AstraZeneca PLC

Sonesitatug vedotin reduced the risk of death by 42% in 2nd and later-line CLDN18.2-positive advanced gastric/GEJ cancers in CLARITY-Gastric01

AstraZeneca's Phase III CLARITY-Gastric01 trial showed sonesitatug vedotin (Sone-Ve) cut the risk of death by 42% versus investigator's choice of chemotherapy in 2nd- and later-line CLDN18.2-positive advanced gastric/GEJ cancer, with median OS of 10.6 vs 6.4 months. In the 3rd- and later-line setting, the primary endpoint, death-risk reduction was 53%, with median OS doubled to 10.0 vs 5.0 months, and benefit was consistent across CLDN18.2 expression levels — supporting use in up to ~60% of these patients. PFS by blinded independent review missed statistical significance (HR 0.77, p=0.053), though investigator-assessed PFS was stronger (HR 0.59) and safety was manageable with fewer Grade 3+ TRAEs than the comparator arm. Results presented at ESMO 2026 could establish Sone-Ve as a new standard of care and underpin regulatory filings for AstraZeneca's CLDN18.2 franchise.

•4h ago

TAGRISSO® (osimertinib) plus savolitinib reduced the risk of disease progression or death by 45% and the risk of death by 32% in MET-driven EGFR-mutated lung cancer after progression on TAGRISSO

AstraZeneca reported positive Phase 3 SAFFRON results showing TAGRISSO plus savolitinib cut the risk of disease progression or death by 45% and the risk of death by 32% versus chemotherapy in MET-driven EGFR-mutated lung cancer after progression on TAGRISSO. Median overall survival was extended by 4.9 months (17.8 vs 12.9 months), with median PFS of 7.6 vs 5.4 months; results were presented at the ESMO Presidential Symposium and published in the New England Journal of Medicine. An NDA has been submitted to the FDA for the combination, which is already approved in China; AstraZeneca jointly develops savolitinib with HUTCHMED and holds commercialization rights.

•4h ago

IMFINZI® (durvalumab) plus tarlatamab-dlle reduced the risk of death by 58% in 1st-line extensive-stage small cell lung cancer in the DeLLphi-305 Phase III trial

AstraZeneca's IMFINZI plus Amgen's tarlatamab-dlle cut the risk of death by 58% versus IMFINZI alone as 1st-line maintenance in extensive-stage small cell lung cancer, per the Phase III DeLLphi-305 interim analysis (OS HR 0.42, p<0.001). Median overall survival reached 21.1 months with the combination versus 12.7 months for IMFINZI alone — described as the longest benefit ever reported in extensive-stage disease in a Phase III trial. Median PFS was 7.4 vs 1.9 months. Results were presented at ESMO Congress 2026 and simultaneously published in the New England Journal of Medicine; the trial was sponsored by Amgen with partial funding and IMFINZI supplied by AstraZeneca. The data strengthen IMFINZI's position as the backbone immunotherapy across SCLC stages and support the combination redefining the ES-SCLC treatment standard — a positive catalyst for both AstraZeneca and Amgen.

•1d ago

Perioperative IMFINZI® (durvalumab) plus neoadjuvant enfortumab vedotin reduced risk of recurrence by 49% and risk of death by 42% in muscle-invasive bladder cancer

AstraZeneca's VOLGA Phase 3 trial showed perioperative IMFINZI plus neoadjuvant enfortumab vedotin cut risk of recurrence, progression or death by 49% and risk of death by 42% in cisplatin-ineligible muscle-invasive bladder cancer. At two years, 64% of patients on the combination were alive and event-free versus 45% with standard of care, and 78% were alive versus 69%; safety was consistent with the known profiles of both drugs. The data were presented at the ESMO 2026 Presidential Symposium and published in NEJM; the FDA already granted Priority Review in September 2026 for this regimen, positioning IMFINZI as a potential new standard of care in a setting where up to half of patients cannot take cisplatin.

•1d ago

ZEGFROVY® (sunvozertinib) now available in the US for patients with previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations

AstraZeneca announced the US availability of ZEGFROVY (sunvozertinib), the only approved oral single-agent targeted therapy for adults with previously treated EGFR exon 20 insertion-mutated NSCLC. The FDA accelerated approval was based on the WU-KONG1B trial, which showed a 46% confirmed overall response rate and 11.1-month median duration of response; continued approval is contingent on confirmatory trial benefit verification. A supplemental application for first-line use, backed by Phase III WU-KONG28 data, is under review at the FDA and China's CDE, both of which granted Breakthrough Therapy Designation — a meaningful expansion opportunity beyond the launch indication.

•3d ago

AZN: 6-K · fda approval

AstraZeneca's Alexion rare-disease unit received US FDA accelerated approval for Ultomiris (ravulizumab) to reduce proteinuria in adults with primary IgA nephropathy (IgAN), making it the first and only C5 complement inhibitor approved for this use. The approval was based on a prespecified interim analysis of the Phase III I CAN trial, in which Ultomiris showed a 43.4% placebo-adjusted reduction in proteinuria at 34 weeks (p<0.0001), with effects visible as early as week 10 and no new safety concerns identified. IgAN affects more than 200,000 people in the US, roughly half of whom with elevated proteinuria or reduced kidney function risk progressing to kidney failure within 10 years. This marks the fifth indication for Ultomiris; continued approval is contingent on confirmatory eGFR data at week 106, with submissions also under review in Japan and other countries.

SEC 6-K•3d ago

TEZSPIRE positive results from Phase III CROSSING trial in eosinophilic esophagitis including symptom improvement, histologic and endoscopic remission presented at United European Gastroenterology Week

AstraZeneca and Amgen's TEZSPIRE met both co-primary endpoints in the Phase 3 CROSSING trial in eosinophilic esophagitis, with histologic remission of 64.8% (210mg) and 68.9% (420mg) at week 24 versus 3.5% on placebo. Efficacy was sustained through week 52, and TEZSPIRE also achieved statistically significant improvements in dysphagia symptoms and endoscopic outcomes, with total endoscopic remission in roughly 30-34% of patients at week 52 versus 4.1% on placebo. Safety was consistent with approved indications. AstraZeneca plans to share the data with regulatory authorities to support an EoE indication, expanding TEZSPIRE beyond severe asthma and CRSwNP; the two partners share profits equally with AstraZeneca leading development outside US sales recorded by Amgen as collaboration revenue.

•5d ago

AstraZeneca to present overall survival data from four pivotal Phase III trials in Presidential Symposia at ESMO 2026 featuring Sone-Ve, IMFINZI® (durvalumab), TAGRISSO® (osimertinib) and savolitinib

AstraZeneca will present data from five pivotal Phase III trials at the ESMO Congress (October 23-27, 2026), with four featured in Presidential Symposia, spanning Sone-Ve, IMFINZI, TAGRISSO and savolitinib. Key highlights include CLARITY-Gastric01, the first Phase III trial to show a statistically significant overall survival benefit for an anti-CLDN18.2 ADC in 2L+ gastric cancer, plus SAFFRON (TAGRISSO + savolitinib in MET-driven EGFRm NSCLC), VOLGA and Amgen-led DeLLphi-305. More than 100 abstracts will feature AstraZeneca medicines and pipeline molecules; the release contains no financial figures and full data will only be available at the sessions.

•6d ago

SOPHiA GENETICS and Myriad Genetics Announce New Collaboration to Advance Prostate Genomic Instability Score Technology

Myriad Genetics and SOPHiA GENETICS announced a collaboration to advance Myriad's prostate cancer-specific genomic instability score (PrGIS) technology with AstraZeneca, aimed at supporting HRD as an actionable biomarker in precision oncology. Myriad's MyChoice CDx test, already a companion diagnostic in ovarian cancer, will produce the PrGIS score, while SOPHiA GENETICS develops a decentralized companion diagnostic solution incorporating PrGIS for its global network of more than 1,000 institutions in over 75 countries. Myriad and AstraZeneca co-authored PrGIS research to be presented at ESMO Congress 2026, expected to further validate the biomarker. No financial terms of the collaboration were disclosed.

•17d ago

AstraZeneca opens new global strategic R&D center in Kendall Square, Cambridge, Massachusetts

AstraZeneca opened a new global strategic R&D center in Kendall Square, Cambridge, backed by more than $1 billion of investment in Massachusetts as part of a broader $50 billion US commitment. The 570,000 square foot, 18-story site will host nearly 2,000 scientists working on oncology, cell therapy, chronic and rare disease programs, and is expected to grow the company's Massachusetts workforce by over 50% in coming years. CEO Pascal Soriot framed the site as a hub for US-led innovation intended to fuel AstraZeneca's growth beyond 2030.

•20d ago

AZN: 6-K · material agreement

AstraZeneca has agreed to invest $2 billion in newly issued convertible preferred equity of Summit Therapeutics, securing rights equivalent to approximately 12.0% of Summit's outstanding common stock (about 10.6% fully diluted), with closing anticipated within one week. The companies also signed a clinical collaboration agreement to combine AstraZeneca's CLDN18.2-targeting ADC sonesitatug vedotin (Sone-Ve) with Summit's PD-1/VEGF bispecific ivonescimab in gastrointestinal cancers, with trials to begin imminently. A broader MOU contemplates combining ivonescimab with AstraZeneca's wider ADC portfolio. The move follows positive CLARITY-Gastric01 overall survival data for Sone-Ve and deepens AstraZeneca's oncology combination strategy, though it commits substantial capital to an external partner's asset.

SEC 6-K•26d ago

Perioperative IMFINZI® (durvalumab) plus neoadjuvant enfortumab vedotin granted Priority Review in the US for patients with muscle-invasive bladder cancer

The FDA has accepted and granted Priority Review to AstraZeneca's sBLA for IMFINZI (durvalumab) plus enfortumab vedotin in muscle-invasive bladder cancer patients ineligible for or declining cisplatin-based chemotherapy, with a PDUFA action date anticipated in Q4 2026. The application is based on the VOLGA Phase III trial, which met its interim analysis with statistically significant improvements in event-free survival and overall survival versus radical cystectomy, with no new safety signals identified. If approved, the regimen would be the first perioperative combination with EV given only before surgery, potentially a new standard of care in a setting where up to half of MIBC patients are cisplatin-ineligible and roughly 50% recur after bladder removal.

•0mo ago

AZN: 6-K · fda approval

AstraZeneca's fixed-dose triple-combination therapy Trixeo Aerosphere (budesonide/glycopyrronium/formoterol) has been approved by the European Commission as a maintenance treatment for asthma in patients 12 years and older inadequately controlled on medium-dose ICS/LABA therapy. Trixeo is the first and only triple-combination therapy approved in the EU for asthma independent of exacerbation history, based on positive results from the KALOS and LOGOS Phase III trials involving approximately 4,300 patients, which showed statistically significant lung function improvements and reduced severe exacerbation rates versus ICS/LABA dual therapy. The approval expands the label of a product already approved as Breztri Aerosphere in the US, China and Japan and for COPD in over 90 countries, with more than 6.8 million patients treated globally in 2025, providing AstraZeneca a growth opportunity in Europe's ~43 million-patient asthma market.

SEC 6-K•1mo ago

AZN: 6-K · regulatory action

AstraZeneca's rare disease unit Alexion received a positive CHMP opinion dated 21 September 2026 recommending EU approval of Klygefa (gefurulimab) as an add-on to standard therapy for adults with AChR antibody-positive generalised myasthenia gravis. The recommendation rests on the PREVAIL Phase III trial, in which Klygefa met its primary endpoint with a statistically significant improvement in MG-ADL total score versus placebo at week 26 (treatment difference -1.6, 95% CI -2.4 to -0.8, p<0.0001), with clinically meaningful benefit visible as early as week one and sustained through week 26. If approved, Klygefa would be the first and only dual-binding nanobody C5 inhibitor for gMG in the EU, offering once-weekly subcutaneous self-administration in a market of roughly 82,500 diagnosed gMG patients across Germany, France, the UK, Italy and Spain, about 66,000 of whom are AChR-positive. Klygefa is already approved in Japan and other countries, and regulatory submissions based on the PREVAIL results remain under review in the US, China and additional markets, making the CHMP opinion a key step in the drug's global rollout.

SEC 6-K•1mo ago

AZN: 6-K · regulatory action

AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been recommended for approval in the EU by the CHMP as an adjuvant monotherapy for adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant treatment. The recommendation moves the drug a final step toward European Commission approval and potential new-standard-of-care status in the early-stage setting. The positive opinion is based on the DESTINY-Breast05 Phase III trial of 1,635 patients, in which Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 (hazard ratio 0.47, p<0.0001). At three years, 92.4% of patients in the Enhertu arm were alive and free of invasive disease compared with 83.7% on T-DM1, and no new safety concerns were identified. Enhertu is already approved in the US for this adjuvant indication, so EU approval would extend a proven label into a large European market and deepen the franchise in the curative-intent setting. The ADC is jointly developed and commercialised by AstraZeneca and Daiichi Sankyo under their March 2019 global collaboration, with Daiichi Sankyo responsible for manufacturing and supply.

SEC 6-K•1mo ago

AZN: 6-K · ownership disclosure

AstraZeneca filed a Form 6-K disclosing that Chief Executive Officer Pascal Soriot purchased 60,000 of the company's ordinary shares at GB£121.02 each on 14 September 2026, executed on the London Stock Exchange. The purchase, valued at approximately £7.26 million, was notified to the company on 16 September 2026 and reported under UK Market Abuse Regulation rules governing persons discharging managerial responsibilities. A sizeable open-market purchase by the chief executive is typically read as a signal of insider confidence in AstraZeneca's outlook, though the disclosure itself involves no change to the company's fundamentals or operations.

SEC 6-K•1mo ago

AZN: 6-K · ownership disclosure

AstraZeneca filed a Form 6-K disclosing that Michel Demaré, the company's Non-Executive Chair of the Board, purchased 2,500 ordinary shares on 14 September 2026 at £121.21 per share on the London Stock Exchange. The disclosure is a standard PDMR (Person Discharging Managerial Responsibilities) notification made under the EU Market Abuse Regulation as retained in UK law, signed by Company Secretary Matthew Bowden. The purchase is small in absolute terms and changes nothing about AstraZeneca's fundamentals, but a chair-level open-market buy is a routine, mildly positive signal of management alignment with shareholders.

SEC 6-K•1mo ago

ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated a median progression-free survival of 14.3 months as 1st-line therapy in patients with HER2-mutant advanced non-small cell lung cancer in DESTINY-Lung04 Phase III trial

AstraZeneca and Daiichi Sankyo's ENHERTU met the primary endpoint of the Phase III DESTINY-Lung04 trial, reducing the risk of disease progression or death by 37.0% (HR 0.63, 95% CI 0.50-0.79, p<0.0001) versus pembrolizumab plus chemotherapy in first-line HER2-mutant advanced non-small cell lung cancer. Median progression-free survival was 14.3 months with ENHERTU versus 8.3 months for standard of care — a six-month improvement — and it is the first HER2-directed therapy to beat standard of care in a Phase III trial in this setting. Objective response rate was 70.0% versus 44.5%, with median duration of response of 13.4 months. Overall survival data were only 46.9% mature with no observed benefit (29.3 vs 33.1 months, HR 1.15), with imbalanced post-progression HER2-directed therapy use potentially limiting interpretation. Interstitial lung disease occurred in 20.8% of ENHERTU patients, including four Grade 5 (fatal) events, though Grade 3+ adverse events were comparable between arms (34.1% vs 33.6%). Presented at the Presidential Symposium of the IASLC 2026 World Conference on Lung Cancer in Seoul, the results support a potential first-line label expansion for the jointly commercialized franchise, which is already an approved second-line standard of care in this indication.

•1mo ago

TAGRISSO® (osimertinib) demonstrated unprecedented eight-year landmark survival in early-stage EGFR-mutated lung cancer in ADAURA Phase III trial

Updated ADAURA Phase III results presented at the IASLC 2026 World Conference on Lung Cancer showed TAGRISSO reduced the risk of death by 47% versus placebo at eight years in Stage II-IIIA EGFR-mutated lung cancer (HR 0.53), the longest survival data ever reported in a global Phase III trial in this setting. An estimated 74% of TAGRISSO-treated patients in the primary population were alive at eight years versus 58% on placebo, and in the overall Stage IB-IIIA population eight-year survival was 79% versus 64%. Complementary real-world evidence showed that discontinuing TAGRISSO before completing the three-year treatment course more than doubled the risk of disease recurrence or death, while FLAURA2 combination safety data with 42.6 months of follow-up remained consistent with established profiles. The findings reinforce TAGRISSO as the adjuvant standard of care and backbone therapy across disease stages, extending the durability of AstraZeneca's flagship oncology franchise.

•1mo ago

IMFINZI® (durvalumab) plus tarlatamab demonstrated a statistically significant and highly clinically meaningful improvement in overall survival and progression-free survival in 1st-line extensive-stage small cell lung cancer

AstraZeneca's IMFINZI (durvalumab) plus Amgen's tarlatamab met the primary endpoint in a planned interim analysis of the Phase III DeLLphi-305 trial, showing a statistically significant and clinically meaningful overall survival improvement versus IMFINZI alone as first-line maintenance in extensive-stage small cell lung cancer. The combination also improved progression-free survival and objective response rate as secondary endpoints across 563 randomized patients, with no new safety signals identified. Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities, and management frames the result as reinforcing IMFINZI as the backbone immunotherapy for SCLC — a potential label-expansion catalyst for a franchise that has treated more than 470,000 patients since 2017.

•1mo ago

Tozorakimab demonstrated statistically significant and highly clinically meaningful reduction in COPD exacerbations in OBERON and TITANIA Phase III trials

Tozorakimab, AstraZeneca's first-in-class anti-IL-33 monoclonal antibody, cut moderate and severe COPD exacerbations by 29-34% versus placebo in the replicate Phase III OBERON and TITANIA trials, making it the first biologic to demonstrate statistically significant efficacy in a broad COPD population. The trials randomized 2,306 patients to tozorakimab 300mg every four weeks or placebo over 52 weeks, and the benefit held across all blood eosinophil counts — a 43% exacerbation reduction at BEC ≥300, 34% at ≥150, and 23% even below 150. Full results were published in the New England Journal of Medicine and presented as a late-breaker at the ERS Congress 2026; the only adverse drug reaction observed was injection-site reaction. The Biologics License Application for tozorakimab has been accepted under FDA Priority Review as an add-on maintenance treatment for adults with COPD, with a PDUFA date anticipated in Q1 2027 following use of a Priority Review voucher; regulatory reviews are also underway in the EU and China, with Phase III viral lower respiratory tract disease and Phase II asthma trials ongoing. Topline positive results were pre-announced in March 2026, so this full-data release is largely confirmatory — but it materially de-risks a potential first-in-class launch in COPD, the third leading cause of death worldwide and a stated growth pillar of AstraZeneca's Respiratory & Immunology franchise.

•1mo ago

AZN: 6-K · fda approval

The US FDA has granted accelerated approval to AstraZeneca's Etcamah (camizestrant), in combination with a CDK4/6 inhibitor, for adults with HR-positive, HER2-negative advanced breast cancer whose tumours develop an ESR1 mutation during first-line aromatase inhibitor and CDK4/6 inhibitor therapy. This is AstraZeneca's tenth FDA approval of the year and its fourth in breast cancer. The approval rests on the SERENA-6 Phase III trial of 315 patients, in which the Etcamah combination cut the risk of disease progression or death by 56% versus an aromatase inhibitor plus a CDK4/6 inhibitor (median PFS 16.0 versus 9.2 months; HR 0.44). A subsequent analysis also showed a statistically significant benefit in time to second disease progression (25.7 versus 19.1 months; HR 0.63). Alongside the drug approval, the FDA cleared a companion diagnostic that detects emerging ESR1 resistance mutations in circulating tumour DNA, enabling therapy switches before radiographic progression. Etcamah is now approved in more than 30 countries, and the US decision opens the world's largest pharmaceutical market for this next-generation oral SERD.

SEC 6-K•1mo ago

ETCAMAH® (camizestrant) in combination with a CDK4/6 inhibitor approved in the US for 1st-line advanced HR-positive breast cancer

The FDA granted accelerated approval to AstraZeneca's ETCAMAH (camizestrant) in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of an ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy. Approval was based on the SERENA-6 Phase III trial, which showed a 56% reduction in the risk of disease progression or death versus staying on an aromatase inhibitor (HR 0.44; p<0.00001), with median PFS of 16.0 versus 9.2 months; a subsequent analysis demonstrated a PFS2 benefit of 25.7 versus 19.1 months while overall survival data continue to mature. The ctDNA-guided switch strategy is the first and only medicine of its type in the 1st-line setting, targeting roughly 37,000 US first-line HR-positive metastatic breast cancer patients, about 30% of whom develop ESR1 mutations; this is AstraZeneca's tenth FDA approval this year and fourth in breast cancer, and the FDA concurrently approved a companion diagnostic for emerging ESR1 mutations. The indication is approved under accelerated approval contingent on confirmatory trial verification of clinical benefit, and the label carries a boxed warning for arrhythmia risk (Torsades de Pointes, sudden death) with concomitant QTc-prolonging drugs such as ribociclib.

•1mo ago

AZN: 6-K · fda approval

AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been approved in the EU for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer, the first new regimen in this setting in more than a decade. The European Commission decision follows a positive CHMP opinion and is based on the DESTINY-Breast09 Phase III trial. In DESTINY-Breast09, the combination reduced the risk of disease progression or death by 44% versus THP (hazard ratio 0.56; p<0.00001), with median progression-free survival of 40.7 months versus 26.9 months for the standard of care. The regimen has been added to ESMO Clinical Practice Guidelines as a Category IA first-line option and is now approved in more than 40 countries/regions worldwide for this indication. On the financial side, a $100 million milestone payment is due from AstraZeneca to Daiichi Sankyo for the indication, and sales of Enhertu in most EU territories are recognised by Daiichi Sankyo under the March 2019 collaboration agreement. Enhertu also remains under EU review for HER2-positive residual invasive disease after neoadjuvant therapy based on the DESTINY-Breast05 trial.

SEC 6-K•1mo ago

AZN: 6-K · clinical trial

AstraZeneca announced positive high-level results from the SANOVO Phase III trial, in which Tagrisso (osimertinib) plus Orpathys (savolitinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival versus Tagrisso alone in treatment-naive patients with MET-overexpressing EGFR-mutated advanced lung cancer. The PFS benefit was shown in both the high MET (IHC 3+) and intention-to-treat populations, with encouraging clinical benefit in overall survival as a secondary endpoint, and the safety profile was consistent with the known profiles of each medicine with no new safety findings. The China-conducted trial randomized 326 treatment-naive patients one-to-one to Tagrisso 80mg once daily plus Orpathys or placebo, and the data will be presented at a forthcoming medical meeting and shared with regulatory authorities to support use of the all-oral combination in the first-line setting in China. Orpathys is jointly developed by AstraZeneca and HUTCHMED and commercialised by AstraZeneca, and the SANOVO result builds on the SAFFRON global and SACHI China trials while reinforcing Tagrisso as the backbone therapy across EGFR-mutated lung cancer.

SEC 6-K•1mo ago

AstraZeneca completes global license agreement for oral EGFR inhibitor ZEGFROVY® (sunvozertinib) for lung cancer

AstraZeneca completed a global license agreement with Dizal Pharmaceutical for ZEGFROVY (sunvozertinib), acquiring worldwide rights to the oral EGFR inhibitor for lung cancer. Financial terms include a $600 million upfront payment and up to $900 million in development, regulatory, and sales milestones. ZEGFROVY is approved in the US and China for 2nd-line NSCLC with EGFR exon 20 insertion mutations, and AstraZeneca plans to launch in the US in Q4 2026.

•1mo ago

TEZSPIRE demonstrates positive Phase III results in eosinophilic esophagitis across both co-primary and all key secondary endpoints

AstraZeneca and Amgen’s TEZSPIRE met both co-primary endpoints and all key secondary endpoints in the Phase III CROSSING trial for eosinophilic esophagitis (EoE), demonstrating significant improvements in histologic remission and dysphagia symptoms. The positive efficacy results were sustained through 52 weeks, and the safety profile remained consistent with the drug’s existing approved indications for severe asthma and nasal polyps. EoE affects more than 470,000 people in the US, and the success in this third epithelial-driven inflammatory disease supports the broad potential of TEZSPIRE.

•1mo ago

A Multibillion-Dollar mRNA Cancer Market Is Taking Shape Targeting Lung Cancer’s Biggest Opportunity

Bristol Myers Squibb announced FDA approval of ZENBEXUS (iberdomide) in combination with daratumumab and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy. ZENBEXUS is the first FDA-approved CELMoD agent, marking the arrival of a new treatment class and validating the company's targeted protein degradation platform. The approval is accelerated and contingent upon verification of clinical benefit in confirmatory trials; the drug carries boxed warnings for embryo-fetal toxicity and thromboembolism.

•1mo ago