Ferrer and Prilenia announce EU authorization of confirmatory PRECISE-HD Study of Pridopidine in Huntington's Disease. * Recruitment is expected to start this month, rolling out to upwards of 31 sites across nine EU countries, and joining the ongoing enrollment in the US and UK, with Canada set to follow. * Ferrer and Prilenia will share new data analyses and clinical trial updates at the European Huntington's Disease Network (EHDN) Clinical Research Congress. Ferrer[i] and Prilenia Therapeutics B.V. announced that the confirmatory Phase 3 PRECISE-HD study of investigational pridopidine in Huntington's disease (HD) has received authorization to begin in participating EU Member States (EU CT number: 2026-526093-16-00, NCT07609108). Recruitment in the EU is expected to commence this month, joining currently recruiting sites in the US and UK, with Canada to follow. Designed to evaluate the efficacy and safety of pridopidine (administered as an oral capsule twice a day), and to generate data for regulatory evaluation, the global, approximately 400-participant, randomized, double-blind, placebo-controlled PRECISE-HD study will assess the clinical effect of the investigational treatment on disease progression, functional capacity, motor function, cognition, speech and quality of life. "The initiation of PRECISE-HD in Europe marks a milestone for the Huntington's disease research community. This confirmatory Phase 3 study has been designed to build on learnings from previous research and to rigorously evaluate the efficacy and safety of pridopidine in people living with HD. As investigators, we look forward to working with participating centers and the HD community to generate robust evidence that can help us better understand the potential role of the study treatment in HD," said Dr. Ralf Reilmann, Principal Investigator and member of the PRECISE-HD Steering Committee. "For people living with Huntington's disease and their families, every step toward a better understanding of the disease and potential treatment options matters. We welcome the involvement of European centers in PRECISE-HD and the continued focus on outcomes that reflect the realities and priorities of people living with HD and their families," said Astri Arnesen, President of the European Huntington Association. "At Ferrer, putting our purpose into practice also means taking on complex scientific challenges, while recognizing the uncertainty inherent in research. The authorization to initiate PRECISE-HD in participating EU Member States is a further step in our work with Prilenia. We approach that work with a clear sense of responsibility: to conduct research with integrity and let the evidence lead the way," said Oscar Pérez, Chief Scientific Officer at Ferrer. EHDN 2026 Clinical Research Congress Ferrer and Prilenia will participate at the upcoming European Huntington's Disease Network (EHDN) Clinical Research Congress 2026, taking place October 22-24, 2026, in Kraków, Poland, with Prilenia's Chief Executive Officer, Dr. Michael R. Hayden, giving an oral presentation on clinical trial design and determination of clinical meaningfulness, in addition to four posters being presented. Huntington's disease (HD) is a rare, inherited, autosomal dominant, neurodegenerative disease that results in functional, motor, cognitive and behavioral symptoms, and ultimately leads to death. HD is caused by a mutation in the huntingtin (HTT) gene[ii,] and each child of a parent with HD has a 50 percent chance of developing the disease[iii.] Across the world an estimated 100,000 people have HD[iv,] with an additional 300,000 people at risk of developing HD[v,vi] It is usually diagnosed between the ages of 35 and 55[vii,viii], although HD can occur at any age, including in children and young adults (known as juvenile onset HD or JHD). The disease progresses slowly over 10 to 30[ix] years, with patients slowly losing their ability to work, communicate, manage day-to-day life and take care of themselves. This increasing disability leads to full reliance on a caregiver and, ultimately, death. The only currently available treatments for HD focus on symptomatic relief and palliative care, with no approved therapies shown to impact measures of overall disease progression. About pridopidine Pridopidine is an investigational highly selective, oral sigma-1 receptor (S1R) agonist. S1R has been shown to play a role in stimulating multiple neuroprotective pathways impaired in neurodegenerative diseases, such as Huntington's disease (HD) and amyotrophic lateral sclerosis (ALS)[x]. In clinical studies to date, pridopidine (taken as an oral capsule twice a day) has shown a generally favorable safety and tolerability profile, with data from more than 1,600 people (mostly from HD studies), some of whom have received active treatment for up to seven years[xi]. Pridopidine is currently in late-stage clinical development for HD and ALS. It has Orphan Drug Designation in HD and ALS in the US and EU, and FDA Fast Track designation in the US for the treatment of HD. These designations do not imply that pridopidine has been approved or that safety and efficacy have been established. About the PRECISE-HD Study PRECISE-HD (Pridopidine Phase 3 Study to Establish Clinical Impact and Safety in Huntington's Disease) is a confirmatory, global, 400-participant, randomized, double-blind, placebo-controlled study designed to further evaluate the efficacy and safety of pridopidine, an investigational medicinal product, in people living with Huntington's disease (HD), from early to mid-stage disease (TFC 7-13). Focused on generating data to further support regulatory evaluation, the study will assess the clinical effect of pridopidine on disease progression, functional capacity, motor function, cognition, speech and quality of life. It incorporates learnings from prior research, advice and input from the HD patient and research community, and regulatory authorities. PRECISE-HD comprises two consecutive stages: a 52-week placebo-controlled stage, with participants randomized to receive either pridopidine or placebo on a 1:1 basis, followed by a 104-week open-label extension stage in which all eligible participants will receive pridopidine. The primary endpoint is the change from baseline to Week 52 in the combined Unified Huntington's Disease Rating Scale (cUHDRS) score. PRECISE-HD will be undertaken at up to 75 sites globally, including sites in the United States, European Union, United Kingdom and Canada. Further details are available at www.clinicaltrials.gov (NCT07609108), www.clinicaltrialsregister.eu/ (EU CT number: 2026-526093-16-00). [i] In April 2025, Prilenia and Ferrer signed a commercialization and co-development agreement for pridopidine. [ii] Eddings CR, Arbez N, Akimov S, Geva M, Hayden MR, Ross CA. Pridopidine protects neurons from mutant-huntingtin toxicity via the sigma-1 receptor. Neurobiol Dis. 2019 Sep;129:118-129. doi: 10.1016/j.nbd.2019.05.009. Epub 2019 May 17. PMID: 31108174; PMCID: PMC6996243. [iii] Myers RH. Huntington's disease genetics. NeuroRx. 2004 Apr;1(2):255-62. doi: 10.1602/neurorx.1.2.255. PMID: 15717026; PMCID: PMC534940.) [iv] Pringsheim T, Wiltshire K, Day L, Dykeman J, Steeves T, Jette N. The incidence and prevalence of Huntington's disease: a systematic review and meta-analysis. Mov Disord. 2012 Aug;27(9):1083-91. doi: 10.1002/mds.25075. Epub 2012 Jun 12. PMID: 22692795. [v] Medina et al., Prevalence and Incidence of Huntington's Disease: An Updated Systematic Review and Meta-Analysis. Mov Disord. 2022 Dec;37(12):2327-2335. [vi] Jiang, A., Handley, R. R., Lehnert, K., & Snell, R. G. (2023). From Pathogenesis to Therapeutics: A Review of 150 Years of Huntington's Disease Research. International Journal of Molecular Sciences, 24(16), 13021. https://doi.org/10.3390/ijms241613021 [vii] EHDN. About Huntington's Disease. April 2024. Available at: https://ehdn.org/about-hd/ (accessed April 2025). [viii] Petracca M, et al. Clinical and genetic characteristics of late-onset Huntington's disease in a large European cohort. Eur J Neurol. 2022;29:1940-51. [x] Lachance V, Bélanger S-M, Hay C, Le Corvec V, Banouvong V, Lapalme M, Tarmoun K, Beaucaire G, Lussier MP, Kourrich S. Overview of Sigma-1R Subcellular Specific Biological Functions and Role in Neuroprotection. International Journal of Molecular Sciences. 2023; 24(3):1971. https://doi.org/10.3390/ijms24031971 [xi] Goldberg YP, Navon-Perry L, Cruz-Herranz A, Chen K, Hecker-Barth G, Spiegel K, Cohen Y, Niethammer M, Tan AM, Schuring H, Geva M, Hayden MR. The Safety Profile of Pridopidine, a Novel Sigma-1 Receptor Agonist for the Treatment of Huntington's Disease. CNS Drugs. 2025 May;39(5):485-498. doi: 10.1007/s40263-025-01171-x. Epub 2025 Mar 7. PMID: 40055280; PMCID: PMC11982116.

Prilenia taps Rick Munschauer as new Chief Medical Officer. Munschauer has been CMO at three previous biopharmaceutical companies, most recently Emalex Biosciences. September 8, 2026 Content Marketing Editor Why This Matters: See our coverage of other industry executive team appointments and promotions here. Prilenia Therapeutics announced the appointment of Frederick (Rick) E. Munschauer III, MD, as its new Chief Medical Officer (CMO). New Chief Medical Officer bona fides. Munschauer joins after having been CMO at three previous biopharmaceutical companies, most recently Emalex Biosciences. He also held the post at MedDay Pharmaceuticals and Marathon Pharmaceuticals. Other previous work experience includes Biogen and EMD Serono, in addition to an extensive academic career. "Prilenia is currently tackling two devastatingly intractable diseases, in HD and ALS, where the unmet need is stark, and where we now have a possibility of changing the course of illness." Rick Munschauer, Prilenia Therapeutics CMO Prilenia's focus, meanwhile, is accelerating scientific progress to help those affected by Huntingdon's disease (HD) and amyotrophic lateral sclerosis (ALS). "Prilenia is currently tackling two devastatingly intractable diseases, in HD and ALS, where the unmet need is stark," Munschauer said. "We now have a possibility of changing the course of illness. What drew me here is the clarity of the mission and the pridopidine story, which has already garnered compelling data. My focus will be on execution - running our pivotal HD and ALS studies to the highest standard." Prilenia moving trials forward. In July 2026, Prilenia and Ferrer announced initiation of a confirmatory study of pridopidine in Huntingdon's disease. Munschauer has been principal or co-principal investigator for over 50 Phase I-IV trials in multiple sclerosis and cerebrovascular disease. He has authored more than 90 peer-reviewed publications. Other conditions Munschauer has worked on include pediatric Tourette syndrome and Duchenne muscular dystrophy. All of that makes for an impressive resume, says Prilenia CEO Michael Hayden, PhD. Munschauer's experience is especially important, explains Hayden, as Prilenia executes Phase III studies in both HD and ALS. "That combination of clinical judgment, regulatory experience and operational discipline will bring significant value to Prilenia, and patients," Hayden said.

Prilenia Therapeutics, a biopharmaceutical company focused on Huntington's disease and Amyotrophic Lateral Sclerosis treatments, has appointed Dr Elisabeth Leiderman as Chief Financial Officer. Leiderman brings over 20 years of finance and corporate development experience in life sciences. She has previously served as CFO at multiple biotech companies including Dewpoint, Atsena and Decibel, and currently sits on the board of Autolus Therapeutics. She also held senior investment banking positions at UBS, Credit Suisse and Nomura. The appointment comes as Prilenia embarks on two Phase 3 studies for its drug pridopidine in HD and ALS. Leiderman will focus on managing the company's financial runway through Phase 3 completion whilst preparing for potential commercialisation.