Gene editors steady despite latest leadership shake-up at FDA

Shares of gene editing companies were largely steady in the premarket on Friday after the FDA’s Center for Biologics Research and Evaluation (CBER) faced another abrupt leadership transition following the sudden departure of its former head, Dr. Peter Marks, early this year.

According to multiple media reports, the director and deputy director of the CBER’s cell and gene therapy division were placed on administrative leave and escorted out of the agency following an all-hands meeting on Wednesday.

The sudden departures of Nicole Verdun, FDA’s Super Office Director of Therapeutic Products, and her deputy Rachael Anatol came weeks after new CBER head Dr. Vinay Prasad took over the division, replacing Marks, who was also forced out of the agency in March.

In a statement to the U.K. pharma publication Pink Sheet, the Health and Human Services (HHS) Department’s press secretary, Andrew Nixon, indicated that the views of Verdun and Anatol diverged from those of Dr. Prasad.

“Center directors deserve to be supported by managers that are aligned with aggressive goals to expeditiously advance therapeutics for rare diseases using the gold standard of science,” Nixon said.

Gene therapy developers sold off in May after the FDA Commissioner, Dr. Marty Makary, announced Dr. Prasad as the new CBER head.

A fierce critic of the FDA’s prior regulatory work, including the controversial approval of Elevidys, a gene therapy developed by Sarepta Therapeutics (NASDAQ:SRPT) and Roche (OTCQX:RHHBY) for Duchenne muscular dystrophy, also became the agency’s chief medical officer and chief scientific officer recently.

Leading gene-editing drug developers Editas Medicine (NASDAQ:EDIT), Intellia Therapeutics (NASDAQ:NTLA), Beam Therapeutics (BEAM), and CRISPR Therapeutics (CRSP) were all in the green notwithstanding the latest changes at the CBER.

However, Capricor Therapeutics (NASDAQ:CAPR), whose cell therapy candidate, deramiocel, is currently under FDA priority review, traded lower. Verdun is said to be a key official tasked with overseeing the company’s marketing application for deramiocel, targeted at Duchenne Muscular Dystrophy.