Axsome Therapeutics Inc AXSM on Monday reported first-quarter 2025 revenues of $121.5 million, up from $75 million a year ago, beating the consensus of $119.87 million.
Auvelity (oral antidepressant) net product sales for the quarter were $96.2 million, up 80% year over year.
Approximately 167,000 prescriptions were written for Auvelity in Q1 of 2025. This represents an increase of 76% compared to the same period in 2024 and an increase of 5% compared to the fourth quarter of 2024.
Sunosi, a sleep disorder medicine, generated net product revenues of $25.2 million, up 17%.
Approximately 46,000 prescriptions were written for Sunosi in the U.S., representing an increase of 12% compared to the same period in 2024, but a decrease of 5% compared to the fourth quarter of 2024.
The company reported an adjusted net loss of 68 cents.
Net loss for the first quarter of 2025 was $59.4 million, or $1.22 per share. Compare that to a net loss of $68.4 million, or $1.44 per share, for the comparable period in 2024.
The net loss in the first quarter of 2025 includes $26.2 million in non-cash charges, primarily $23.3 million in stock-based compensation expenses.
FDA Approval: The FDA approved Axsome Therapeutics’ Symbravo (meloxicam and rizatriptan). This treatment is for the acute treatment of migraine with or without aura in adults.
The company expects SYMBRAVO to be commercially available in the U.S. in approximately four months (June 2025).
Development Pipeline:
AXS-05 (dextromethorphan-bupropion)
- Alzheimer’s Disease Agitation: In March, Axsome received formal pre-NDA meeting minutes from the FDA for AXS-05 in AD agitation, supporting a supplemental NDA (sNDA) submission. The company is on track to submit the sNDA in the third quarter of 2025.
- Smoking Cessation: Axsome plans to initiate a pivotal Phase 2/3 trial of AXS-05 in smoking cessation in 2025.
- Solriamfetol (dopamine and norepinephrine reuptake inhibitor (DNRI), TAAR1 agonist): In March, Axsome announced topline results from the FOCUS Phase 3 trial evaluating the efficacy and safety of solriamfetol in Attention Deficit Hyperactivity Disorder (ADHD) in adults. The company plans to initiate a Phase 3 trial of solriamfetol in ADHD in pediatric patients in 2025.
- SYMBRAVO (MoSEIC meloxicam-rizatriptan): In February 2025, Axsome announced topline results from the EMERGE Phase 3 trial of Symbravo in migraine patients experiencing inadequate response to oral CGRP inhibitors.
- AXS-12 (reboxetine): Axsome previously announced the completion of its clinical program of AXS-12 in patients with narcolepsy with cataplexy. The company anticipates submitting an NDA to the FDA in the second half of 2025.
- AXS-14 (esreboxetine): Axsome has submitted an NDA to the FDA for AXS-14 for fibromyalgia. The company anticipates the FDA’s decision on acceptance of the filing in the second quarter of 2025.
- In April, Axsome announced topline results from the PARADIGM Phase 3 proof-of-concept trial. The company plans to initiate a Phase 3 trial of solriamfetol in Major Depressive Disorder patients with excessive daytime sleepiness in 2025.
What’s Next
- Axsome is conducting the ENGAGE Phase 3 study of solriamfetol in Binge Eating Disorder. The company anticipates topline results in 2026.
- Axsome is conducting the SUSTAIN Phase 3 study in adults with Shift Work Disorder. Topline data is anticipated in 2026.
Price Action: AXSM stock is up 5.16% at $118 during the premarket session at the last check Monday.
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