In an interview over the weekend, FDA Commissioner Dr. Marty Makary came across as “scientifically-grounded level-headed with regards to registrational requirements, drug approval processes, and modernizing data capture, and willing to work with industry appropriately,” RBC Capital tells investors in a research note. The firm believes this suggests Makary may not dramatically break from the FDA’s trend of biomarker-based accelerated approvals followed by confirmatory studies, which is potentially positive for PTC Therapeutics (PTCT), Sarepta (SRPT), Biohaven (BHVN), Edgewise Therapeutics (EWTX), Design Therapeutics (DSGN), Ultragenyx (RARE), Avidity Biosciences (RNA), Dyne Therapeutics (DYN), Wave Life Sciences (WVE), MeiraGTx (MGTX), uniQure (QURE), Regenxbio (RGNX), and Lexeo Therapeutics (LXEO).
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