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Curia Anuncia Refinanciamento Estratégico em Apoio ao Crescimento Contínuo

ALBANY, N.Y., March 08, 2025 (GLOBE NEWSWIRE) — A Curia Global, Inc. (Curia), uma organização líder em contratos de pesquisa, desenvolvimento e fabricação, anunciou hoje que refinanciou suas linhas de crédito seniores garantidas.

A transação fornece à Curia capital incremental e estende os vencimentos das suas linhas de crédito garantidas, posicionando a empresa para um crescimento contínuo, permitindo que a empresa capitalize as atraentes oportunidades nos mercados de desenvolvimento e fabricação de medicamentos, e avançando a sua missão de fazer parcerias com clientes biofarmacêuticos para levar ao mercado terapias que mudam a vida.

“O refinanciamento demonstra a confiança que nossos credores e investidores têm na Curia”, disse Philip Macnabb, Diretor Executivo. “A nova linha de crédito nos permitirá continuar investindo em projetos de crescimento importantes que aprimorem nossas capacidades diferenciadas e ofereçam maior valor para nossos clientes.”

As recentes iniciativas de crescimento orgânico incluem um investimento significativo nas instalações da Curia em Rensselaer, Nova York, para expandir a capacidade de fabricação comercial de ingredientes farmacêuticos ativos complexos. A Curia também fez um investimento significativo em novos recursos de processamento final estéril de última geração nas instalações da empresa em Albuquerque, Novo México, com planos adicionais para expandir os recursos de processamento final nas suas instalações em Glasgow, no Reino Unido, que mais do que dobrarão o tamanho atual do lote de GMP.

Sobre a Curia

A Curia é uma Organização de Desenvolvimento e Fabricação por Contratos (CDMO) com mais de 30 anos de experiência, uma rede integrada de mais de 20 locais em todo o mundo e mais de 3.100 funcionários em parcerias com clientes biofarmacêuticos para lançamento no mercado terapias que mudam a vida. Nossas ofertas de pequenas moléculas, APIs genéricos e produtos biológicos resultam em descobertas através da comercialização, com integridade regulatória, de capacidade analítica e processamento final estéril. Nossos especialistas científicos e de processos, juntamente com nossas instalações em conformidade regulatórias, oferecem a melhor experiência em fabricação de medicamentos e produtos farmacêuticos. Da curiosidade à cura, proporcionamos todas as etapas necessárias para acelerar sua pesquisa e melhorar a vida dos pacientes. Visite–nos em curiaglobal.com.

Contato Corporativo:
Viana Bhagan
Curia Global, Inc.
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9391383)

Curia kündigt strategische Refinanzierung zur Unterstützung weiteren Wachstums an

ALBANY, N.Y., March 08, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), ein führendes Auftragsforschungs–, Entwicklungs– und Produktionsunternehmen, gab heute bekannt, dass es seine vorrangig gesicherten Kreditmittel refinanziert hat.

Die Transaktion verschafft Curia zusätzliches Kapital und verlängert die Laufzeiten seiner gesicherten Kreditmittel, wodurch das Unternehmen für weiteres Wachstum positioniert wird. So kann das Unternehmen die attraktiven Marktchancen in den Bereichen Arzneimittelentwicklung und –herstellung nutzen und seine Mission, mit biopharmazeutischen Kunden zusammenzuarbeiten, um lebensverändernde Therapien auf den Markt zu bringen, vorantreiben.

„Die Refinanzierung zeigt das Vertrauen, welches unsere Darlehensgeber und Investoren in Curia haben“, so Philip Macnabb, Chief Executive Officer. „Die neue Kreditfazilität wird es uns ermöglichen, weiterhin in wichtige Wachstumsprojekte zu investieren, die unsere differenzierten Fähigkeiten verbessern und unseren Kunden einen höheren Mehrwert bieten.“

Zu den jüngsten Initiativen für organisches Wachstum gehört eine bedeutende Investition in die Anlage von Curia in Rensselaer, New York, um die Produktionskapazität für komplexe pharmazeutische Wirkstoffe zu erweitern. Curia investiert außerdem erheblich in neue, hochmoderne sterile Abfüllanlagen am Unternehmensstandort in Albuquerque, New Mexico, und plant, die Abfüllanlagen am Standort in Glasgow, Großbritannien, zu erweitern, wodurch die derzeitige GMP–Chargengröße mehr als verdoppelt wird.

Über Curia

Curia ist ein Auftragsforschungs–, Entwicklungs– und Produktionsunternehmen (CDMO) mit über 30 Jahren Erfahrung, einem integrierten Netzwerk von mehr als 20 globalen Standorten und mehr als 3.100 Mitarbeitern. Das Unternehmen arbeitet mit biopharmazeutischen Kunden zusammen, um lebensverändernde Therapien auf den Markt zu bringen. Unser Angebot an niedermolekularen, generischen Wirkstoffen und Biologika reicht von der Entdeckung bis zur Vermarktung und umfasst integrierte regulatorische, analytische und sterile Abfüll– und Veredelungskapazitäten. Unsere wissenschaftlichen und technischen Experten bieten zusammen mit unseren regulatorisch konformen Einrichtungen erstklassige Erfahrung in der Herstellung von Arzneimitteln und Produkten. Von der Neugier bis zur Heilung – wir unterstützen Sie bei jedem Schritt, um Ihre Forschung zu beschleunigen und das Leben von Patienten zu verbessern. Besuchen Sie uns unter curiaglobal.com.

Firmenkontakt:
Viana Bhagan
Curia Global, Inc.
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9391383)

Curia annonce un refinancement stratégique visant à soutenir la poursuite de sa croissance

ALBANY, New York, 08 mars 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), l’une des principales organisations de recherche, de développement et de fabrication sous contrat, a annoncé aujourd’hui le refinancement de ses facilités de crédit garanties de premier rang.

La transaction apporte à Curia des capitaux supplémentaires et prolonge les échéances de ses facilités de crédit garanties, ce qui permettra à l’entreprise de poursuivre sa croissance, de tirer parti des opportunités attrayantes sur les marchés du développement et de la fabrication de médicaments, et de poursuivre sa mission de partenariat avec des clients biopharmaceutiques afin d’introduire sur le marché des thérapies qui changent la vie.

« Le refinancement témoigne de la confiance que nos bailleurs de fonds et nos investisseurs accordent à Curia », a déclaré Philip Macnabb, Président–directeur général. « La nouvelle facilité de crédit nous permettra de poursuivre nos investissements dans des projets porteurs de croissance qui renforcent nos capacités de différenciation et apportent une plus grande valeur ajoutée à nos clients. »

Les récentes initiatives de croissance organique comprennent notamment un investissement important dans le site de Curia à Rensselaer, dans l’État de New York, afin d’accroître la capacité de fabrication commerciale d’ingrédients pharmaceutiques actifs complexes. Curia a également investi massivement dans de nouvelles capacités ultramodernes de remplissage et de finition stériles sur son site d’Albuquerque, au Nouveau–Mexique, et prévoit d’étendre ses capacités de remplissage et de finition sur son site de Glasgow, au Royaume–Uni, ce qui représentera plus du double de la taille actuelle des lots BPF.

À propos de Curia

Curia est une organisation de recherche, de développement et de fabrication sous contrat (ou CDMO) forte de plus de 30 ans d’expérience. Elle exploite un réseau intégré de plus de 20 sites à travers le monde et emploie quelque 3 100 collaborateurs travaillant en partenariat avec des clients biopharmaceutiques pour mettre sur le marché des thérapies qui changent la vie. Nos offres en matière de petites molécules, d’API génériques et de produits biologiques couvrent le cycle complet, de la découverte à la commercialisation, et intègrent des capacités réglementaires, analytiques et de remplissage et finition stérile. Nos scientifiques, nos experts en processus ainsi que nos installations conformes aux réglementations applicables apportent une expérience de premier ordre dans la fabrication de substances et de produits pharmaceutiques. De la curiosité au traitement, nous exécutons toutes les étapes pour accélérer vos recherches et améliorer la vie des patients. Consultez notre site à l’adresse www.curiaglobal.com.

Contact de l’entreprise :
Viana Bhagan
Curia Global, Inc.
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9391383)

Curia Announces Strategic Refinancing to Support Continued Growth

ALBANY, N.Y., March 07, 2025 (GLOBE NEWSWIRE) — Curia Global, Inc. (Curia), a leading contract research, development and manufacturing organization, today announced it has refinanced its senior secured credit facilities.

The transaction provides Curia with incremental capital and extends the maturities of its secured credit facilities, positioning the business for continued growth, allowing the company to capitalize on the attractive market opportunities in the drug development and manufacturing markets, and advancing its mission of partnering with biopharmaceutical customers to bring life–changing therapies to market.

“The refinancing demonstrates the confidence our lenders and investors have in Curia,” said Philip Macnabb, Chief Executive Officer. “The new credit facility will enable us to continue investing in key growth projects that enhance our differentiated capabilities and deliver greater value for our customers.”

Recent organic growth initiatives include a significant investment in Curia’s Rensselaer, New York, facility to expand commercial manufacturing capacity for complex active pharmaceutical ingredients. Curia has also made a significant investment in new state–of–the–art sterile fill–finish capabilities at the company’s facility in Albuquerque, New Mexico, with further plans to expand fill–finish capabilities at its Glasgow, UK facility that will more than double current GMP batch size.

About Curia

Curia is a contract research, development and manufacturing organization (CDMO) with over 30 years of experience, an integrated network of 20+ global sites and 3,100+ employees partnering with biopharmaceutical customers to bring life–changing therapies to market. Our offerings in small molecule, generic APIs and biologics span discovery through commercialization, with integrated regulatory, analytical and sterile fill–finish capabilities. Our scientific and process experts, along with our regulatory compliant facilities, provide a best–in–class experience across drug substance and drug product manufacturing. From curiosity to cure, we deliver every step to accelerate your research and improve patients’ lives. Visit us at curiaglobal.com.

Corporate Contact:
Viana Bhagan
Curia Global, Inc.
+1 518 512 2111
[email protected]


GLOBENEWSWIRE (Distribution ID 9391212)

Society for Clinical Research Sites (SCRS) e Fortrea Fazem Parceria para Promover a Colaboração na Pesquisa Clínica

DURHAM, N.C., Feb. 20, 2025 (GLOBE NEWSWIRE) — A Society for Clinical Research Sites (SCRS) e a Fortrea (Nasdaq: FTRE), uma organização líder global de pesquisa por contrato (CRO), tem o prazer de anunciar o patrocínio da Fortrea do grupo de trabalho SCRS Collaborate Forward.

Composto por 16 organizações líderes de Parceiros de Impacto Global, o grupo de trabalho Collaborate Forward explorará e desenvolverá as melhores práticas para reduzir os encargos administrativos em todo o ecossistema de pesquisa clínica. O grupo está empenhado em promover transparência e colaboração para enfrentar os desafios enfrentados pelos centros de pesquisa clínica. O aprimoramento dos processos internos visa tornar os sites mais sustentáveis e os ensaios mais eficientes – levando, em última análise, a uma experiência mais simplificada para os pacientes.

O patrocínio da Fortrea é um investimento significativo para a promoção da inovação em todo o setor e reflete a dedicação da empresa em colocar os sites na vanguarda do planejamento de ensaios clínicos.

“Estamos entusiasmados com a parceria com a SCRS para lançar e apoiar este grupo de trabalho”, disse Mike Clay, vice–presidente sênior de Entrega Global de Projetos da Fortrea. “Os ensaios clínicos estão se tornando cada vez mais complexos, e a indústria enfrenta uma pressão crescente para acelerar a inovação para os pacientes. Acreditamos que a colaboração com centros de pesquisa clínica é essencial para a disponibilidade de eficiências e ganhos de produtividade que irão agilizar o processo de testes clínicos. Esta iniciativa desenvolverá soluções tangíveis que patrocinadores de estudos clínicos, CROs, fornecedores, sites e grupos de defesa do paciente podem apoiar. Como CRO líder, temos orgulho de estar na vanguarda desse esforço, garantindo que os sites permaneçam centrais para impulsionar o progresso e promover maior colaboração em toda a indústria para a oferta de tratamentos que mudem mais rapidamente a vida dos pacientes.”

“A pesquisa clínica requer uma interdependência única para gerar os melhores resultados. O Collaborate Forward compartilhará sucessos de parcerias que impactam as pessoas, os processos e a tecnologia que melhoram a pesquisa clínica hoje ”, acrescentou Sean Soth, vice–presidente sênior de Estratégia e Parcerias de Negócios Globais da SCRS. “É um prazer ter a Fortrea como patrocinadora da Collaborate Forward. Essa parceria ressalta o valor da colaboração intersetorial e do esforço coletivo necessário para impulsionar um progresso significativo para a criação de um ecossistema de ensaios clínicos mais conectado e eficiente.”

O Collaborate Forward se concentrará inicialmente na inicialização do estudo, mostrando as vantagens da colaboração por meio de histórias convincentes, estudos de caso e insights baseados em dados. O grupo se reunirá regularmente para trocar ideias, avaliar as tendências do setor e desenvolver ferramentas pragmáticas que patrocinadores e CROs possam implementar em suas organizações. As atualizações sobre o progresso do grupo de trabalho serão compartilhadas ao longo de 2025 por meio de Summits e publicações da SCRS Site Solutions, destacando os principais resultados e realizações colaborativas.

A SCRS convida patrocinadores e CROs comprometidos com a sustentabilidade do site a se juntarem a esse esforço e contribuírem para moldar um cenário de pesquisa clínica mais eficaz e sinérgico. Para mais informação sobre como participar, contacte Brian Egan.

Sobre a Society for Clinical Research Sites

A Society for Clinical Research Sites (SCRS) é a principal organização de defesa dedicada a unificar a voz da comunidade global de centros de pesquisa clínica. Representando mais de 11.000 sites de pesquisa em todo o mundo, a SCRS facilita colaborações e conversas da indústria dedicadas à defesa, educação, orientação e conexão focadas no site. A SCRS é uma defensora ativa e influente de sites em iniciativas do setor para garantir que a perspectiva dos sites seja ouvida e valorizada. Saiba mais e participe em myscrs.org. Nossa voz. Nossa comunidade. Seu sucesso.

Sobre a Fortrea

A Fortrea (Nasdaq: FTRE) é fornecedora líder global de soluções para o desenvolvimento clínico para a indústria de ciências da vida. Fazemos parcerias com grandes e emergentes empresas biofarmacêuticas, de biotecnologia, de dispositivos médicos e de diagnóstico para impulsionar a inovação na saúde que acelera terapias que mudam a vida dos pacientes. A Fortrea fornece gerenciamento de testes clínicos de fase I–IV, farmacologia clínica e serviços de consultoria. As soluções da Fortrea utilizam suas três décadas de experiência abrangendo mais de 20 áreas terapêuticas, sua dedicação ao rigor científico, insights excepcionais e uma forte rede de pesquisadores. Nossa equipe talentosa e diversificada que trabalha em cerca de 100 países é dimensionada para fornecer soluções focadas e ágeis para clientes de todo o mundo. Saiba mais sobre como a Fortrea está se tornando uma força transformadora de pipeline para pacientes em Fortrea.com e siga–nos em LinkedIn e X (ex–Twitter).

Contatos da SCRS:

Marissa Hill (Mídia) – 267–865–3296, [email protected]
Brian Egan (Mídia) – 518–207–6965, [email protected]

Contatos da Fortrea:

Galen Wilson (Mídia) – 703–298–0802, [email protected]
Kate Dillon (Mídia) – 646–818–9115, [email protected]


GLOBENEWSWIRE (Distribution ID 9362056)

La Society for Clinical Research Sites (SCRS) et Fortrea s’associent pour promouvoir la collaboration dans le domaine de la recherche clinique

DURHAM, N.C., 20 févr. 2025 (GLOBE NEWSWIRE) — La Society for Clinical Research Sites (SCRS) et Fortrea (Nasdaq : FTRE), l’une des principales organisations de recherche contractuelle (ORC) à l’international, ont le plaisir d’annoncer que Fortrea parraine désormais le groupe de travail Collaborate Forward de la SCRS.

Le groupe de travail Collaborate Forward, composé de 16 grandes organisations Global Impact Partner, a pour mission d’explorer et de développer les meilleures pratiques pour réduire la charge administrative dans l’ensemble du secteur de la recherche clinique. Le groupe s’engage à favoriser la transparence et la collaboration pour relever les défis auxquels sont confrontés les sites de recherche clinique. Il cherche à rendre les sites plus durables et les essais plus efficaces en améliorant les processus internes, ce qui permettra aux patients de bénéficier d’une expérience plus sereine.

Le parrainage de Fortrea constitue un investissement important dans la promotion de l’innovation à travers le secteur et témoigne de son engagement à donner la priorité aux sites lors de la planification des essais cliniques.

« Nous sommes ravis de travailler en partenariat avec la SCRS pour créer et accompagner ce groupe de travail », déclare Mike Clay, vice–président senior de Global Project Delivery chez Fortrea. « Les essais cliniques deviennent de plus en plus complexes et le secteur fait face à une pression croissante pour accélérer l’innovation au service des patients. Nous sommes convaincus qu’une collaboration avec les sites de recherche clinique est essentielle pour réaliser des gains d’efficacité et de productivité qui permettront de simplifier le processus d’essai clinique. Cette initiative permettra de mettre au point des solutions concrètes auxquelles les promoteurs d’études cliniques, les ORC, les fournisseurs, les sites et les groupes de défense des intérêts des patients pourront adhérer. En tant qu’ORC de premier plan, nous sommes fiers de participer à cet effort, en veillant à ce que les sites restent au cœur du progrès et en encourageant une plus grande collaboration à travers le secteur, afin de mettre plus rapidement à la disposition des patients des traitements qui changeront leur vie. »

« La recherche clinique nécessite une interdisciplinarité particulière pour générer les meilleurs résultats. Collaborate Forward partagera les réussites de partenariats qui ont un impact sur les personnes, les processus et la technologie qui améliorent la recherche clinique aujourd’hui », ajoute Sean Soth, vice–président senior de la stratégie et des partenariats commerciaux mondiaux chez la SCRS. « Nous sommes ravis de pouvoir compter sur Fortrea en tant que promoteur fondateur de Collaborate Forward. Ce partenariat souligne l’importance de la collaboration interdisciplinaire et de l’effort collectif nécessaire pour réaliser des progrès significatifs dans la création d’un système d’essais cliniques plus connecté et plus efficace. »

Collaborate Forward se concentrera d’abord sur le lancement d’études, en présentant les avantages de la collaboration par le biais de témoignages convaincants, d’études de cas et d’informations fondées sur des données. Le groupe se réunira régulièrement pour échanger des points de vue, évaluer les tendances du secteur et développer des outils pragmatiques que les promoteurs et les ORC pourront mettre en œuvre au sein de leurs organisations. Des informations sur les progrès réalisés par le groupe de travail seront communiquées tout au long de l’année 2025 lors des sommets SCRS Site Solutions ainsi que dans des publications, mettant en évidence les principaux résultats et les réussites en matière de collaboration.

La SCRS invite les promoteurs et les ORC impliqués dans la durabilité des sites à se joindre à cet effort et à contribuer à la création d’un environnement de recherche clinique plus efficace et plus dynamique. Pour plus d’informations sur les modalités de participation, veuillez contacter Brian Egan.

À propos de la Society for Clinical Research Sites

La Society for Clinical Research Sites (SCRS) est la principale organisation de défense des intérêts des sites de recherche clinique à l’échelle internationale. Représentant plus de 11 000 sites de recherche dans le monde, elle facilite les collaborations au sein du secteur et les conversations sur la défense des intérêts des sites, l’éducation, le mentorat et les relations. La SCRS est un porte–parole actif et influent pour les sites dans les initiatives du secteur, qui s’assure que le point de vue des sites est entendu et pris en compte. Pour en savoir plus et participer, consultez le site myscrs.org. Notre voix. Notre communauté. Votre succès.

À propos de Fortrea

Fortrea (Nasdaq : FTRE) est un fournisseur mondial de premier plan de solutions de développement clinique pour le secteur des sciences de la vie. Fortrea s’associe à des sociétés établies et émergentes du domaine biopharmaceutique, de la biotechnologie, des dispositifs médicaux et des diagnostics pour stimuler l’innovation en matière de santé, et accélérer la mise au point de traitements révolutionnaires pour les patients. Fortrea propose des services de gestion d’essais cliniques de phase I à IV, de pharmacologie clinique et de consulting. Nos solutions s’appuient sur 30 ans d’expérience dans 20 disciplines thérapeutiques, une passion pour la rigueur scientifique, des connaissances exceptionnelles et un solide réseau de centres de recherche. Notre équipe talentueuse et diversifiée, qui travaille dans une centaine de pays, est dimensionnée pour fournir des solutions ciblées et flexibles à nos clients, partout dans le monde. Pour en savoir plus sur la manière dont Fortrea est un moteur d’influence du pipeline au patient, rendez–vous sur Fortrea.com et suivez–nous sur LinkedIn et X (anciennement Twitter).

Contacts SCRS :

Marissa Hill (Média) – 267–865–3296, [email protected]
Brian Egan (Média) – 518–207–6965, [email protected]

Contacts Fortrea :

Galen Wilson (Média) – 703–298–0802, [email protected]
Kate Dillon (Média) – 646–818–9115, [email protected]


GLOBENEWSWIRE (Distribution ID 9362056)

Society for Clinical Research Sites (SCRS) und Fortrea gehen eine Partnerschaft zur Förderung der Zusammenarbeit in der klinischen Forschung ein

DURHAM, North Carolina, Feb. 20, 2025 (GLOBE NEWSWIRE) — Die Society for Clinical Research Sites (SCRS) und Fortrea (Nasdaq: FTRE), ein führendes globales Auftragsforschungsinstitut (Contract Research Organization, CRO), freuen sich, die Förderung der Arbeitsgruppe „SCRS Collaborate Forward“ durch Fortrea bekanntzugeben.

Die Arbeitsgruppe „Collaborate Forward“, die aus 16 führenden Global Impact Partner–Organisationen besteht, wird bewährte Verfahren zur Reduzierung des Verwaltungsaufwands im gesamten Bereich der klinischen Forschung untersuchen und entwickeln. Die Gruppe setzt sich für Transparenz und Zusammenarbeit ein, um die Herausforderungen zu bewältigen, mit denen klinische Forschungszentren konfrontiert sind. Durch die Verbesserung interner Prozesse sollen die Standorte nachhaltiger und die Studien effizienter werden, was letztlich zu einem reibungsloseren Ablauf für die Patienten führt.

Die Förderung durch Fortrea stellt eine bedeutende Investition in die Förderung branchenweiter Innovationen dar und spiegelt das Engagement des Unternehmens wider, Prüfzentren an die Spitze der Planung klinischer Studien zu bringen.

„Wir freuen uns, mit der SCRS zusammenzuarbeiten, um diese Arbeitsgruppe ins Leben zu rufen und zu unterstützen“, so Mike Clay, Senior Vice President of Global Project Delivery bei Fortrea. „Klinische Studien werden immer komplexer und die Branche steht unter zunehmendem Druck, Innovationen für Patienten zu beschleunigen. Wir sind der Meinung, dass die Zusammenarbeit mit klinischen Forschungszentren der Schlüssel zu mehr Effizienz und Produktivitätssteigerungen ist, die den Prozess klinischer Studien optimieren werden. Diese Initiative wird konkrete Lösungen entwickeln, hinter denen sich Sponsoren klinischer Studien, CROs, Anbieter, Prüfzentren und Patientenvertretungsgruppen versammeln können. Als führendes Auftragsforschungsinstitut sind wir stolz darauf, bei diesen Bemühungen an vorderster Front zu stehen und sicherzustellen, dass die Prüfzentren weiterhin eine zentrale Rolle bei der Förderung des Fortschritts und der Förderung einer stärkeren branchenweiten Zusammenarbeit spielen, um Patienten schneller lebensverändernde Behandlungen zukommen zu lassen.“

„Klinische Forschung erfordert eine einzigartige Interdependenz, um die besten Ergebnisse zu erzielen. Collaborate Forward wird über Erfolge von Partnerschaften berichten, die sich auf die Menschen, Prozesse und Technologien auswirken und die klinische Forschung heute verbessern“, fügte Sean Soth, Senior Vice President, Strategy and Global Business Partnerships, SCRS, hinzu. „Wir freuen uns, Fortrea als Gründungssponsor von Collaborate Forward begrüßen zu dürfen. Diese Partnerschaft unterstreicht den Wert branchenübergreifender Zusammenarbeit und der gemeinsamen Anstrengungen, die erforderlich sind, um einen bedeutenden Fortschritt bei der Schaffung eines stärker vernetzten und effizienteren Ökosystems für klinische Studien zu erzielen.“

Collaborate Forward wird sich zunächst auf den Beginn von Studien konzentrieren und die Vorteile der Zusammenarbeit durch fesselnde Geschichten, Fallstudien und datengestützte Erkenntnisse aufzeigen. Die Gruppe wird regelmäßig zusammenkommen, um Erkenntnisse auszutauschen, Branchentrends zu bewerten und pragmatische Tools zu entwickeln, die Sponsoren und CROs in ihren Organisationen umsetzen können. Über den Fortschritt der Arbeitsgruppe wird im Laufe des Jahres 2025 auf den SCRS Site Solutions Summits und in Veröffentlichungen berichtet, in denen die wichtigsten Ergebnisse und Erfolge der Zusammenarbeit hervorgehoben werden.

Die SCRS lädt Sponsoren und CROs, die sich für die Nachhaltigkeit von Standorten einsetzen, ein, sich diesen Bemühungen anzuschließen und zur Gestaltung einer effektiveren und synergetischeren klinischen Forschungslandschaft beizutragen. Für weitere Informationen zur Teilnahme wenden Sie sich bitte an Brian Egan.

Über die Society for Clinical Research Sites

Die Society for Clinical Research Sites (SCRS) ist die führende Interessenvertretung, die sich dafür einsetzt, der weltweiten Gemeinschaft der klinischen Forschungszentren eine gemeinsame Stimme zu verleihen. Die SCRS vertritt mehr als 11.000 Forschungszentren weltweit und fördert die Zusammenarbeit und den Austausch in der Branche, die sich für standortbezogene Interessenvertretung, Bildung, Mentoring und Vernetzung einsetzen. Die SCRS ist ein aktiver und einflussreicher Fürsprecher für Standorte in Brancheninitiativen, um sicherzustellen, dass die Perspektive der Prüfzentren gehört und geschätzt wird. Erfahren Sie mehr und engagieren Sie sich unter myscrs.org. Unsere Stimme. Unsere Gemeinschaft. Ihr Erfolg.

Über Fortrea

Fortrea (Nasdaq: FTRE) ist ein weltweit führender Anbieter von Lösungen für die klinische Entwicklung in der Life–Science–Branche. Wir arbeiten mit aufstrebenden und großen biopharmazeutischen, biotechnologischen, medizintechnischen und diagnostischen Unternehmen zusammen, um Innovationen im Gesundheitswesen voranzutreiben, die das Angebot lebensverändernder Therapien für Patienten beschleunigen. Fortrea bietet Management von klinischen Studien der Phasen I–IV, klinische Pharmakologie und Beratungsdienste an. Die Lösungen von Fortrea basieren auf drei Jahrzehnten Erfahrung in mehr als 20 Therapiegebieten, einer Leidenschaft für wissenschaftliche Strenge, außergewöhnlichen Erkenntnissen und einem starken Netzwerk von Prüfzentren. Unser talentiertes und vielfältiges Team, das in etwa 100 Ländern tätig ist, ist darauf ausgelegt, Kunden weltweit fokussierte und flexible Lösungen zu bieten. Erfahren Sie mehr darüber, wie Fortrea von der Pipeline zum Patienten zu einer transformativen Kraft wird, unter Fortrea.com und folgen Sie uns auf LinkedIn und X (ehemals Twitter).

SCRS – Kontakte:

Marissa Hill (Medien) – 267–865–3296, [email protected]
Brian Egan (Medien) – 518–207–6965, [email protected]

Kontakt zu Fortrea:

Galen Wilson (Medien) – 703–298–0802, [email protected]
Kate Dillon (Medien) – 646–818–9115, [email protected]


GLOBENEWSWIRE (Distribution ID 9362056)

Society for Clinical Research Sites (SCRS) and Fortrea Partner to Advance Collaboration in Clinical Research

DURHAM, N.C., Feb. 20, 2025 (GLOBE NEWSWIRE) — The Society for Clinical Research Sites (SCRS) and Fortrea (Nasdaq: FTRE), a leading global contract research organization (CRO), are pleased to announce Fortrea’s sponsorship of the SCRS Collaborate Forward working group.

Comprising 16 leading Global Impact Partner organizations, the Collaborate Forward working group will explore and develop best practices to reduce administrative burdens across the clinical research ecosystem. The group is committed to fostering transparency and collaboration to tackle challenges faced by clinical research sites. By improving internal processes, it aims to make sites more sustainable and trials more efficient—ultimately leading to a smoother experience for patients.

Fortrea’s sponsorship marks a significant investment in fostering industry–wide innovation and reflects the company’s dedication to placing sites at the forefront of clinical trial planning.

“We are excited to partner with SCRS to launch and support this working group,” said Mike Clay, senior vice president of Global Project Delivery at Fortrea. “Clinical trials are becoming increasingly complex, and the industry faces mounting pressure to accelerate innovation for patients. We believe that collaboration with clinical research sites is key to unlocking efficiencies and productivity gains that will streamline the clinical trial process. This initiative will develop tangible solutions that clinical study sponsors, CROs, vendors, sites and patient advocacy groups can rally behind. As a leading CRO, we are proud to be at the forefront of this effort, ensuring that sites remain central to driving progress and fostering greater industry–wide collaboration to bring life–changing treatments to patients faster.”

“Clinical research requires a unique interdependency to generate the best outcomes. Collaborate Forward will share partnership successes that impact the people, process and technology improving clinical research today,” added Sean Soth, senior vice president, Strategy and Global Business Partnerships, SCRS. “We are pleased to welcome Fortrea as the charter sponsor of Collaborate Forward. This partnership underscores the value of cross–industry collaboration and the collective effort needed to drive meaningful progress in creating a more connected and efficient clinical trial ecosystem.”

Collaborate Forward will initially focus on study startup, showcasing the advantages of collaboration through compelling stories, case studies and data–driven insights. The group will convene regularly to exchange insights, assess industry trends and develop pragmatic tools that sponsors and CROs can implement within their organizations. Updates on the working group's progress will be shared throughout 2025 via SCRS Site Solutions Summits and publications, highlighting key findings and collaborative achievements.

SCRS invites sponsors and CROs committed to site sustainability to join this effort and contribute to shaping a more effective and synergistic clinical research landscape. For more information on how to participate, please contact Brian Egan.

About The Society for Clinical Research Sites

The Society for Clinical Research Sites (SCRS) is the leading advocacy organization dedicated to unifying the voice of the global clinical research site community. Representing more than 11,000 research sites globally, SCRS facilitates industry collaborations and conversations dedicated to site–focused advocacy, education, mentorship and connection. SCRS is an active and influential champion for sites in industry initiatives to ensure that the perspective of sites is heard and valued. Learn more and get involved at myscrs.org. Our voice. Our community. Your success. 

About Fortrea

Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, biotechnology, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients. Fortrea provides phase I–IV clinical trial management, clinical pharmacology and consulting services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in about 100 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com and follow us on LinkedIn and X (formerly Twitter).

SCRS Contacts:

Marissa Hill (Media) – 267–865–3296, [email protected]
Brian Egan (Media) – 518–207–6965, [email protected]

Fortrea Contacts:

Galen Wilson (Media) – 703–298–0802, [email protected]
Kate Dillon (Media) – 646–818–9115, [email protected]


GLOBENEWSWIRE (Distribution ID 9361361)

EFFECTS OF EB613 TABLETS [ORAL PTH(1-34)] ON TRABECULAR AND CORTICAL BONE USING 3D-DXA: POST-HOC RESULTS FROM PHASE 2 STUDY Accepted for Oral Presentation at World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases

JERUSALEM , Feb. 19, 2025 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of oral peptide and protein replacement therapies in tablet form, today announced that the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO–IOF–ESCEO) Scientific Programme Committee has accepted both submitted abstracts related to EB613 for presentation at the WCO–IOF–ESCEO congress. The congress will take place at the Roma Convention Center, Rome, Italy from April 10 to April 13, 2025.

EB613 is being developed as the first once–daily oral anabolic (bone forming) PTH(1–34) tablet treatment to support earlier osteoanabolic intervention, for high–risk post–menopausal women with osteoporosis. In a Placebo–controlled Phase 2 study, 6 months of EB613 treatment demonstrated fast onset of action and robust increases in BMD at all skeletal sites. Further, EB613 induced increases in bone formation (P1NP) and suppression of bone resorption (CTX).

“EFFECTS OF EB613 TABLETS [ORAL PTH(1–34)] ON TRABECULAR AND CORTICAL BONE USING 3D–DXA: POST–HOC RESULTS FROM PHASE 2 STUDY” will be presented as an Oral Presentation Friday April 11 at 10:00 GMT in the Auditorium A.

“EB613 TABLET TREATMENT [ORAL PTH(1–34)] – DOES PK DRIVE BONE MODELING VERSUS BONE REMODELING?” will be presented as a Poster Presentation Friday April 11th – Sunday April 13th 2025.

“We thank our distinguished authors and are looking forward to sharing further mechanistic insights on EB613 with the thousands of top researchers and healthcare professionals who attend WCO–IOF–ESCEO,” said Miranda Toledano, Chief Executive Officer of Entera.

It is estimated that 50 percent of women and 20 percent of men over the age of 50 are at risk of a fragility fractures and approximately 1 in 5 adults will die within the year following a hip fracture. Post menopausal osteoporosis afflicts more women than cancer and cardiovascular disease and is a serious health concern for an estimated 200 million women globally.

EB613 is intended to provide an anabolic ‘boost’ to strengthen skeletal microarchitecture and induce rapid BMD gains, followed by consolidation with an antiresorptive agent. “Available injectable anabolic treatments, while efficacious and recommended across medical guidelines, unfortunately do not provide a viable solution for most patients with high–risk osteoporosis requiring an anabolic intervention. Our EB613 program is being developed to address the treatment chasm in current osteoporosis care and hopefully present a treatment for the majority of patients to adequately manage their bone health with a simple once daily tablet treatment,” Said Toledano.

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N–Tab™) and its pipeline includes five differentiated, first–in–class oral peptide programs targeting PTH(1–34), GLP–1 and GLP–2. The Company’s most advanced product candidate, EB613 (oral PTH(1–34)), is being developed as the first oral, osteoanabolic (bone building) once–daily tablet treatment for post–menopausal women with low BMD and high–risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint. The EB612 program is being developed as the first oral PTH(1–34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP–2 peptide tablet as an injection–free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this presentation are “forward–looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward–looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward–looking statements. Forward–looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward–looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.

Important factors that could cause actual results to differ materially from those reflected in Entera’s forward–looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward–Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10–K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10–Q and Current Reports on Form 8–K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward–looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward–looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward–looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.


GLOBENEWSWIRE (Distribution ID 9360860)

Zenas BioPharma Announces Key 2024 Accomplishments and 2025 Business Objectives to Support the Global Development and Commercialization of Therapies for Autoimmune Diseases

– Advancing Phase 2 and Phase 3 trials of obexelimab, a unique CD–19 x FcγRIIb inhibitor of B cell function–

–Topline results from Phase 2 Trial in Relapsing Multiple Sclerosis (MoonStone) expected in third quarter 2025–

–Topline results from pivotal Phase 3 Trial in Immunoglobulin G4–Related Disease (INDIGO) expected year–end 2025–

– Enrollment of Phase 2 Trial in Systemic Lupus Erythematosus (SunStone) expected to be completed in 2025–

– Out–licensed greater–China anti–IGF–1R Thyroid Eye Disease programs to Zai Lab –

WALTHAM, Mass., Feb. 05, 2025 (GLOBE NEWSWIRE) — Zenas BioPharma, Inc. (“Zenas” or the “Company”) (Nasdaq: ZBIO), a clinical–stage global biopharmaceutical company committed to being a leader in the development and commercialization of therapies for autoimmune diseases, today announced its 2024 accomplishments, outlined its key business objectives for 2025 and announced preliminary unaudited cash balance as of year–end 2024.

“Based upon the progress achieved across all of our corporate goals and objectives during 2024, we enter 2025 with an opportunity to achieve major value–driving milestones with the anticipated results from our ongoing obexelimab Phase 2 and Phase 3 clinical trials,” said Lonnie Moulder, Founder and Chief Executive Officer of Zenas. “We are extremely proud of the accomplishments of our dedicated team as we enter the year well–financed and able to focus on execution, and achievement of our key objectives for the year.”

The Company enters 2025 well–capitalized to deliver its key milestones with approximately $350 million in cash, cash equivalents, and short–term investments as of December 31, 2024, 1 which is expected to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2026.

2024 Accomplishments and Recent Achievements

During 2024, the Company achieved the following objectives and announced a recent business development transaction:

  • Completed enrollment of the Phase 3 INDIGO trial, a global Phase 3 registration–directed, randomized, double–blind placebo–controlled trial of obexelimab in patients with Immunoglobulin–G4 Related Disease (IgG4–RD), the largest clinical trial ever conducted in this patient population.
  • Initiated the Phase 2 MoonStone trial, a Phase 2, multicenter, randomized, double–blind, placebo–controlled trial, to evaluate the efficacy and safety of obexelimab in patients with Relapsing Multiple Sclerosis (RMS).
  • Initiated the Phase 2 SunStone trial, a Phase 2, multicenter, randomized, double–blind, placebo–controlled trial, to evaluate the efficacy and safety of obexelimab to reduce disease activity in patients with Systemic Lupus Erythematosus (SLE).
  • Provided initial data from the Phase 2 SApHiAre trial, a global, multicenter, open–label safety and dose confirmation run–in period (SRP) to evaluate the safety and activity of obexelimab in patients with warm Autoimmune Hemolytic Anemia (wAIHA). Obexelimab achieved clinical proof–of–mechanism by increasing hemoglobin levels and red blood cells, and decreasing LDH and total bilirubin levels. Obexelimab was well tolerated in the SRP.
  • Completed an upsized Series C and initial public offering, raising approximately $458.7 million in aggregate gross proceeds to fund its planned activities for obexelimab and the Company’s growth strategy.
  • Bolstered its leadership team with the appointments of Chief Commercial Officer, Orlando Oliveira, and Chief Legal Officer, Jeff Held.
  • Out–licensed ZB005, a human IgG4 monoclonal antibody designed to bind only to the active form of C1s, for which Zenas held the development and commercialization rights in China, Hong Kong, Macau and Taiwan (Greater China) through an exclusive license with Dianthus.
  • The Company recently out–licensed regional rights to its thyroid eye disease programs, including ZB001, an insulin–like growth factor–1 receptor (anti–IGF–1R) monoclonal antibody, to Zai Lab (Zai).  Zenas received an upfront fee and is eligible to receive milestone payments and royalties in the future, as consideration for an exclusive sublicense to Zai to develop and commercialize ZB001 and related programs in Greater China.

Anticipated 2025 Clinical Milestones for Obexelimab

Obexelimab is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self–administered, subcutaneous once–weekly injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. Obexelimab has been evaluated in five completed clinical trials in a total of 198 patients who received obexelimab either as an intravenous infusion or as a subcutaneous injection. Obexelimab was well tolerated and demonstrated clinical activity across these five clinical trials, providing the Company an initial clinical proof of concept for obexelimab as a potent B cell inhibitor for the treatment of patients living with certain autoimmune diseases.

During 2025, the Company expects to achieve the following key clinical milestones:

  • Report the 12–week primary endpoint results in the third quarter of 2025 from the Phase 2 MoonStone trial in patients with RMS.

The role of B cells in the pathogenesis of multiple sclerosis including RMS has been demonstrated through the successful clinical development, approval and clinical use of anti–CD20 B cell targeting therapies of other companies, including OCREVUS® (ocrelizumab) and KESIMPTA® (ofatumumab), which selectively deplete CD20–expressing B cells. The Company believes obexelimab’s unique mechanism of action to potently inhibit but not deplete a broader B cell lineage than CD20, nonclinical data, and a subcutaneous injection regimen, supports its potential for the treatment of RMS.

  • Following an initial screening period, patients in the MoonStone trial are being randomized 2:1 to 250 mg of obexelimab or placebo administered as a subcutaneous injection every seven days for a 12–week treatment period.
  • The primary objective of this double–blinded portion of the trial will be to assess the change from baseline in the cumulative number of gadolinium (Gd) enhancing lesions identified on T1–weighted magnetic resonance imaging (MRI).
  • Upon completion of the 12–week period, patients will enter an open–label period where patients on placebo will receive obexelimab treatment for at least three months, and patients initially randomized to obexelimab will continue treatment.
  • Important secondary endpoints during this open–label period include using standardized assessments, novel 3D imaging and biomarkers, including serum neurofilament light chain (NfL), to evaluate the impact of obexelimab on disease progression.

More information on the Phase 2 MoonStone trial (NCT06564311) is available at clinicaltrials.gov

  • Report topline results year–end 2025 from the Phase 3 INDIGO trial in patients with IgG4–RD.

IgG4–RD is a chronic fibro–inflammatory disease that can affect virtually all organ systems, including the pancreas, biliary tract, salivary and lacrimal glands, lungs, and kidneys. Patients with IgG4–RD may present with a single organ involved but more frequently present with multiple organ involvement. As the disease progresses and patients experience new or worsening symptoms (i.e., flares), lesions develop in additional organs and the cellular inflammation characterizing early disease moves toward a more fibrotic stage, which can lead to major irreversible tissue damage and ultimately organ failure. We estimate that the currently diagnosed population of IgG4–RD patients in the U.S. is approximately 20,000, with comparable prevalence rates globally.

Despite the growing recognition of IgG4–RD and advances in the understanding of its pathophysiology, there are no approved therapies for the treatment of this disease and there remains high unmet medical need. The current standard of care is treatment with glucocorticoids (GCs). Although GCs are initially effective, treatment with GCs can often result in various complications and co–morbidities. Most patients can relapse within 12 months of discontinuing GC treatment, and maintenance therapy with GCs has not been shown to prevent recurrence of disease.

The pathogenesis of IgG4–RD suggests that B cell–targeted therapies may provide therapeutic benefit. Although not approved by any regulatory authorities to treat IgG4–RD, certain B cell depleting agents (e.g., rituximab) are occasionally administered to patients with IgG4–RD. However, B cell depleting agents are often associated with infections, including serious opportunistic infections, and can compromise a patient’s ability to mount a response to vaccinations.

The reported evidence for the role of B cells in the pathogenesis of IgG4–RD, the observed effects of B cell targeting agents in previous trials in IgG4–RD, the data from our Phase 2 IgG4–RD trials with obexelimab, and its unique, non–depleting mechanism and once–weekly, subcutaneous injection regimen support its development in patients with IgG4–RD.

  • INDIGO is the largest clinical trial conducted in patients living with IgG4–RD and is designed to evaluate the safety and efficacy of obexelimab in approximately 190 patients with active IgG4–RD and being conducted at approximately 100 sites in 20 countries.
  • Following an initial screening period, patients were randomized 1:1 to 250 mg of obexelimab or placebo administered as a subcutaneous injection every seven days for 52 weeks, followed by an opportunity for eligible patients to continue in an open–label extension period where all patients will receive treatment with obexelimab.
  • The primary efficacy endpoint of INDIGO is the time to first IgG4–RD flare, as determined per protocol by the investigator and the adjudication committee.
  • Secondary endpoints include annualized flare rate, the proportion of patients achieving complete remission, and use and quantity of rescue medication, including GCs.

More information on the Phase 3 INDIGO trial (NCT05662241) is available at clinicaltrials.gov

  • Complete enrollment in 2025 in the Phase 2 SunStone trial in patients with SLE and report topline results in the first half of 2026.

The crucial role of B cells in SLE pathogenesis is well recognized, from producing autoantibodies to abnormal regulation of immune responses. Moreover, SLE is an autoimmune disease characterized by B cell dysfunction, the production of autoantibodies toward cellular and nuclear components, and multiorgan damage caused by immune complex deposition and inflammation within affected tissues. Current treatments are limited in number and modestly effective. Obexelimab has demonstrated clinical activity in a prior Phase 2 double–blind, randomized trial demonstrating proof–of–concept in the overall trial population and increased response in patients who maintained higher systemic exposure to obexelimab, and also in biomarker–defined subpopulations. Coupled with the safety data obtained to date, we believe these data provide support for the development of obexelimab in patients with SLE.

  • Patients with active SLE determined at screening by the investigator and adjudication committee are randomized 1:1 to obexelimab 250 mg or placebo administered as a subcutaneous injection every seven days for 24 weeks.
  • The 250 mg once–weekly subcutaneous injection dose has been selected to maximize the potential for clinical activity as higher systemic exposure (Ctrough) correlated with greater clinical activity in the prior Phase 2 trial in SLE.
  • The primary endpoint is the percentage of responders, defined by BILAG–based Composite Lupus Assessment, with a reduction of SLE disease activity at week 24.
  • Biomarker analysis is planned to be conducted in all patients, including baseline RNA expression profiles to immunophenotype patients and evaluation of their differential responses to treatment.

More information on the Phase 2 SunStone trial (NCT06559163) is available at clinicaltrials.gov

About Zenas BioPharma, Inc.

Zenas is a clinical–stage global biopharmaceutical company committed to becoming a leader in the development and commercialization of transformative therapies for patients with autoimmune diseases. Our core business strategy combines our experienced leadership team with a disciplined product candidate acquisition approach to identify, acquire and develop product candidates globally that we believe can provide superior clinical benefits to patients living with autoimmune diseases. Zenas’ lead product candidate, obexelimab, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, which are broadly present across B cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. We believe that obexelimab’s unique mechanism of action and self–administered, subcutaneous injection regimen may broadly and effectively address the pathogenic role of B cell lineage in chronic autoimmune disease. For more information about Zenas BioPharma, please visit www.zenasbio.com and follow us on LinkedIn.

Forward looking statements

This press release contains “forward–looking statements” which involve risks, uncertainties and contingencies, many of which are beyond the control of the Company, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. All statements other than statements of historical facts contained in this press release are forward–looking statements. In some cases, forward–looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward–looking statements contain these words. Forward–looking statements include, but are not limited to, statements concerning Zenas’s plans, objectives, expectations and intentions; the timing and results of ongoing and future clinical trials, including expectations on the timing of reporting INDIGO trial topline results, the 12–week primary endpoint data for the MoonStone trial and the anticipated timing of completing enrollment and reporting topline results for the SunStone trial; its growth strategy; the Company’s preliminary unaudited cash, cash equivalents and short–term investments as of December 31, 2024; and cash runway guidance. The forward–looking statements in this press release speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause the Company’s actual results to differ materially from those anticipated in the forward–looking statements, including, but not limited to: the Company’s limited operating history, incurrence of substantial losses since the Company’s inception and anticipation of incurring substantial and increasing losses for the foreseeable future; the Company’s need for substantial additional financing to achieve the Company’s goals; the uncertainty of clinical development, which is lengthy and expensive, and characterized by uncertain outcomes, and risks related to additional costs or delays in completing, or failing to complete, the development and commercialization of the Company’s current product candidates or any future product candidates; delays or difficulties in the enrollment and dosing of patients in clinical trials; the impact of any significant adverse events or undesirable side effects caused by the Company’s product candidates; potential competition, including from large and specialty pharmaceutical and biotechnology companies, many of which already have approved therapies in the Company’s current indications; the Company’s ability to realize the benefits of the Company’s current or future collaborations or licensing arrangements and ability to successfully consummate future partnerships; the Company’s ability to obtain regulatory approval to commercialize any product candidate in the United States or any other jurisdiction, and the risk that any such approval may be for a more narrow indication than the Company seeks; the Company’s dependence on the services of the Company’s senior management and other clinical and scientific personnel, and the Company’s ability to retain these individuals or recruit additional management or clinical and scientific personnel; the Company’s ability to grow the Company’s organization, and manage the Company’s growth and expansion of the Company’s operations; risks related to the manufacturing of the Company’s product candidates, which is complex, and the risk that the Company’s third–party manufacturers may encounter difficulties in production; the Company’s ability to obtain and maintain sufficient intellectual property protection for the Company’s product candidates or any future product candidates the Company may develop; the Company’s reliance on third parties to conduct the Company’s preclinical studies and clinical trials; the Company’s compliance with the Company’s obligations under the licenses granted to the Company by others, for the rights to develop and commercialize the Company’s product candidates; risks related to the operations of the Company’s suppliers, many of which are located outside of the United States, including the Company’s current sole contract manufacturing organization for drug substance and drug product, WuXi Biologics (Hong Kong) Limited, which is located in China; and other risks and uncertainties described in the section “Risk Factors” in the Company’s Quarterly Report on Form 10–Q for the quarter ended September 30, 2024, as well as other information we file with the Securities and Exchange Commission. The forward–looking statements in this press release are inherently uncertain, speak only as of the date of this press release and may prove incorrect. These statements are based upon information available to the Company as of the date of this press release and while the Company believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that the Company has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Because forward–looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond the Company’s control, these forward–looking statements should not be relied upon as guarantees of future events. The events and circumstances reflected in the forward–looking statements may not be achieved or occur and actual future results, levels of activity, performance and events and circumstances could differ materially from those projected in the forward–looking statements. Moreover, the Company operates in an evolving environment. New risks and uncertainties may emerge from time to time, and management cannot predict all risks and uncertainties. Except as required by applicable law, the Company does not undertake to publicly update or revise any forward–looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

The Zenas BioPharma word mark and logos are trademarks of Zenas BioPharma, Inc. or its affiliated companies.

Investor Contact:

Matthew Osborne

Investor Relations and Corporate Communications
[email protected]

Media Contact:

Argot Partners
[email protected]

1 This amount is preliminary and unaudited and is subject to completion of the Company’s financial closing procedures. As a result, this amount may differ materially from the amount that will be reflected in the Company’s consolidated financial statements for the year ended December 31, 2024.


GLOBENEWSWIRE (Distribution ID 9353140)