Key Takeaways
- The Meals and Drug Administration (FDA) delayed its approval for a leukemia drug from Syndax Prescription drugs after receiving extra data from the corporate.
- The biopharmaceutical firm stated the FDA determination on the drug was pushed again three months from the unique Sept. 26 date.
- 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 call on approving its experimental remedy for acute leukemia.
The corporate stated that the FDA “prolonged the Prescription Drug Consumer Charge Act (PDUFA) motion date for the New Drug Software (NDA)” for revumenib as a result of regulators “required extra time to conduct a full evaluation of supplemental data” 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 ‘Assist Approval’
Chief Government Officer (CEO) Michael Metzger stated that revumenib can be the primary drugs accredited 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 information supplied, “assist approval” by the FDA.
After the FDA determination 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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