Paragon Advances Registration-Ready CNS Asset Addressing Important Unmet Need and Closes Sale to Teva Pharmaceutical

Key Terms

central nervous system medical

The central nervous system (CNS) is the body's main control center, made up of the brain and spinal cord, that processes information and directs movement, sensation and basic functions like breathing. For investors, CNS-related products and research matter because they face long development times, strict safety testing and regulatory hurdles; success or failure can dramatically affect a company’s costs, timelines and potential market value.

tourette syndrome medical

Tourette syndrome is a neurological condition that causes repeated, involuntary movements or sounds known as tics, which typically begin in childhood and vary widely in severity. Investors pay attention because it creates a defined need for medical treatments, therapies, and support services—similar to how recurring software bugs create demand for updates—affecting market size, regulatory scrutiny, clinical trial opportunities and potential workforce or cost implications for healthcare and education sectors.

nda regulatory

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

phase 3 medical

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

open-label extension medical

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

u.s. food and drug administration regulatory

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

milestone payments financial

Milestone payments are predetermined sums a company agrees to pay or receive when specific development, regulatory, or commercial goals are reached in a partnership or license deal. Think of them like progress bonuses: they turn uncertain future outcomes into conditional cash events, so investors track them as potential sources of revenue, value inflection points, and risk—payments only arrive if the agreed milestones are actually achieved.

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Agreement highlights Paragon’s ability to build companies around important science, advance registration-ready assets, and deliver value through strategic transactions

CHICAGO--(BUSINESS WIRE)-- 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/

media@paragonbiosci.com

Source: Paragon Biosciences