Is Cancer the Next Breakthrough for Moderna After COVID-19?

Shares of Moderna MRNA soared 177% yesterday, hitting a 52-week high, as investors appeared to receive the clinical validation they had been waiting for as the company works to build a business beyond COVID-19 vaccines.

The one-day surge added more than $44 billion to Moderna’s market capitalization after the company and its partner, Merck MRK, announced positive phase III results for their personalized mRNA cancer therapy, intismeran autogene (V940/mRNA-4157).

Moderna’s Cancer Therapy Delivers First Phase III Win

The late-stage study, called INTerpath-001, evaluated intismeran in combination with Merck’s blockbuster immunotherapy Keytruda in patients with high-risk (Stage IIB-IV) melanoma whose tumors had been removed through surgery. About two-thirds of the patients received the combination, while the rest received Keytruda alone.

The study met its primary endpoint of recurrence-free survival (RFS), which measures how long patients remain free without their cancer returning. The regimen also met a key secondary goal of distant metastasis-free survival (DMFS), meaning patients stayed free of cancer spreading to other parts of the body for longer.

Although Moderna and Merck did not report any numbers to support the results, they stated that the improvements were both statistically significant and clinically meaningful. The companies said that the results represent the first positive phase III readout for an individualized neoantigen therapy (INT) and an mRNA-based cancer therapy.

The INTerpath-001 success also builds on encouraging earlier-stage evidence. In June, the companies reported five-year data from a phase IIb study, which showed that intismeran plus Keytruda reduced the risk of cancer returning or death by 49% and the risk of cancer spreading to distant parts of the body or death by 59%

The phase III study is still ongoing, with overall survival (OS) still among the key endpoints being evaluated. Moderna and Merck also plan to present the detailed findings at a future medical meeting, which should provide more insight into the magnitude of the treatment benefit. The companies intend to engage with regulators on potential filings based on the results.

Following the announcement, shares of Merck also closed about 13% higher yesterday, reaching a 52-week high. An unexpected beneficiary of the news was BioNTech BNTX, whose stock rose 22% following the announcement. Like Moderna, BioNTech is seeking to expand its mRNA platform beyond vaccines, with oncology among the key areas of focus.

MRNA’s Plans for Intismeran Extend Beyond Melanoma

The success in melanoma could be just the beginning for intismeran. Moderna and Merck are testing the personalized mRNA therapy across a broader range of cancers, with nine phase II and phase III studies underway in indications including non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma. The goal is to determine whether the approach that showed promise in melanoma can be replicated across different tumor types.

Unlike conventional vaccines, intismeran is individually designed for each patient, using mutations identified from the patient’s tumor to create a personalized treatment intended to help the immune system recognize and attack cancer cells. This individualized approach could allow the therapy to be adapted to the unique characteristics of different patients and tumor types.

The broader development program could significantly expand the potential opportunity for intismeran if the therapy continues to deliver positive results in other cancers. For Moderna, success across multiple indications would also provide stronger validation that its mRNA platform can be used to develop personalized treatments beyond vaccines, rather than creating a single oncology product centered on melanoma.

The company’s progress in these studies will therefore be important to watch as Moderna seeks to build a more diversified business beyond COVID-19 vaccines.

Moderna Leverages Its mRNA Platform Beyond Vaccines

The positive melanoma result is particularly important because intismeran sits within Horizon 1, the most advanced layer of Moderna’s three-horizon strategy. When Moderna outlined this framework at its Science Day earlier this year, it identified its commercial products and late-stage pipeline, including the Merck-partnered cancer therapy, as the foundation of its business beyond COVID-19 vaccines.

But Moderna’s ambitions extend well beyond its current cancer program. Horizon 2 includes additional mRNA-based therapeutic approaches already moving through development, including cancer antigen therapies, T-cell engagers, cell-therapy enhancers and an investigational therapy for multiple sclerosis. Horizon 3 comprises earlier-stage technologies, including in-vivo CAR-T and CAR-M cell therapies, which could become future growth platforms for Moderna.

Together, the three horizons highlight that intismeran is only one part of Moderna’s broader effort to turn its mRNA platform into a diversified medicines business.

MRNA’s Price Performance, Valuation & Estimates

Shares of Moderna have skyrocketed more than 490% year today, significantly outperforming the industry’s 7% growth.

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From a valuation standpoint, the company is currently trading at a premium to the industry. Based on the price-to-sales (P/S) ratio, the stock trades at 28.92 times forward 12-month sales, higher than the industry average of 1.94 times.

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Estimates for Moderna’s 2026 and 2027 bottom line have been mixed over the past 30 days.

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Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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