Paragon Advances Registration-Ready CNS Asset Addressing Important Unmet Need and Closes Sale to Teva Pharmaceutical
Agreement highlights Paragon's ability to build companies around important science, advance registration-ready assets, and deliver value through strategic transactions
Paragon Biosciences today announced the closing of the sale of Emalex Biosciences to Teva Pharmaceutical, reinforcing Paragon's ability to build innovative biotechnology companies that deliver important treatments to the patients who need them.
Emalex is another Paragon Biosciences-founded company built to develop a novel class of treatment for patients with central nervous system disorders, following in the footsteps of other successful Paragon companies such as Harmony Biosciences (NASDAQ:HRMY). Ecopipam, an investigational compound, was developed by Emalex for Tourette syndrome, a neurodevelopmental disorder that can significantly affect daily life for patients and families.
Paragon, supporting Emalex, advanced the drug through clinical development and the compilation of the NDA that will be submitted in the second half of 2026. The acquisition by Teva comprises $700 million in cash and up to $200 million in commercial milestone payments as well as net-sales-based royalties, subject to regulatory approval.
"This transaction is a testament to the talent, perseverance and vision of the Paragon and Emalex teams. Together, they transformed promising science into a registration-ready program with the potential to become the first new treatment option for Tourette syndrome in over a decade. Their work demonstrates the power of focused innovation to address diseases that have been underserved for far too long," said Jeff Aronin, Paragon Biosciences founder and CEO.
"Building companies that translate scientific breakthroughs into medicines for patients is the foundation of Paragon's mission. From CNS disorders to rare diseases, we continue to identify important unmet needs, assemble exceptional teams and advance therapies that have the potential to change lives. We are incredibly proud of what the Emalex team has accomplished and excited to see ecopipam move into its next chapter," Aronin added.
Phase 3 results published in JAMA Neurology showed that ecopipam reduced time to relapse compared to placebo and maintained clinically meaningful tic improvement in subjects with Tourette syndrome.
Ecopipam remains investigational and has not been approved by the U.S. Food and Drug Administration.
"Emalex reflects what Paragon does best, building companies with discipline, urgency and a clear path from scientific insight to patient impact," said Eric Messner, chief executive officer of Emalex Biosciences. "From the beginning, the team focused on rigorous clinical execution and a significant unmet need. With the transaction now closed, ecopipam is positioned for its next stage as it approaches planned regulatory submission and, if approved, potential access for patients."
About Ecopipam
Ecopipam is a first-in-class investigational compound designed to block dopamine signaling at the D1 receptor. D1 receptor hypersensitivity may contribute to repetitive and compulsive behaviors associated with Tourette syndrome.
Ecopipam has received Orphan Drug and Fast Track designations from the FDA for the treatment of pediatric patients with Tourette syndrome. Orphan Drug designation is reserved for patient populations of 200,000 or fewer.
The Phase 3 Tourette syndrome study results were recently published in JAMA Neurology. The primary efficacy endpoint in the study was time to relapse for pediatric patients stable and responding to ecopipam then randomized to ecopipam or placebo. The study showed statistical significance between ecopipam and placebo for the primary efficacy endpoint in pediatric patients (p = 0.0084).
Ecopipam was generally well-tolerated in the study and the most common adverse events related to ecopipam therapy were somnolence (10.2%), insomnia (7.4%), anxiety (6.0%), fatigue (5.6%), and headache (5.1%).
About Paragon Biosciences
Paragon Biosciences, founded by Jeff Aronin, creates, builds and funds innovative biology-based companies. Its portfolio companies advance scientific breakthroughs aimed at addressing significant unmet medical needs. Learn more at paragonbiosciences.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260611949436/en/