Shares of Moderna (MRNA +6.23%) are falling on Monday. The company's stock lost 7.9% as of 1:30 p.m. ET and was down as much as 13.9% earlier in the day. The steep decline comes as the S&P 500 and Nasdaq Composite lost 0.4% and 1.1%, respectively.
The vaccine maker's shares tumbled following the resignation of a key U.S. Food and Drug Administration (FDA) official who oversaw vaccine approvals.
NASDAQ: MRNA
Key Data Points
The top FDA vaccine regulator leaves
Peter Marks, who led the FDA's Center for Biologics Evaluation and Research (CBER), resigned Friday. As the head of CBER, Marks was critical in the rapid approval of COVID-19 vaccines during the pandemic and, more recently, was heavily involved in the regulator's oversight of cutting-edge cell and gene therapies.
The resignation came amid pressure from Donald Trump's Health and Human Services Secretary, Robert F. Kennedy Jr., a known vaccine skeptic. Marks stated in his resignation letter that it was "clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies."
It's not a good sign for the industry
BMO Capital Markets analyst Evan David Seigerman called the resignation a "significant negative" for biotech and biopharma companies, especially vaccine manufacturers like Moderna. He explained that the "politicization of FDA runs counter to the agency's mission" and introduces major uncertainty for drugmakers. Moderna could see its vaccine development programs delayed as the FDA takes a less friendly or possibly hostile stance. I would avoid Moderna and other biotechs until a clearer picture emerges as to how the FDA seeks to move forward.
