NASDAQ
6 days, 11 hours ago 
AXSM
Axsome Therapeutics, INC
Form 4: Axsome Therapeutics General Counsel Completes Pre-Scheduled Share Sales Under 10b5-1 Plan
Axsome Therapeutics' General Counsel, Hunter R. Murdock, completed pre-scheduled transactions under a 10b5-1 plan, exercising stock options and immediately selling the acquired common stock for total proceeds exceeding $1.37 million.
NASDAQ
11 days, 10 hours ago 
AXSM
Axsome Therapeutics, INC
Form 4: Axsome Therapeutics General Counsel Executes Pre-Planned Stock Option Exercises and Sales
Axsome Therapeutics' General Counsel, Hunter R. Murdock, reported the exercise of stock options and subsequent sale of common stock totaling 22,500 shares over three days in June 2025, all conducted under a pre-approved 10b5-1 trading plan.
NASDAQ
19 days, 12 hours ago 
AXSM
Axsome Therapeutics, INC
Form 4: Axsome Therapeutics Director Mark Coleman Receives Equity Grants Valued at Over $350,000
Axsome Therapeutics, Inc. Director Mark Coleman was granted 3,166 stock options and 1,429 restricted stock units (RSUs) on June 6, 2025, as part of his compensation.
NASDAQ
19 days, 12 hours ago 
AXSM
Axsome Therapeutics, INC
Form 4: Axsome Therapeutics Director Roger Jeffs Receives New Equity Compensation
Axsome Therapeutics, Inc. Director Roger Jeffs was granted 3,166 stock options and 1,429 restricted stock units (RSUs) as part of his compensation, aligning his interests with shareholders.
NASDAQ
19 days, 12 hours ago 
AXSM
Axsome Therapeutics, INC
Form 4: Axsome Therapeutics Director Receives Significant Equity Compensation Package
Mark E. Saad, a Director at Axsome Therapeutics, Inc. (AXSM), was granted 3,166 stock options and 1,429 restricted stock units (RSUs) on June 6, 2025, as part of his compensation.
NASDAQ
19 days, 12 hours ago 
AXSM
Axsome Therapeutics, INC
Form 4: Axsome Therapeutics Director Susan Mahony Granted Stock Options and Restricted Stock Units
Axsome Therapeutics, Inc. Director Susan Mahony was granted 3,166 stock options and 1,429 restricted stock units on June 6, 2025, as part of her compensation.
NASDAQ
19 days, 12 hours ago 
AXSM
Axsome Therapeutics, INC
Form 4: Axsome Therapeutics COO Exercises Stock Options and Sells Shares for Substantial Gain
Axsome Therapeutics' Chief Operating Officer, Mark L. Jacobson, executed a pre-planned transaction, exercising 25,000 stock options and subsequently selling the acquired common shares for a significant profit.
NASDAQ
19 days, 23 hours ago 
AXSM
Axsome Therapeutics, INC
8-K: Axsome Therapeutics Launches SYMBRAVO for Acute Migraine Treatment, Addressing Unmet Patient Needs
Axsome Therapeutics, Inc. announced the commercial availability of SYMBRAVO (meloxicam and rizatriptan) in the United States for the acute treatment of migraine with or without aura in adults, offering a novel multi-mechanistic approach.
NASDAQ
20 days, 14 hours ago 
AXSM
Axsome Therapeutics, INC
8-K: Axsome Therapeutics Stockholders Affirm Corporate Governance and Executive Compensation at 2025 Annual Meeting
Axsome Therapeutics, Inc. announced that its stockholders approved all four proposals, including the election of a Class I director, the 2025 Long-Term Incentive Plan, the ratification of Deloitte & Touche LLP as auditors, and executive compensation, at its Annual Meeting held on June 6, 2025.
NASDAQ
21 days, 0 hours ago 
AXSM
Axsome Therapeutics, INC
8-K: Axsome Therapeutics Faces Setback as FDA Issues Refusal to File Letter for Fibromyalgia Drug AXS-14, New Trial Planned
Axsome Therapeutics announced it received a Refusal to File letter from the FDA for its New Drug Application for AXS-14 for fibromyalgia, necessitating an additional controlled trial.
Delay expected
 
Worse than expected
 
AXSM 
Axsome Therapeutics, INC 
NASDAQ

8-K: Axsome Therapeutics Faces Setback as FDA Issues Refusal to File Letter for Fibromyalgia Drug AXS-14, New Trial Planned

Sentiment:
 Regulatory Update
 9 June 2025 7:05 AM

Axsome Therapeutics announced it received a Refusal to File letter from the FDA for its New Drug Application for AXS-14 for fibromyalgia, necessitating an additional controlled trial.

Delay expected
  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
  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. 

Summary
  • Axsome Therapeutics, Inc. received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for AXS-14 (esreboxetine) for the management of fibromyalgia.
  • The FDA stated that the NDA was not sufficiently complete to permit a substantive review, specifically citing the second of two placebo-controlled trials as inadequate.
  • The inadequacy stemmed from the second trial's 8-week primary endpoint and flexible-dose paradigm, while the first trial (12-week endpoint, fixed-dose) was deemed adequate.
  • The FDA did not raise any questions regarding the positive results of the studies, both of which met their primary endpoints.
  • To address the FDA's feedback, Axsome plans to conduct an additional controlled trial, which will incorporate a fixed-dose paradigm and a 12-week primary endpoint.
  • Axsome anticipates initiating this new trial in the fourth quarter of 2025.
Sentiment

Score: 3

Explanation: The Refusal to File letter from the FDA is a significant setback, requiring an additional clinical trial and delaying potential market entry for AXS-14. While the FDA did not question the positive results of the initial trials and provided clear feedback, the need for further trials introduces substantial delays and costs, negatively impacting the near-term outlook for this specific drug candidate.

Positives
  • The FDA did not question the positive results of the initial studies, both of which met their primary endpoints for AXS-14.
  • The FDA provided clear and specific feedback, which allows Axsome to move expeditiously with the continued development of AXS-14.
  • AXS-14 has demonstrated consistent efficacy across a broad range of fibromyalgia symptoms, including significant improvements in pain, function, and fatigue in completed trials.
  • Fibromyalgia represents a high unmet medical need, affecting approximately 17 million patients in the U.S. with only three currently FDA-approved pharmacologic treatments.
Negatives
  • Axsome Therapeutics received a Refusal to File (RTF) letter from the FDA for its AXS-14 New Drug Application (NDA).
  • The FDA deemed the NDA 'not sufficiently complete' for substantive review, specifically finding one of the two pivotal trials inadequate.
  • The company is required to conduct an additional controlled trial, which will delay the potential approval and commercialization of AXS-14.
Risks
  • The commercial success of the Company's SUNOSI, AUVELITY, and SYMBRAVO products and the ability to obtain additional indications.
  • The Company's ability to maintain and expand payer coverage for its products.
  • The success, timing, and cost of ongoing and anticipated clinical trials for product candidates, including funding, enrollment pace, and data readouts.
  • The Company's ability to fund additional clinical trials to advance its product candidates.
  • The timing of and the Company's ability to obtain and maintain U.S. Food and Drug Administration (FDA) or other regulatory authority approval for its product candidates.
  • The Company's ability to successfully defend its intellectual property or obtain necessary licenses at an acceptable cost.
  • The Company's ability to successfully resolve any intellectual property litigation.
  • The successful implementation of the Company's research and development programs and collaborations.
  • The success of the Company's license agreements.
  • The acceptance by the market of the Company's products and product candidates, if approved.
  • The Company's anticipated capital requirements and the potential impact on its cash runway.
  • The Company's ability to convert sales to recognized revenue and maintain a favorable gross to net sales.
  • Unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts, or a global pandemic.
  • General economic conditions and regulatory developments not within the Company's control.
Future Outlook

Axsome Therapeutics plans to conduct an additional controlled trial for AXS-14, incorporating the FDA's feedback by using a fixed-dose paradigm and a 12-week primary endpoint. This trial is anticipated to be initiated in the fourth quarter of 2025.

Management Comments
  • Herriot Tabuteau, MD, Chief Executive Officer of Axsome, stated: "The clear feedback provided by the FDA’s Division of Anesthesiology, Addiction Medicine, and Pain Medicine allows us to move expeditiously with the continued development of this important investigational medicine for the approximately 17 million patients in the U.S. living with fibromyalgia."
  • Dr. Tabuteau also commented: "We are well positioned to initiate a new controlled trial that will incorporate the FDA’s feedback by the end of 2025."
Industry Context

Fibromyalgia is a chronic debilitating disorder affecting approximately 17 million Americans, predominantly women, characterized by widespread pain, fatigue, disturbed sleep, depression, and cognitive impairment. Treatment options are limited, with only three pharmacologic treatments currently approved by the FDA, indicating a high unmet medical need. AXS-14 aims to address this significant gap in care.

Comparison to Industry Standards
  • The document does not provide specific comparable companies, projects, or results for AXS-14's trial outcomes.
  • It highlights that only three pharmacologic treatments are currently FDA-approved for fibromyalgia, suggesting a significant unmet medical need in the market.
  • The FDA's feedback on trial design (12-week endpoint, fixed-dose paradigm) aligns with established standards for demonstrating efficacy in chronic conditions.
Stakeholder Impact
  • Shareholders: Potential negative impact due to delayed revenue from AXS-14, increased R&D costs for the new trial, and uncertainty regarding future approval.
  • Patients (Fibromyalgia): Delayed access to a potential new treatment option (AXS-14) that has shown consistent efficacy in previous trials.
  • Employees: Continued work on AXS-14 development, but potential impact on morale due to regulatory setback.
Next Steps
  • Axsome Therapeutics will conduct an additional controlled trial for AXS-14.
  • The new trial will use a fixed-dose paradigm and a 12-week primary endpoint, as requested by the FDA.
  • Initiation of this trial is anticipated in the fourth quarter of 2025.
Key Dates
  • June 9, 2025: Date of earliest event reported and issuance of the press release regarding the AXS-14 NDA update.
  • Fourth Quarter of 2025: Anticipated initiation of the additional controlled trial for AXS-14.
Keywords
Axsome Therapeutics, AXSM, AXS-14, esreboxetine, fibromyalgia, FDA, New Drug Application, NDA, Refusal to File, RTF, biopharmaceutical, CNS disorders, clinical trial, pain management, central nervous system
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.
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.
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.
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.
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.
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.
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.
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.
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.