After years of underperformance relative to the market due to the contraction of its COVID-19 business, biotechnology company Moderna (MRNA) is regaining market favor through significant clinical and regulatory advances in its mRNA vaccine platform. As of the time of publication, the company’s stock has risen 402% year-to-date. This strong performance has not peaked, and with the continued realization of its platform potential, there may be further upside ahead.
Recently, Moderna achieved two key milestones. First, the U.S. Food and Drug Administration (FDA) approved its influenza vaccine mFLUSIVA on August 5. Clinical trial data show that the vaccine demonstrates superior efficacy compared to existing influenza vaccines on the market, potentially addressing a long-standing unmet medical need in this field. According to data from the U.S. Centers for Disease Control and Prevention, traditional vaccines in the current flu season have effectiveness rates ranging from only 40% to 60%, leaving elderly patients at high risk of severe illness, hospitalization, and even death. The approval of mFLUSIVA is expected to significantly improve this situation.
However, the more far-reaching advancement lies in its personalized cancer vaccine. On August 19, Moderna announced positive Phase 3 clinical data for its investigational personalized cancer vaccine intismeran autogene in combination with the anticancer drug Keytruda for the treatment of advanced melanoma. The results showed that the combination therapy significantly improved recurrence-free survival compared to Keytruda monotherapy. Although the vaccine had previously shown promise in Phase 2 trials, the success of the Phase 3 trial not only validates its own value but, more importantly, strongly demonstrates that Moderna’s mRNA technology platform can be successfully applied beyond COVID-19 vaccines and even beyond infectious diseases—such as in oncology. This directly propelled the stock to surge over 100% on that day.
Currently, intismeran autogene is being extended into studies for multiple cancer types, including non-small cell lung cancer, renal cell carcinoma, and bladder cancer, and is expected to become a significant product in oncology. Although profits must be shared with partner Merck (MRK), further clinical successes in other indications would further boost the stock price. Moreover, Moderna’s R&D pipeline extends well beyond this, with its portfolio also covering potential vaccines and therapeutics targeting HIV, Lyme disease, norovirus, multiple myeloma, and several other targets.
While no biotechnology company can guarantee 100% success for all products in development, Moderna, leveraging its platform advantages, is well-positioned to sustain a considerable R&D success rate over the next five years and achieve a transformation of its approved product portfolio. By that time, the company will be able to truly reduce its dependence on its COVID-19 business and generate stable revenue and profits through the launch of new products. For long-term investors willing to hold for at least five years, the stock remains attractive.
