Moderna’s stock soared after the company and Merck announced that an experimental mRNA-based melanoma treatment met key Phase 3 endpoints, even though the complete trial results have not been published, intensifying calls from physicians and researchers for the underlying data.
By yourNEWS Media Newsroom.
Moderna’s announcement of successful late-stage results for an experimental mRNA-based melanoma treatment triggered a dramatic Wall Street reaction this week before physicians, researchers or the public were given access to the complete clinical-trial data behind the claims.
Shares of the biotechnology company climbed 177% following the cancer-treatment announcement, an extraordinary increase that followed a 357% gain earlier this year.
The surge came after Moderna and Merck announced “positive topline results” from their Phase 3 INTerpath-001 study evaluating intismeran in combination with Merck’s Keytruda in melanoma patients following removal of cancerous tumors. Moderna’s announcement said the trial achieved its primary endpoint of “recurrence-free survival” and secondary endpoint of “distant metastasis-free survival.”
The companies have not yet published the complete Phase 3 results, Just the News reported.
Moderna has said the data will be “presented at an upcoming international medical meeting and shared with regulatory authorities.”
That gap between the announcement and public availability of the underlying evidence became an immediate focus among physicians and researchers as discussion of Moderna’s announcement spread on X.
“No data presented, no paper published – but apparently the stock market has already completed peer review,” Charlotte Kupperwasser, a cancer biology professor at Tufts Medical School, wrote on X.
Joseph Marine, vice director for operations in Johns Hopkins Hospital’s cardiology division, also questioned the response to the preliminary announcement.
“Seeing numerous doctors and scientists hail this [Moderna cancer] ‘breakthrough,’” Marine wrote.
He subsequently described what he views as a broader process through which “pharma companies manipulate the US health system” into paying the “highest drug prices in the world, even for many products that produce minimal real-world results.”
“Press release amplified by ‘thought leaders’ produces media feeding frenzy and huge pop in stock price,” Marine wrote. “Public and market expectations are now permanently anchored into ‘breakthrough miracle cure.’ Even if published trial results are much more modest […] the public will demand that government and insurance companies pay” the “astronomical” prices.
“These corporations have learned how to play the medical-scientific establishment like a Stradivarius,” Marine wrote.
His comments were circulated further on X.
The experimental melanoma product, which Moderna has been developing with Merck, is generally described as a personalized cancer vaccine. One physician commenting on the announcement argued that the treatment is technically not a “vaccine”, while another highlighted that the announcement did not specify how long the reported benefit lasted.
The criticism does not establish that Moderna’s melanoma results will prove unsuccessful when the complete data are released. Instead, the dispute centers on how much can be concluded from topline corporate statements before the underlying trial figures, adverse-event information, subgroup analyses and other details become available for independent examination.
Mary Talley Bowden, a physician and medical-freedom activist who has previously faced professional consequences after questioning COVID-19 vaccines, responded directly to Moderna.
“Show us some actual data,” Bowden wrote.
“Remember that press release when you told us [the] Covid-19 vaccine was 94.5% effective in preventing transmission?” she added.
Her comment referred to the publicity surrounding Moderna’s original COVID-19 vaccine, whose Phase 3 efficacy announcement received broad attention. Subsequent discussion has focused on the distinction between relative and absolute risk and on how the trial’s efficacy figures were interpreted.
Sportswriter Luke Epplin also became part of the online debate after praising his wife, Merck Vice President of Oncology Jane Healy, as a “superstar”.
After users raised questions about the findings and challenged the limited information disclosed, Epplin responded, “Isn’t my wife awesome?”
The exchange was also widely circulated on X.
The debate over disclosure comes only two weeks after the FDA approved Moderna’s mRNA influenza vaccine, the first mRNA flu vaccine to receive U.S. authorization.
Moderna, which received billions of dollars connected to development and sales of its COVID-19 vaccine, announced the flu approval at approximately 10 p.m., before the FDA had publicly posted the agency’s decision. Moderna issued its announcement that night, and its shares were up approximately 4% the following morning.
The approval represented an important development for Moderna after revenue fell sharply with declining demand for COVID-19 vaccines. Pfizer faced similar market conditions and canceled a trial this spring involving an updated mRNA COVID-19 vaccine.
A detailed report by Just the News questioned both the presentation of the melanoma announcement and public access to data supporting Moderna’s newly approved influenza product.
The publication previously reported that Moderna’s mRNA influenza shot had a higher rate of serious adverse events than a conventional flu vaccine in the comparison it examined and said approximately 5,000 vaccinations would be required to prevent one hospitalization. It drew a comparison with safety questions previously raised regarding Moderna’s Omicron-specific COVID-19 vaccine.
Data from what has been described as the “pivotal clinical trial” supporting the mRNA influenza vaccine approval were still not publicly available through the National Institutes of Health’s ClinicalTrials.gov, according to FDA adviser Retsef Levi.
“Is it not mandated?” Levi asked, directing his question to NIH Director Jay Bhattacharya and Health and Human Services Secretary Robert F. Kennedy Jr. “How come the data from the major trial used for approval [is] not publicly reported?”
Levi co-authored a 2022 peer-reviewed study that found COVID vaccination was “significantly associated” with an increase in emergency cardiovascular events among young people in Israel during the period examined.
Robert Malone, an early mRNA researcher, responded to the dispute, “Rules for thee but not for me.”
The exchange over the unavailable flu-trial information was also shared broadly on X.
Questions about how medical products are evaluated before becoming widely accepted have emerged elsewhere as well.
A new randomized trial involving Roche’s oseltamivir, better known as Tamiflu, reported fatality rates of about 20% among critically ill influenza patients receiving the drug for five to 10 days, compared with approximately 14% in the control group.
The study has not yet been peer-reviewed.
Tamiflu, which has generated an estimated $18 billion, has long been widely used and stockpiled.
Harvard Medical School professor Paul Sax wrote in New England Journal of Medicine Voices that the research was the first to compare the drug with “no antiviral treatment in a randomized trial of critically ill patients with influenza.”
“We somehow reached a point where a drug was routinely given, endorsed by guidelines, placed on the World Health Organization’s Essential Medicines List specifically for severe influenza, and stockpiled by governments – all without that trial ever having been done,” Sax wrote.
Former New York Times pharmaceutical-industry reporter Alex Berenson highlighted the Tamiflu findings and separately pointed to another example involving a gonorrhea vaccine.
Berenson had previously questioned the risks of promoting medical interventions before rigorous randomized evidence is available, citing a gonorrhea vaccine study published in the New England Journal of Medicine.
That randomized, placebo-controlled trial involved men who have sex with men and followed earlier observational research that had suggested the vaccine might provide a benefit. According to the material cited, the randomized trial found no benefit for the treatment group and identified serious harms among some participants.
“Not one mainstream American news outlet reported the vaccine’s failure” and England is “so far still recommending it despite the new results,” Berenson wrote.
The controversy over publication standards has also extended into research critical of COVID-19 vaccines.
Kupperwasser said earlier this month that a paper by Levi and former FDA drug evaluation chief Tracy Beth Hoeg examining “observed-to-expected fetal losses” following COVID vaccination remained in “pre-print purgatory because of journal gatekeeping”.
She connected the issue to her own writing about scientific gatekeeping involving “early warning signals” for cancer.
Kupperwasser told Just the News that five journals had received the fetal-loss preprint, which is now more than a year old, and had “rejected it without external peer review” without providing transparent explanations.
The contrasting experiences have fueled a larger argument among the physicians and scientists quoted in the debate: preliminary corporate announcements can immediately generate market value and favorable attention, while other medical research may remain unpublished or unavailable for extended periods.
For Moderna, the financial implications are particularly significant. The company’s fortunes rose sharply during the COVID-19 pandemic through its mRNA vaccine and the billions in revenue and government support connected to it, before declining as demand for COVID vaccinations fell.
Its newest growth prospects now include an FDA-approved mRNA influenza vaccine and an experimental individualized melanoma therapy that has not yet received FDA approval.
Whether the extraordinary market response to the melanoma announcement is ultimately supported by the complete Phase 3 findings will depend on data Moderna and Merck have said they will disclose at a future international medical meeting.
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