Biogen to Acquire Alcyone Therapeutics, Expanding Drug Delivery Solution Portfolio for Key Product and Pipeline Candidates
Biogen (Nasdaq: BIIB) has announced its acquisition of Alcyone Therapeutics for an upfront payment of $85 million plus milestone payments. The acquisition centers on ThecaFlex DRx™, an implantable device designed for intrathecal delivery of antisense oligonucleotides (ASOs).
The device aims to provide an alternative to repeat lumbar punctures for chronic medicine administration, initially being evaluated with SPINRAZA® for spinal muscular atrophy patients. Biogen plans to launch the delivery system by early 2028, subject to clinical trials and regulatory approval.
As part of the deal, Alcyone's remaining assets will be divested into a new company, Neela Therapeutics. The transaction includes convertible debt financing in Neela from existing investors, including Biogen.
Biogen (Nasdaq: BIIB) ha annunciato l'acquisizione di Alcyone Therapeutics per un pagamento iniziale di 85 milioni di dollari più pagamenti legati a traguardi. L'acquisizione ruota attorno a ThecaFlex DRx™, un dispositivo impiantabile progettato per la somministrazione intratecale di oligonucleotidi antisenso (ASO).
Il dispositivo mira a offrire un'alternativa alle puncioni lombari ripetute per l'amministrazione di farmaci cronicamente, inizialmente valutato con SPINRAZA® per i pazienti affetti da atrofia muscolare spinale. Biogen prevede di lanciare il sistema di somministrazione entro all'inizio del 2028, soggetto a trial clinici e approvazioni regolatorie.
Come parte dell'accordo, le rimanenti attività di Alcyone saranno cedute a una nuova società, Neela Therapeutics. La transazione comprende finanziamenti in debito convertibile in Neela da investitori esistenti, tra cui Biogen.
Biogen (Nasdaq: BIIB) ha anunciado la adquisición de Alcyone Therapeutics por un pago inicial de 85 millones de dólares más pagos por hitos. La adquisición se centra en ThecaFlex DRx™, un dispositivo implantable diseñado para la administración intratecal de oligonucleótidos antisense (ASO).
El dispositivo busca ofrecer una alternativa a las punciones espinales repetidas para la administración crónica de medicamentos, inicialmente evaluado con SPINRAZA® para pacientes con atrofia muscular espinal. Biogen planea lanzar el sistema de administración a principios de 2028, sujeto a ensayos clínicos y aprobación regulatoria.
Como parte del acuerdo, los activos restantes de Alcyone serán transferidos a una nueva empresa, Neela Therapeutics. La transacción incluye financiamiento de deuda convertible en Neela por parte de inversores existentes, entre ellos Biogen.
바이오젠(Biogen, Nasdaq: BIIB)은 Alcyone Therapeutics를 8500만 달러의 선급금과 마일스톤 지급으로 인수했다고 발표했습니다. 인수의 중심은 ThecaFlex DRx™로, 뇌척수액 내 전달용으로 고안된 삽입형 기기입니다. ASO(antisense oligonucleotides) 전달.
이 기기는 만성 약물 투여를 위한 반복적인 요추 천자를 대체하는 것을 목표로 하며, 초기에는 SPINRAZA®를 척수성 근위축증 환자에게 평가하고 있습니다. Biogen은 임상 시험 및 규제 승인을 전제로 2028년 초까지 전달 시스템을 출시할 계획입니다.
거래의 일환으로 Alcyone의 남은 자산은 새로운 회사 Neela Therapeutics로 양도될 예정입니다. 거래에는 Biogen을 포함한 기존 투자자들로부터의 Neela의 전환 사채 자금 조달이 포함됩니다.
Biogen (Nasdaq : BIIB) a annoncé l'acquisition d'Alcyone Therapeutics pour un paiement initial de 85 millions de dollars plus des paiements au titre de jalons. L'acquisition porte sur ThecaFlex DRx™, un dispositif implantable conçu pour l'administration intrathécale d'oligonucléotides antisens (ASO).
Le dispositif vise à offrir une alternative aux ponctions lombaires répétées pour l'administration de médicaments chroniques, évalué initialement avec SPINRAZA® pour les patients atteints d'amyotrophie spinale. Biogen prévoit de lancer le système de délivrance d'ici début 2028, sous réserve des essais cliniques et de l'approbation réglementaire.
Dans le cadre de l'accord, les actifs restants d'Alcyone seront cédés à une nouvelle société, Neela Therapeutics. La transaction comprend un financement par dette convertible pour Neela de la part d'investisseurs existants, y compris Biogen.
Biogen (Nasdaq: BIIB) hat die Übernahme von Alcyone Therapeutics für eine voreilige Zahlung von 85 Millionen US-Dollar zuzüglich Meilensteinzahlungen angekündigt. Die Übernahme konzentriert sich auf ThecaFlex DRx™, ein implantierbares Gerät zur intrathekalen Verabreichung von Antisense-Oligonukleotiden (ASOs).
Das Gerät zielt darauf ab, eine Alternative zu wiederholten Lumbalpunktionen für die chronische Medikamentengabe zu bieten und wird zunächst mit SPINRAZA® bei Patienten mit spinaler Muskelatrophie evaluiert. Biogen plant, das Verabreichungssystem bis Anfang 2028 auf den Markt zu bringen, vorbehaltlich klinischer Prüfungen und behördlicher Genehmigungen.
Im Rahmen des Deals werden Alcyones verbleibende Vermögenswerte in ein neues Unternehmen, Neela Therapeutics, veräußert. Die Transaktion umfasst eine wandelbare Fremdfinanzierung (convertible debt financing) in Neela von bestehenden Investoren, einschließlich Biogen.
بيوجين (ناسداك: BIIB) أعلن عن استحواذه على Alcyone Therapeutics مقابل دفعة مقدمة قدرها 85 مليون دولار بالإضافة إلى دفعات milestones. يركز الاستحواذ على ThecaFlex DRx™، جهاز قابل للزرع مصمم لتوصيل الأحماض النووية المضادة للحس antisense (ASOs) داخل سحاب النخاع.
يهدف الجهاز إلى توفير بديل للثقب القطني المتكرر لإدارة الأدوية المزمنة، حيث يتم تقييمه مبدئياً مع SPINRAZA® لمرضى الضمور العضلي الشوكي. تخطط Biogen لإطلاق نظام التوصيل بحلول أوائل 2028، رهناً بالتجارب السريرية والموافقة التنظيمية.
كجزء من الصفقة، سيتم بيع الأصول المتبقية لشركة جديدة Neela Therapeutics. تشمل الصفقة تمويل ديون قابل للتحويل في Neela من مستثمرين حاليين، بمن فيهم Biogen.
Biogen（纳斯达克股票代码：BIIB）宣布以8500万美元的预付款加里程碑付款收购Alcyone Therapeutics。此次收购聚焦于 ThecaFlex DRx™，一种用于鞘内递送反义寡核苷酸（ASO）的植入设备。
该设备旨在为慢性药物给药提供重复腰穿的替代方案，初步与SPINRAZA®一起在脊髓性肌萎缩症患者中进行评估。Biogen计划在2028年初前推出递送系统，前提是临床试验和监管批准。
作为交易的一部分，Alcyone的剩余资产将转让给一家新公司Neela Therapeutics。交易包括由现有投资者，包括Biogen在内的对Neela的可转换债务融资。
- Strategic acquisition of innovative drug delivery technology that could improve patient experience
- Potential to enhance the value proposition of Biogen's existing medicines through improved administration
- Integration of Alcyone's specialized employees into Biogen's product delivery solutions team
- Local manufacturing capabilities already established for ThecaFlex DRx™
- $85 million upfront cash payment plus milestone payments will impact Biogen's Q4 2025 expenses
- Launch timeline extends to 2028, requiring successful clinical trials and regulatory approval
- Risk associated with clinical trial outcomes and regulatory approval process
Insights
Biogen's $85M acquisition of Alcyone adds strategic delivery technology that could enhance SPINRAZA's value proposition and patient experience.
Biogen's acquisition of Alcyone Therapeutics represents a targeted technology acquisition focused on enhancing drug delivery capabilities. The
The strategic rationale centers on improving patient experience with SPINRAZA® (nusinersen), Biogen's treatment for spinal muscular atrophy (SMA). Currently, SPINRAZA administration requires repeated lumbar punctures—an invasive and uncomfortable procedure. ThecaFlex potentially offers a more convenient alternative that could substantially improve the treatment experience for patients requiring chronic ASO administration.
This acquisition aligns with broader industry trends toward combination products that enhance therapeutic value through improved delivery mechanisms. For Biogen specifically, this represents an opportunity to extend the competitive positioning of SPINRAZA as other SMA treatments emerge in the market. If successful, the technology could be leveraged across Biogen's broader ASO portfolio, potentially creating a proprietary delivery platform that differentiates multiple products.
The transaction structure is notable—Biogen is acquiring only the device technology while Alcyone's therapeutic assets and other technology platforms will be spun out into a new company (Neela Therapeutics). This surgical approach suggests Biogen has a specific strategic interest in the ThecaFlex platform rather than Alcyone's broader pipeline. The projected 2028 commercial introduction indicates a long development runway before potential revenue impact.
- Biogen to drive end-to-end development and commercialization of ThecaFlex DRx™, an investigational implantable device for intrathecal delivery of antisense oligonucleotides (ASOs)
- ThecaFlex DRx™ has the potential to be a new, convenient way to administer medicines to patients living with neurological disorders.
CAMBRIDGE, Mass., Sept. 18, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the company has entered into a definitive agreement to acquire Massachusetts-based Alcyone Therapeutics. As part of an existing partnership with Alcyone Therapeutics, the companies are advancing ThecaFlex DRx™, an implantable subcutaneous port and catheter device being investigated for the intrathecal delivery of antisense oligonucleotides (ASOs). ThecaFlex DRx™ is designed to provide an alternative to repeat lumbar punctures in chronic intrathecal administration of medicines, which could ease both patient experience and accessibility for a broader population of people living with neurologic disorders.
Biogen will drive end-to-end development, manufacturing and commercialization of ThecaFlex DRx™. Upon closing, Alcyone employees who will join Biogen will be integrated into the company’s product delivery solutions team, building upon the existing portfolio and expertise in drug-device combination products. The ThecaFlex DRx™ System is initially being evaluated with SPINRAZA® (nusinersen) in patients with spinal muscular atrophy, which will inform pathways for Biogen's broader portfolio of investigational therapies.
“For nearly three decades, Biogen has pioneered ASO development, and we are committed to continuing to improve patient experience and ease of administration," said Nicole Murphy, Head of Pharmaceutical Operations and Technology at Biogen. "We believe the acquisition of Alcyone Therapeutics offers a strategic opportunity to both expand the company’s capabilities and enhance the value proposition of our medicines by offering a meaningful, patient-centered solution.”
“Alcyone has been a pioneer in precision CNS delivery. With ThecaFlex DRx™, following our productive partnership with Biogen, we now have the opportunity to further deliver what could be the first truly patient-centered, chronic intrathecal delivery option for these important therapies,” said PJ Anand, Founder, President, and Chief Executive Officer of Alcyone Therapeutics. “We believe Biogen’s deep expertise in ASOs and its proven track record in advancing drug delivery innovations make it the ideal partner to bring this technology forward.”
Biogen and Alcyone Therapeutics have collaborated since 2023 on the development of ThecaFlex DRx™, with the PIERRE and PIERRE-PK clinical studies for nusinersen currently underway. Nusinersen is currently marketed under the brand name SPINRAZA® and is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. Biogen plans to introduce the new drug delivery system for SPINRAZA in early 2028, contingent upon the successful completion of clinical trials and regulatory approval.
Alcyone Therapeutics is based in Lowell, Massachusetts. ThecaFlex DRx™ has been in development since 2019 and is manufactured locally.
Financial Details and Terms of the Transaction
Under the terms of the agreement, Biogen has agreed to acquire Alcyone Therapeutics for an upfront cash payment of
With the acquisition, Biogen expects to oversee the end-to-end development, manufacturing and commercialization of ThecaFlex DRx™, while Alcyone’s remaining therapeutic assets along with its Falcon™ precision intra-cerebrospinal fluid (CSF) drug transport modeling, and intraparenchymal delivery will be divested into a new independent company, Neela Therapeutics, Inc. The transaction will include a convertible debt financing in Neela Therapeutics, Inc. from existing investors, including Biogen.
About The ThecaFlex DRx™ System
The ThecaFlex DRx™ System (ThecaFlex), a technology within Alcyone’s Falcon™ Delivery Platform, is an investigational implantable intrathecal (IT) catheter, catheter fixation device, and subcutaneous port system designed to provide access to the cerebrospinal fluid (CSF) for the infusion of therapies by IT bolus administration. Lumbar puncture (LP) is the current standard of care approach to delivering therapeutics into the CSF. ThecaFlex is designed to be an alternative to repeated LP. ThecaFlex has received a CE Mark in Europe and IDE (Investigational Device Exemption) from the U.S. Food and Drug Administration (FDA) to conduct a clinical investigation but has not yet been approved for commercial use by FDA. In addition, ThecaFlex has received Breakthrough Device Designation from FDA.
About SPINRAZA
SPINRAZA (nusinersen) 12mg/5 mL injection is approved in more than 71 countries to treat infants, children and adults with spinal muscular atrophy (SMA). As a foundation of care in SMA, more than 14,000 individuals have been treated with SPINRAZA worldwide.1
SPINRAZA is an antisense oligonucleotide (ASO) that targets the underlying cause of motor neuron loss by continuously increasing the amount of full-length survival motor neuron (SMN) protein produced in the body.2 It is administered directly into the central nervous system, where motor neurons reside, to deliver treatment where the disease starts.2
SPINRAZA has shown efficacy across ages and SMA types with a well-established safety profile based on data in patients treated up to 10 years,3,4 combined with unsurpassed real-world experience. The most common adverse events observed in clinical studies were respiratory infection, fever, constipation, headache, vomiting and back pain. Laboratory tests can monitor for renal toxicity and coagulation abnormalities, including acute severe low platelet counts, which have been observed after administration of some ASOs.
Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals, Inc. (Nasdaq: IONS). Please click here for Important Safety Information and full Prescribing Information for SPINRAZA in the U.S., or visit your respective country’s product website.
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.
About Alcyone Therapeutics
Alcyone Therapeutics is a clinical-stage biotechnology company committed to transforming pediatric care through a diversified portfolio of precision CNS therapeutics and dosing platforms. The Company is advancing a therapeutic pipeline in collaboration with Nationwide Children’s Hospital (AWRI) focused on severe pediatric neurological diseases. Alcyone’s lead programs include miRNA sponge for X chromosome reactivation to treat X-linked genetic disorders, including Rett syndrome and a clinical-stage gene therapy for CLN3 Batten disease and a follow-on pipeline that includes EPH-101, targeting Ephrin pathway to address neurodegeneration. Alcyone’s proprietary FalconTM precision intra-cerebrospinal fluid (CSF) drug transport modeling and delivery platform technology incorporates deep knowledge of CSF dynamics, artificial intelligence, computational modeling, and bioengineering. This comprehensive approach allows for the optimization of central nervous system (CNS) dosing and delivery to better target the pathophysiology and anatomy specific to various neurological diseases. For more information, visit www.alcyonetx.com.
Biogen Safe Harbor
This press release contains forward-looking statements, relating to: Biogen’s agreement to acquire Alcyone Therapeutics; the anticipated and potential benefits of the potential transaction, including the potential to expand our capabilities and enhance the value proposition of our medicines; our strategy and plans; costs and other expected financial impacts of the proposed transaction; potential of, and expectations for, the development of ThecaFlex DRx™ and Biogen’s other commercial business and pipeline programs, including nusinersen (marketed as SPINRAZA); clinical development programs, clinical trials, and data readouts and presentations; regulatory discussions, submissions, filings, and approvals; the potential benefits, safety, and efficacy of our and our collaboration partners’ products and investigational therapies; and our future financial and operating results. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “guidance,” “hope,” “intend,” “may,” “objective,” “outlook,” “plan,” “possible,” “potential,” “predict,” “project,” “prospect,” “should,” “target,” “will,” “would” or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements.
Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management’s current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part.
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These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned “Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
References:
- Based on commercial patients, early access patients, and clinical trial participants through December 31, 2022.
- SPINRAZA U.S. Prescribing Information. Available at: https://www.spinraza.com/content/dam/commercial/specialty/spinraza/caregiver/en_us/pdf/spinraza-prescribing-information.pdf. Accessed: July 2024.
- Core Data sheet, Version 13, October 2021. SPINRAZA. Biogen Inc, Cambridge, MA.
- Finkle et al. Cure SMA 2024. “Final Safety and Efficacy Data From the SHINE Study in Participants With Infantile-Onset and Later-Onset SMA.”
| MEDIA CONTACT(S): Biogen Madeleine Shin + 1 781 464 3260 public.affairs@biogen.com | INVESTOR CONTACT(S): Biogen Tim Power +1 781 464 2442 IR@biogen.com |
FAQ
What is the acquisition price for Biogen's purchase of Alcyone Therapeutics?
What is ThecaFlex DRx™ and how will it benefit Biogen's patients?
When does Biogen plan to launch the ThecaFlex DRx™ system for SPINRAZA?
How will the Alcyone Therapeutics acquisition affect Biogen's financials?
What happens to Alcyone's other assets after the Biogen acquisition?
