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EyesOn BioPharma News
We've had EyesOn some of the latest News Makers in the BioPharma Sector. Today we're covering two that caught our interest, Moderna's cancer vaccine data + the new choice for the FDA Commissioner.
Moderna was in the news again after a phase 3 announcement that increased Moderna’s market capitalisation by $45 billion. Experts have started to wonder if the vaccine’s use will be as widespread as Keytruda - this question could define cancer therapy in the years to come.
Following the announcement of a topline victory from a phase 3 trial of its cancer vaccine, which is partnered with Merck & Co., Moderna’s share price closed up 177%. Analysts attributed the increase to the participation of short sellers and retail investors, respectively, but this only partially explains the increase. Merck’s stock, which has a significantly higher market capitalisation, ended the day up over 13%.
The potential for the cancer vaccine intismeran autogene to function in conditions other than the adjuvant melanoma indication covered by last week’s INTerpath-001 update is reflected in the stock rises. Adjuvant melanoma sales could surpass $2 billion, according to experts, although wider application will be required to support Moderna and Merck’s recently increased values.
As experts pointed out, the discussion among investors will not focus on whether this product can be as broad as Keytruda or how much the ITerpath-001 data has reduced the risk of intismeran in other cancer situations. By confirming the checkpoint inhibitor across a wide range of applications, Merck increased Keytruda sales to above $30 billion annually. Moderna informed investors last month that there is more reason to think intismeran will be effective against Keytruda-vulnerable diseases.
Whether Intismeran functions outside of those environments is the key question.
Even without accounting for the possibility that intismeran could be effective in conditions where checkpoint inhibitors have failed, including pancreatic cancer, analysts have produced enormous revenue projections. Analysts estimated that Moderna could book $5.4 billion in intismeran sales in melanoma by 2040 under its 50/50 profit-share agreement with Merck, based on the phase 3 success.
Sales of $10 billion for non-small cell lung cancer (NSCLC) and $3.3 billion for renal cell carcinoma (RCC) are now included in the analysts’ Moderna model for 2040. Analysts believe that RCC has upside potential, pending the development of more potent treatments for this high-unmet-need indication.
Nine phase 2 and 3 trials are being conducted by Merck and Moderna, offering prospects beyond melanoma, NSCLC, and RCC.
The trials provide Moderna with an opportunity to expand beyond its flatlining COVID-19 vaccine business. The trials are crucial for Merck as well. According to experts, intismeran may play a significant role in the company’s expansion as it attempts to deal with biosimilar and pricing pressure for Keytruda beginning later this decade. In 2028, Keytruda may encounter competition from biosimilars.
According to analysts, Merck and Moderna need a hazard ratio of 0.65 or below to clearly differentiate intismeran. The next question is whether the excitement survives a look at the complete data from the adjuvant melanoma trial. The analysts warned that the share price swings with significantly more confidence than the data released thus far supports, therefore a hazard ratio above 0.75 would underwhelm them.
If the phase 3 figures are poor, the impact might affect several companies. Arcturus Therapeutics and BioNTech’s stock prices ended the day up over 20%. Some analysts interpreted the Merck-Moderna result as a positive signal for BioNTech’s cancer vaccine, while others noted that intismeran might increase interest in Arcturus’ platform.
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President Trump has announced his choice for the FDA’s next commissioner, following three months without a permanent head.
Currently serving as a White House adviser, Heidi Overton, M.D., Ph.D., will appear before the Senate in an attempt to become the nation’s top drug regulator. In a Truth Social post, Trump affirmed his decision.
The president said, “Dr. Heidi has been a ROCKSTAR in my Administration, where she has worked directly with Secretary Kennedy, Dr. Oz, and team to deliver on the MOST TRANSFORMATIVE Health Agenda in History. To make sure that the United States continues to be the WORLD LEADER in scientific discovery and cures, we now need her leadership at the FDA.”
After graduating from the University of New Mexico School of Medicine, Overton went east to pursue a PhD in clinical investigation at the Johns Hopkins University Bloomberg School of Public Health.
After serving as a White House fellow during Trump’s first term, she switched to the America First Policy Institute, a right-wing thought group created in 2021 by other Trump administration alumni, after he was not reelected in 2020. She was the chief policy officer and director of the Center for a Healthy America, which was affiliated with MAHA.
Overton returned to Trump as deputy director of the White House Domestic Policy Council following his reelection in 2024.
Overton must withstand a grilling by the Senate Committee on Health, Education, Labour, and Pensions, led by lame-duck Republican Louisiana Sen. Bill Cassidy, M.D., even though she has been rumoured as a front-runner for FDA leadership since former Commissioner Marty Makary, M.D., left in May.
After losing his reelection primary to a Trump-backed candidate, Cassidy - a physician himself - has become a potential point of contention for the administration’s nominations. Cassidy held his nose to vote for Robert F. Kennedy Jr.’s confirmation as Health and Human Services Secretary.
Kennedy claims that Overton has proven her capacity to question presumptions, demand perfection, and transform audacious concepts into significant outcomes. She would improve the safety of food supply, modernise medication approvals, unleash American medical innovation, expedite access to life-saving therapies, increase the agency’s accountability and transparency, and reinstate Gold Standard Science as the cornerstone of every decision.
Kyle Diamantas, a member of the FDA’s food control division, has been in charge of the agency since Makary left. The FDA has appeared more stable under Diamantas, reversing some contentious decisions but continuing to implement changes aimed at accelerating drug development.
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