Key Takeaways
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The Meals and Drug Administration (FDA) delayed its approval for a leukemia drug from Syndax Prescription drugs after receiving extra info from the corporate.
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The biopharmaceutical firm stated the FDA resolution on the drug was pushed again three months from the unique Sept. 26 date.
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Syndax shares moved sharply decrease on Monday.
Shares of Syndax Prescription drugs (SNDX) plunged in intraday buying and selling Monday after the biopharmaceutical firm reported that the Meals and Drug Administration (FDA) delayed a choice on approving its experimental remedy for acute leukemia.
The corporate stated that the FDA “prolonged the Prescription Drug Person Payment Act (PDUFA) motion date for the New Drug Software (NDA)” for revumenib as a result of regulators “required further time to conduct a full overview of supplemental info” they requested from Syndax.
Syndax added that the motion date can be pushed again by three months. The unique motion date had been set for Sept. 26.
CEO Says Earlier Trials ‘Help Approval’
Chief Govt Officer (CEO) Michael Metzger stated that revumenib can be the primary medication authorised to deal with sufferers with KMT2A-rearranged acute leukemia, a illness with low median survival charges. Metzger stated these affected are a “inhabitants with vital unmet want,” including that analysis from earlier trials of revumenib, plus the brand new knowledge offered, “help approval” by the FDA.
After the FDA resolution delay information, Syndax Prescription drugs shares dropped virtually 13% to $21.36 as of two:40 p.m. ET Monday, falling into unfavourable territory for 2024.
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