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Syndax >> Syndax Pharmaceuticals and Incyte Announce Global Collaboration to Develop and Commercialize Axatilimab for Chronic Graft - Versus - Host Disease and Other Fibrotic Diseases September 27 , 2021 - Syndax to receive $ 152 million in cash ( $ 117 million upfront plus a $ 35 million equity investment , with potential for $ 450 million in additional milestone payments ; 50:50 profit share in the U.S. and double - digit royalties on ex - U.S . sales - - The two companies expect to expand development of axatilimab in chronic graft - versus - host disease ( cGVHD ) with additional monotherapy and combination trials planned in 2022 - - Syndax to commence Phase 2 proof of concept trial in idiopathic pulmonary fibrosis ( IPF ) in early 2022 - - Incyte to lead U.S. and global commercial activities ; Syndax retains option to co - promote in the U.S. - - Syndax to host conference call today at 8:00 a.m. ET ; Incyte to host conference call today at 10:00 a.m. ET - WALTHAM , Mass . and WILMINGTON , Del . , Sept. 27 , 2021 / PRNewswire / -- Syndax Pharmaceuticals , Inc. ( Nasdaq : SNDX ) and Incyte ( Nasdaq : INCY ) announced today that they have entered into an exclusive worldwide collaboration and license agreement to develop and commercialize axatilimab , Syndax's anti - CSF - 1R monoclonal antibody . " This partnership has the potential to significantly expand and maximize the axatilimab program across multiple lines of treatment in chronic graft- versus - host Disease ( cGVHD ) , as well as additional indications in which the monocyte - macrophage lineage plays a vital role in the fibrotic disease process , such as idiopathic pulmonary fibrosis ( IPF ) , " said Briggs W. Morrison , M.D. , Chief Executive Officer of Syndax . " Incyte is a proven leader in the development and commercialization of many important innovative therapies , including a treatment for GVHD . We are thrilled to be working alongside this talented and determined team to combine our expertise as we strive to provide new treatment options for patients in desperate need of effective interventions . " " We are excited to partner with Syndax and for the opportunity to bring another potential treatment to patients with life - threatening conditions , like GVHD , " said Hervé Hoppenot , Chief Executive Officer of Incyte . " Collaborations between companies like Incyte and Syndax , who are both dedicated to scientific advancement , contribute to the development of new innovative medicines that may benefit patient communities around the world . " Syndax and Incyte are seeking to develop axatilimab as a backbone therapy for patients with cGVHD as well as in additional immune - mediated diseases where CSF - 1R - dependent monocytes and macrophages are believed to contribute to organ fibrosis . Syndax recently completed a Phase 1/2 trial of axatilimab in patients with cGVHD . Data from the Phase 1 portion of the trial highlighting the tolerability and high response rate of axatilimab in CGVHD patients refractory to multiple therapeutic agents were reported during an oral presentation at the American Society of Hematology Annual Meeting in December 2020. Updated results from the Phase 1 portion and preliminary results from the Phase 2 expansion portion of the study , which evaluated 1 mg / kg of axatilimab every two weeks , are expected to be presented at a medical meeting in the fourth quarter of 2021 . Enrollment continues in the ongoing global pivotal Phase 2 AGAVE - 201 trial of axatilimab monotherapy in patients with cGVHD , with topline data expected in 2023. The companies also plan to initiate additional trials of axatilimab in patients with cGVHD in 2022 , including a Phase 2 trial in combination with a JAK inhibitor in patients with steroid - refractory cGVHD . Beyond cGVHD , Syndax plans to commence a Phase 2 proof of concept trial of axatilimab early next year in patients with IPF , a serious , life - limiting orphan disease for which axatilimab could represent a much - needed treatment option with a novel mechanism of action . Terms of the Collaboration Under the terms of the agreement , Incyte will lead global commercial activities for axatilimab across all indications . The companies will participate in a 50:50 profit share in the U.S. , and Syndax will receive double - digit royalties on sales outside of the U.S. Syndax will retain the option to co - promote axatilimab for any approved indications in the U.S. In connection with the agreement , Syndax will receive an upfront payment of $ 117 million plus 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 September 24 , 2021. Syndax will also be eligible to receive up to an additional $ 450 million in potential regulatory , development and commercial milestone payments . The companies will share development costs associated with global and U.S. - specific trials for all agreed upon trials at a rate of 55 % ( Incyte ) and 45 % ( Syndax ) , with Incyte responsible for 100 % of future development costs for trials that are specific to ex - U.S . countries . Syndax will fund the initial development of axatilimab in IPF and Incyte will have the option to co - fund late - stage development for this indication . The agreement between Syndax and Incyte , including the upfront payment and equity investment , is subject to clearance by the U.S. antitrust authorities under the Hart - Scott - Rodino Act and will become effective as soon as these conditions have been met . Goldman Sachs & Co. LLC is acting as the exclusive financial advisor to Syndax . Syndax Conference Call and Webcast In connection with this announcement , Syndax's management team will host a conference call and live audio webcast at 8:00 a.m. ET today , September 27 , 2021 . The live audio webcast may be accessed through the Events & Presentations page in the Investors section of Syndax's website at www.syndax.com . Alternatively , the conference call may be accessed through the following : Conference ID : 9875536 Domestic Dial - in Number : ( 855 ) 251-6663