Shares of biotechnology company Moderna (MRNA) made a dizzying leap, surging more than 100% in premarket trading on Wednesday to reach $122.51. The reason for such excitement was the announcement of positive results from the third phase of clinical trials of a personalized mRNA cancer vaccine, developed in collaboration with pharmaceutical giant Merck (MRK).
It is worth emphasizing that at the close of trading on Tuesday, Moderna shares on the New York Stock Exchange were worth $62.96, and the main session had not yet begun. However, investors have already reacted swiftly, pricing in a potential revolution in the treatment of oncological diseases.
Breakthrough in Personalized mRNA Therapy
As part of the INTerpath-001 study, a fundamentally new approach was tested. Doctors analyzed mutations in each individual patient's tumor, after which Moderna created a personalized mRNA vaccine encoding up to 34 tumor targets, so-called neoantigens. In essence, the drug "trains" the immune system to precisely recognize and attack exactly those cells that need to be destroyed.
The study involved 1,137 patients with stage IIB–IV melanoma — one of the most aggressive forms of skin cancer — after surgical intervention. The results are impressive: those who received the vaccine in combination with Merck's Keytruda remained relapse-free longer than patients taking only Keytruda. Moreover, the combination significantly slowed the spread of cancer throughout the body.
This is particularly important because Keytruda is considered the standard of care for such patients. Previously, no drug had surpassed it after surgery. According to a joint statement from the companies, no mRNA cancer therapy has yet successfully completed a third phase of research. The safety profile remained unchanged: no new side effects were identified.
The market scale is enormous: in the United States alone, Merck expects about 112,000 new cases of melanoma and more than 8,500 deaths in 2026. In an earlier interim study, the combination reduced the risk of recurrence or death by 49% over a five-year horizon. Moderna CEO Stéphane Bancel called the results a "turning point for oncology," noting that the idea of creating a drug tailored to a specific patient's tumor had recently seemed unattainable.
Outlook for Moderna Shares
Few stocks needed a rebound as badly. In August 2021, Moderna traded above $480 — when COVID-19 vaccine sales made it a market favorite. However, after the decline in demand, the shares lost more than 90% of their value.
The recovery began before Wednesday. In 2026, the shares had already more than doubled, aided by the approval of a flu vaccine and the expansion of the product pipeline. On Wednesday, the shares briefly rose to nearly $130, closing around $122. Merck shares gained about 6%.
However, caution remains. Detailed efficacy data have not yet been published, and information on patient survival is still being collected. The companies plan to disclose all results at a medical conference and discuss the data with regulators. The same combination is currently being tested in nine studies for lung, bladder, and kidney cancers.
The key question is whether the premarket rally can hold after the main session opens. In the long term, in my view, this is not just a corporate victory but a paradigm shift in oncology. But investors should remember: years will pass before widespread adoption and, consequently, real revenue, and volatility in biotech is the norm.