Solriamfetol

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Tonix Pharmaceuticals appoints Bradley Raudabaugh as VP of Marketing and Errol Gould as VP of Medical Affairs to support the launch of TNX-102 SL for fibromyalgia. The NDA for TNX-102 SL was submitted to the FDA in October 2024, with an expected decision in 2025, potentially marking the first new drug for fibromyalgia in over 15 years.

Axsome Therapeutics reports $104.8M in 3Q 2024 net product revenue, 81% YoY growth. Auvelity sales grew 113% YoY to $80.4M, Sunosi revenue increased 21% YoY to $24.4M. Plans second Auvelity sales force expansion in 1Q 2025. FDA accepted NDA resubmission for AXS-07 migraine treatment with PDUFA goal date of January 31, 2025. Topline results for AXS-05 Alzheimer’s disease agitation and AXS-12 narcolepsy trials expected in 4Q 2024. Solriamfetol ADHD and MDD trial results anticipated in 1Q 2025. NDA submission for AXS-14 fibromyalgia treatment planned for November 2024.

Axsome Therapeutics' Auvelity, launched in 2022 for MDD, generated $118.4M in H1 2024, up 172.8% YoY. Auvelity is being studied for AD agitation and smoking cessation. Sunosi, acquired from Jazz in 2022, contributed $42.2M in H1 2024, up 35.2% YoY. AXSM's pipeline includes AXS-07 for migraine, AXS-14 for fibromyalgia, and AXS-12 for narcolepsy. Competition from Acadia and Jazz's other drugs poses challenges.

Axsome Therapeutics, a mid-cap biotech, focuses on CNS diseases with two marketed products: Auvelity for depression and Sunosi for narcolepsy. Despite being unprofitable, its revenue grew 87% YoY in Q2, driven by Auvelity's 135% sales increase. Axsome's pipeline includes potential approvals for migraines, Alzheimer's agitation, ADHD, shift work disorder, and fibromyalgia, suggesting future growth and stock price potential.

Axsome Therapeutics reported strong Q1 2024 financial results with $75M in net product revenue, a 160% YoY growth. The company advanced its neuroscience pipeline, including positive results for AXS-12 in narcolepsy and progress towards NDA submissions for AXS-07 and AXS-14. Axsome expects continued momentum in 2024, focusing on commercial growth and pipeline development for CNS disorders.

Axsome Therapeutics reported Q2 2023 earnings with a miss on expectations, posting a $-1.54 EPS against $1.24 expectations. Total net product sales were $46.7M, driven by Auvelity and Sunosi. The company is expanding its Auvelity sales force and advancing its CNS pipeline, including solriamfetol for ADHD, binge eating disorder, and shift work disorder. Axsome closed a public offering, raising $258.8M, strengthening its financial position for future growth.