.S. countries. Syndax will fund the initial development of axatilimab in idiopathic pulmonary fibrosis (IPF) and Incyte will have the option to co-fund late-stage development for this indication.
The two companies plan to expand the development of axatilimab in chronic graft-versus-host disease (cGVHD) with additional monotherapy and combination trials planned in 2022. Syndax recently completed a phase I/II study of axatilimab in patients with cGVHD. Enrollment is underway in the ongoing global phase II study, AGAVE-201, evaluating axatilimab monotherapy in patients with cGVHD. The top-line data is expected in 2023.
The companies also plan to initiate additional trials of axatilimab in patients with cGVHD in 2022, including a phase II study in combination with a JAK inhibitor in patients with steroid-refractory cGVHD. Moreover, Syndax plans to commence a phase II proof of concept trial of axatilimab early next year in patients with IPF.
The successful development of axatilimab will strengthen Incyte’s GVHD franchise.
Shares of the company have lost 20.5% in the year so far compared with the
industry’s 2.6% decline. Image Source: Zacks Investment Research
The FDA recently approved a label expansion of Incyte’s JAK1/JAK2 inhibitor, Jakafi (ruxolitinib), for the treatment of cGVHD after the failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. It is also approved for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older among other indications. Incyte has a collaboration agreement with
Novartis ( NVS Quick Quote NVS - Free Report) for Jakafi.
Incyte’s lead drug Jakafi’s sales recorded growth in the second quarter after a soft first quarter. The company’s efforts to diversify its revenue base are encouraging as well and approval of additional drugs will boost revenues.
Last month, Incyte and partner
MorphoSys AG ( MOR Quick Quote MOR - Free Report) obtained the European Commission’s approval for tafasitamab under the brand name Minjuvi for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
Incyte currently carries a Zacks Rank #3 (Hold). You can see
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