Blueprint’s Ayvakit Mastocytosis Results Raise Commercial Uncertainty
The Phase III PIONEER study in indolent systemic mastocytosis met the primary endpoint, but the magnitude of benefit came up short of analysts’ expectations.
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Blueprint Presents Positive Ayvakit Data, But Commercial Debate Could Continue
Detailed data in indolent systemic mastocytosis show improvement across primary and key secondary endpoints, but analysts pointed to lower improvement on symptoms outside of those affecting the skin.
Blueprint Prepares To Take On Novartis In Advanced Systemic Mastocytosis
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.
FDA Lifts Hold On Blueprint’s CDK2 Inhibitor Trial, Potentially Calming Nerves
The FDA placed a partial hold in February amid ocular adverse event concerns, but soon lifted it. Other CDK2 inhibitors have had ocular toxicity issues as well.