The European Commission cleared AstraZeneca's triple-combination inhaler Trixeo Aerosphere for asthma patients aged 12 and over, extending a drug already established in COPD treatment.

The EU medicines regulator recommended Enhertu for adjuvant use in HER2-positive early breast cancer, backed by a trial showing a 53% reduction in disease recurrence or death versus current standard care.

The European regulator's advisory committee has recommended Alexion's gefurulimab for approval in generalised myasthenia gravis, setting up a potential first-in-class launch in the EU.

It failed to show a statistically significant improvement in progression-free survival in first-line advanced breast cancer, though a numerical benefit was observed.

AstraZeneca said Imfinzi plus Amgen's Imdelltra significantly improved overall survival in a Phase III trial of extensive-stage small cell lung cancer, positioning the combination as a new first-line maintenance standard.

The FDA cleared the oral SERD, paired with a CDK4/6 inhibitor, for HR-positive breast cancer patients who develop a resistance mutation before their disease progresses.

AstraZeneca and Daiichi Sankyo's Enhertu combined with pertuzumab has secured EU clearance as the first new first-line regimen for HER2-positive metastatic breast cancer in more than a decade, triggering a $100 million milestone payment.

AstraZeneca has finalised an exclusive global licence for lung cancer drug Zegfrovy, paying Dizal Pharmaceutical $600m upfront with up to $900m in further milestones.

The Phase III SANOVO trial showed Tagrisso plus Orpathys significantly improved progression-free survival in treatment-naïve, MET-overexpressing EGFR-mutated lung cancer patients, extending the combination's reach into first-line treatment.

The Phase III CROSSING trial showed statistically significant and sustained improvements in eosinophilic esophagitis, positioning Tezspire for a third disease indication alongside Amgen.

It has priced €2.55 billion of Eurobonds across four maturities, with proceeds earmarked for general corporate purposes.

AstraZeneca is discontinuing its eVOLVE-Lung02 trial after an independent monitoring committee found volrustomig unlikely to beat pembrolizumab on survival endpoints.

The SAFFRON Phase III trial showed Tagrisso plus Orpathys significantly extended progression-free and overall survival in EGFR-mutated lung cancer patients who had progressed on Tagrisso alone.

Monday's market was reacting to reports AstraZeneca held talks in recent months over a potential takeover of Bristol Myers Squibb that would create a roughly $400 billion pharmaceutical group, sending its shares sharply lower.

The European Commission cleared Datroway as first-line monotherapy for metastatic triple-negative breast cancer patients ineligible for immunotherapy, making it the only TROP2-directed drug with a proven survival benefit in this setting.

DB analyst Emmanuel Papadakis reiterates his Sell rating on the pharma giant after a mixed second-quarter print, with the price target sitting well below the last close of 12,888p.

The Phase III ALXN1210-TMA-313 trial failed to show statistically significant event-free survival benefit versus placebo in adults and adolescents with a rare post-transplant complication, though a companion paediatric study supports regulatory filings.

The CLARITY-Gastric01 Phase III trial showed sonesitatug vedotin significantly improved overall survival in previously treated Claudin 18.2-positive gastric cancers, the first such result for an antibody drug conjugate targeting this protein.

The drug maker grew first-half revenue 6% at constant exchange rates as oncology and rare disease gains outweighed the loss of Farxiga's US patent protection, while reconfirming its 2026 guidance.

Etcamah, paired with a CDK4/6 inhibitor, becomes the first EU-approved first-line treatment targeting emerging drug resistance in advanced ER-positive breast cancer.

"AstraZeneca is a leader in treating EGFR-mutated lung cancer, and we are eager to add Zegfrovy to our world-class portfolio", said Dave Fredrickson

Analyst Emmanuel Papadakis maintains his 11,500p target on AstraZeneca, arguing the market's outsized reaction to the Wainua trial failure reflects a broader repricing of pipeline risk rather than the miss alone.

The CARDIO-TTRansform Phase III trial of Wainua in transthyretin amyloid cardiomyopathy did not meet its composite cardiovascular mortality and events endpoint.

Europe's medicines committee has backed AstraZeneca and Daiichi Sankyo's antibody drug conjugate for patients ineligible for immunotherapy, citing a five-month overall survival gain over chemotherapy.

AstraZeneca's Truqap (capivasertib) has been approved by the US FDA as the first and only targeted therapy for adult patients with PTEN‑deficient metastatic androgen pathway modulation‑naïve or sensitive (mAPMN/S) prostate cancer.

The FDA cleared Imfinzi (durvalumab) in combination with BCG for adult patients with BCG‑naïve, high‑risk non‑muscle‑invasive bladder cancer after the POTOMAC Phase III trial showed a 32% reduction in risk of recurrence, progression or death.

The US Food and Drug Administration has extended the Prescription Drug User Fee Act decision date for AstraZeneca's camizestrant combination filing to permit review of additional analyses requested for the SERENA-6-based NDA.

Deutsche Bank rates AstraZeneca as a Sell, with a 11500p price target, implying roughly 18% downside.

"The nearly double‑digit placebo‑adjusted systolic blood pressure reduction achieved with Baxfendy is exciting and clinically meaningful for clinicians and patients," Dr Bryan Williams

"These 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," said Dave Fredrickson

It produced statistically significant and clinically meaningful improvements in event‑free survival and overall survival in the Phase III VOLGA trial of muscle‑invasive bladder cancer patients.

The FDA panel agreed that Truqap (capivasertib) plus abiraterone and ADT has a favourable benefit‑risk profile for a form of prostate cancer.

An FDA Oncologic Drugs Advisory Committee voted 3-6 and did not reach a majority in favour of the benefit-risk profile for camizestrant combined with a CDK4/6 inhibitor in first-line HR-positive, HER2‑negative advanced breast cancer.

AstraZeneca said Ultomiris (ravulizumab) produced a statistically significant, clinically meaningful reduction in proteinuria at week 34 in the I CAN Phase III trial, with declines evident as early as week 10.