Enhertu Wins EU Approval in Early Breast Cancer, Triggering $75M Milestone
AZN is trading near its 52-week low of $153.413 (13% above the low).
Summary
The European Commission approved Enhertu as a monotherapy in the adjuvant setting for adults with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane and HER2 targeted therapy. The decision rests on DESTINY-Breast05, where Enhertu cut the risk of invasive disease recurrence or death by 53% versus T-DM1 (HR=0.47) and produced a three-year invasive disease-free survival rate of 92.4% against 83.7% for T-DM1. The approval triggers a $75 million milestone payment from AstraZeneca to Daiichi Sankyo; Enhertu sales in most EU territories are booked by Daiichi Sankyo, so the direct revenue line for AstraZeneca is shared economics rather than consolidated sales. This adds a new curative-intent indication in Europe to an Enhertu label already cleared in more than 35 countries for this adjuvant use, extending the franchise earlier in the treatment course. It follows the September 1 EU approval of Enhertu plus pertuzumab in first-line HER2 positive metastatic breast cancer, reinforcing the breast cancer franchise.
Updates
· SEC 6-K — Enhertu is now approved in more than 35 countries for this adjuvant HER2-positive early breast cancer indication.
At the time of this announcement, AZN was trading at $172.89 on NYSE in the Life Sciences sector, with a market capitalization of approximately $266.8B. The 52-week trading range was $153.41 to $212.71. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: BusinessWire.