Axsome Therapeutics, Inc. - Common Stock (AXSM)

Axsome Therapeutics beats Q2 2025 revenue estimates with $150M, driven by Auvelity's 84% YoY growth. Shares rise 6% pre-market on improved EPS.

The FDA rejected Axsome's AXS-14 fibromyalgia, prompting a new trial and pushing the expected drug launch to 2028.

The regulator said that upon preliminary review, it found that the new drug application for AXS-14 was not sufficiently complete to permit a substantive review.

Teva starts IND-enabling studies for BD9, a dual-target therapy for asthma and atopic dermatitis, under license from Biolojic Design.

Axsome beat Q1 expectations with $121.5 million in revenue and strong Auvelity sales as it prepares Symbravo's U.S. launch and advances key drug programs.

Stocks are modestly higher Tuesday afternoon, as Wall Street shakes off a sluggish open amid a new wave of economic data.

The company posted mixed results for its depression treatment, noting it appears to work in a smaller patient group.

Axsome's Phase 3 trial for solriamfetol in MDD did not meet its primary endpoint, but positive data in severe EDS patients supports plans for a new study in 2025.