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Ultragenyx Pharmaceutical Reports FDA Acceptance of IND Application for UX016
Ultragenyx Pharmaceutical announced that the FDA has accepted its Investigational New Drug (IND) application for UX016, an experimental small-molecule prodrug for GNE myopathy (GNEM). A phase I/II clinical trial for UX016 is expected to begin in the latter half of 2026, aiming to assess its safety, efficacy, and pharmacokinetics in adult GNEM patients. The company currently holds a Zacks Rank #3 (Hold) and has four other approved therapies on the market.