BridgeBio Says FDA Granted Regenerative Medicine Advanced Therapy Designation To BBP-812
Portfolio Pulse from Benzinga Newsdesk
BridgeBio Pharma announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational gene therapy, BBP-812, for Canavan disease. This designation follows positive clinical data from the CANaspire Phase 1/2 trial.
September 10, 2024 | 8:46 pm
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BridgeBio Pharma's BBP-812 has been granted RMAT designation by the FDA, indicating promising clinical data and potential for addressing unmet medical needs in Canavan disease.
The RMAT designation is a significant regulatory milestone that suggests the FDA sees promise in BBP-812's clinical data. This can lead to expedited development and review processes, potentially accelerating the therapy's path to market. Such designations often boost investor confidence and can positively impact stock prices in the short term.
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