Moderna MRNA shares surged in premarket trading on Wednesday after the company said its mRNA vaccine, when combined with Merck’s Keytruda immunotherapy, delivered positive results in a late-stage trial for skin cancer.
At one point, before the bell, the stock doubled, jumping more than 99% to $125.68, from Tuesday’s close of $62.96, putting it on track for its highest level since 2024.
At the time of writing, it was up over 87%.
Merck shares also rose over 7% before the market opened.
The results marked the first positive outcome from a late-stage trial of Moderna’s mRNA cancer vaccine, known as Intismeran.
The companies said interim results showed that the treatment met both the primary goal of reducing cancer recurrence and the secondary goal of preventing the disease from spreading to other parts of the body.
“Today’s results represent a landmark moment for adjuvant melanoma treatment,” said Professor Georgina Long, the study’s principal investigator and medical director of Melanoma Institute Australia.
How does Moderna’s cancer vaccine work?
The treatment combines Merck’s Keytruda immunotherapy with a personalized mRNA vaccine developed by Moderna.
Unlike conventional vaccines, the therapy is designed using an analysis of mutations found in an individual patient’s tumor.
The aim is to train the immune system to recognize and attack cancer cells carrying those specific mutations.
The phase-three trial enrolled 1,137 patients with high-risk stage IIB to stage IV melanoma whose tumors had been surgically removed.
Participants were randomly assigned to receive up to nine doses of the personalized vaccine alongside Keytruda for about a year, or Keytruda alone.
The companies said no new safety signals emerged during the trial.
The study remains ongoing, with Moderna and Merck planning to present the findings at an upcoming medical meeting and share the results with regulators.
The latest findings build on results announced in January from a mid-stage study, which showed that the treatment reduced the risk of recurrence or death by 49% after five years.
Investors see potential beyond melanoma
The results are particularly important for Moderna as it attempts to rebuild its business following the sharp decline in demand for Covid-19 vaccines.
The company became one of the biggest corporate success stories of the pandemic as its mRNA vaccine played a central role in the global response to Covid-19.
But sales have since fallen sharply as vaccination demand has weakened.
Even after Wednesday’s surge, Moderna shares remained roughly 75% below their 2021 peak, when the company was riding the success of its Covid-19 vaccine.
Moderna has been trying to diversify its portfolio, including through an FDA-approved flu vaccine and experimental vaccines targeting diseases such as norovirus and Lyme disease.
The cancer program, however, has emerged as one of the most closely watched parts of its pipeline.
Barclays analysts said last month that they expect the melanoma treatment could generate around $3 billion in annual sales by 2035.
Leerink Partners analyst Mani Foroohar had previously described the phase-three results as a make-or-break event for Moderna’s stock.
Cancer pipeline could reshape Moderna
Analysts have also pointed to the possibility that the technology could eventually be used across multiple cancer types.
Moderna and Merck are studying the personalized vaccine approach in trials involving other tumors, including non-small cell lung cancer, bladder cancer and renal cell carcinoma.
That broader opportunity is a major reason investors have been watching the melanoma trial closely.
A successful treatment could potentially validate Moderna’s personalized mRNA platform beyond a single cancer indication.
The latest results therefore represent more than a single clinical milestone.
They offer Moderna investors evidence that the company’s mRNA technology may have a future beyond the pandemic, while potentially opening a new avenue for growth in one of the pharmaceutical industry’s most competitive areas.
Melanoma remains the deadliest form of skin cancer.
More than 1.5 million people in the US were living with the disease in 2023, according to the National Cancer Institute.
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