Syndax Pharma’s Axatilimab Receives Orphan Drug Designation For Treatment Of Chronic Lung Disease


Clinical-stage biopharmaceutical company Syndax Pharmaceuticals, Inc. has received Orphan Drug Designation for axatilimab from the U.S. Food and Drug Administration (FDA) for treating patients with idiopathic pulmonary fibrosis (IPF).  Axatilimab is a monoclonal antibody that targets CSF-1R, a cell surface protein.

Syndax Pharmaceuticals (SNDX) Chief Executive Officer Briggs W. Morrison, M.D., said, “IPF is a serious, life-limiting orphan disease, and today’s Orphan Drug Designation validates axatilimab’s potential to serve as an effective therapeutic option for the currently-underserved patients living with this rare disease.”

Morrison added, “Building on promising data demonstrating meaningful multiorgan clinical benefit in patients with chronic graft versus host disease, we are actively evaluating options to expand the axatilimab franchise into additional areas of high unmet need where the monocyte-macrophage lineage plays a key role in the fibrotic disease process.” (See Syndax Pharmaceuticals stock analysis on TipRanks)

IPF is a chronic lung disease with a median survival of 3-5 years post-diagnosis. Present therapies on the market only slow the disease but do not stop its progression. The only curative therapy for IPF is a lung transplant. According to the company, IPF could affect about 150 thousand patients in the U.S. and 260 thousand patients across the 7 major pharmaceutical markets.

On March 31, axatilimab also received orphan drug designation for the treatment of patients with chronic graft versus host disease (cGVHD).

Last month, Stifel Nicolaus analyst Konstantinos Aprilakis reiterated a Buy rating on the stock with a $39 price target (71.1% upside potential).

Aprilakis commented, “We expect the company to continue finding success with SNDX-5613, its lead asset and menin/MLL inhibitor for potential use in acute leukemias, and axatilimab, an anti-CSF-1R antibody currently being developed in cGVHD.”

Consensus on the street is that Syndax Pharmaceuticals is a Strong Buy based on 3 unanimous Buys. The average analyst price target of $35.33 implies upside potential of 55%. Shares have gained about 149.3% over the past year.

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