Axsome Therapeutics, Inc. 8K

Axsome Therapeutics reported strong second quarter 2026 revenue growth, ongoing net losses, expanded launches and sales efforts for AUVELITY, SUNOSI, and SYMBRAVO, and significant clinical and regulatory progress across its CNS pipeline, including FDA acceptance of the AXS-12 NDA with a May 1, 2027 PDUFA date.

On August 10, 2026, Axsome Therapeutics, Inc. reported its second quarter 2026 financial results and provided a business update, highlighting total net product revenue of $218.4 million (46% year-over-year growth) driven primarily by AUVELITY, SUNOSI, and SYMBRAVO, alongside a net loss of $51.3 million, expanded commercial activities including the June 2026 U.S. launch of AUVELITY for agitation associated with dementia due to Alzheimer’s disease, substantial growth in prescriptions and payer coverage for its marketed products, progress across its late-stage neuroscience pipeline including initiation of Phase 3 ADHD trials for solriamfetol, FDA acceptance of the NDA for AXS-12 for cataplexy in narcolepsy with a PDUFA date of May 1, 2027, and plans to initiate a pivotal Phase 2/3 trial of AXS-05 for smoking cessation while maintaining a cash balance of $319.9 million that management believes is sufficient to fund operations into cash flow positivity.

Filing Facts

CIK

1579428

Ticker

AXSM

Form

8K

Source Type

fda

Accession

0001193125-26-341206

Alert Tier

6