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Blueprint Presents Positive Ayvakit Data, But Commercial Debate Could Continue

 
• By Alaric DeArment

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 unveiled detailed data for the Phase III PIONEER study of Ayvakit in indolent systemic mastocytosis • Source: Shutterstock

Blueprint Medicines Corporation’s presentation of full data from the Phase III PIONEER study of Ayvakit (avapritinib) in indolent systemic mastocytosis (ISM) bolsters the drug’s chances of winning approval while allaying some – but not all – of the concerns about its commercial potential in that disease amid a debate that arose when the company announced topline results from the study in 2022.

The biotech presented the data on 26 February at the American Academy of Allergy, Asthma & Immunology (AAAI) meeting

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Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

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