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Key Takeaways
- The Food and Drug Administration (FDA) delayed its approval for a leukemia drug from Syndax Pharmaceuticals after receiving more information from the company.
- The biopharmaceutical company said the FDA decision on the drug was pushed back three months from the original Sept. 26 date.
- Syndax shares moved sharply lower on Monday.
Shares of Syndax Pharmaceuticals (SNDX) plunged in intraday trading Monday after the biopharmaceutical company reported that the Food and Drug Administration (FDA) delayed a decision on approving its experimental treatment for acute leukemia.Â
The company said that the FDA “extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA)” for revumenib because regulators “required additional time to conduct a full review of supplemental information” they requested from Syndax.Â
Syndax added that the action date would be pushed back by three months. The original action date had been set for Sept. 26.Â
CEO Says Earlier Trials ‘Support Approval’
Chief Executive Officer (CEO) Michael Metzger said that revumenib would be the first medicine approved to treat patients with KMT2A-rearranged acute leukemia, a disease with low median survival rates. Metzger said those affected are a “population with significant unmet need,” adding that research from earlier trials of revumenib, plus the new data provided, “support approval” by the FDA.
After the FDA decision delay news, Syndax Pharmaceuticals shares dropped almost 13% to $21.36 as of 2:40 p.m. ET Monday, falling into negative territory for 2024.