Moderna Therapeutics Inc (NASDAQ:MRNA) revealed positive data from its second cut of the cancer vaccine for adjuvant melanoma in combination with Keytruda.
The report indicates a 49% recurrence-free survival (RFS) benefit, an improvement from the previous 44%.
The results were encouraging, with 51 events compared to 40 in the previous report. Notably, the distant metastasis-free survival (DMFS) endpoint at the three-year follow-up showed a 62% benefit, slightly lower than the 65% benefit at the two-year mark.
While Moderna aims to discuss this data with the FDA and considers potential accelerated approval, analysts at Jefferies are skeptical, deeming it a bullish scenario.
The FDA might be inclined to wait for Phase III results to better assess the treatment's overall benefit, Jefferies wrote in a note following the release of the data.
According to Jefferies, baseline imbalances, particularly in ctDNA and BRAF mutations, could become points of contention.
More broadly, Jefferies points out that investor focus remains on the COVID-19 landscape for 2024. This scrutiny comes in the wake of Pfizer's 2024 guidance, signaling a considerable drop in COVID vaccine sales.
Moderna's own 2024 guidance estimates around $4 billion, with approximately $3.8 billion attributed to COVID vaccines and $200 million for the upcoming RSV launch.
Jefferies has a Buy rating on Moderna’s stock with a price target of $100, suggesting potential 27% upside.
Shares of Moderna were up around 12.8% on Thursday morning in New York.