Summit Therapeutics and AstraZeneca Enter $2B Strategic Investment and Oncology Collaboration

Shots: AstraZeneca will invest $2B in Summit through convertible preferred shares, representing a conversion price of $18.36/share, while the companies will collaborate on the development of ivonescimab & sonesitatug vedotin (sone-ve). The clinical collaboration will evaluate ivonescimab with sone-ve in GI cancers, with studies expected to begin soon. Companies will share study costs, while each…

ByRidhi Rastogi2 days ago

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AstraZeneca Secures US FDA Priority Review for Imfinzi + Enfortumab Vedotin for Muscle-Invasive Bladder Cancer

Shots: The US FDA has accepted sBLA and granted Priority Review to Imfinzi (durvalumab) + enfortumab vedotin (EV) for the treatment of pts with MIBC who are ineligible for or have declined cisplatin-based CT (PDUFA: Q4’26). Regulatory review is ongoing in EU & Japan sBLA was based on the P-III (VOLGA) trial, which randomized 695…

ByRidhi Rastogi3 days ago

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The EC Approves AstraZeneca’s Trixeo Aerosphere for Uncontrolled Asthma

Shots: The EC has approved Trixeo Aerosphere(320/28.8/10μg) for the maintenance treatment of asthma in pts (≥12yrs.) who are not adequately controlled by a combination of a medium ICS & LABA Approval was based on the P-III (LOGOS & KALOS) trials evaluating Trixeo vs two fixed-dose dual-combination therapies of ICS & LABA: Symbicort pMDI & PT009 (in an…

ByRidhi RastogiSeptember 23, 2026

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AstraZeneca Reports the CHMP Positive Opinion for Klygefa to Treat Generalised Myasthenia Gravis

Shots: The CHMP has recommended Klygefa(gefurulimab; SC, QW) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adults who are AChR antibody-positive; filings are under review in the US, China & other countries Opinion was supported by the P-III (PREVAIL) trial assessing Klygefavs PBO in 260 gMG adults for…

ByRidhi RastogiSeptember 21, 2026

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Daiichi Sankyo and AstraZeneca Report the P-III (DESTINY-Lung04) Trial Data on Enhertu for HER2-Mutant Non-Squamous NSCLC

Shots: Daiichi Sankyo & AZ have reported P-III (DESTINY-Lung04) trial data assessing Enhertu (5.4mg/kg) vs Pt-pemetrexed doublet CT + Keytruda as the 1L treatment in 454 pts with unresectable, locally advanced or metastatic, nsq-NSCLC harboring a HER2 exon 19 or 20 mutation Enhertu improved PFS by 37% (mPFS: 14.3 vs 8.3mos.) & showed ORR of 70%…

ByRidhi RastogiSeptember 14, 2026

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Amgen and AstraZeneca Report the P-III (DeLLphi-305) Trial Data on Imfinzi + Imdelltra for 1L ES-SCLC

Shots: Amgen & AZ have reported the P-III (DeLLphi-305) trial data assessing Imfinzi + Imdelltra vs Imfinzi as the 1L maintenance treatment for pts (n=563) with ES-SCLC who have not progressed following induction treatment with Imfinzi + PT-based CT & etoposide Trial showed improved OS (1EP) & demonstrated benefits across 2EPs, incl. PFS & ORR;…

ByRidhi RastogiSeptember 9, 2026

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AstraZeneca Reports P-III OBERON and TITANIA Results for Tozorakimab in COPD at ERS’26

Shots: AstraZeneca reported full results from the P-III OBERON and TITANIA studies, showing that tozorakimab 300 mg Q4W reduced moderate-to-severe COPD exacerbations versus PBO in pts. receiving inhaled standard of care In the primary population of former smokers, tozorakimab reduced exacerbations by 29% in OBERON and 34% in TITANIA, while reductions in the overall population…

ByPrince GiriSeptember 8, 2026

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HUTCHMED Reports P-III Trial Data on Orpathys + Tagrisso for Previously Untreated MET-Overexpressing EGFRm NSCLC

Shots: The P-III (SANOVO) trial assessed Orpathys (300 or 200mg, BID) + Tagrisso (80mg, QD) vs Tagrisso in 326 treatment-naïvepts with locally advanced or metastatic NSCLC harboring EGFR mutations (exon 19 deletion or L858R) & MET overexpression The combination significantly improved PFS in both high-MET and ITT populations, while also showing encouraging OS benefit; follow-up…

ByRidhi RastogiSeptember 1, 2026

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Daiichi Sankyo and AstraZeneca Report EC Approval of Enhertu + Perjeta to Treat HER2+ Metastatic Breast Cancer

Shots: The EC has approved Enhertu (5.4mg/kg) + Perjeta for the 1L treatment of pts with unresectable or metastatic HER2+ (IHC 3+ or ISH+) breast cancer (MBC), backed by P-III (DESTINY-Breast09) trial data (n=1157) Trial assessed Enhertu ± Perjeta vs THP, where it improved PFS by 44% in 383 pts who had not received prior…

ByRidhi RastogiSeptember 1, 2026

NEWS

AstraZeneca and Amgen Report P-III (CROSSING) Trial Data on Tezspire for Eosinophilic Esophagitis

Shots: Amgen & AstraZeneca have reported the top-line P-III (CROSSING) trial results assessing Tezspire at one of two doses (tezepelumab-ekko; SC, Q4W) vs PBO in pts living with eosinophilic esophagitis (EoE) Trial showed improvements across co-1EPs (histologic remission, and the frequency & severity of dysphagia) & key 2EPs at Wk. 24 which were sustained through Wk. 52; data…

ByRidhi RastogiAugust 27, 2026

Summit Therapeutics and AstraZeneca Enter $2B Strategic Investment and Oncology Collaboration

AstraZeneca Secures US FDA Priority Review for Imfinzi + Enfortumab Vedotin for Muscle-Invasive Bladder Cancer

The EC Approves AstraZeneca’s Trixeo Aerosphere for Uncontrolled Asthma

AstraZeneca Reports the CHMP Positive Opinion for Klygefa to Treat Generalised Myasthenia Gravis

Daiichi Sankyo and AstraZeneca Report the P-III (DESTINY-Lung04) Trial Data on Enhertu for HER2-Mutant Non-Squamous NSCLC

Amgen and AstraZeneca Report the P-III (DeLLphi-305) Trial Data on Imfinzi + Imdelltra for 1L ES-SCLC

AstraZeneca Reports P-III OBERON and TITANIA Results for Tozorakimab in COPD at ERS’26

HUTCHMED Reports P-III Trial Data on Orpathys + Tagrisso for Previously Untreated MET-Overexpressing EGFRm NSCLC

Daiichi Sankyo and AstraZeneca Report EC Approval of Enhertu + Perjeta to Treat HER2+ Metastatic Breast Cancer

AstraZeneca and Amgen Report P-III (CROSSING) Trial Data on Tezspire for Eosinophilic Esophagitis

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