Cyclerion Announces Transformational Relaunch as a Neuropsychiatric Company
Cyclerion Therapeutics (CYCN) announced a strategic relaunch as a neuropsychiatric company through a licensing agreement with MIT. The company's transformation focuses on developing novel therapies for neuropsychiatric conditions, starting with treatment-resistant depression (TRD).
The company's lead program combines anesthetic agents with a proprietary tech-driven system to resynchronize brain region communication for 3 million Americans affected by TRD. A Phase 2 proof-of-concept trial is planned to begin in 2026, with initial data expected in 2027.
Under CEO Regina Graul's leadership and guided by industry experts including Dr. Errol DeSouza and Dr. Steven Hyman, Cyclerion aims to expand beyond TRD to develop additional neuropsychiatric therapies. The company will host a webcast on September 24, 2025 to discuss future plans.
Cyclerion Therapeutics (CYCN) ha annunciato un rilancio strategico come azienda neuropsichiatrica tramite un accordo di licensing con MIT. La trasformazione dell’azienda si concentra sullo sviluppo di terapie innovative per condizioni neuropsichiatriche, a partire dalla depressione resistente al trattamento (TRD).
Il programma principale combina anestetici con un sistema proprietario guidato dalla tecnologia per riprogrammare la comunicazione tra le regioni cerebrali, con l’obiettivo di 3 milioni di americani colpiti dalla TRD. Si prevede un trial di fase 2-proof-of-concept che inizierà nel 2026, con i primi dati attesi nel 2027.
Sotto la guida della CEO Regina Graul e con il supporto di esperti del settore, tra cui il Dr. Errol DeSouza e il Dr. Steven Hyman, Cyclerion punta ad espandersi oltre la TRD per sviluppare ulteriori terapie neuropsichiatriche. L’azienda terrà una trasmissione webcast il 24 settembre 2025 per discutere i piani futuri.
Cyclerion Therapeutics (CYCN) anunció un relanzamiento estratégico como empresa neuropsiquiátrica a través de un acuerdo de licencia con MIT. La transformación de la empresa se centra en desarrollar terapias novedosas para trastornos neuropsiquiátricos, empezando por la depresión resistente al tratamiento (TRD).
El programa principal de la empresa combina agentes anestésicos con un sistema propietario impulsado por tecnología para re-sincronizar la comunicación entre regiones cerebrales en 3 millones de estadounidenses afectadas por TRD. Se planea un ensayo de fase 2 de prueba conceptual que comenzará en 2026, con datos iniciales esperados en 2027.
Bajo el liderazgo de la CEO Regina Graul y guiada por expertos de la industria, incluidos el Dr. Errol DeSouza y el Dr. Steven Hyman, Cyclerion aspira a expandirse más allá de TRD para desarrollar otras terapias neuropsiquiátricas. La empresa ofrecerá una webcast el 24 de septiembre de 2025 para discutir los planes futuros.
Cyclerion Therapeutics (CYCN)가 MIT와의 라이선스 계약을 통해 신경정신과 기업으로의 전략적 재출발을 발표했다. 회사의 변화는 신경정신과 질환을 위한 새로운 치료법 개발에 집중하며, 우선은 치료 저항성 우울증(TRD)을 시작으로 한다.
회사의 주력 프로그램은 마취제와 독점 기술 기반 시스템을 결합하여 뇌 영역 간의 의사소통을 재동기화하고 TRD에 영향을 받는 300만 미국인의 상태를 개선하는 것을 목표로 한다. 2026년에 2상 개념 검증 시험이 시작될 예정이며 최초 데이터는 2027년에 기대된다.
CEO 레지나 글라우의 리더십 아래 및 Dr. Errol DeSouza와 Dr. Steven Hyman 같은 업계 전문가의 지도 아래 Cyclerion은 TRD를 넘어 추가적인 신경정신과 치료제를 개발하는 것을 목표로 한다. 회사는 2025년 9월 24일에 향후 계획을 논의하는 웹캐스트를 주최할 것이다.
Cyclerion Therapeutics (CYCN) a annoncé un redémarrage stratégique en tant qu’entreprise neuropsychiatrique via un accord de licence avec MIT. La transformation de la société se concentre sur le développement de thérapies innovantes pour les affections neuropsychiatriques, en commençant par une dépression résistante au traitement (TRD).
Le programme phare de l’entreprise combine des agents anesthésiques avec un système propriétaire piloté par la technologie pour resynchroniser la communication entre les régions cérébrales chez 3 millions d’Américains touchés par la TRD. Un essai de Phase 2 proof-of-concept est prévu pour démarrer en 2026, avec des premiers résultats attendus en 2027.
Sous la direction de la CEO Regina Graul et avec l’appui d’experts de l’industrie, dont le Dr. Errol DeSouza et le Dr. Steven Hyman, Cyclerion vise à étendre au-delà de la TRD pour développer d’autres thérapies neuropsychiatriques. L’entreprise organisera un webinaire le 24 septembre 2025 pour discuter des plans futurs.
Cyclerion Therapeutics (CYCN) kündigte einen strategischen Neustart als Neuropsychiatrie-Unternehmen durch eine Lizenzvereinbarung mit MIT an. Die Transformation des Unternehmens konzentriert sich auf die Entwicklung neuartiger Therapien für neuropsychiatrische Erkrankungen, beginnend mit therapieresistenter Depression (TRD).
Das führende Programm des Unternehmens kombiniert anästhetische Mittel mit einem proprietären, technikgetriebenen System, um die Kommunikation zwischen Hirnregionen für 3 Millionen Amerikaner mit TRD neu zu synchronisieren. Es ist eine Phase-2-Proof-of-Concept-Studie geplant, die 2026 beginnen soll, mit ersten Daten, die 2027 erwartet werden.
Unter der Leitung von CEO Regina Graul und geleitet von Branchenexperten wie Dr. Errol DeSouza und Dr. Steven Hyman plant Cyclerion, über TRD hinaus weitere neuropsychiatrische Therapien zu entwickeln. Das Unternehmen wird am 24. September 2025 einen Webcast abhalten, um die zukünftigen Pläne zu besprechen.
Cyclerion Therapeutics (CYCN) أعلنت عن إعادة إطلاق استراتيجية كشركة عصبية نفسية من خلال اتفاقية ترخيص مع MIT. تركّز تحول الشركة على تطوير علاجات جديدة للحالات العصبية النفسية، بدءاً من الاكتئاب المقاوم للعلاج (TRD).
يجمِع البرنامج الرائد للشركة بين عوامل التخدير ونظام تقني مملوك لإعادة تزامن التواصل بين مناطق الدماغ لـ ثلاثة ملايين أميركي يعانون TRD. من المخطط إجراء تجربة إثبات المفاهيم في المرحلة الثانية Phase 2 ستبدأ في 2026، مع بيانات أولية متوقعة في 2027.
تقاد الشركة تحت قيادة الرئيسة التنفيذية ريجينا غراول وبإرشاد خبراء الصناعة بما في ذلك الدكتور إرو DeSouza والدكتور ستيفن هايمين، تهدف Cyclerion إلى التوسع خارج TRD لتطوير علاجات أخرى في مجال العصبيات النفسية. ستستضيف الشركة بثًا مباشراً في 24 سبتمبر 2025 لمناقشة الخطط المستقبلية.
Cyclerion Therapeutics (CYCN) 宣布通过与 MIT 的许可协议，将作为神经精神科公司进行战略重启。公司的转型聚焦于开发神经精神科疾病的新型疗法，首先针对治疗耐药性抑郁症（TRD）。
公司的主导项目将麻醉剂与一套由技术驱动的专有系统相结合，旨在为受 TRD 影响的 300万美国人 重新同步大脑区域之间的通信。计划在 2026 年启动 阶段2概念验证试验，预计 2027 年获得初步数据。
在 CEO Regina Graul 的领导下，并由行业专家包括 Dr. Errol DeSouza 与 Dr. Steven Hyman 指导，Cyclerion 旨在除了 TRD 外，开发其他神经精神科治疗。公司将于 2025 年 9 月 24 日 举行网络广播，讨论未来计划。
- Strategic repositioning into the promising neuropsychiatric therapeutics market
- Secured valuable intellectual property through MIT licensing agreement
- Phase 2-ready program targeting large market of 3 million Americans with TRD
- Strong leadership team with expertise in neuropsychiatry and CNS disorders
- Extended timeline to clinical results with Phase 2 data not expected until 2027
- Early-stage company with no immediate revenue prospects
- Faces competition in the crowded neuropsychiatric treatment space
Insights
Cyclerion's strategic pivot to neuropsychiatry with MIT-licensed technology could revitalize the company with a Phase 2-ready TRD treatment program.
Cyclerion's transformation represents a significant strategic redirection from its previous focus to becoming a dedicated neuropsychiatric company. The licensing agreement with MIT provides Cyclerion with intellectual property that will serve as the foundation for developing therapies targeting treatment-resistant depression (TRD), a condition affecting approximately 3 million Americans with limited therapeutic options.
The company's approach combines established anesthetic agents with a proprietary technology-driven delivery system designed to resynchronize neural communication between key brain regions. This mechanism aims to restore functional connectivity in TRD patients – a potentially meaningful innovation in a therapeutic area that has seen limited advances despite substantial unmet need.
From a development perspective, Cyclerion has outlined a clear timeline with a Phase 2 proof-of-concept trial planned for 2026 and initial data expected in 2027. This positions the company with a relatively near-term clinical milestone that could serve as a significant value inflection point if successful.
The company's leadership includes notable expertise in neuropsychiatry, with Dr. Errol DeSouza (known for CNS disorder treatment advancements) as Board Chairperson and Steven Hyman from the Broad Institute as a board member. The multidisciplinary team encompasses specialists in neuropsychiatry, anesthesiology, machine learning, and therapeutic delivery – suggesting a comprehensive approach to addressing the complex challenges of TRD treatment.
Beyond its lead program, Cyclerion indicates plans for pipeline expansion into additional neuropsychiatric conditions, suggesting a platform approach rather than a single-product strategy. This could provide multiple opportunities for value creation if the underlying technology demonstrates efficacy.
– Cyclerion Relaunches, Advancing a Phase 2–Ready Program for Millions Living with Treatment-Resistant Depression Through MIT License Agreement –
– Webcast to be held September 24, 2025 at 10:30 a.m. ET –
CAMBRIDGE, Mass., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Cyclerion Therapeutics, Inc. today announced that it has entered into a licensing agreement with the Massachusetts Institute of Technology (“MIT”), securing the intellectual property that will serve as the cornerstone of its strategic relaunch. This agreement marks a pivotal milestone in Cyclerion’s transformation into a new, innovation-driven company focused on delivering potential novel, improved or first--in-class therapies for neuropsychiatric conditions with large unmet needs, beginning with treatment-resistant depression (“TRD”).
“This relaunch represents a pivotal moment for Cyclerion Therapeutics as we refocus our efforts on advancing breakthrough neuropsychiatric treatments for patients who have limited therapeutic options today,” said Dr. Errol DeSouza, a leader in the advancement of treatments for Central Nervous Disorders and Chairperson of Cyclerion’s Board of Directors. “Our board remains committed to partnering with management to support the strategic vision and ensure we have the resources necessary to develop innovative therapies that can meaningfully improve outcomes for individuals suffering from serious neuropsychiatric conditions. We believe this new chapter positions the company to make a significant impact in this underserved therapeutic area while creating sustainable value for all stakeholders.”
Cyclerion’s lead program leverages common anesthetic agents and a proprietary, tech-driven system to resynchronize communication between key brain regions and restore functional connectivity in patients with TRD. For the 3 million Americans living with TRD, this approach could deliver a long-awaited alternative to current limited treatment options.
“Cyclerion’s approach to drug development is grounded in compelling science and clinical precedent,” said Steven Hyman, M.D., Director of the Program in Brain Health at the Broad Institute and member of Cyclerion’s Board of Directors. “By leveraging known anesthetic mechanisms and pairing them with intelligent delivery systems, Cyclerion is pioneering a new class of neuropsychiatric therapies that could offer meaningful relief to patients with treatment-resistant depression.”
Cyclerion’s relaunch is supported by a world-class team of experts in neuropsychiatry, anesthesiology, machine learning and therapeutic delivery. The Company’s operating model is designed to maximize value creation and advance programs through de-risked inflection points. A Phase 2 proof-of-concept trial for its lead program is expected to initiate in 2026, with an initial data set anticipated in 2027.
In addition to its lead program, Cyclerion is actively exploring expansion into other neuropsychiatric diseases. The company’s strategic vision includes building a pipeline of novel, improved or first-in-class therapies that combine clinical efficacy with commercial differentiation.
“This agreement marks the launch of a new era at Cyclerion,” said Regina Graul, Ph.D., Chief Executive Officer of Cyclerion. “We are building a company that combines the rigor of a leading biopharma with the agility of a startup. For patients who have exhausted traditional options and for those underserved by current treatments, our foundational therapeutic candidate could represent the future of care in treatment-resistant depression. We believe Cyclerion will lead the way in advancing precision neuropsychiatric solutions beyond TRD—potentially bringing forward additional therapies that are safe, effective and accessible.”
Webcast Information
Cyclerion will make a recorded webcast presentation available on its website tomorrow, September 24, 2025 at 10:30am Eastern Time, to discuss this milestone and the Company’s future plans. To access the webcast, please visit the “Events” page of the Cyclerion website at www.cyclerion.com. The replay will be available after posting and will remain archived for one year.
For more information about Cyclerion, please visit https://www.cyclerion.com/ and follow us on X (@Cyclerion) and LinkedIn (www.linkedin.com/company/cyclerion).
About Cyclerion Therapeutics
Cyclerion Therapeutics, Inc. (“Cyclerion” or the “Company”) is a clinical-stage biopharmaceutical company focused on building a new pipeline of therapeutics for neuropsychiatric diseases, with an individualized therapy for treatment-resistant depression (“TRD”) as its foundational product candidate. Given the significant unmet medical need in TRD, the program’s stage of clinical development, and the strong commercial opportunity, the Company believes this program is well positioned to serve as the cornerstone of its future growth.
Cyclerion became an independent, publicly traded company on April 1, 2019, following a tax-free spin-off from Ironwood Pharmaceuticals, Inc. The Company was originally established to develop novel soluble guanylate cyclase (sGC) stimulators for serious diseases in both the central nervous system (CNS) and the periphery. As part of its strategic shift toward neuropsychiatry, Cyclerion sold zagociguat and CY3018 to Tisento in 2023, out-licensed praliciguat in 2021, and entered into a non-binding license option agreement for olinciguat in 2024. The Company continues to leverage these legacy sGC assets with the goal of generating revenues to help fund its strategic pipeline in neuropsychiatry.
Forward Looking Statement
Certain matters discussed in this press release are “forward-looking statements”. We may, in some cases, use terms such as “believes,” “potential,” “anticipates,” “expects,” “plans,” “could,” “will,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements involve risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. We caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements about our ability to develop product candidates and the timing of related milestones. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. Some of the key factors that could cause actual performance and results to differ materially from those projected or suggested in the forward- looking statements include, but are not limited to, the substantial doubt regarding the our ability to continue as a going concern, our ability to raise additional funding, our ability to enroll patients in future clinical studies, our ability to obtain regulatory approval for our product candidates, unanticipated changes to our nonclinical or clinical study protocols due to regulatory reasons or unanticipated events, which could lead to increased costs to us and could delay our development timeline, our reliance on third parties to conduct clinical studies and to manufacture drug supplies for our product candidates, our ability to adequately protect our intellectual property, and the other important risk factors discussed under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on March 5, 2024 as well as other risks and uncertainties which may be described in any subsequent quarterly report on Form 10-Q filed by the Company and the other reports the Company files with the SEC. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. 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 circumstances.
Contacts
Investor & Media Relations Email: IR@cyclerion.com
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