Moderna Inc. MRNA, -1.20% and Merck Inc. MRK, +0.08% shares increased in after-hours trading Wednesday after the pharmaceutical companies announced that a cancer-vaccine candidate received the “breakthrough therapy” designation from the Food and Drug Administration. The designation, which allows for expedited review of a candidate, was granted after a Phase 2b study of the personalized vaccine — known as mRNA-4157/V940 — in combination with Merck’s Keytruda. “mRNA-4157/V940 in combination with KEYTRUDA provided the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial and potentially represents a new frontier in treating melanoma and other cancers,” Moderna President Steven Hoge said in a statement. “We look forward to publishing the full data set and sharing the results at an upcoming oncology medical conference, as well as continuing discussions with health authorities.” A Phase 3 study focusing on melonoma will begin this year. Moderna shares rose 3% and Merck shares increased about 0.5% in late trading.
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