AstraZeneca PLC

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

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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

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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

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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

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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

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Entry

Phase 3 SAFFRON: Tagrisso plus Orpathys improved PFS and OS in EGFRm lung cancer · Clinical trial results (readout / topline data)

Drug

Tagrisso (osimertinib) + Orpathys (savolitinib)

For

MET-driven EGFR-mutated advanced NSCLC after Tagrisso progression

Stage

Phase 3 · the last stage before a drug can be approved

When

Aug 17, 2026

Source note

First global Phase III to show significant progression-free and overall survival benefit in MET-driven EGFR-mutated NSCLC after progression on Tagrisso.

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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

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Entry

Phase 3 eVOLVE-Lung02 discontinued; volrustomig unlikely to meet endpoints · Clinical trial results (readout / topline data)

Drug

volrustomig

For

PD-L1-negative metastatic non-small cell lung cancer

Stage

Phase 3 · the last stage before a drug can be approved

When

Aug 17, 2026

Source note

AstraZeneca discontinued the 895-patient trial of volrustomig plus chemotherapy in metastatic NSCLC after the IDMC concluded it was unlikely to meet PFS or OS endpoints in PD-L1-negative tumours. Other volrustomig trials continue.

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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

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Entry

Phase 3 DESTINY-Lung04: Enhertu improved PFS in first-line HER2-mutant NSCLC · Clinical trial results (readout / topline data)

Drug

Enhertu (trastuzumab deruxtecan)

For

First-line HER2-mutant advanced NSCLC

Stage

Phase 3 · the last stage before a drug can be approved

When

Aug 17, 2026

Source note

Enhertu showed a statistically significant and clinically meaningful PFS improvement as first-line treatment of HER2-mutant advanced non-small cell lung cancer.

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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

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Entry

Phase 3 CARDIO-TTRansform: eplontersen missed primary endpoint in ATTR-CM · Clinical trial results (readout / topline data)

Drug

Wainua (eplontersen)

For

Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM)

Stage

Phase 3 · the last stage before a drug can be approved

When

Jul 9, 2026

Source note

Wainua failed to show a statistically significant benefit on the primary efficacy endpoint in ATTR-CM patients on contemporary standard of care, most of whom were on a stabiliser. A prespecified monotherapy subgroup was nominally 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

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Entry

FDA approves Truqap combination for PTEN-deficient metastatic prostate cancer · Regulatory approval

Drug

Truqap (capivasertib) + abiraterone + prednisone

For

PTEN-deficient metastatic hormone-sensitive prostate cancer

Stage

Regulatory (sNDA)

When

Jun 15, 2026

Source note

Approval based on CAPItello-281, which showed a 19% reduction in risk of radiographic progression or death and median rPFS of 33.2 versus 25.7 months.

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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
• Drugs@FDA ↗ — search the drug name for approval letters
• AZN headlines on this site

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Entry

Phase 3 VOLGA: Imfinzi plus neoadjuvant EV improved EFS and OS in bladder cancer · Clinical trial results (readout / topline data)

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

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Entry

FDA ODAC votes 7-1 that Truqap has favourable benefit-risk in prostate cancer · FDA advisory panel meeting (AdComm)

Drug

Truqap (capivasertib) + abiraterone + ADT

For

PTEN-deficient metastatic hormone-sensitive prostate cancer

Stage

Regulatory (sNDA)

When

May 1, 2026

Source note

ODAC voted 7 to 1 with 1 abstention that Truqap plus abiraterone and ADT showed a favourable benefit-risk profile based on the CAPItello-281 Phase III trial in PTEN-deficient metastatic hormone-sensitive prostate cancer.

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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
• FDA advisory committee calendar ↗
• AZN headlines on this site

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Entry

Phase 3 OBERON and TITANIA: tozorakimab met primary endpoint in COPD · Clinical trial results (readout / topline data)

Drug

tozorakimab

For

Chronic obstructive pulmonary disease

Stage

Phase 3 · the last stage before a drug can be approved

When

Mar 27, 2026

Source note

Both replicate Phase 3 trials showed significant reductions in annualised moderate-to-severe COPD exacerbations versus placebo in former smokers and the overall population - the first IL-33-targeting biologic to do so.

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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

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page