Ionis Announces Pivotal Phase 3 Trial Design for ION582 in Angelman Syndrome [Yahoo! Finance]
Ionis Pharmaceuticals, Inc. (IONS)
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Source: Yahoo! Finance
Initiation of ION582 Phase 3 study planned for H1 2025 Ionis to share ION582 program update at the FAST Global Science Summit in November CARLSBAD, Calif. Nov. 6, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced the pivotal Phase 3 study design following successful alignment with the U.S. Food and Drug Administration (FDA) on ION582, an investigational medicine for the treatment of people living with Angelman syndrome (AS). AS typically presents in infancy and is characterized by profound intellectual disability, impaired verbal abilities and severe motor impairment. "Following positive results for ION582 in the Phase 2 HALOS trial, we are pleased to have alignment with the FDA on the design of our Phase 3 REVEAL trial, which will address clinical endpoints that reflect the most pressing and meaningful outcomes for people living with AS and their caregivers," said Brett Monia , Ph.D., chief executive officer of Ionis. "We will enroll a broad group
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- 11/6/24 - Beat
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- 11/14/24 - Form SC
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