Blueprint Medicine Gains US Approval For First Drug, Precision Medicine Ayvakit
Targets Mutation In GIST tumors
The FDA has granted full approval to the drug based on Phase I efficacy data and safety studies, reflecting lack of existing treatment options
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The company’s rollout plans for Ayvakit appear similar to its approach when it marketed the drug for GIST, with an education plan to help boost sales.
Qinlock (ripretinib), approved as the US FDA rejected Blueprint Medicines’ Ayvakit (avapritinib) in the same indication, is priced on par with the rival drug cleared in January for a narrower GIST use.
Blueprint and Zymeworks raise $300m-plus in follow-on offerings. Also, Arcutis, Black Diamond and Annovis bring the 2020 US IPO count to four; Spring Bank, Surface Oncology and Decibel reveal strategic shifts; and Harmony’s $200m in venture debt leads recent VC deals.