NAARDEN, Netherlands WALTHAM, Mass.--(BUSINESS WIRE)--Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, today announced the presentation of the latest research from the pridopidine Huntington disease (HD) and amyotrophic lateral sclerosis (ALS) programs at the American Academy of Neurology (AAN) Annual Congress, in Denver, Colorado, April 13-18. “Pridopidine is now in pre-registration phase in HD, with a first submission planned Mid 2024i, and is also set to commence a global Phase 3 study in ALS later this year. We are making significant strides forward and this is reflected by presentation of the data at one of the most important medical congresses in the field of Neurology,” said Jina Swarz, MD. Ph.D., the recently appointed Chief Medical Officer of Prilenia. “Pridopidine is one of the most advanced investigational new drugs in HD and ALS and has shown consistent treatment benefits across independent measures that are important to patients and families. The presented data advances knowledge in the field, providing important learnings for both clinical practice and for the design of our programs going forward

NAARDEN, Netherlands WALTHAM, Mass.--(BUSINESS WIRE)--Prilenia Therapeutics B.V., a clinical stage biotechnology company focused on the urgent mission to develop novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, announced its plan to submit a Marketing Authorization Application (MAA) for pridopidine for the treatment of Huntington’s disease (HD) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). This decision follows positive pre-submission meetings with regulatory authorities in the European Union. Submission is planned for mid-2024. “Pridopidine demonstrates consistent treatment benefits across independent measures that are important to patients and families. These measures include day-to-day function, cognition, motor and clinical progression in people living with HD. The benefits are clearly evident in those with HD who are not taking anti-dopaminergic medications (ADM),” said Dr

On the heels of promising HEALEY-ALS Phase 2 trial data, Prilenia Therapeutics plans to launch a pivotal Phase 3 study of pridopidine, its candidate amyotrophic lateral sclerosis (ALS) treatment, in the second half of this year.