FDA OKs Phase 2 Trial Design for Xanamem

FDA OKs Phase 2 Trial Design for Xanamem

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FDA OKs Phase 2 Trial Design for Xanamem

The U.S. Food and Drug Administration (FDA) has given positive feedback to Actinogen’s pre-investigational new drug (pre-IND) submission regarding Xanamem, its experimental oral therapy for fragile X syndrome. In a written response following a pre-IND meeting with Actinogen, the FDA agreed the data gathered and the proposed trial design would be sufficient to support an IND application, depending on the review of additional documentation. A pre-IND meeting helps create a strategy for the therapy’s development process by reviewing…

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