RBC Capital analyst Brian Abrahams believes the resignation of the head of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, is “not good for the biotech industry even beyond vaccines.” Marks had been a key advocate for more flexible, efficient approval processes for drugs, particularly those for orphan diseases such as gene therapies, the analyst tells investors in a research note. Additionally, the news highlights risk of further attrition among leaders and personnel at the FDA potentially frustrated with Robert F. Kennedy Jr.’s “lack of expertise/experience, which could slow engagement with drugmakers and drug review processes,” contends RBC. The firm expects some weakness for biotech stocks “as uncertainty continues to be perpetuated.” RBC believes the companies in its coverage that could see the greatest impact include Sarepta (SRPT) (SPRT), Legend Biotech (LEGN), Gilead (GILD), Regeneron (REGN), Vertex Pharmaceuticals (VRTX), PTC Therapeutics (PTCT), Galapagos (GLPG), Regenxbio (RGNX), Avidity Biosciences (RNA), Dyne Therapeutics (DYN), Moderna (MRNA), Karyopharm (KPTI), MeiraGTx (MGTX), and Pacira (PCRX).
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