STOCK TITAN

CytoDyn Engages Leading CRO For Phase II Inflammation Trial

Rhea-AI Impact
(Moderate)
Rhea-AI Sentiment
(Neutral)

CytoDyn Inc. (OTCQB: CYDY) has announced the engagement of Syneos Health as the contract research organization (CRO) for its upcoming Phase II study on leronlimab's effects on chronic inflammation. Syneos Health is a leading biopharmaceutical solutions provider with a strong track record, having contributed to the development or commercialization of 92% of novel new drugs approved by the FDA in the last five years (2019-2023) and 91% of products granted marketing authorization by the European Medicines Agency.

Dr. Jacob Lalezari, CEO of CytoDyn, expressed optimism about the collaboration, stating that their goal is to generate clinical data that will affirm leronlimab's utility in addressing various medical concerns impacting patients globally.

CytoDyn Inc. (OTCQB: CYDY) ha annunciato l'impegno di Syneos Health come organizzazione di ricerca contrattuale (CRO) per il suo prossimo studio di Fase II sugli effetti del leronlimab sull'infiammazione cronica. Syneos Health è un fornitore leader di soluzioni biofarmaceutiche con un solido curriculum, avendo contribuito allo sviluppo o alla commercializzazione del 92% dei nuovi farmaci approvati dalla FDA negli ultimi cinque anni (2019-2023) e al 91% dei prodotti autorizzati alla commercializzazione dall'Agenzia Europea dei Medicinali.

Il Dr. Jacob Lalezari, CEO di CytoDyn, ha espresso ottimismo riguardo alla collaborazione, affermando che il loro obiettivo è generare dati clinici che confermeranno l'utilità del leronlimab nell'affrontare varie problematiche mediche che colpiscono i pazienti a livello globale.

CytoDyn Inc. (OTCQB: CYDY) ha anunciado la contratación de Syneos Health como la organización de investigación contratada (CRO) para su próximo estudio de Fase II sobre los efectos del leronlimab en la inflamación crónica. Syneos Health es un proveedor líder de soluciones biofarmacéuticas con un fuerte historial, habiendo contribuido al desarrollo o comercialización del 92% de los nuevos fármacos aprobados por la FDA en los últimos cinco años (2019-2023) y al 91% de los productos autorizados para comercialización por la Agencia Europea de Medicamentos.

El Dr. Jacob Lalezari, CEO de CytoDyn, expresó optimismo sobre la colaboración, afirmando que su objetivo es generar datos clínicos que afirmen la utilidad del leronlimab para abordar diversas preocupaciones médicas que afectan a pacientes en todo el mundo.

CytoDyn Inc. (OTCQB: CYDY)는 만성 염증에 대한 레론리맙의 효과에 대한 2상 연구를 위해 계약 연구 기관(CRO)으로 Syneos Health를 고용한다고 발표했습니다. Syneos Health는 지난 5년(2019-2023) 동안 FDA에서 승인한 신규 약물의 92%의 개발 또는 상용화에 기여한 강력한 이력을 가진 선도적인 생물 제약 솔루션 제공업체입니다. 또한 유럽 의약품 청에서 마케팅 허가를 받은 제품의 91%에도 기여했습니다.

CytoDyn의 CEO인 Jacob Lalezari 박사는 이번 협력에 대해 낙관적인 입장을 밝혔으며, 그들의 목표는 레론리맙이 전 세계 환자들에게 영향을 미치는 다양한 의료 문제를 해결하는 데 유용하다는 것을 입증할 임상 데이터를 생성하는 것이라고 전했습니다.

CytoDyn Inc. (OTCQB: CYDY) a annoncé le partenariat avec Syneos Health en tant qu'organisation de recherche contractée (CRO) pour son prochain étude de Phase II sur les effets du leronlimab sur l'inflammation chronique. Syneos Health est un fournisseur leader de solutions biopharmaceutiques avec un solide bilan, ayant contribué au développement ou à la commercialisation de 92% des nouveaux médicaments approuvés par la FDA au cours des cinq dernières années (2019-2023) et 91% des produits ayant obtenu l'autorisation de mise sur le marché de l'Agence Européenne des Médecines.

Le Dr. Jacob Lalezari, PDG de CytoDyn, a exprimé son optimisme concernant cette collaboration, déclarant que leur objectif est de générer des données cliniques qui affirmeront l'utilité du leronlimab pour traiter diverses préoccupations médicales touchant les patients à l'échelle mondiale.

CytoDyn Inc. (OTCQB: CYDY) hat die Beauftragung von Syneos Health als Auftragsforschungsinstitut (CRO) für die bevorstehende Phase-II-Studie zu den Auswirkungen von Leronlimab auf chronische Entzündungen bekannt gegeben. Syneos Health ist ein führender Anbieter von biopharmazeutischen Lösungen mit einer starken Erfolgsbilanz und hat in den letzten fünf Jahren (2019-2023) zur Entwicklung oder Vermarktung von 92% der neuartigen, von der FDA genehmigten Medikamente beigetragen, sowie zu 91% der Produkte, die von der Europäischen Arzneimittel-Agentur eine Zulassung erhalten haben.

Dr. Jacob Lalezari, CEO von CytoDyn, äußerte sich optimistisch über die Zusammenarbeit und erklärte, dass ihr Ziel darin besteht, klinische Daten zu generieren, die die Nützlichkeit von Leronlimab zur Behandlung verschiedener medizinischer Anliegen belegen, die weltweite Patienten betreffen.

Positive
  • Engagement of a leading CRO (Syneos Health) for Phase II inflammation trial
  • Syneos Health has a strong track record in drug development and commercialization
Negative
  • None.

VANCOUVER, Washington, Aug. 23, 2024 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that it has engaged Syneos Health as the contract research organization (“CRO”) for its upcoming Phase II study exploring leronlimab and its effects on chronic inflammation.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization providing services across the drug development lifecycle to help customers accelerate the delivery of life saving therapies to market. Syneos Health has helped to develop or commercialize 92% of novel new drugs approved by the FDA in the last five years (2019-2023) and 91% of products granted marketing authorization by the European Medicines Agency.

“We are looking forward to working with Syneos Health to advance our Phase II study of leronlimab’s effects on chronic inflammation. With the company’s support, our goal is to generate clinical data that we believe will affirm the utility of leronlimab in addressing a number of medical concerns impacting patients globally,” said Dr. Jacob Lalezari, CEO.

About CytoDyn

CytoDyn is a clinical-stage biotechnology company focused on the development and commercialization of leronlimab, an investigational humanized IgG4 monoclonal antibody (mAb) that is designed to bind to C-C chemokine receptor type 5 (CCR5), a protein on the surface of certain immune system cells that is believed to play a role in numerous disease processes. Leronlimab is being studied for oncology and inflammation, as well as other potential indications, including but not limited to HIV and MASH.

About Syneos Health

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. Syneos Health translates unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Syneos Health brings a talented team of professionals with a deep understanding of patient and physician behaviors and market dynamics. Together, Syneos Health shares insights, uses the latest technologies and applies advanced business practices to speed its customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment. To learn more about how Syneos Health is shortening the distance from lab to life®, visit syneoshealth.com.

CONTACT

CytoDyn
Investor Relations
CytoDyn Inc.
ir@cytodyn.com


FAQ

What is the purpose of CytoDyn's (CYDY) upcoming Phase II study?

CytoDyn's upcoming Phase II study aims to explore the effects of leronlimab, a CCR5 antagonist, on chronic inflammation.

Who has CytoDyn (CYDY) engaged as the CRO for its Phase II inflammation trial?

CytoDyn has engaged Syneos Health as the contract research organization (CRO) for its Phase II inflammation trial.

What is Syneos Health's track record in drug development?

Syneos Health has contributed to the development or commercialization of 92% of novel new drugs approved by the FDA in the last five years (2019-2023) and 91% of products granted marketing authorization by the European Medicines Agency.

What is the potential of leronlimab according to CytoDyn (CYDY)?

According to CytoDyn, leronlimab is a CCR5 antagonist with the potential for multiple therapeutic indications.

CYTODYN INC

OTC:CYDY

CYDY Rankings

CYDY Latest News

CYDY Stock Data

157.94M
1.20B
0.66%
0.02%
Biotechnology
Healthcare
Link
United States of America
Vancouver