Sage Therapeutics Announces Discontinuation of the Collaboration with Biogen on the SAGE-324 Program
Sage Therapeutics announced that Biogen has terminated its rights to the SAGE-324 program following negative results from the Phase 2 KINETIC 2 Study for essential tremor treatment. The termination will be effective on February 17, 2025, with Sage resuming full ownership of the asset. Sage plans to evaluate other potential indications for SAGE-324.
Despite this, Sage and Biogen will continue their partnership on ZURZUVAE® (zuranolone), the first FDA-approved oral treatment for women with postpartum depression (PPD). The companies remain committed to their shared vision of helping women suffering from PPD.
The press release also includes important safety information for ZURZUVAE, highlighting potential side effects and precautions for its use.
Sage Therapeutics ha annunciato che Biogen ha terminato i suoi diritti sul programma SAGE-324 a seguito di risultati negativi dallo studio di Fase 2 KINETIC 2 per il trattamento del tremore essenziale. La cessazione sarà efficace dal 17 febbraio 2025, con Sage che riprenderà piena proprietà dell'asset. Sage intende valutare altre potenziali indicazioni per SAGE-324.
Nonostante ciò, Sage e Biogen continueranno la loro collaborazione su ZURZUVAE® (zuranolone), il primo trattamento orale approvato dalla FDA per le donne con depressione postpartum (PPD). Le aziende rimangono impegnate nella loro visione condivisa di supportare le donne che soffrono di PPD.
Il comunicato stampa include anche importanti informazioni sulla sicurezza di ZURZUVAE, evidenziando i potenziali effetti collaterali e le precauzioni per il suo utilizzo.
Sage Therapeutics anunció que Biogen ha terminado sus derechos sobre el programa SAGE-324 tras resultados negativos del estudio de Fase 2 KINETIC 2 para el tratamiento del temblor esencial. La terminación será efectiva a partir del 17 de febrero de 2025, con Sage recuperando la propiedad total del activo. Sage planea evaluar otras indicaciones potenciales para SAGE-324.
A pesar de esto, Sage y Biogen continuarán su asociación en ZURZUVAE® (zuranolona), el primer tratamiento oral aprobado por la FDA para mujeres con depresión posparto (PPD). Las compañías siguen comprometidas con su visión compartida de ayudar a las mujeres que sufren de PPD.
El comunicado de prensa también incluye información importante sobre la seguridad de ZURZUVAE, destacando los posibles efectos secundarios y precauciones para su uso.
세이지 테라퓨틱스(Sage Therapeutics)는 바이오젠(Biogen)가 본질적 떨림 치료를 위한 제2상 KINETIC 2 연구에서 부정적인 결과가 나옴에 따라 SAGE-324 프로그램에 대한 권리를 종료했다고 발표했습니다. 이 종료는 2025년 2월 17일부터 효력을 발생하며, 세이지는 자산에 대한 완전한 소유권을 회복하게 됩니다. 세이지는 SAGE-324의 다른 잠재적 적응증을 평가할 계획입니다.
그럼에도 불구하고 세이지와 바이오젠은 ZURZUVAE®(즈라놀론)에서 파트너십을 지속할 것이며, 이는 산후 우울증(PPD)을 겪는 여성들을 위한 첫 번째 FDA 승인 경구 치료제입니다. 두 회사는 PPD로 고통받는 여성들을 돕겠다는 공동의 비전에 계속해서 헌신하고 있습니다.
보도 자료에는 ZURZUVAE의 안전성에 대한 중요한 정보도 포함되어 있으며, 그 사용에 대한 잠재적 부작용과 예방 조치가 강조되고 있습니다.
Sage Therapeutics a annoncé que Biogen a mis fin à ses droits sur le programme SAGE-324 suite à des résultats négatifs de l'étude de phase 2 KINETIC 2 concernant le traitement du tremblement essentiel. La résiliation prendra effet le 17 février 2025, Sage reprenant la pleine propriété de l'actif. Sage prévoit d'évaluer d'autres indications potentielles pour SAGE-324.
Malgré cela, Sage et Biogen continueront leur partenariat sur ZURZUVAE® (zuranolone), le premier traitement oral approuvé par la FDA pour les femmes souffrant de dépression postpartum (PPD). Les entreprises restent engagées dans leur vision commune d'aider les femmes souffrant de PPD.
Le communiqué de presse contient également d'importantes informations de sécurité concernant ZURZUVAE, soulignant les effets secondaires potentiels et les précautions à prendre lors de son utilisation.
Sage Therapeutics gab bekannt, dass Biogen seine Rechte am SAGE-324 Programm nach negativen Ergebnissen der Phase-2-Studie KINETIC 2 zur Behandlung des essentiellen Tremors beendet hat. Die Beendigung wird am 17. Februar 2025 wirksam, wobei Sage die vollständige Eigentümerschaft des Vermögenswerts zurückerhält. Sage plant, weitere potenzielle Indikationen für SAGE-324 zu evaluieren.
Trotzdem werden Sage und Biogen ihre Partnerschaft an ZURZUVAE® (Zuranolon), der ersten von der FDA zugelassenen oralen Behandlung für Frauen mit postpartaler Depression (PPD), fortsetzen. Die Unternehmen bleiben ihrem gemeinsamen Ziel, Frauen mit PPD zu helfen, verpflichtet.
Die Pressemitteilung enthält auch wichtige Sicherheitsinformationen zu ZURZUVAE und hebt mögliche Nebenwirkungen sowie Vorsichtsmaßnahmen für die Anwendung hervor.
- Continued partnership with Biogen on ZURZUVAE, the first FDA-approved oral treatment for postpartum depression
- Sage regains full ownership of the SAGE-324 asset, allowing for potential development in other indications
- Termination of Biogen's rights to the SAGE-324 program
- Negative results from Phase 2 KINETIC 2 Study of SAGE-324 for essential tremor treatment
- Discontinuation of SAGE-324 clinical development in essential tremor
Insights
The discontinuation of the SAGE-324 collaboration with Biogen is a significant setback for Sage Therapeutics. This decision follows the negative results from the Phase 2 KINETIC 2 Study for essential tremor treatment, highlighting the challenges in drug development. However, it's important to note that the partnership for ZURZUVAE®, their FDA-approved postpartum depression treatment, remains intact.
The termination's effective date of February 17, 2025, gives Sage time to strategize for the future of SAGE-324. While they plan to evaluate other potential indications, this represents a narrowing of their pipeline and a loss of shared development costs with Biogen. For investors, this news underscores the risks associated with biotech investments and the importance of diversified product portfolios.
The continued collaboration on ZURZUVAE® is a silver lining, as it's the first oral treatment for postpartum depression. This unique position in the market could be a significant revenue driver, potentially offsetting some of the disappointment from the SAGE-324 program's setback.
From a financial perspective, this development has mixed implications for Sage Therapeutics. The termination of the SAGE-324 collaboration means Sage will lose Biogen's financial support for this program, potentially increasing their R&D expenses if they choose to continue development independently. However, regaining full ownership of the asset by 2025 could be valuable if new indications prove promising.
Investors should focus on the continued partnership for ZURZUVAE®, which represents a near-term revenue opportunity. With a market cap of
This news may lead to increased volatility in SAGE's stock price as the market reassesses the company's pipeline potential and near-term revenue prospects. Long-term investors should evaluate Sage's ability to leverage ZURZUVAE® and potentially repurpose SAGE-324 for other indications.
Sage and Biogen will continue to partner on ZURZUVAE®, the first and only FDA-approved oral treatment for women with postpartum depression
Sage and Biogen will continue to partner on ZURZUVAE® (zuranolone), the first and only FDA-approved oral treatment for women with postpartum depression (PPD) and will continue to work on their shared vision to help women suffering from PPD.
Under the terms of the collaboration and license agreement, the termination will be effective on February 17, 2025, and Sage will resume full ownership of the SAGE-324 asset at that time. Sage plans to continue to evaluate other potential indications, if any, for SAGE-324.
SELECT IMPORTANT SAFETY INFORMATION FOR ZURZUVAE:
ZURZUVAE (zuranolone) CIV, is a neuroactive steroid gamma-aminobutyric acid A (GABAA) receptor positive modulator indicated for the treatment of postpartum depression in adults.
This does not include all the information needed to use ZURZUVAE safely and effectively. See full prescribing information for ZURZUVAE.
ZURZUVAE may cause serious side effects. The most common side effects of ZURZUVAE include sleepiness or drowsiness, dizziness, common cold, diarrhea, feeling tired, weak, or having no energy, and urinary tract infection. ZURZUVAE may decrease your awareness and alertness, which can affect your ability to drive safely or safely do other dangerous activities. Do not drive, operate machinery, or do other dangerous activities until at least 12 hours after taking each dose during your 14-day treatment course of ZURZUVAE. You may not be able to tell on your own if you can drive safely or tell how much ZURZUVAE is affecting you. ZURZUVAE may cause sleepiness, drowsiness, slow thinking, dizziness, confusion, and trouble walking. Because of these symptoms, you may be at a higher risk for falls during treatment with ZURZUVAE. Taking alcohol, other medicines that cause CNS depressant effects, or opioids while taking ZURZUVAE can make these symptoms worse and may also cause trouble breathing. Tell your healthcare provider if you develop any of these symptoms, or if they get worse during treatment with ZURZUVAE. Your healthcare provider may decrease your dose or stop ZURZUVAE treatment if you develop these symptoms. ZURZUVAE is a federal controlled substance (C-IV) because it contains zuranolone, which can be abused or lead to dependence. Tell your healthcare provider right away if you become pregnant or plan to become pregnant during treatment with ZURZUVAE. You should use effective birth control (contraception) during treatment with ZURZUVAE and for 1 week after the final dose. ZURZUVAE and other antidepressant medicines may increase the risk of suicidal thoughts and actions in people 24 years of age and younger. ZURZUVAE is not for use in children.
About SAGE-324
SAGE-324 is an investigational oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM). NAS GABAA receptor PAMs bind to both synaptic and extrasynaptic GABAA receptors, enhancing inhibitory activity of the GABAergic system, the major inhibitory neurotransmission system in the brain. GABA is the primary inhibitory neurotransmitter in the central nervous system and plays a critical role in maintaining balanced neuronal activity in the brain. The safety and effectiveness of SAGE-324 have not been established.
About Sage Therapeutics
Sage Therapeutics (Nasdaq: SAGE) is a biopharmaceutical company committed to our mission of pioneering solutions to deliver life-changing brain health medicines, so every person can thrive. Sage developed the only two FDA-approved treatments indicated for postpartum depression and is advancing a robust pipeline to target unmet needs in brain health. Sage was founded in 2010 and is headquartered in
Find out more at www.sagerx.com or engage with us on Facebook, LinkedIn, Instagram, and X.
Sage Forward-Looking Statements
Various statements in this release concern our future expectations, plans and prospects, including without limitation statements regarding: our plans to continue to evaluate potential indications for SAGE-324, our vision to help women with PPD with ZURZUVAE, our mission and goals, and the opportunity and potential for our business. These statements constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: we may decide not to pursue any further development of SAGE-324 in any indication; the results of ongoing, planned or future clinical studies or nonclinical work with respect to any of our product candidates may be negative; results of earlier trials of any of our product candidates may not be replicated in ongoing or future trials; clinical and nonclinical data we generate in the course of any development program may not be sufficient to move to the next phase of development for an indication or may not support further development at all; with respect to our vision for ZURZUVAE, we may not achieve the clinical benefit, clinical use or level of market acceptance from healthcare professionals, patients or payors for ZURZUVAE in the treatment of PPD we expect or we may encounter reimbursement-related or other market-related issues or issues with our distribution network that impact the success of our commercialization efforts, including our ability to achieve our vision for this product; we may encounter adverse events at any stage that negatively impact further development and the potential for approval of our product candidates or the potential for successful commercialization of any of our approved products or that require additional nonclinical and clinical work which may not yield positive results; and we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates or the commercialization of any marketed product which may delay our timing or change our plans, increase our costs or otherwise negatively impact our business; as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent quarterly report filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
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MEDIA:
Sage Therapeutics
Matthew Henson
+1 917 930 7147
Matthew.Henson@sagerx.com
INVESTOR:
Sage Therapeutics
Katie Plante
+1 978 968 9099
Katie.Plante@sagerx.com
Source: Sage Therapeutics, Inc.
FAQ
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