AXSM
Axsome Therapeutics, INC
NASDAQ
8-K: Axsome Therapeutics Announces Mixed Results from Phase 3 Trial of Solriamfetol in Major Depressive Disorder
Sentiment:
Press Release
1 April 2025 7:06 AM
Axsome Therapeutics' Phase 3 PARADIGM trial of solriamfetol in MDD showed no statistically significant improvement in the overall patient population, but demonstrated promising results in a subgroup with severe excessive daytime sleepiness (EDS), leading to plans for a Phase 3 trial in MDD patients with EDS.
Worse than expected
The PARADIGM Phase 3 trial did not meet its primary endpoint in the overall patient population, indicating worse than expected results.
Summary
- Axsome Therapeutics announced the results of its PARADIGM Phase 3 proof-of-concept trial of solriamfetol in major depressive disorder (MDD) with and without severe excessive daytime sleepiness (EDS).
- The study did not demonstrate a statistically significant change on the Montgomery-sberg Depression Rating Scale (MADRS) total score compared to placebo in the overall patient population.
- However, in the prespecified subgroup of patients with severe EDS, treatment with solriamfetol resulted in greater improvements in depressive symptoms compared to placebo.
- The study was a 6-week, randomized, double-blind, placebo-controlled, multicenter, U.S. trial.
- MDD patients with severe EDS (n=51) and without severe EDS (n=295) were randomized to treatment with solriamfetol 300 mg or placebo.
- In MDD patients with severe EDS (ESS score 16), solriamfetol treatment resulted in clinically meaningful and numerically greater improvements compared to placebo on multiple efficacy measures at Week 6.
- Axsome plans to initiate a Phase 3 trial in MDD patients with EDS in 2025.
- Solriamfetol was safe and well tolerated in the trial, with a side effect profile consistent with its established safety profile.
Sentiment
Score: 5
Explanation: The sentiment is neutral. While the overall trial failed to meet its primary endpoint, there were positive signals in the EDS subgroup, warranting further investigation. The company is proceeding with a Phase 3 trial, indicating some confidence in the drug's potential.
Positives
- Solriamfetol showed promising results in MDD patients with severe EDS, with clinically meaningful and numerically greater improvements compared to placebo on multiple efficacy measures.
- Solriamfetol was safe and well tolerated in the trial, with a side effect profile consistent with its established safety profile.
- Axsome plans to initiate a Phase 3 trial in MDD patients with EDS in 2025, indicating continued development and potential for approval in this specific patient population.
Negatives
- The PARADIGM Phase 3 trial did not meet its primary endpoint in the overall patient population of MDD patients with and without severe EDS.
- The study was not powered to demonstrate statistical significance in the prespecified subgroups, which limits the strength of the findings in the EDS subgroup.
Risks
- The planned Phase 3 trial in MDD patients with EDS may not be successful.
- Regulatory approval for solriamfetol in MDD with EDS is not guaranteed.
- The market acceptance of solriamfetol for MDD with EDS, if approved, is uncertain.
Future Outlook
Axsome plans to initiate a Phase 3 trial in MDD patients with EDS in 2025 based on the promising results observed in the EDS subgroup of the PARADIGM trial.
Management Comments
- Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics, said, 'We are pleased to have completed the PARADIGM trial which provides data on the potential utility of solriamfetol in patients with MDD.'
- He also stated, 'The promising results with solriamfetol in MDD patients with severe EDS align with its known pharmacology and support its further evaluation in this potentially new indication.'
Industry Context
The announcement highlights the unmet need for therapies to treat MDD with EDS, a condition affecting approximately 50% of MDD patients. Axsome is positioning solriamfetol as a potential treatment option for this specific patient population.
Comparison to Industry Standards
- Currently, no therapies are approved to treat MDD with EDS, making solriamfetol a potential first-in-class treatment if approved.
- Other companies developing treatments for MDD include Eli Lilly (Prozac, Cymbalta), Pfizer (Zoloft), and GlaxoSmithKline (Paxil), but these treatments do not specifically target EDS in MDD patients.
- The efficacy of solriamfetol in the EDS subgroup will need to be confirmed in a larger, statistically powered Phase 3 trial to meet regulatory standards for approval.
Stakeholder Impact
- Shareholders may react positively to the plan to initiate a Phase 3 trial in MDD patients with EDS, but negatively to the failure of the overall trial to meet its primary endpoint.
- Patients with MDD and EDS may benefit from the development of a new treatment option.
- Employees of Axsome Therapeutics will be involved in the planning and execution of the Phase 3 trial.
Next Steps
- Initiate a Phase 3 trial in MDD patients with EDS in 2025.
- Present full results of the PARADIGM trial at future scientific conferences.
Key Dates
- April 01, 2025: Date of the press release and 8-K filing announcing the results of the PARADIGM Phase 3 trial.
- 2025: Planned initiation of a Phase 3 trial in MDD patients with EDS.
Keywords
Solriamfetol, MDD, EDS, Major Depressive Disorder, Excessive Daytime Sleepiness, Phase 3 Trial, Axsome Therapeutics, PARADIGM, CNS Disorders
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.
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.
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
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.
Disclaimer: This summary was generated by artificial intelligence and its accuracy is not guaranteed. The information provided here is for general informational purposes only and does not constitute financial advice, recommendation, or endorsement of any kind. It may contain errors or omissions. You should not rely on this information to make financial decisions. Always seek the advice of a qualified financial professional before making any investment or financial decisions. Use of this information is at your own risk.