Axsome targets one NDA per year through 2030 as AXS-12 gets May 1, 2027 PDUFA date

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Axsome Therapeutics signaled a pipeline cadence of roughly one new drug application filing per year through 2030, with its AXS-12 for cataplexy in narcolepsy receiving a PDUFA target action date of May 1, 2027. The company reported second-quarter 2026 net product revenue of $218 million, a 46% increase from the prior year, driven by AUVELITY and SUNOSI. AUVELITY net product sales reached $180.3 million, SUNOSI net product revenue was $35.8 million, and SYMBRAVO net sales were $2.3 million, though SYMBRAVO faced gross-to-net discount pressure that pushed the metric into the high 80% range due to a prior-period adjustment and patient service utilization. Management expects SYMBRAVO gross-to-net to normalize for the remainder of the year and reiterated that its current cash balance of approximately $320 million is sufficient to fund operations into cash flow positivity. Early launch metrics for AUVELITY in Alzheimer’s disease agitation showed a 126% increase in new-to-brand prescriptions among patients 65 and older during the first eight weeks compared to the same period in the prior quarter.

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Axsome Therapeutics Inc
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AXS-12 receives PDUFA date and pipeline cadence of one NDA per year through 2030, indicating strong R&D progress.

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