Biotech investors are grappling with fresh uncertainty following the abrupt resignation of Dr. Peter Marks, a key figure in the US Food and Drug Administration.
Marks, who was instrumental in Operation Warp Speed and known for championing fast-tracked drug approvals, announced his departure on Friday, citing fundamental disagreements with Health and Human Services Secretary Robert F Kennedy Jr.
In a resignation letter obtained by CNBC, Marks accused Kennedy of spreading “misinformation and lies” about vaccines, warning that a growing measles outbreak linked to declining immunization rates was a direct consequence of such rhetoric.
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.
Biotech stocks suffer worst drop in months
Marks’ exit sparked fears that Kennedy’s influence could extend beyond vaccines to the broader drug-approval process, potentially shifting the FDA’s stance on innovative treatments such as gene therapies and mRNA vaccines.
The reaction was swift on Wall Street. On Monday, biotech stocks suffered their worst single-day decline in months.
Moderna tumbled 13%, Beam Therapeutics—known for its gene-editing technology—fell over 15%, and gene therapy developer Sarepta Therapeutics lost 9%.
Meanwhile, the SPDR S&P Biotech ETF slid nearly 5%.
Shares of Pfizer, which has broader businesses to insulate it from damage to its vaccine portfolio, lost about 2% before recovering some losses.
“Taking a step back, 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,” analysts at BMO Capital Markets wrote in a note.
Marks is the third high-ranking official to leave the FDA this year, following the exits of drug chief Dr. Patrizia Cavazzoni and human foods chief Jim Jones.
Some investors had hoped that newly appointed FDA Commissioner Dr Marty Makary, a former Johns Hopkins surgeon, would help insulate the agency from political influence.
RFK Jr.’s growing influence raises concerns
Kennedy, a long-time vaccine skeptic, has already taken steps that public health experts say could undermine immunization efforts in the US.
He has downplayed the importance of childhood vaccines, while the Centers for Disease Control and Prevention has launched a study into widely debunked claims linking vaccines to autism—led by a researcher with a history of spreading misinformation.
Analysts at Leerink Partners warned that the fallout from Marks’ resignation would depend on his replacement and whether Republican leaders in Washington begin pushing back against Kennedy’s policies.
“Will new FDA Commissioner Marty Makary be able to support scientifically-proven research and products and effectively manage upward with RFK Jr., or will he ultimately face the same fate as Dr. Marks?” asked David Risinger, an analyst at Leerink Partners.
Future of FDA remains uncertain
Despite Monday’s turmoil, some analysts cautioned against assuming the worst for the biotech sector.
“Though many believe the Marks resignation is a very bad omen for the healthcare industry and innovation at large, it may be a bit premature to cast too dark of a shadow on the entirety of pharma and biotech,” wrote Mizuho Securities analyst Jared Holz.
For vaccine makers like Moderna, however, the outlook appears bleak.
The company’s stock is down 75% year-to-date, reflecting broader concerns about the sector’s future under Kennedy’s leadership.
While the FDA’s direction remains uncertain, investors are left questioning whether regulatory risks will continue to rise—or if recent stock declines present a buying opportunity.
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