Axsome Pharmaceuticals is making strides in addressing unmet needs in brain health. The company is focusing on developing innovative therapies for Alzheimer’s disease agitation, narcolepsy, fibromyalgia, ADHD, MDD, binge eating disorder, and shift work disorder. Their product revenues for the quarter reached $171 million, showing impressive growth.
AXS-05 and AXS-12 are promising treatments for Alzheimer’s disease agitation and narcolepsy, respectively, with potential to set new standards in treatment. Solriamfetol has shown positive results in adults with ADHD, leading to plans for a Phase III trial in children and adolescents. The company’s diverse pipeline includes treatments for MDD, binge eating disorder, and shift work disorder.
Axsome’s financial results for the quarter demonstrate significant growth in total product revenues, with AUVELITY and SUNOSI driving this increase. The company’s expenses have also increased, attributed to commercialization activities and the launch of new products. Despite a net loss for the quarter, Axsome remains confident in its cash balance to fund anticipated operations.
The commercial team at Axsome has made significant progress in promoting their products, with AUVELITY showing strong momentum in major depressive disorder. Prescription growth for AUVELITY has been impressive, with approximately 209,000 prescriptions in the quarter. The company continues to focus on strategic commercial investments to drive further growth and success. In the third quarter, the antidepressant market grew by 1% year-over-year. Since the expansion of the psychiatry sales force, new-to-brand prescriptions for AUVELITY have increased by 35%. Approximately 5,000 new prescribers were activated, bringing the total to 46,000. Commercial coverage for AUVELITY increased to 75%.
SYMBRAVO had a successful first full quarter on the market, with over 5,000 prescriptions written and 3,300 new patients starting the medication. Feedback from patients has been positive, with SYMBRAVO’s MoSEIC technology resonating with healthcare providers. Payer coverage for SYMBRAVO is at approximately 52% of all lives.
SUNOSI saw strong performance in the quarter, with 53,000 prescriptions representing 12% year-over-year and 5% sequential growth. The wake-promoting agent market grew by 4% year-over-year. Payer coverage for SUNOSI remains at approximately 83% of lives covered across channels.
Primary care is a key growth driver for AUVELITY, with approximately 1/3 of prescribers being primary care clinicians. The primary care segment is contributing significantly to scripts for AUVELITY, with strong performance in new patient starts and overall prescriptions. The company is focused on increasing prescribing in targeted clinicians and improving market access. The company is focusing on growing the primary care segment with an expanded sales force, increased market access, and a direct-to-consumer campaign to ease the prescribing path for primary care clinicians. Early positive signals are seen in patient awareness and requests for the product, indicating potential growth in primary care and psychiatry settings.
The company is optimistic about AXS-05’s impact on the Alzheimer’s agitation market, targeting various specialties and settings of care. Leveraging the existing sales force and investing in long-term care promotion are key strategies. Learnings from REXULTI’s success will be incorporated into the launch strategy if AXS-05 is approved.
The sales force expansion has led to significant growth in new prescribers and patients. Additional representatives will be added to support Alzheimer’s agitation approval, with plans for further expansion in early 2026. SG&A increased due to the launch of a DTC campaign and commercialization activity for SYMBRAVO.
The FDA typically informs sponsors of potential acceptance within 74 days following submission, with no expected impact from the government shutdown on the timing of the review process. The company anticipates sharing updates on potential acceptance decision for the AD agitation application.
Two Phase III readouts for SUNOSI in binge eating and shift work disorder are expected, with positive data needed to file two more sNDAs next year or in 2027. The study designs include parallel-group designs, with plans for additional trials based on the results of the initial study for binge eating disorder. Solriamfetol is being explored for use in ADHD, with one positive Phase III trial completed in adults. A second study in pediatric patients is set to begin in the fourth quarter. The company has three marketed products and multiple late-stage assets, positioning them for growth and potential additions to the pipeline. The company is open to enhancing their pipeline strategically and remains focused on making good decisions to drive future success.
Reboxetine, a product focused on norepinephrine reuptake inhibition, shows promise in addressing orexin neuron loss in patients. The company is excited about the potential of reboxetine, especially in addressing the unmet medical need in the sleep space. Clinical trials have shown great efficacy in cataplexy and a favorable tolerability profile, positioning the product well in the market. The company sees strong synergy with their current sales and marketing infrastructure, creating an exciting opportunity for growth.
The demand for SUNOSI is primarily coming from patients with obstructive sleep apnea (OSA), representing about two-thirds of the overall prescribing. There is significant unmet need in excessive sleepiness among OSA patients, driving strong demand for SUNOSI in this segment. While narcolepsy remains an important component, increased awareness of sleepiness in OSA patients has led to increased utilization. The company’s priority is to get AXS-12 approved before considering combining it with SUNOSI, as they focus on driving success in the market. The goal of providing clinicians with extra treatment options, including SUNOSI and AXS-12 for patients with narcolepsy, was discussed. Expansion to primary care markets for SYMBRAVO was mentioned, with no specific timeline for a DTC campaign. AXS-05 for Alzheimer’s disease agitation is aiming for a standard review, with potential eligibility for priority review. Efforts for long-term care promotion were detailed, focusing on a different approach from traditional outpatient facilities.
Questions were raised about the need for an AdCom for AXS-05 given a previous one for REXULTI, with no definitive answer provided. Commercial success of AUVELITY was highlighted, with a decrease in gross to net from mid-50s to high 40s in Q3. Progress in contracting was noted, with potential for further gains in the future. AUVELITY saw a net price improvement and added 28 million lives in Q3. The company aims to cover 100% of lives with the third GPO signed. Plans for sales force expansion for ADA are in progress, contingent on drug approval. DTC impact on prescriptions for AUVELITY may take 8-12 weeks to show results. FDA interactions remain positive amid recent industry news. Axsome Pharmaceuticals is experiencing growth in per prescriber activity for their drugs AUVELITY and SUNOSI. The increase is attributed to productivity among existing writers and adding new writers to the prescriber mix. Four Phase III trials are set to launch this quarter, with a natural cadence expected. Axsome remains confident in their estimates of 185,000 people in the U.S. suffering from narcolepsy. The company continues to drive growth and looks forward to sharing progress in the future. 1. The Motley Fool reported on Axsome Therapeutics’ Q3 2025 earnings call. The company revealed a net loss of $70.5 million in the quarter, with positive data from its clinical trials for major depressive disorder and migraine treatment.
2. Axsome Therapeutics shared that its lead product candidate, AXS-05, showed promising results in the treatment of major depressive disorder. The company plans to seek FDA approval for this indication in the near future.
3. In addition to its success in major depressive disorder, Axsome Therapeutics also reported positive data for its migraine treatment candidate, AXS-07. The company is optimistic about the potential of these treatments to address unmet medical needs.
Read more at Yahoo Finance: Axsome (AXSM) Q3 2025 Earnings Call Transcript