AXSM
Axsome Therapeutics, INC
NASDAQ
8-K: Axsome Therapeutics Reveals High Unmet Needs in Narcolepsy Type 1 Patients Despite Treatment
Sentiment:
Patient Survey Results Announcement
25 March 2024 9:06 AM
A recent survey by Axsome Therapeutics shows that a significant portion of narcolepsy type 1 patients continue to experience symptoms despite being on treatment.
Worse than expected
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.
Summary
- Axsome Therapeutics released the results of the CRESCENDO survey, which focused on the experiences of 203 adult patients with narcolepsy type 1 (NT1).
- The survey, conducted in partnership with Narcolepsy Network, aimed to understand the patient journey, measure disease symptoms, and assess the burden of illness.
- Despite being on treatment, 77% of patients reported experiencing cataplexy, 64% experienced excessive daytime sleepiness (EDS), and 74% exhibited cognitive impairment.
- The most common treatments reported by patients were wake promoting agents (53%), oxybates (47%), and stimulants (42%).
- Additionally, 45% of patients experienced depression and 57% experienced anxiety.
- The survey highlights the significant unmet needs in treated narcolepsy type 1 patients.
Sentiment
Score: 4
Explanation: The document highlights significant unmet needs in narcolepsy treatment, which is a negative finding. However, it also shows Axsome's commitment to addressing these needs, which is a positive. The overall sentiment is slightly negative due to the poor patient outcomes despite treatment.
Positives
- The CRESCENDO survey provides valuable insights into the patient experience with narcolepsy type 1.
- The survey highlights the need for improved treatments for narcolepsy type 1.
- The partnership with Narcolepsy Network ensures a patient-centric approach to the research.
- Axsome plans to present the detailed results of the CRESCENDO survey at upcoming scientific meetings, which will further disseminate the findings.
Negatives
- A large percentage of patients continue to experience significant symptoms despite being on treatment.
- The high rates of cataplexy, excessive daytime sleepiness, and cognitive impairment indicate that current treatments are not fully effective.
- The prevalence of depression and anxiety among patients highlights the psychological burden of the condition.
Risks
- The survey results indicate a significant unmet need in the treatment of narcolepsy type 1, which could impact the market potential for existing and future treatments.
- The company's future success depends on the development of more effective treatments for narcolepsy.
- The company's forward-looking statements are subject to risks and uncertainties, including the success of clinical trials and regulatory approvals.
Future Outlook
Axsome plans to present the detailed results of the CRESCENDO survey at upcoming scientific meetings. The company's future success depends on the development of more effective treatments for narcolepsy and other CNS conditions.
Management Comments
- Dr. Karl Doghramji stated that narcolepsy is underrecognized and underdiagnosed, and the CRESCENDO survey is an important step in raising awareness.
- Axsome is committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians.
Industry Context
The announcement highlights the ongoing challenges in treating narcolepsy, a condition with limited treatment options. This underscores the need for innovative therapies and aligns with the broader industry focus on addressing unmet needs in CNS disorders.
Comparison to Industry Standards
- The high rates of persistent symptoms reported in the CRESCENDO survey, such as 77% experiencing cataplexy and 64% experiencing excessive daytime sleepiness, suggest that current treatments for narcolepsy are not as effective as desired when compared to the goals of complete symptom control.
- While specific comparative data for other narcolepsy patient surveys is not provided in this document, the results indicate a significant gap in treatment efficacy compared to the ideal outcomes.
- The survey results highlight the need for novel therapies that can address the unmet needs of narcolepsy patients, which is a common goal across the pharmaceutical industry.
Stakeholder Impact
- The survey results highlight the need for improved treatments for narcolepsy, which could benefit patients.
- The findings may influence the development of new therapies by Axsome and other pharmaceutical companies.
- The results could also impact the perception of current treatments among healthcare providers and patients.
Next Steps
- Axsome plans to present the detailed results of the CRESCENDO survey at upcoming scientific meetings.
Key Dates
- October-December 2023: The CRESCENDO survey was conducted during this period.
- March 25, 2024: Axsome Therapeutics issued a press release announcing the results of the CRESCENDO survey.
Keywords
narcolepsy, cataplexy, excessive daytime sleepiness, cognitive impairment, CNS disorders, Axsome Therapeutics, CRESCENDO survey, patient survey, unmet needs, sleep disorders
AXSM
Axsome Therapeutics, INC
NASDAQ
Sector: TBD
Filings with Classifications
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.
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.
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.
Better than expected
5 May 2025 4:47 PM
Quarterly Report
- Revenue increased significantly year over year.
- Net loss decreased year over year.
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 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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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