The stock market—and biotech insiders—reacted negatively to the allegedly forced resignation of CBER Director Peter Marks, who said RFK Jr. does not seek “truth and transparency” but rather “subservient confirmation of his misinformation and lies.”
Shares of several biotechs tumbled Monday after news broke this weekend that Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, had resigned.
Marks’ “abrupt resignation” equals a “new wave of uncertainty at FDA,” BMO Capital Markets said in a Monday investor note.
Marks, who has helmed the CBER division since 2016, has been a staunch supporter of vaccines, accelerated approval and regulatory flexibility for gene therapies for rare diseases. While Marks had made clear his intention to stay in his role under the new Trump administration, he was forced Friday to choose between resignation and being fired, according to several media outlets.
In his resignation letter, Marks said he was “willing to work” to address the concerns expressed by Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. about the safety of vaccinations. However, “it has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies,” he wrote.
Kennedy, who was confirmed as HHS secretary in February, has a long history of vocal vaccine mistrust—something that was broadly raised during his Senate confirmation hearings.
“We view this departure as a significant negative for the biopharma and biotech sectors, as FDA’s independence rooted in sound scientific rigor is critical for their efficient functioning,” the BMO analysts added in their note.
Marks’ departure follows that of several other prominent FDA leaders, including Patrizia Cavazzoni, who left her post as head of the agency’s Center for Drug Evaluation and Research (CDER) in January, resurfacing as Pfizer’s new chief medical officer last month. According to a Monday investor note by William Blair, Oncology Center of Excellence (OCE) deputy directors Paul Kluetz and Marc Theoret also plan to leave the agency “imminently” and “there are concerns that [OCE Director] Richard Pazdur . . . may also be at risk of leaving.”
As was indicated by Marks in his resignation letter, the main points of contention between him and Kennedy were vaccine safety and transparency, the latter of which has also been a concern for the FDA and biotech companies since President Donald Trump took office in January.
In reference to the job cuts enacted at the FDA in February shortly after Kennedy’s confirmation, Ovid Therapeutics CEO Jeremy Levin told BioSpace, “The extent and the rapidity of the actions taken has been remarkable, and that has perhaps led to, in many cases, the concern that there is no understanding of exactly why they’re being done.”
In a LinkedIn post this weekend, Levin expressed “grave concern” over Marks’ resignation. “His resignation is far more than the departure of a highly respected figure. It is a stark and unequivocal warning,” Levin wrote. “In this letter—especially in the final paragraphs—Dr. Marks makes clear that the FDA, long held as the gold standard in global regulatory science, is now under threat from political interference and the systematic distortion of scientific truth.”
The biotech stock market appeared to heed this warning, as gene therapy– and vaccine-focused companies including Taysha Gene Therapies, Solid Biosciences, Sarepta and Novavax, all fell between 5% and 10% before the bell on Monday, Reuters reported.
“Our industry conversations over the weekend suggest the resignation of Dr. Peter Marks . . . was a negative surprise, and we expect companies with vaccine businesses to be volatile this week as investors digest this update,” Truist Securities wrote in a note Monday morning. The analysts also expressed concern that “a CBER yes-person may expand the influence of RFK Jr’s vaccine rhetoric.”
Marks’ last day at CBER will be this Saturday, April 5.
