Syndax Pharmaceuticals stock tumbles on failed IPF trial

Investing.com -- Syndax Pharmaceuticals (NASDAQ: SNDX) shares fell 15% after-hours Monday following the company’s announcement that its axatilimab drug failed to meet the primary endpoint in a Phase 2 trial for idiopathic pulmonary fibrosis (IPF).

The MAXPIRe trial did not achieve its primary endpoint of the annualized rate of decline in forced vital capacity (FVC), the company said. Based on these results, Syndax does not plan to pursue further development of axatilimab in IPF.

The trial enrolled 145 patients across 62 sites in 14 countries. Patients were randomized 2:1 to receive axatilimab 0.3 mg/kg or placebo every two weeks over a 26-week period.

Despite the trial’s failure, axatilimab was well tolerated with a safety profile comparable to placebo, and no new safety signals were observed. Rates of treatment-emergent adverse events leading to treatment discontinuation were low in both arms, and there were no treatment-related fatal adverse events in either arm.

The company stated that the results from the MAXPIRe trial do not affect ongoing trials of axatilimab in other indications. Axatilimab is FDA approved for treating chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

Syndax said it continues to advance axatilimab in multiple trials for cGVHD, with results expected later this year and early 2028. The company also stated it remains focused on advancing its pipeline, including revumenib and axatilimab in frontline settings.

Original Article

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