FDA's cell and gene therapy supervisors collectively suspended gene editing stocks and were hit again

The Zhitong Finance App noticed that at the beginning of the US stock market on Friday, the overall stock price of gene editing companies remained stable, then fell along with the general market. Earlier, the US FDA Biological Products Evaluation and Research Center (CBER) had another sudden personnel change — following the sudden departure of former director Dr. Peter Marx at the beginning of the year, the head and deputy director of its cell and gene therapy department were collectively suspended on Wednesday.

Nicole Weldon, director of CBER's cell and gene therapy department, and her deputy Rachel Annato were suspended and escorted out of the agency after a full staff meeting was held on Wednesday, according to several media reports. The personnel earthquake occurred a few weeks after the new CBER director Dr. Vinay Prasad took over the department, and Prasad succeeded Dr. Max, who was also forced to leave office in March.

US Department of Health and Human Services (HHS) press secretary Andrew Nixon issued a statement to the British pharmaceutical media “Pink Sheet” saying that Weldon and Anato's supervisory philosophy disagree with Prasad. Center directors deserve the support of the management team, and these managers must agree with our positive goal of using scientific gold standards to accelerate the treatment of rare diseases.”

The stock price of gene therapy developers was sold off in May, when FDA Director Marty Macari announced the appointment of Prasad to head CBER. The scholar, known for his sharp criticism of the FDA's past regulatory work — including the controversial approval of Sarepta treatment (SRPT.US) and Elevidys, a gene therapy for Duncan muscular dystrophy developed by Roche — also recently served as FDA's Chief Medical Officer and Chief Scientific Officer.

Despite CBER's human turmoil, the stock prices of leading gene-editing pharmaceutical companies Editas Medicine (EDIT.US), Intellia Therapeutics (NTLA .US), Beam Therapeutics (BEAM .US), and CRISPR Therapeutics (CRSP .US) rose for a while. However, the stock price of Capricorn Therapeutics (CAPR.US), which is promoting priority review of cell therapy deramiocel (for Duchenne muscular dystrophy), fell by more than 10%. It is reported that Weldon is the key official responsible for overseeing the drug's marketing application.