Beren Therapeutics P.B.C.

https://www.berentx.com/

Beren Therapeutics P.B.C. is a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of first-in-class cyclodextrin-based medicines. Founded in 2020 as a Public Benefit Corporation (P.B.C.), its core mission is to deliver novel pharmaceutical therapies that provide optimal benefit for patients, integrating the needs of patients, caregivers, clinicians, and health systems throughout the development process. The company is headquartered in Thousand Oaks, California, United States.

Beren Therapeutics primarily focuses on developing treatments for conditions characterized by defective cholesterol trafficking, with a significant emphasis on rare diseases. Its lead product candidate, adrabetadex, is an investigational cyclodextrin-based therapy aimed at treating infantile-onset Niemann-Pick disease type C (NPC), a severe neurodegenerative disorder. The company also operates Mandos LLC, a wholly-owned subsidiary that has been instrumental in the adrabetadex program, including its Expanded Access Program (EAP). Beyond drug development, Beren is committed to building comprehensive support programs for families navigating the NPC journey, from diagnosis to long-term care.

Led by Founder, President, and CEO Jason Camm, Beren Therapeutics has achieved several notable milestones. In February 2026, the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for adrabetadex in infantile-onset NPC for Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of November 17, 2026. The company secured $300 million in combined financing in June 2026 to support the potential commercial launch of adrabetadex and long-term patient care initiatives. Additionally, Beren expanded its intellectual property estate in August 2026 with eight new U.S. patents related to its proprietary cyclodextrins, and established Beren Therapeutics K.K. in Japan in 2025 to broaden its global footprint.

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