Arvinas Announces FDA Acceptance of the New Drug Application for Vepdegestrant for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer
– Filing based on pivotal Phase 3 VERITAC-2 clinical trial demonstrating statistically significant and clinically meaningful improvement in median progression-free survival versus fulvestrant –
What are the implications for ARVS’s cash runway and need for additional financing if the drug requires a larger commercial launch budget?
How might the trial’s safety profile and adverse event data influence investor sentiment and potential pricing strategies?
What regulatory or reimbursement hurdles could affect Vepdegestrant’s commercialization in key markets (US, EU, Asia)?
18 days ago