Summit shares surge after-hours on $2 billion AstraZeneca equity deal

AstraZeneca's Imfinzi-EV regimen for bladder cancer received US FDA Priority Review. The decision is expected in Q4 2026. The regimen showed improvements in survival rates in the Phase III VOLGA trial. AstraZeneca aims to extend Imfinzi's use to patients ineligible for cisplatin-based chemotherapy.

AstraZeneca and Daiichi Sankyo's Enhertu received NICE approval for HER2-positive breast cancer treatment. The drug, priced at £1,455 per 100mg vial, was initially rejected due to cost but gained approval after NICE's valuation methodology change. It extends patient lifespans by an average of seven months.

AstraZeneca's Imfinzi has received FDA Priority Review for bladder cancer treatment. The drug is being evaluated for use in patients with high-risk, non-muscle invasive bladder cancer. According to the company, this designation expedites the review process. The FDA decision is expected in the first quarter of 2024.

The FDA granted priority review to AstraZeneca's application for durvalumab (Imfinzi) plus enfortumab vedotin (Padcev) to treat muscle-invasive bladder cancer. The approval is based on the VOLGA trial showing improved event-free and overall survival. The decision is expected in Q4 2026. AstraZeneca aims for this to become a new standard of care.

AstraZeneca (AZN) announced the FDA granted Priority Review for its IMFINZI-enfortumab vedotin regimen for muscle-invasive bladder cancer. The application is based on positive Phase 3 trial results showing improved event-free and overall survival. The FDA decision is expected in Q4 2026. AZN stock closed at $164.56, up 0.75%.

Several biotech and pharma companies received regulatory approvals. MESO, LLY, ANIP, GRAL, AZN, TLSI, ABBV, RHHBY, MRK, AMRX, and ABEO gained approvals for various treatments. ABBV and RHHBY also announced strategic partnerships. LLY, GRAL, and ABBV saw notable stock price changes.