Tag: children

Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP

STOUGHTON, Mass., June 18, 2025 (GLOBE NEWSWIRE) -- The company formerly known as Aqua Leisure Recreation announces it has rebranded as Helio Outdoors (HelioOutdoors.com). Founded in 1970 in Stoughton, Mass., Helio Outdoors is a collection of category leading brands in the outdoor recreation space, including Aqua®, Airhead®, Inyo Pools™, Purleine™ and Yukon Charlies®. The rebrand provides clarity of purpose as a house of brands serving a growing outdoor recreation category estimated at $109 billion in the U.S. in 2024.¹

Aliso Viejo, CA , June 18, 2025 (GLOBE NEWSWIRE) -- Galacxia, Inc., developer of the Life Backup Plan digital health platform, proudly announces its advancement to the second round of Pepperdine University’s Most Fundable Companies® 2025 competition. The company earned a “B” rating, reflecting “Great Potential” among a competitive national pool of startups evaluated for scalability, business fundamentals, and investor appeal.

CAMBRIDGE, Mass., June 18, 2025 (GLOBE NEWSWIRE) --  Biogen Inc. (Nasdaq: BIIB) announced the initiation of dosing in the BRAVE study, a global Phase 3 clinical trial. The BRAVE study will evaluate the efficacy and safety of omaveloxolone in children with Friedreich ataxia (FA) between the ages of 2 to <16. Both non-ambulatory and ambulatory participants may qualify for the study. Participants will be randomized 2:1 to receive omaveloxolone or placebo once a day for 52 weeks before having the opportunity to move into the open-label extension (OLE). Currently, omaveloxolone is commercialized under the brand name SKYCLARYS^® in over 40 countries, including in the U.S. and the European Union, and is the only approved product for FA in adults and adolescents aged 16 years and older.