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Shares of Moderna (NASDAQ:MRNA) rise 2.5% to $164 after the market.
The breakthrough tag is granted by the U.S. Food and Drug Administration (FDA) based on data from a mid-stage study of the drug that showed the therapy reduced risk of skin cancer’s recurrence or death by 44% compared with Keytruda alone.
The FDA’s breakthrough therapy designation is granted to expedite the development and review of drugs that are intended to treat a serious condition.
The companies said they plans to initiate a late-stage study in adjuvant treatment of melanoma in 2023.
