AXSM
Axsome Therapeutics, INC
NASDAQ
8-K: Axsome Therapeutics' Solriamfetol Achieves Positive Phase 3 Results in ADHD Trial
Sentiment:
Clinical Trial Results
25 March 2025 7:06 AM
Axsome Therapeutics announces positive results from its Phase 3 FOCUS trial of solriamfetol in adults with ADHD, demonstrating statistically significant improvements in ADHD symptoms and disease severity compared to placebo.
Better than expected
The FOCUS Phase 3 trial achieved both its primary and key secondary endpoints, demonstrating statistically significant improvements in ADHD symptoms and disease severity compared to placebo.
Summary
- Axsome Therapeutics' FOCUS Phase 3 trial of solriamfetol in adults with ADHD met its primary and key secondary endpoints.
- The trial demonstrated a statistically significant improvement in ADHD symptoms as measured by the AISRS total score compared to placebo (p=0.039, 150 mg solriamfetol).
- A statistically significant reduction in overall ADHD disease severity was observed as measured by the CGI-S score compared to placebo (p=0.017, 150 mg solriamfetol).
- The study involved 516 adults with ADHD who were randomized to receive solriamfetol 150 mg, solriamfetol 300 mg, or placebo once daily for 6 weeks.
- Patients treated with solriamfetol 150 mg showed a 45% mean reduction from baseline in ADHD symptoms.
- Clinical response, defined as a 30% improvement from baseline in the AISRS total score, was achieved by 53.5% of patients treated with solriamfetol 150 mg compared to 41.3% with placebo (p=0.024).
- The onset of action was observed as early as Week 1 compared to placebo (p=0.036, AISRS, 150 mg solriamfetol).
- Solriamfetol was generally well-tolerated, with a safety profile consistent with prior trials.
- Axsome plans to initiate a trial in pediatric patients this year.
Sentiment
Score: 8
Explanation: The document presents positive clinical trial results, suggesting a potential new treatment option for ADHD. The sentiment is optimistic due to the statistically significant improvements and favorable safety profile.
Positives
- Solriamfetol demonstrated statistically significant improvements in ADHD symptoms and disease severity compared to placebo.
- The drug was well-tolerated with a safety profile consistent with prior trials.
- The onset of action was observed as early as Week 1.
- The results support the potential of solriamfetol as a new treatment option for adults with ADHD.
- The company plans to initiate a trial in pediatric patients this year.
Negatives
- Results on the primary and key secondary endpoints for the exploratory 300 mg solriamfetol dose were numerically superior compared to placebo but were not statistically significant.
Risks
- The commercial success of Sunosi, Auvelity, and Symbravo products and the success of the Company's efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05 are not guaranteed.
- The company's ability to maintain and expand payer coverage is subject to change.
- The success, timing and cost of the Company's ongoing clinical trials and anticipated clinical trials for the Company's current product candidates are subject to change.
- The company's ability to fund additional clinical trials to continue the advancement of the Company's product candidates is not guaranteed.
- The timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration (FDA) or other regulatory authority approval of, or other action with respect to, the Company's product candidates is not guaranteed.
- The company's ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all is not guaranteed.
- The successful implementation of the Company's research and development programs and collaborations is not guaranteed.
- The success of the Company's license agreements is not guaranteed.
- The acceptance by the market of the Company's products and product candidates, if approved is not guaranteed.
- The Company's anticipated capital requirements, including the amount of capital required for the commercialization of Sunosi, Auvelity, and Symbravo and for the Company's commercial launch of its other product candidates, if approved, and the potential impact on the Company's anticipated cash runway are subject to change.
- The Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales is not guaranteed.
- Unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company's control are subject to change.
Future Outlook
Axsome plans to advance the development of solriamfetol as a potential new treatment for ADHD and initiate a trial in pediatric patients this year.
Management Comments
- Gregory Mattingly, M.D., stated that the results demonstrate that solriamfetol was able to reduce mean ADHD symptom burden by nearly fifty percent, which contributed to significant reductions in disease severity.
- Herriot Tabuteau, MD, Chief Executive Officer of Axsome, said they are pleased with the positive results of the FOCUS trial and look forward to advancing the development of solriamfetol as a new, differentiated potential treatment for patients living with ADHD.
Industry Context
The positive results from the FOCUS trial position Axsome Therapeutics to potentially compete in the ADHD treatment market, which has a significant unmet need, with an estimated 15.5 million adults and 7 million children affected in the U.S.
Comparison to Industry Standards
- The efficacy of solriamfetol in reducing ADHD symptoms, as measured by the AISRS and CGI-S scores, can be compared to existing ADHD medications such as stimulants (e.g., Adderall, Ritalin) and non-stimulants (e.g., Strattera, Intuniv).
- A direct comparison would require a head-to-head trial, but the reported 45% mean reduction from baseline in ADHD symptoms with solriamfetol 150 mg suggests a potentially competitive efficacy profile.
- The safety and tolerability profile of solriamfetol will also be a key factor in its adoption compared to existing treatments, some of which have known side effects such as insomnia, appetite suppression, and cardiovascular risks.
Stakeholder Impact
- Shareholders may react positively to the news of successful trial results.
- Patients with ADHD may benefit from a new treatment option.
- The company's employees may be impacted by the increased workload associated with advancing the development of solriamfetol.
Next Steps
- Axsome plans to advance the development of solriamfetol for ADHD treatment.
- The company intends to initiate a trial in pediatric patients this year.
Key Dates
- March 25, 2025: Date of report and press release announcing FOCUS Phase 3 trial results.
Keywords
Solriamfetol, ADHD, Axsome Therapeutics, Clinical Trial, FOCUS Trial, CNS Disorders, AISRS, CGI-S, Phase 3 Trial
AXSM
Axsome Therapeutics, INC
NASDAQ
Sector: TBD
Filings with Classifications
Delay expected
9 June 2025 7:05 AM
Regulatory Update
- The Refusal to File (RTF) letter from the FDA necessitates an additional controlled trial for AXS-14.
- This new trial is anticipated to be initiated in the fourth quarter of 2025, indicating a delay in the regulatory pathway and potential market entry for AXS-14.
Worse than expected
9 June 2025 7:05 AM
Regulatory Update
- The FDA issued a Refusal to File (RTF) letter for the AXS-14 NDA, indicating the application was not sufficiently complete for substantive review.
- This requires Axsome to conduct an additional controlled trial, delaying the potential approval and commercialization of AXS-14.
Capital raise
13 May 2025 7:06 AM
8-K Filing
- Axsome conducted a private placement of 140,000 shares of common stock to Blackstone at a price of $107.14 per share.
- The gross proceeds from the private placement were approximately $15 million.
- Purchasers agreed to a lock-up period of 120 days from the closing date, restricting the sale or transfer of the securities.
Capital raise
5 May 2025 4:47 PM
Quarterly Report
- The Company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Delay expected
5 May 2025 4:47 PM
Quarterly Report
- If Subtenant is delayed in completing the New Premises Subtenant Work and vacate the Original Premises within four (4) months of the New Premises Commencement Date, subject to Force Majeure, then, notwithstanding anything to the contrary contained herein, Subtenant shall not be required to pay holdover rent as set forth in Section 3 above for the amount of time that Prime Landlords actions delayed Subtenant in completing the New Premises Subtenant Work (such amount of time, the Prime Landlord Delay) and the Original Premises Termination Date shall be extended by such period of Prime Landlord Delay; provided however that maximum amount of time for the delay in Subtenant paying holdover rent pursuant to Section 3 hereof shall be an additional thirty (30) days so that if Subtenant has not vacated the Original Premises and delivered possession of the Original Premises to Sublandlord due to Prime Landlord Delay within five (5) months of the New Premises Commencement Date, for whatever reason whatsoever, Subtenant shall pay such holdover rent pursuant to Section 3 hereof.
Better than expected
5 May 2025 4:47 PM
Quarterly Report
- Revenue increased significantly year over year.
- Net loss decreased year over year.
Better than expected
5 May 2025 7:33 AM
Quarterly Report
- The company's revenue growth exceeded expectations, driven by strong sales of AUVELITY and SUNOSI.
- The approval of SYMBRAVO and positive clinical trial results for solriamfetol in ADHD and SYMBRAVO in migraine patients were better than expected.
Worse than expected
1 April 2025 7:06 AM
Press Release
- The PARADIGM Phase 3 trial did not meet its primary endpoint in the overall patient population, indicating worse than expected results.
Better than expected
25 March 2025 7:06 AM
Clinical Trial Results
- The FOCUS Phase 3 trial achieved both its primary and key secondary endpoints, demonstrating statistically significant improvements in ADHD symptoms and disease severity compared to placebo.
Capital raise
18 February 2025 5:10 PM
Annual Results
- The company may need to raise additional financing to support its continuing operations.
- The company may seek to fund its operations through public or private equity, debt financings, or other sources.
Worse than expected
18 February 2025 5:10 PM
Annual Results
- The company's net loss increased from 2023 to 2024.
- Research and development expenses increased from 2023 to 2024.
- Selling, general, and administrative expenses increased from 2023 to 2024.
Delay expected
18 February 2025 7:06 AM
Annual Results
- Topline results from the ENGAGE Phase 3 trial of solriamfetol in BED are now anticipated in 2026.
Better than expected
18 February 2025 7:06 AM
Annual Results
- The company's revenue growth exceeded expectations, driven by strong sales of Auvelity and Sunosi.
- The FDA approval of Symbravo was a positive development, expanding the company's commercial portfolio.
- The successful completion of Phase 3 trials for AXS-05 and AXS-12 positions the company for potential NDA submissions and future product launches.
Better than expected
30 January 2025 5:55 PM
Press Release
- SYMBRAVO demonstrated statistically significant superiority compared to rizatriptan on sustained pain freedom from 2 to 24 hours.
Better than expected
30 December 2024 7:56 AM
Clinical Trial Results
- The ACCORD-2 trial met its primary endpoint with a statistically significant result, demonstrating a 3.6-fold lower risk of relapse compared to placebo, which is better than expected.
- The ACCORD-2 trial also met its key secondary endpoint, showing statistically significant prevention of relapse of agitation, which is better than expected.
- AXS-05 reduced the worsening of overall Alzheimer's disease severity compared to placebo in the ACCORD-2 trial, which is better than expected.
Better than expected
26 November 2024 7:05 AM
Clinical Trial Results
- The trial met its primary endpoint with statistically significant results, showing a reduction in cataplexy attacks compared to placebo.
- The drug also demonstrated statistically significant improvements in cognition and overall narcolepsy symptoms, exceeding expectations.
Capital raise
12 November 2024 9:43 AM
Quarterly Report
- The company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Worse than expected
12 November 2024 9:43 AM
Quarterly Report
- The company's net loss increased compared to the same period last year, indicating worse than expected results.
Better than expected
12 November 2024 7:07 AM
Quarterly Report
- The company's revenue growth significantly exceeded expectations, with Auvelity sales growing by 113% year-over-year.
- The company is progressing its pipeline faster than expected with multiple topline results expected in the near term.
- The company has sufficient cash to fund operations into cash flow positivity, which is better than expected.
Better than expected
1 October 2024 5:24 PM
Loan Agreement Amendment
- The loan amendment provides better terms for Axsome, including an increased tranche commitment, extended availability periods, and more flexible performance covenants.
Worse than expected
5 August 2024 4:30 PM
Quarterly Report
- The company reported a net loss of $79.3 million for the quarter, which is worse than the net loss of $67.2 million reported for the same period in the previous year.
Capital raise
5 August 2024 4:30 PM
Quarterly Report
- The company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Better than expected
5 August 2024 7:05 AM
Quarterly Report
- The company's revenue growth of 87% year-over-year and Auvelity sales growth of 135% year-over-year significantly exceeded expectations.
Delay expected
5 June 2024 7:38 AM
Settlement Announcement
- The settlement delays the entry of a generic version of Sunosi until at least June 30, 2042.
Capital raise
6 May 2024 5:20 PM
Quarterly Report
- The company may use a combination of public and private equity offerings, debt financings, other third-party funding, strategic alliances, licensing arrangements or marketing and distribution arrangements if market conditions are favorable or as a result of other strategic considerations to finance its future cash needs.
Worse than expected
6 May 2024 5:20 PM
Quarterly Report
- The company's net loss increased significantly compared to the same period last year, indicating worse than expected financial performance.
Worse than expected
6 May 2024 7:05 AM
Quarterly Report
- The company's net loss of $68.4 million for the quarter was significantly worse than the $11.2 million loss in the same period of 2023.
Worse than expected
25 March 2024 9:06 AM
Patient Survey Results Announcement
- The survey results show that a high percentage of patients continue to experience symptoms despite being on treatment, indicating that current treatments are not as effective as expected.
Better than expected
25 March 2024 9:02 AM
Clinical Trial Results
- The results of the SYMPHONY trial were better than expected, as AXS-12 demonstrated statistically significant improvements across multiple endpoints compared to placebo.
Delay expected
20 February 2024 7:05 AM
Annual Results
- The completion of the ADVANCE-2 trial for Alzheimer's disease agitation is now anticipated in the second half of 2024, due to enrollment trends and market dynamics, which is a delay from previous expectations.
Better than expected
20 February 2024 7:05 AM
Annual Results
- The company's revenue growth of 309% year-over-year significantly exceeded expectations.
- Auvelity's sales of $130.1 million in its first full year of launch surpassed initial projections.
- Sunosi's 67% year-over-year revenue growth was also better than anticipated.
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