Ex-FDA Official Ejected By RFK Jr. Joins Firm — Will Investors Warm Up?
Investors reacted to the company’s leadership shake-up and new data from its ulcerative colitis therapy Omvoh showing sustained remission over four years.
Eli Lilly’s stock slid marginally in extended trading on Tuesday after the drugmaker said that Peter Marks, the former top vaccine regulator in the U.S. Food and Drug Administration who was ousted earlier this year, has joined the company to lead molecule discovery and infectious disease research.
Shares of Eli Lilly closed down 0.2% at $843.63 to end Tuesday’s regular session, and slipped a further 0.02% in after-hours trading.
Marks, who was at the center of the COVID-19 vaccine push in Donald Trump’s first term, resigned in March after Health Secretary Robert F. Kennedy Jr. gave him an ultimatum to resign or be terminated, Reuters reported.
Marks had been the director of the Center for Biologics Evaluation and Research (CBER) since 2016 and became one of the most public-facing scientists during the COVID-19 pandemic, leading Operation Warp Speed, the government effort to speed up vaccine development. In 2021, while already running CBER, he also took over direction of the office within CBER responsible for vaccine approval decisions.
His sudden ouster earlier this year unsettled the biotech sector, where he was regarded as a supporter of faster approvals for rare disease and gene therapies. RBC Capital said his exit was “not good for the biotech industry even beyond vaccines,” while analysts at Cantor Fitzgerald called for Kennedy’s removal, saying he was “undermining the trusted leadership of healthcare in this country.”
Meanwhile, Lilly said Marks’ expertise will strengthen its work in both existing and emerging therapeutic areas, adding that it continues to evaluate breakthrough science that could benefit patients. Leerink Partners’ David Risinger said Marks’ background in gene therapies and rare diseases would add significant value to the drugmaker.
Marks’ move follows a string of similar industry transitions by former FDA leaders, including Patrizia Cavazzoni, who became Pfizer’s chief medical officer in February, and ex-FDA Commissioner Scott Gottlieb, who serves on Pfizer’s board.
Meanwhile, Lilly also unveiled fresh clinical data on Tuesday showing that its ulcerative colitis drug Omvoh aided long-term remission of up to four years in patients. The results of the Phase 3 LUCENT-3 study, presented at the United European Gastroenterology (UEG) Week in Berlin, showed a durable remission on key endpoints of symptom relief and steroid-free control of disease, even in patients who had failed other advanced therapies previously.
The company said Omvoh’s safety profile remained stable over the four-year period with no new concerns identified. Lilly added that it’s continuing to test new combination approaches in inflammatory bowel disease and explore the role of incretin-based therapies in immune disorders. Omvoh is already approved to treat ulcerative colitis and Crohn’s disease in adults and has regulatory clearance in 44 countries worldwide.
On Stocktwits, retail sentiment for Eli Lilly was ‘bearish’ amid ‘normal’ message volume.
“Lol, Peter Marks now hired by $LLY. We all know how much he loved $SRPT time to buy them for cheap now,” posted one user, referring to Mark’s controversial decision last year to overrule three separate review teams on Sarepta Therapeutics’ Duchenne muscular dystrophy treatment, Elevidys.
Another user expressed a bearish view, suggesting that Eli Lilly’s stock could retreat toward the $800 level.
Eli Lilly’s stock has risen nearly 10% so far in 2025.
For updates and corrections, email newsroom[at]stocktwits[dot]com.