On, February, 22, 2023, Moderna Inc. said that US regulators have given its experimental personalised mRNA skin cancer vaccine and Merck & Co.’s drug Keytruda the designation of breakthrough therapies as an additional treatment for high-risk patients. After the market closed Moderna shares rose 2.5% to $164.
Based on data from a mid-stage drug study that showed the therapy reduced the risk of skin cancer recurrence or death by 44% compared to Keytruda alone, the U.S. Food and Drug Administration (FDA) granted the breakthrough tag.
The FDA grants the designation of breakthrough therapy to drugs that are intended to treat serious conditions to speed up the process of developing and reviewing them. The companies said that they intend to launch a late-stage study on adjuvant melanoma treatment in 2023.