Moderna Inc. (NASDAQ:MRNA) saw its share price soar by 156 percent in August—making it the highest-gaining stock for the month—driven primarily by the strong clinical trial results of its therapy candidate for melanoma, supported by a recent regulatory approval for its updated COVID-19 vaccines.
It can be recalled that Moderna and Merck recently partnered for the development of a therapy to treat the most common type of skin cancer through the combination of intismeran autogene with Keytruda.
The third phase of the clinical trial achieved the primary endpoint of recurrence-free survival (RFS) and the key secondary target of distant metastasis-free survival (DMFS).
Photo by Tima Miroshnichenko on Pexels
It marked the first positive readout from a phase 3 clinical trial for a combination of individualized neoantigen therapy (INT) and mRNA-based cancer therapy, as well as the first phase 3 study to demonstrate a clinically meaningful improvement over Keytruda alone.
Huge Addressable Market
For investors, the readout was a significant milestone for its huge addressable market and revenue growth potential.
According to Moderna Inc. (NASDAQ:MRNA), the US alone is expected to register 112,000 new cases of melanoma by the end of the year, with 8,500 deaths resulting from the disease.
Melanoma is responsible for a large majority of skin cancer deaths. In 2022 alone, some 330,000 cases were diagnosed globally, making it one of the most common types of cancer diagnosed.
FDA OKs Updated COVID-19 Vaccines
The rally was supported by the Food and Drug Administration’s recent approval of its biologics license application for the 2026 to 2027 formulas of Spikevax and mNEXSPIKE vaccines to help prevent COVID-19.
The updated formula for Spikevax is now approved for individuals aged 6 months to 64 with at least one underlying condition, as well as all adults 65 years of age and older.
On the other hand, mNEXSPIKE—its latest Covid-19 vaccine—is approved for individuals 12 to 64 with at least one underlying condition that puts them at high risk for severe outcomes from Covid-19, and all adults 65 years of age and older.
COVID-19 was responsible for claiming the lives of 7.1 million individuals worldwide.
Higher Hedge Fund Conviction
Institutional conviction appeared to have strengthened for Moderna Inc. (NASDAQ:MRNA) in the second quarter of the year despite some hedge funds exiting the company during the period.
Data from Insider Monkey showed that in the second quarter of the year, 49 hedge funds held positions in the stock, lower than the 52 in the first quarter of the year.
However, their combined holdings increased by 10 percent to $1.5 billion from $1.4 billion quarter-on-quarter, signaling that existing investors are increasing their exposure due to optimism about its long-term growth trajectory.
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