A busy session for regulatory milestones dominated the health and biotech space, with AstraZeneca (LSE:AZN) securing two separate FDA approvals in a single day, for its blood pressure drug Baxfendy and breast cancer treatment Enhertu.
AstraZeneca wins FDA clearance for blood pressure drug Baxfendy
AstraZeneca (LSE:AZN) received US regulatory approval for Baxfendy, its treatment for hypertension, adding a significant new commercial asset to its cardiovascular portfolio. Dr Bryan Williams, commenting on the approval, described the "nearly double-digit placebo-adjusted systolic blood pressure reduction achieved with Baxfendy" as "exciting and clinically meaningful for clinicians and patients." The shares edged up 0.81% to 13,742p on the day's combined newsflow.
AstraZeneca's Enhertu cleared by FDA in early breast cancer
In a second approval on the same day, AstraZeneca secured FDA clearance for Enhertu in early breast cancer, broadening the drug's reach beyond its existing indications. Dave Fredrickson said the approvals "mark an important step forward, expanding the possibility of cure to more patients for the first time in many years and positioning Enhertu as a foundational treatment in early breast cancer." The back-to-back regulatory wins underline AstraZeneca's accelerating oncology pipeline.
CelLBxHealth deploys Parsortix platform in two US cancer trials
CelLBxHealth (AIM:CLBX) announced that its Parsortix circulating tumour cell platform will be deployed in two clinical studies led by AdventHealth, testing exercise interventions in patients with colon, gastrointestinal and lung cancer. The trials represent a meaningful commercial validation of the Parsortix technology in a US hospital setting. The shares slipped 5.45% to 1.04p on the day.
GSK wins expanded RSV vaccine approval in Japan
GSK (LSE:GSK) secured an expanded approval in Japan for its RSV vaccine Arexvy, with the updated label covering all at-risk adults in the country, the first such broad designation in Japan. Sanjay Gurunathan said the approval "can help reduce potentially severe outcomes of RSV," as GSK (LSE:GSK) continues to build out the commercial footprint of its respiratory vaccine franchise across major markets. The shares added 0.78% to 1,877p.
