Blueprint Medicines Q4 2020 Earnings Report
Key Takeaways
Blueprint Medicines reported Q4 2020 financial results, including $6.0 million in net product revenues from AYVAKIT and $0.7 million from GAVRETO. The FDA accepted the supplemental NDA for AYVAKIT for advanced systemic mastocytosis, granting priority review with an action date of June 16, 2021.
AYVAKIT/AYVAKYT recorded $6.0 million in net product revenue.
GAVRETO recorded $0.7 million in net product revenue.
FDA accepted supplemental NDA for AYVAKIT for advanced systemic mastocytosis with priority review.
A Type II variation MAA was submitted to the EMA for AYVAKYT for advanced systemic mastocytosis.
Blueprint Medicines
Blueprint Medicines
Forward Guidance
Blueprint Medicines plans to achieve several milestones by mid-2021, including providing portfolio updates at the AACR 2021 Annual Meeting, obtaining regulatory approval from the European Commission and launching GAVRETO in Europe, initiating a Phase 1 trial of BLU-945, obtaining FDA approval and launching AYVAKIT in advanced SM in the U.S., completing enrollment of the registration-enabling Part 2 of the PIONEER trial of AYVAKIT, and initiating the Phase 2 HARBOR trial of BLU-263.
Positive Outlook
- Provide portfolio updates across clinical and research programs at the AACR 2021 Annual Meeting.
- Obtain regulatory approval from the European Commission and launch GAVRETO in RET fusion-positive NSCLC in Europe in the first half of 2021.
- Initiate a Phase 1 trial of BLU-945, a triple-mutant EGFR inhibitor, in patients with treatment-resistant EGFR-driven NSCLC in the first half of 2021.
- Obtain FDA approval and launch AYVAKIT in advanced SM in the U.S. in the first half of 2021.
- Complete enrollment of the registration-enabling Part 2 of the PIONEER trial of AYVAKIT in non-advanced SM in mid-2021.