Phase 3 VOLGA: Imfinzi plus neoadjuvant EV improved EFS and OS in bladder cancer
AstraZeneca reported results from its Phase 3 study of Imfinzi (durvalumab) + enfortumab vedotin for Cisplatin-ineligible muscle-invasive bladder cancer on May 14, 2026. The study met its main goal.
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- Company
- AstraZeneca PLC AZN
- Drug
- Imfinzi (durvalumab) + enfortumab vedotin
- For
- Cisplatin-ineligible muscle-invasive bladder cancer
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- May 14, 2026
- Source note
- Perioperative Imfinzi with neoadjuvant enfortumab vedotin significantly improved event-free and overall survival in cisplatin-ineligible muscle-invasive bladder cancer. The Imfinzi plus Imjudo arm improved EFS but OS was not yet significant.
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- Source: investegate.co.uk ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- AZN headlines on this site
The FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve AstraZeneca’s Camizestrant (next-gen oral SERD) + CDK4/6 inhibitor for 1L HR+/HER2- advanced breast cancer with emergent ESR1 mutations. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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- Entry
- Extended FDA decision window for camizestrant (SERENA-6) · FDA decision due (PDUFA date)
- Drug
- Camizestrant (next-gen oral SERD) + CDK4/6 inhibitor
- For
- 1L HR+/HER2- advanced breast cancer with emergent ESR1 mutations
- Stage
- NDA under review (PDUFA extended)
- When
- H2 2026 · the company gave a window, not a day
- Source note
- On May 27, 2026 AstraZeneca disclosed the FDA extended the PDUFA date to review additional SERENA-6 analyses (ctDNA clearance linked to longer-term outcomes); the new date was not disclosed. An April 2026 advisory committee failed to reach majority support. Trackers estimate a Q4 2026 decision.
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- Source: stocktitan.net ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- AZN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
AstraZeneca expects to report results from its Phase 3 study of Datopotamab deruxtecan (Datroway) + durvalumab (Imfinzi) for First-line TROP2+ non-squamous advanced NSCLC in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
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- Entry
- Phase 3 AVANZAR topline: Datroway + Imfinzi in 1L NSCLC · Clinical trial results (readout / topline data)
- Drug
- Datopotamab deruxtecan (Datroway) + durvalumab (Imfinzi)
- For
- First-line TROP2+ non-squamous advanced NSCLC
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- AstraZeneca guided on its Q2 2026 earnings call that the AVANZAR readout is expected in H2 2026; a key catalyst for the Datroway franchise.
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- Source: investing.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- AZN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
The FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve AstraZeneca’s Ultomiris (ravulizumab-cwvz) for Immunoglobulin A nephropathy (adults). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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- Entry
- PDUFA for Ultomiris in IgA nephropathy · FDA decision due (PDUFA date)
- Drug
- Ultomiris (ravulizumab-cwvz)
- For
- Immunoglobulin A nephropathy (adults)
- Stage
- sBLA under Priority Review
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- AstraZeneca/Alexion announced FDA Priority Review based on the Phase 3 I-CAN interim analysis (43.4% placebo-adjusted proteinuria reduction); PDUFA date anticipated during Q4 2026 per the company release.
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- Source: astrazeneca.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- AZN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
The FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve AstraZeneca’s Gefurulimab (C5 nanobody) for Generalized myasthenia gravis. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.
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- Entry
- Estimated FDA action on gefurulimab in generalized myasthenia gravis · FDA decision due (PDUFA date)
- Drug
- Gefurulimab (C5 nanobody)
- For
- Generalized myasthenia gravis
- Stage
- BLA under review
- When
- Q4 2026 · the company gave a window, not a day
- Source note
- pdufa.bio lists a Q4 2026 (estimated) FDA action date. No AstraZeneca press release stating the PDUFA date was located; treat as tracker estimate.
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- Source: pdufa.bio ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- AZN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
AstraZeneca expects to report results from its Phase 3 study of laroprovstat (AZD0780) for Hypercholesterolemia / dyslipidaemia in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
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- Entry
- Laroprovstat (oral PCSK9) first Phase III data in H1 2027 · Clinical trial results (readout / topline data)
- Drug
- laroprovstat (AZD0780)
- For
- Hypercholesterolemia / dyslipidaemia
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H1 2027 · the company gave a window, not a day
- Source note
- From AstraZeneca H1 2026 results slides (July 27, 2026) as summarized by Investing.com; AZ also guided 25 Phase III readouts over the next 18 months and six NME readouts in 2027, with puxi-sam first Phase III data in H2 2027 (outside window).
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- Source: investing.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- AZN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page