Axsome Therapeutics Announces FDA Acceptance of NDA Resubmission for AXS-07 for the Acute Treatment of Migraine
Axsome Therapeutics (NASDAQ: AXSM) announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for AXS-07, a treatment for acute migraine. The FDA has classified it as a Class 2 resubmission and set a PDUFA action goal date of January 31, 2025. This development marks a significant milestone in Axsome's efforts to bring a new migraine treatment to market. The acceptance of the NDA resubmission indicates progress in addressing previous FDA concerns and moves AXS-07 closer to potential approval. Investors and patients alike will be closely watching the outcome, as a successful approval could impact both Axsome's market position and migraine treatment options.
Axsome Therapeutics (NASDAQ: AXSM) ha annunciato che la FDA ha accettato la nuova presentazione della sua Domanda di Nuovo Farmaco (NDA) per AXS-07, un trattamento per l'emicrania acuta. La FDA ha classificato questa presentazione come una risubmissione di Classe 2 e ha stabilito una data obiettivo per l'azione PDUFA del 31 gennaio 2025. Questo sviluppo segna un traguardo significativo negli sforzi di Axsome per portare un nuovo trattamento per l'emicrania sul mercato. L'accettazione della risubmissione dell'NDA indica progressi nel risolvere le precedenti preoccupazioni della FDA e avvicina AXS-07 a una potenziale approvazione. Sia gli investitori che i pazienti seguiranno attentamente l'esito, poiché un'approvazione favorevole potrebbe influenzare sia la posizione di mercato di Axsome che le opzioni di trattamento per l'emicrania.
Axsome Therapeutics (NASDAQ: AXSM) anunció que la FDA ha aceptado la reenvío de su Solicitud de Nuevo Medicamento (NDA) para AXS-07, un tratamiento para la migraña aguda. La FDA ha clasificado esto como un reenvío de Clase 2 y ha establecido una fecha objetivo para la acción PDUFA del 31 de enero de 2025. Este desarrollo marca un hito significativo en los esfuerzos de Axsome para llevar un nuevo tratamiento para la migraña al mercado. La aceptación del reenvío de la NDA indica avances en la atención a las preocupaciones previas de la FDA y acerca a AXS-07 a una posible aprobación. Tanto los inversores como los pacientes estarán observando de cerca el resultado, ya que una aprobación exitosa podría impactar tanto la posición de mercado de Axsome como las opciones de tratamiento para la migraña.
Axsome Therapeutics (NASDAQ: AXSM)는 FDA가 급성 편두통 치료제 AXS-07에 대한 신규 의약품 신청(NDA)을 재제출했음을 발표했습니다. FDA는 이를 클래스 2 재제출로 분류하고 2025년 1월 31일을 PDUFA 조치 목표일로 설정했습니다. 이번 발전은 Axsome이 새로운 편두통 치료제를 시장에 출시하기 위한 노력에서 중요한 이정표가 됩니다. NDA 재제출의 수용은 이전 FDA의 우려를 해소하는 진전을 나타내며 AXS-07의 잠재적인 승인에 더욱 가까워지게 합니다. 투자자와 환자 모두 결과를 주의 깊게 지켜볼 것이며, 성공적인 승인은 Axsome의 시장 위치와 편두통 치료 옵션 모두에 영향을 미칠 수 있습니다.
Axsome Therapeutics (NASDAQ: AXSM) a annoncé que la FDA a accepté la nouvelle soumission de sa Demande de Nouveau Médicament (NDA) pour AXS-07, un traitement contre la migraine aigüe. La FDA a classé cela comme une resoumission de Classe 2 et a fixé une date d'objectif d'action PDUFA au 31 janvier 2025. Ce développement constitue une étape importante dans les efforts d'Axsome pour commercialiser un nouveau traitement de la migraine. L'acceptation de la resoumission de la NDA indique des progrès dans la prise en compte des préoccupations antérieures de la FDA et rapproche AXS-07 d'une éventuelle approbation. Les investisseurs et les patients suivront de près l'issue, car une approbation réussie pourrait avoir un impact à la fois sur la position d'Axsome sur le marché et sur les options de traitement de la migraine.
Axsome Therapeutics (NASDAQ: AXSM) gab bekannt, dass die FDA die erneute Einreichung ihres Antrags auf Zulassung eines neuen Arzneimittels (NDA) für AXS-07, eine Behandlung für akute Migräne, akzeptiert hat. Die FDA hat dies als eine erneute Einreichung der Klasse 2 eingestuft und ein Zieltermin für die PDUFA-Aktion am 31. Januar 2025 festgelegt. Diese Entwicklung stellt einen bedeutenden Meilenstein in den Bestrebungen von Axsome dar, eine neue Migränebehandlung auf den Markt zu bringen. Die Akzeptanz der NDA-Neueinreichung zeigt Fortschritte bei der Lösung früherer Bedenken der FDA und bringt AXS-07 näher an eine mögliche Genehmigung. Sowohl Investoren als auch Patienten werden das Ergebnis genau beobachten, da eine erfolgreiche Genehmigung sowohl die Marktposition von Axsome als auch die Behandlungsoptionen für Migräne beeinflussen könnte.
- FDA acceptance of NDA resubmission for AXS-07
- PDUFA action goal date set for January 31, 2025
- Progress towards potential approval of a new acute migraine treatment
- Extended timeline for potential approval (PDUFA date in 2025)
- Class 2 resubmission designation, indicating more complex review process
Insights
The FDA's acceptance of Axsome's NDA resubmission for AXS-07 is a significant milestone in the drug's development journey. The Class 2 designation indicates that the FDA considers this a major amendment, requiring up to 6 months for review. This timeline suggests substantial new data or analyses were submitted.
The January 31, 2025 PDUFA date provides a clear target for potential market entry. If approved, AXS-07 could offer a new treatment option for the
Axsome's focus on CNS disorders positions them in a high-need therapeutic area. The potential addition of AXS-07 to their portfolio could strengthen their market position, but it's important to consider the competitive landscape and potential differentiation of this product.
This regulatory progress for AXS-07 is potentially positive for Axsome's financial outlook. The migraine market represents a substantial revenue opportunity, with leading drugs in this space generating annual sales in the hundreds of millions to billions of dollars range.
However, investors should consider that Axsome faces a 16-month wait until the PDUFA date, which could impact short-term stock performance. The extended timeline may also necessitate additional capital to fund operations until a potential launch.
It's important to evaluate Axsome's cash position and burn rate in light of this extended timeline. Additionally, consider the potential impact on Axsome's valuation if AXS-07 is approved, factoring in market size, competition and projected market share.
FDA sets PDUFA action goal date of January 31, 2025
NEW YORK, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Company’s New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The FDA designated the resubmission as a Class 2 resubmission and set a Prescription Drug User Fee Act (PDUFA) action goal date of January 31, 2025.
About Migraine
Migraine is a serious neurological condition characterized by recurrent attacks of pulsating, often severe and disabling head pain associated with nausea, sensitivity to light, and sensitivity to sound.1 An estimated 39 million Americans suffer from migraine, and it is the leading cause of disability among neurological disorders in the United States according to the American Migraine Foundation.2,3 Published surveys of migraine sufferers found that more than
About AXS-07
AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine, consisting of MoSEIC™ meloxicam and rizatriptan. Meloxicam is a new molecular entity for migraine enabled by Axsome’s MoSEIC (Molecular Solubility Enhanced Inclusion Complex) technology, which results in rapid absorption of meloxicam while maintaining a long plasma half-life. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug and rizatriptan is a 5-HT1B/1D agonist. AXS-07 is designed to provide rapid, enhanced and consistent relief of migraine, with reduced symptom recurrence. AXS-07 is covered by more than 200 issued U.S. and international patents which provide protection until at least 2038. AXS-07 is not approved by the FDA.
About Axsome Therapeutics
Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, we are transforming the approach to treating CNS conditions. At Axsome, we are committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians. For more information, please visit the Company’s website at www.axsome.com.
Forward Looking Statements
Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the continued commercial success of the Company’s Sunosi® and Auvelity® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s 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 of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; whether issues identified by FDA in the complete response letter may impact the potential approvability of the Company’s NDA for AXS-07 for the acute treatment of migraine in adults with or without aura, pursuant to the Company’s special protocol assessment for the MOMENTUM clinical trial; 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; 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, including the amount of capital required for the continued commercialization of Sunosi and Auvelity 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; 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 and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance.
Investors:
Mark Jacobson
Chief Operating Officer
(212) 332-3243
mjacobson@axsome.com
Media:
Darren Opland
Director, Corporate Communications
(929) 837-1065
dopland@axsome.com
References
- Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
- American Migraine Foundation. 2023.
- Steiner TJ, et al. Migraine remains the second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137.
- Smelt AF, Louter MA et al. What do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi study. PLoS One. 2014 Jun 16;9(6):e98933.
- Lipton RB, Stewart WF. Acute migraine therapy: do doctors understand what patients with migraine want from therapy? Headache. 1999;39(suppl 2):S20-S26.
FAQ
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