MediciNova Appoints Dr. Christopher Breder, MD, PhD as Clinical and Regulatory Advisor
MediciNova (NASDAQ:MNOV) announced on November 18, 2025 the appointment of Dr. Christopher D. Breder, MD, PhD as Clinical and Regulatory Advisor. Dr. Breder will provide strategic guidance for MediciNova’s drug development programs and will lead the Scientific Advisory Board upon its formation.
Dr. Breder brings over two decades of regulatory and clinical experience, including more than a decade at the FDA as Medical Officer and Lead Medical Officer, involvement in NDA review and safety analysis training, and participation in reviews and initial approvals for therapies targeting ALS, myasthenia gravis, and Duchenne muscular dystrophy. He holds an MD and PhD from the University of Chicago and completed clinical training at Johns Hopkins Hospital.
MediciNova (NASDAQ:MNOV) ha annunciato il 18 novembre 2025 la nomina di Dr. Christopher D. Breder, MD, PhD come Consulente Clinico e Regolatorio. Il Dr. Breder fornirà orientamenti strategici per i programmi di sviluppo di farmaci di MediciNova e guiderà il Scientific Advisory Board al momento della sua formazione.
Il Dr. Breder porta oltre due decenni di esperienze regolatorie e cliniche, inclusa oltre un decennio alla FDA come Medical Officer e Lead Medical Officer, coinvolgimento nella revisione NDA e formazione sull'analisi di sicurezza, e partecipazione a revisioni e approvazioni iniziali per terapie mirate ad ALS, miastenia gravis e distrofia muscolare di Duchenne. Ha conseguito MD e PhD presso l'Università di Chicago e ha completato la formazione clinica all'Johns Hopkins Hospital.
MediciNova (NASDAQ:MNOV) anunció el 18 de noviembre de 2025 la designación de el Dr. Christopher D. Breder, MD, PhD como Asesor Clínico y Regulatorio. El Dr. Breder proporcionará orientación estratégica para los programas de desarrollo de fármacos de MediciNova y dirigirá el Comité Asesor Científico cuando se forme.
El Dr. Breder aporta más de dos décadas de experiencia regulatoria y clínica, incluyendo más de una década en la FDA como Medical Officer y Lead Medical Officer, participación en la revisión de NDA y en la formación de análisis de seguridad, y participación en revisiones y aprobaciones iniciales para terapias dirigidas a ELA, miastenia grave y atrofia muscular de Duchenne. Posee un MD y un PhD de la Universidad de Chicago y completó la formación clínica en Johns Hopkins Hospital.
MediciNova (NASDAQ:MNOV)는 2025년 11월 18일에 Dr. Christopher D. Breder, MD, PhD를 임상 및 규제 자문으로 임명했다고 발표했습니다. Breder 박사는 MediciNova의 약물 개발 프로그램에 대한 전략적 지침을 제공하고 설립 시 과학 자문 이사회를 이끌 것이라고 전했습니다.
Breder 박사는 FDA에서 Medical Officer 및 Lead Medical Officer로 10년이 넘는 규제 및 임상 경험을 포함해 NDA 검토 및 안전성 분석 훈련 참여, ALS, 근위축성 측삭마비, 듀센근육이영양증 치료법에 대한 리뷰 및 초기 승인에 참여하는 등 20년이 넘는 경력을 보유하고 있습니다. 그는 시카고 대학교에서 의학박사(MD)와 박사학위(PhD)를 취득했고 Johns Hopkins Hospital에서 임상 훈련을 마쳤습니다.
MediciNova (NASDAQ:MNOV) a annoncé le 18 novembre 2025 la nomination de Dr. Christopher D. Breder, MD, PhD comme Conseiller Clinique et Réglementaire. Le Dr Breder fournira des orientations stratégiques pour les programmes de développement de médicaments de MediciNova et dirigera le Scientific Advisory Board lors de sa formation.
Le Dr Breder apporte plus de deux décennies d'expérience réglementaire et clinique, dont plus d'une décennie à la FDA en tant que Medical Officer et Lead Medical Officer, participation à la revue NDA et à la formation en analyse de sécurité, et participation à des revues et des premières approbations pour des thérapies ciblant la SLA, la myasthénie grave et la dystrophie musculaire de Duchenne. Il est titulaire d'un MD et d'un PhD de l'Université de Chicago et a effectué sa formation clinique au Johns Hopkins Hospital.
MediciNova (NASDAQ:MNOV) kündigte am 18. November 2025 die Ernennung von Dr. Christopher D. Breder, MD, PhD zum Clinical and Regulatory Advisor an. Dr. Breder wird strategische Leitlinien für die Entwicklungsprogramme von MediciNova bereitstellen und das Scientific Advisory Board bei seiner Gründung leiten.
Dr. Breder bringt über zwei Jahrzehnte regulatorische und klinische Erfahrung mit, darunter mehr als ein Jahrzehnt bei der FDA als Medical Officer und Lead Medical Officer, Beteiligung an NDA-Überprüfungen und Schulungen zur Sicherheitsanalyse sowie Teilnahme an Reviews und ersten Zulassungen für Therapien gegen ALS, Myasthenia gravis und Duchenne-Muskeldystrophie. Er hält einen MD und PhD von der University of Chicago und absolvierte seine klinische Ausbildung am Johns Hopkins Hospital.
MediciNova (NASDAQ:MNOV) أعلنت في 18 نوفمبر 2025 عن تعيين الدكتور كريستوفر د. بريدَر، MD، PhD كمستشار سريري وتنظيمي. سيقدم د. بريدَر إرشادات استراتيجية لبرامج تطوير الأدوية في MediciNova و< b>سيقود المجلس الاستشاري العلمي عند تشكيله
يجلب د. بريدَر أكثر من عقدين من الخبرة التنظيمية والسريرية، بما في ذلك أكثر من عقد في إدارة الغذاء والدواء الأميركية كمسؤول طبي ومسؤول طبي رئيسي، والمشاركة في مراجعة NDA وتدريب تحليل السلامة، ومشاركته في المراجعات والموافقات الأولية لعلاجات تستهدفALS، الوهن العضلي الوبيل، وضمور Duchenne العضلي. يحمل MD و PhD من جامعة شيكاغو وأكمل تدريبه السريري في Johns Hopkins Hospital.
- Appoints seasoned regulatory expert with 20+ years of experience
- Will lead Scientific Advisory Board upon its formation
- None.
LA JOLLA, Calif., Nov. 18, 2025 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), is pleased to announce the appointment of Dr. Christopher D. Breder, MD, PhD as Clinical and Regulatory Advisor. Dr. Breder will provide strategic guidance for MediciNova’s Drug Development programs and will lead the Scientific Advisory Board upon its formation.
Dr. Christopher D. Breder, MD, PhD, is a distinguished physician-scientist and regulatory expert with over two decades of experience across the U.S. Food and Drug Administration (FDA) and major pharmaceutical companies. He served for more than a decade at the FDA, including roles as Medical Officer and Lead Medical Officer, where he developed and taught NDA review and safety analysis courses for FDA reviewers. He played a key role in the review and initial approvals of numerous therapies for neurological conditions, including treatments for Amyotrophic Lateral Sclerosis (ALS), Myasthenia Gravis (MG), and Duchenne’s Muscular Dystrophy (DMD). More recently, Dr. Breder contributed as an industry advisor to another ALS drug approval in 2022.
Dr. Breder's dual perspective provides deep expertise in clinical trial design, regulatory strategy, and the development of novel therapies in neuroscience and rare diseases. And his extensive experience bridges regulatory science and industry innovation, making him uniquely positioned to advise MediciNova on advancing its pipeline and navigating regulatory pathways. He holds an M.D. and a Ph.D. from the University of Chicago and completed his clinical training at The Johns Hopkins Hospital.
“We are honored to welcome Dr. Breder to our team” said Yuichi Iwaki, M.D., Ph.D., MediciNova President and Chief Executive Officer. "His deep understanding of FDA processes and proven track record in ALS and other neurological disorders will be invaluable as we accelerate our mission to deliver transformative therapies to patients."
“Our mission is to advance innovative solutions for neurodegenerative diseases,” said Dr. Breder, who serves as a strategic advisor to the program. “By combining rigorous science with patient-centered design, we aim to accelerate meaningful outcomes.”
About MediciNova
MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-001 (tipelukast) is in a Phase 2 trial treating hypertriglycedemia in type 2 diabetic patients. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.
Forward-Looking Statements
Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166 and MN-001. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166 and MN-001, and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2024 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.
INVESTOR CONTACT:
David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com
FAQ
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