Axsome Therapeutics, Inc. is a commercial-stage biopharmaceutical company, which engages in the development of novel therapies for the management of central nervous system disorders. Its portfolio consists of Products Overview and Pipeline Overview. The Products Overview includes Auvelity and Sunosi. The Pipeline Overview contain AXS-05, AXS-07, AXS-12, and AXS-14. The company was founded by Herriot Tabuteau on January 12, 2012 and is headquartered in New York, NY.
相关临床试验
38
4 进行中
药物批准
4
批准总数
监管机构
1
监管机构数
成立时间
2012
进行中（未招募）
1
2.6%
已完成
20
52.6%
Enrolling By Invitation
3
7.9%
招募中
9
23.7%
终止
2
5.3%
Unknown
3
7.9%
- No disease-modifying therapies currently exist for Parkinson's disease, with only three of 84 Phase 2 and 3 DMT studies registered over the last decade testing combination approaches. - A Cure Parkinson's workshop in June 2025 explored how combination therapies, proven in oncology and infectious disease, could address the molecular complexity and patient heterogeneity of PD. - Case studies including Auvelity (dextromethorphan-bupropion) and AMX0035 (sodium phenylbutyrate-TUDCA) illustrate the mechanistic, regulatory, and patenting considerations for developing combination treatments. - Workshop attendees emphasized early regulatory engagement, patient stratification, and multi-arm platform trials as key strategies for advancing combination DMTs in PD.
- Axsome Therapeutics has settled all outstanding patent litigation related to its wake-promoting therapy SUNOSI (solriamfetol) with the last remaining first-to-file generic applicant. - Under the settlement, five generic companies may begin selling generic versions of SUNOSI starting on or after March 1, 2040, or September 1, 2040 if pediatric exclusivity is granted. - The resolution eliminates all legal uncertainty surrounding SUNOSI's intellectual property and provides Axsome with long-term revenue visibility for the product. - The settlement agreement will be submitted to the U.S. Federal Trade Commission and Department of Justice for review as required by law.
- Axsome Therapeutics presented 12-month data from the Phase III MOVEMENT trial showing Symbravo (meloxicam + rizatriptan) improved migraine disability scores in 45.1% of patients. - The study demonstrated sustained improvements across multiple quality of life measures, with up to 60.7% of patients achieving meaningful improvements in work and social function domains. - Long-term safety data showed only 1.8% discontinuation rate due to adverse events, supporting Symbravo's tolerability profile over extended use. - The positive long-term outcomes position Symbravo to compete with gepants and other newer migraine therapies in the crowded acute treatment market.
- The FDA has approved dextromethorphan-bupropion (Auvelity) for treating agitation associated with Alzheimer's disease, providing a new therapeutic option for a condition affecting up to 76% of Alzheimer's patients. - The approval was supported by positive results from the ADVANCE-1 trial, where the drug demonstrated statistically significant improvement in agitation symptoms compared to placebo at week 5. - Auvelity joins brexpiprazole (Rexulti) as the second FDA-approved medication specifically for Alzheimer's disease agitation, following Rexulti's approval in May 2023. - The drug received FDA Breakthrough Therapy designation and Priority Review, reflecting its potential to address significant unmet medical needs in dementia care.
- More than three pharmaceutical companies are actively developing over four promising hypersomnia treatment candidates, signaling growing innovation in sleep disorder management. - Avadel Pharmaceuticals received FDA orphan drug designation in June 2025 for Lumryz, an extended-release sodium oxybate therapy for idiopathic hypersomnia. - Alkermes initiated a Phase II trial in April 2025 evaluating ALKS 2680, a selective orexin receptor modulator, in patients with idiopathic hypersomnia across global sites. - Axsome Therapeutics reported positive Phase III results in November 2024 for AXS-12 (reboxetine), demonstrating significant reductions in cataplexy episodes.
- Superstring Capital Management initiated a new $6.84 million position in Axsome Therapeutics during Q4 2025, acquiring 37,433 shares of the CNS-focused biopharmaceutical company. - The investment represents nearly 4% of Superstring's assets under management, highlighting confidence in Axsome's commercial CNS portfolio and late-stage pipeline. - Axsome reported $638.5 million in full-year revenue, up 66% from 2024, while advancing multiple CNS therapies including a Phase 3 trial for solriamfetol in major depressive disorder. - The company's stock has gained 27% over the past year, outperforming the S&P 500's 19% gain during the same period.
- Axsome Therapeutics received FDA priority review designation for AXS-05 to treat Alzheimer's disease agitation, with a target action date of April 30, 2026. - The company's existing drug Auvelity (AXS-05) is already approved for major depressive disorder and generated 80% of quarterly revenue with 69% year-over-year growth. - Up to 76% of Alzheimer's patients experience agitation with limited approved treatments, representing a significant unmet medical need. - Axsome stock surged over 20% following the announcement, reflecting investor confidence in the drug's commercial potential.
- Fortress Biotech achieved a 20.5% increase in net revenue to $17.6 million in Q3 2025, driven by strong performance from its dermatology products portfolio. - The company completed strategic exits with Sun Pharma acquiring Checkpoint Therapeutics for ~$28 million upfront to Fortress, plus potential additional payments and royalties. - Dotinurad, a next-generation URAT1 inhibitor for gout treatment, advanced into two Phase 3 trials following Crystalys Therapeutics' $205 million Series A financing. - Journey Medical's rosacea treatment Emrosi demonstrated statistical superiority over existing therapies in pooled Phase 3 analysis, with expanded payer coverage reaching over 100 million lives.
- Axsome Therapeutics has acquired exclusive global rights to AZD7325, a novel oral GABAA receptor α2,3 subtype-selective positive allosteric modulator, through the acquisition of Baergic Bio from Avenue Therapeutics. - The compound has demonstrated favorable safety and tolerability profiles in clinical studies involving over 700 patients and showed anti-convulsant effects in multiple preclinical seizure models. - Axsome plans to begin Phase 2 trial-enabling activities in 2026 for epilepsy treatment, addressing a significant unmet medical need where more than one-third of patients do not respond to current treatments. - The transaction includes milestone payments up to $79 million in sales-based milestones and tiered mid-to-high single-digit royalties on potential global net sales.
- Axsome Therapeutics has submitted a supplemental NDA to the FDA for AXS-05 (dextromethorphan-bupropion) to treat agitation associated with Alzheimer's disease, addressing a critical unmet medical need affecting millions of patients. - The ACCORD-2 phase 3 study demonstrated that AXS-05 met its primary efficacy endpoint and showed a tolerable safety profile for treating Alzheimer's disease agitation. - Previous pivotal ADVANCE-1 trial results showed AXS-05 achieved a statistically significant 15.4-point reduction in agitation scores compared to 11.5 points for placebo, with the drug being well-tolerated without cognitive impairment or sedation. - AXS-05 received FDA Breakthrough Therapy designation for Alzheimer's disease agitation in 2020, making it the second such designation for this novel NMDA receptor antagonist and sigma-1 agonist combination therapy.
