NAARDEN, The Netherlands, WALTHAM, Mass. & BARCELONA, Spain — Prilenia Therapeutics B.V. and Ferrer today announced that the US Food and Drug Administration (FDA) has cleared the start of the pivotal, 500-patient, randomized, placebo-controlled Phase 3 study of pridopidine in participants with rapidly progressive amyotrophic lateral sclerosis (ALS) early in their disease course....
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NAARDEN, The Netherlands, WALTHAM, Mass. & BARCELONA, Spain — Prilenia Therapeutics B.V. and Ferrer today announced the presentation of five posters outlining slowing of clinical progression and additional pridopidine data at the 2025 HSG HD Clinical Research Congress, 10-13 October, 2025. “The data show pridopidine’s ability to deliver consistent and sustained slowing of...
NAARDEN, Netherlands – Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pridopidine for development as a potential treatment for Huntington’s Disease (HD). Fast Track is a...
NAARDEN, Netherlands – Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, received a positive opinion on European Orphan Drug Designation for pridopidine in Amyotrophic lateral sclerosis (ALS). The orphan designation is expected to be granted within 30 days, following the positive...
NAARDEN, the Netherlands – FDA Grants Orphan Drug Designation for pridopidine for the Treatment of Amyotrophic Lateral Sclerosis (ALS) Prilenia Therapeutics B.V., a clinical stage biotech company focused on developing novel treatments for neurodegenerative and neurodevelopmental disorders, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted...
Relacorilant plus nab-paclitaxel improved progression-free and overall survival and did not increase side effect burden Results will support a New Drug Application (NDA) in the United States and a Marketing Authorization Application (MAA) in Europe Relacorilant plus nab-paclitaxel has the potential to become a new standard of care for patients with platinum-resistant ovarian...
CAMBRIDGE, Mass — Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated, one-time curative genetic therapies, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for PM359, submitted on March 29, for the...
CAMBRIDGE, Mass. — Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated, one-time curative genetic therapies, today reported new preclinical data demonstrating the ability of its ex vivo Prime Editing program, PM359, to correct a common disease-causing mutation of chronic granulomatous disease (CGD)....
Amsterdam, Netherlands – Worldwide, an estimated, 40 million people live with HIV. Two-thirds of this group on the African continent. In 2022, more than 600,000 people died from HIV-related causes and more than 1.3 million were infected. There is no vaccine against the world’s second most deadly infection, after TB....
CAMBRIDGE, Mass. — Prize4life and the Alzheimer Research Forum announce the release of the ALS Forum (www.ResearchALS.org), a web-based resource for researchers interested in amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease or motor neuron disease. The site is modeled on the Alzheimer Research Forum’s popular website, www.alzforum.org,...