"Intelligence that goes beyond profiles"
(AstraZeneca) Tagrisso Intelligence Event:
| Date | Product | Trial | Event | Outcome | Indication | Intelligence Insight |
|---|---|---|---|---|---|---|
| 14 Sep 2026 | Tagrisso | ADAURA Phase III | 8-year overall survival update | Positive long-term OS data | Early-stage EGFR-mutated NSCLC | 47% reduction in risk of death vs placebo in Stage II–IIIA population |
| 1 Sep 2026 | Tagrisso + Orpathys | SANOVO Phase III | Positive Phase III results | Improved PFS vs Tagrisso alone | 1L locally advanced/metastatic EGFR-mutated NSCLC with MET overexpression | Supports development of the Tagrisso + Orpathys combination |
Tezspire Intelligence Event:
| Date | Product | Trial | Event | Outcome | Indication | Intelligence Insight |
|---|---|---|---|---|---|---|
| 27 Aug 2026 | Tezspire | CROSSING Phase III | Positive Phase III results | Met both co-primary and all key secondary endpoints; improvements sustained through Week 52 | Eosinophilic esophagitis (EoE) | Supports potential expansion of Tezspire into a third epithelial-driven inflammatory disease |
Baxfendy(baxdrostat):
| Date | Product | Trial | Event | Outcome | Indication | Intelligence Insight |
|---|---|---|---|---|---|---|
| 15 May 2026 | BAXFENDY (baxdrostat) | BaxHTN Phase III | US FDA approval | First-in-class aldosterone synthase inhibitor approved for hypertension | Adults with hypertension not adequately controlled on other antihypertensive agents | 9.8 mmHg placebo-adjusted reduction in systolic BP at 2 mg |
Some Important News
02 OCT 2026
Datroway (datopotamab deruxtecan)
Strategic Collaboration
AstraZeneca and Daiichi Sankyo announced a clinical collaboration with Summit Therapeutics to evaluate Datroway in combination with ivonescimab across multiple tumour types.
28 SEP 2026
AstraZeneca Invests $2 Billion in Summit Therapeutics
Strategic Investment · Oncology
AstraZeneca announced a $2 billion strategic equity investment in Summit Therapeutics to accelerate development of ivonescimab in combination with AstraZeneca's antibody-drug conjugate (ADC) portfolio. The collaboration initially includes Sone-Ve (sonesitatug vedotin) + ivonescimab in gastrointestinal cancers, with a broader development programme planned across additional AstraZeneca cancer medicines.
25 SEP 2026
Imfinzi + Enfortumab Vedotin Granted US FDA Priority Review
Regulatory Milestone · Oncology
AstraZeneca's perioperative Imfinzi + neoadjuvant enfortumab vedotin regimen received US FDA Priority Review for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy. The application is supported by positive Phase III VOLGA results demonstrating improvements in event-free survival and overall survival.
23 SEP 2026
Trixeo Approved in the EU for Asthma
Regulatory Milestone · Respiratory & Immunology
Trixeo Aerosphere was approved in the EU as a maintenance treatment for asthma in patients aged 12 years and older whose disease is not adequately controlled on medium-dose ICS/LABA therapy. The approval was supported by positive KALOS and LOGOS Phase III results.
18 SEP 2026
Efzimfotase Alfa Granted US FDA Priority Review
Regulatory Milestone · Rare Disease
AstraZeneca's Alexion received US FDA Priority Review for efzimfotase alfa, an investigational enzyme replacement therapy for patients aged 2 years and older with hypophosphatasia (HPP). The application is supported by the HICKORY, MULBERRY and CHESTNUT Phase III programme.
04 SEP 2026
Etcamah Approved in the US for HR-Positive Breast Cancer
Regulatory Milestone · Oncology
AstraZeneca's Etcamah (camizestrant), in combination with a CDK4/6 inhibitor, received US FDA accelerated approval for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer with an ESR1 mutation detected during aromatase inhibitor and CDK4/6 inhibitor therapy. The approval was based on the SERENA-6 Phase III trial.
01 SEP 2026
Enhertu + Pertuzumab Approved in the EU for 1L HER2-Positive Metastatic Breast Cancer
Regulatory Milestone · Oncology
AstraZeneca and Daiichi Sankyo received EU approval for Enhertu (trastuzumab deruxtecan) + pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. The approval was based on DESTINY-Breast09 Phase III results, which demonstrated a 44% reduction in the risk of disease progression or death versus THP.
(Biogen) Empaveli Intelligence Event:
TYSABRI → No dedicated recent PR
| Date | Product | Trial | Event | Outcome | Indication | Intelligence Insight |
|---|---|---|---|---|---|---|
| 17 Sep 2026 | EMPAVELI | VALIANT Phase III | Pediatric Data Published | Positive | C3G / Primary IC-MPGN | Adolescents achieved a 75% relative reduction in proteinuria vs placebo at Week 26; 57% achieved stable kidney function plus ≥50% proteinuria reduction. |
Some Important News
02 OCT 2026
Litifilimab (BIIB059)
R&D Milestone · Immunology
Biogen announced new 52-week AMETHYST Phase 2 data showing rapid and durable efficacy of litifilimab in patients with cutaneous lupus erythematosus (CLE), with continued improvement in clinical outcomes through Week 52.
16 SEP 2026
Leqembi Pen (lecanemab)
Regulatory Milestone · Neurology
Eisai and Biogen announced Japan’s approval of LEQEMBI Pen, the once-weekly subcutaneous formulation for early Alzheimer’s disease following approvals in the U.S. (July 2026) and China (September 2026). Japan became the third country globally to approve the subcutaneous formulation (September 2026)
03 SEP 2026
Zorevunersen
R&D Milestone · Neurology
Stoke Therapeutics and Biogen presented long-term clinical data supporting the disease-modifying potential of zorevunersen in Dravet syndrome, with four-year data showing durable seizure reductions and continued improvements in cognition and behavior.
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