H.C. Wainwright initiated coverage of Syndax Pharmaceuticals (NASDAQ:SNDX) with a “buy” rating and $31 price target. The stock closed at $17.51 on April 8.
Syndax is a clinical-stage biopharmaceutical company focused on development of drugs for the treatment of several oncology indications and chronic graft versus host disease (cGvHD). The company has two product candidates in pivotal development, SNDX-5613 and axatilimab.
Analyst Edward White writes that SNDX-5613 is a potential first-in-class treatment for acute leukemias. The company has three independent AUGMENT-101 pivotal trials underway in distinct patient populations. Other studies are expected to initiate in the first half of 2022 to expand opportunities for SNDX-5613, such as combinations in frontline AML patients, chemo combination in relapsed or refractory (r/r) AML/ALL patients, and monotherapy in MRD-positive AML patients, he added.
“The company’s overall strategy for SNDX-5613 is to achieve approval in r/r disease and eventually in the frontline and maintenance settings in combination with other drugs,” Mr. White said.
Mr. White said axatilimab has a potential best-in-class profile for cGvHD and is anticipated to be in development for other indications in the future.
The pivotal AGAVE-201 trial of monotherapy axatilimab in cGvHD is ongoing with topline data expected in the first half of 2023. Additional trials in cGvHD are expected to launch this year, including a Phase 2 proof-of-concept trial of axatilimab in patients with idiopathic pulmonary fibrosis, he added.
In September 2021, the company entered into a global collaboration and license agreement with Incyte for the development and commercialization of axatilimab. Syndax received an upfront payment of $117-million in connection with the Incyte agreement.
