Syndax Pharmaceuticals Shares Drop After-Hours as Lung Disease Trial Fails
Syndax Pharmaceuticals (SNDX) shares dropped 15% in extended trading on Monday following news that its experimental treatment, axatilimab, failed to meet the primary objective of a Phase 2 trial. The mid-stage MAXPIRe study evaluated whether adding axatilimab to standard treatments could slow the decline of lung function in roughly 145 patients with idiopathic pulmonary fibrosis (IPF). However, the drug did not show a statistically significant benefit over placebo in preserving lung function or improving secondary measures such as quality of life.
Because the trial failed to demonstrate effectiveness, Syndax is discontinuing its development plans for axatilimab in IPF. The failure closes off a potential new indication for the drug, despite safety results showing no new safety concerns and low rates of treatment discontinuation.
Moving forward, Syndax plans to concentrate on its approved commercial treatments and ongoing trials in other disease areas. Axatilimab is already marketed as Niktimvo for chronic graft-versus-host disease, where Syndax and its partner Incyte are evaluating combination therapies for newly diagnosed patients. Investors will be watching for additional clinical trial data expected later this year and in early 2028, as well as progress on the company's second commercial drug, revumenib.
Key points
- Axatilimab failed to meet its primary goal of slowing lung function decline in a Phase 2 trial for idiopathic pulmonary fibrosis.
- Syndax Pharmaceuticals is ending all further development of axatilimab for idiopathic pulmonary fibrosis following the results.
- The trial reported no new safety concerns, with patient discontinuation rates remaining low and comparable to placebo.
- Syndax continues to market axatilimab as Niktimvo for chronic graft-versus-host disease alongside partner Incyte.
- Combination study results for Niktimvo in newly diagnosed graft-versus-host disease patients are expected later this year and in 2028.
Written by our AI from expert market sources across the web. It can contain mistakes: check the facts before acting on them. Write-ups powered by the free AI API at FreeTheAI.org
How we writeDisclaimerQuestions and answers
Why did Syndax Pharmaceuticals stock drop after hours?
Syndax stock fell after its experimental drug axatilimab failed to meet the main goal of slowing lung function decline in a mid-stage study for idiopathic pulmonary fibrosis.
Is Syndax dropping development of axatilimab?
Syndax is ending development of axatilimab for idiopathic pulmonary fibrosis, but the drug remains approved as Niktimvo for chronic graft-versus-host disease with ongoing trials in other indications.
When will Syndax release its next trial results for axatilimab?
Syndax and partner Incyte expect additional data from trials testing axatilimab combination regimens in newly diagnosed graft-versus-host disease patients later this year and in early 2028.