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Facet Life Sciences Named Regulatory Partner for Cybin's Neuropsychiatry Therapeutics Development Pipeline

Facet Life Sciences Named Regulatory Partner for Cybin's Neuropsychiatry Therapeutics Development Pipeline

Facet Life Sciences被指定爲Cybin的神經精神藥物開發項目的監管合作伙伴
PR Newswire ·  12/05 03:00

PHOENIXVILLE, Pa., Dec. 4, 2024 /PRNewswire/ -- Facet Life Sciences, a leader in US regulatory strategy and product development solutions for the life sciences industry, has been named as the US regulatory partner for Cybin Inc. ("Cybin"), a late-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative treatment options to address the large unmet need for people who suffer from mental health conditions. This collaboration will support Cybin's pioneering work in next generation therapeutics, particularly for conditions like Major Depressive Disorder, Generalized Anxiety Disorder, and Central Nervous System disorders.

賓夕法尼亞州鳳凰城,2024年12月4日/美通社/ - 生物醫學科學公司Facet Life Sciences在美國監管策略和產品開發解決方案領域處於領先地位,已被命名爲Cybin Inc.(「Cybin」)的美國監管合作伙伴,後者是一家專注於革命性精神醫療的晚期突破性神經精神病學公司,致力於通過開發新的創新治療選擇來應對那些患有精神健康問題的人們的巨大未滿足需求。這一合作將支持Cybin在下一代治療領域的開創性工作,特別是針對重大抑鬱症、廣泛性焦慮症和中樞神經系統疾病等疾病。

Facet Life Sciences will leverage its extensive expertise in US regulatory submissions to guide Cybin's development programs to and through the U.S. Food and Drug Administration ("FDA") review and approval process. Cybin's work involves novel, proprietary molecules which are in advanced clinical development. Facet Life Sciences' role will encompass strategic nonclinical, CMC, clinical, and procedural regulatory development guidance, tactical regulatory, medical writing support and submission management for Cybin's key therapies, including CYB003, Cybin's proprietary deuterated psilocin program in Phase 3 development for the potential adjunctive treatment of major depressive disorder which received FDA Breakthrough Therapy Designation earlier this year.

Facet Life Sciences將利用其在美國監管提交方面的豐富專業知識,指導Cybin的開發項目通過美國食品和藥物管理局(「FDA」)的審查和批准流程。 Cybin的工作涉及處於先進臨床開發階段的新穎專有分子。 Facet Life Sciences的作用將包括戰略性非臨床、CMC、臨床和程序性監管發展指導,爲Cybin的關鍵療法提供戰術性監管、醫學撰寫支持和提交管理, 其中包括CYB003,Cybin的專有的第三階段開發中的假死草素替代治療計劃,用於可能作爲重大抑鬱症的輔助治療,今年早些時候獲得了FDA突破性療法評定。

Facet Life Sciences Named Regulatory Partner for Cybin's Neuropsychiatry Therapeutics Development Pipeline

Facet Life Sciences被命名爲Cybin神經精神病治療產品線的監管合作伙伴

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"We are excited to collaborate with Cybin as their regulatory partner, supporting their mission to redefine mental health treatment through innovation," said Ken VanLuvanee, Founder and CEO, Facet Life Sciences. "Cybin's approach aligns with our mission to help advance groundbreaking therapeutics while meeting the highest regulatory standards, including our desire to bring efficacious and safe therapeutics to patients suffering with various neuropsychiatric diseases."

"作爲他們的監管合作伙伴,我們很高興與Cybin合作,支持他們通過創新重新定義心理健康治療的使命," Facet Life Sciences的創始人兼首席執行官Ken VanLuvanee表示。 "Cybin的方法與我們的使命相符,即在滿足最高監管標準的同時幫助推進具有突破性的治療方案,包括我們希望爲患有各種神經精神疾病的患者提供有效和安全的治療。"

About Facet Life Sciences
Facet Life Sciences provides integrated clinical, non-clinical, manufacturing, regulatory, statistics, marketing, and commercialization services to help small and mid-sized companies achieve success. Facet's team of experts have hundreds of years of combined experience making them uniquely equipped to guide companies from the bench through development, approval, and to patients in need.

關於Facet Life Sciences
Facet Life Sciences提供整合的臨床、非臨床、製造、法規、統計、市場營銷和商業化服務,幫助中小型公司取得成功。Facet的專家團隊擁有數百年的經驗,使他們能夠爲公司從實驗室階段、經過研發、獲得批准,以及走向需要的患者提供獨特的支持。

About Cybin
Cybin is a clinical-stage breakthrough neuropsychiatry company committed to revolutionizing mental healthcare by developing new and innovative next generation treatment options to address the large unmet need for people who suffer from mental health conditions.

關於Cybin
Cybin是一家臨床階段的突破性神經精神病學公司,致力於通過開發新的創新下一代治療選擇,改變精神健康護理,以滿足患有心理健康狀況的人們的巨大未滿足需求。

Founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom, the Netherlands and Ireland. To learn more about Cybin, visit .

成立於2019年,Cybin在加拿大、美國、英國、荷蘭和愛爾蘭運營。要了解更多關於Cybin的信息,請訪問 .

For media inquiries, contact:

媒體垂詢請聯繫:

  • Facet Life Sciences: [email protected]
  • Cybin: [email protected]
  • Facet Life Sciences: [email protected]
  • 賽賓: [email protected]

SOURCE Facet Life Sciences

來源: Facet Life Sciences

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