Vaccine Stocks Tank, Moderna Craters After FDA Biologics Head Abruptly Steps Down

Vaccine stocks tumbled in the early U.S. cash session after Peter Marks—a top FDA regulator and pro-vaxxer—abruptly resigned on Friday.

Wall Street analysts view Marks' departure as a bearish signal for vaccine stocks, such as Moderna, Novavax, BioNTech, and others, which already face mounting headwinds, including a wave of layoffs expected at the Department of Health and Human Services.

Moderna puked at the open, down 12% in early trading, while the SPDR S&P Biotech ETF sank 2%. Other makers of vaccine stocks plunged, including Novavax -10% and BioNTech -5.8%.

Moderna shares are also down 95% from peak Covid highs.

Bloomberg provided color on Marks' role and how his departure is bearish for the industry: 

As the leader of the FDA's Center for Biologics Evaluation and Research, Marks was a key figure in the quick approvals of Covid vaccines during the pandemic. Along with shots, he was responsible for the agency's evaluation of cutting-edge treatments such as cell and gene therapies.

In his resignation letter, Marks cited friction with the views of Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine critic.

"I was willing to work to address the Secretary's concerns regarding vaccine safety and transparency," he said. "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."

Analysts—including BMO Capital Markets' Evan David Seigerman—view the departure as a "significant negative" for the biotech and biopharma sectors.

"It's no secret that Biotech has been under immense pressure recently given broader macro issues, this unfortunate update does nothing to reassure investors or provide relief," Seigerman told clients, adding that gene and cell therapy companies are under pressure given Marks' relationship with many of them. 

Here's further analyst insight into the change of guard at the FDA in the era of Robert F. Kennedy Jr. running the Department of Health and Human Services (courtesy of Bloomberg):

William Blair, Matt Larew

• Expects in the space could weaken further given that Marks "was a cheerleader for innovation in biotech and strong supporter of new modalities"

• Says Marks's departure and the recently announced HHS cuts stack on top of "an unsettlingly large pile of news flow in the space year-to-date that creates uncertainty for funding, regulatory and approval processes, and supply chains"

• Adds that the steady stream of negative news flow "has simply been too much for stocks in the space to overcome

RBC Capital Markets, Brian Abrahams

• Says the news is not good for the biotech industry even beyond vaccines, as Marks had been a key advocate for more flexible, efficient approval processes for drugs particularly those for orphan diseases such as gene therapies

• "We expect some weakness for biotech as uncertainty continues to be perpetuated"

Truist, Joon Lee

• Says news of the resignation could put some pressure on companies whose drugs are currently, or planned to be, under review by the FDA's Center for Biologics Evaluation and Research

Last week, Bloomberg reported that leaked documents reveal the Trump administration plans to slash $28 billion in global health initiatives—including funding cuts to Bill Gates' vaccine alliance, Gavi.

Meanwhile...

• USAID Panic Mode: Bill Gates Goes On MSM, Bashes Musk's DOGE, Fear-Mongers About Next Pandemic

• Climate Group Controlled By Bill Gates Hit By Layoffs

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