Catalyst calendar

PDUFA target action date stated by Nuvalent when the FDA accepted the new drug application. Nuvalent's first potential approval.

Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee reviews GRAIL's premarket approval application. The first FDA-level judgement on a multi-cancer blood screening test.

Europe's largest oncology congress. Watch for: TROPION-Breast05, first-line ADC + IO data, late-breaking radioligand and bispecific ADC results.

The breast cancer congress. Post-neoadjuvant TNBC ADC trials (ASCENT-05, TROPION-Breast03) and sac-TMT first-line TNBC data are candidates for presentation here or at ESMO.

Haematology's main congress: CAR-T, bispecifics, menin inhibitors, BCL-2 combinations.

All-stock deal at $16.25 per share announced July 2026; the companies guided to a close in late 2026 or early 2027.

Primary completion per registry falls in 2026; timing of topline is our estimate. Would complete the ADC + IO first-line picture alongside ASCENT-04.

Topline positive 19 August 2026; hazard ratios and curves expected at a late-2026 congress (ESMO or SMR), with regulatory filings to follow.

Full results presented at ASCO 2026 (primary stage III–IV endpoint not met; stage IV reduction reported). NHS England said it would wait for final results before any rollout decision; timing of a decision is not announced.

Novartis announced the supplemental filing after the PSMAddition results in 2025. No action date has been disclosed; the year is our estimate.

Fully enrolled; event-driven OS endpoint. Sponsor has guided to a 2026–27 readout. The first pivotal test of a pan-RAS inhibitor.

Early science and first-in-human data: next-generation ADC payloads, degraders, in vivo CAR-T.

Where most practice-changing phase 3 trials are first presented.

Global first-line trial of the EGFR×HER3 bispecific ADC; timing is an estimate from enrolment start (2025).

Registry estimated primary completion 20 September 2027; topline may lag.

Follows the 23 September 2026 advisory committee. PMA decisions typically come months after the panel; no date has been announced.

The first head-to-head test of the PD-1 x VEGF bispecific against pembrolizumab in a Western population. Timing is our estimate from the registry record; the sponsor has not given a date.

Phase 3 in first-line KRAS G12C-mutant NSCLC. Timing is a registry-based estimate.

The first phase 3 comparing KRAS G12C inhibitors head to head. Timing is a registry-based estimate.

Pivotal phase 3 for the B7-H3 ADC from the Merck and Daiichi Sankyo collaboration. Timing is a registry-based estimate.

Phase 2/3 for the CDH6 ADC. Timing is a registry-based estimate.

Would move the TROP2 ADC into the first-line EGFR-mutant setting on top of the standard TKI. Timing is a registry-based estimate.

Tests the ADC as the first chemotherapy after endocrine therapy. Timing is a registry-based estimate.

The sponsors said filings would follow the positive topline result of August 2026 and the full data presentation. Timing is our estimate.

Merck holds a Commissioner's National Priority Voucher (July 2026) that promises a 1–2 month review once filed. No PDUFA date has been disclosed; indication (TNBC vs EGFR-mutant NSCLC) and filing timing are not public.

Event-driven iDFS endpoint in patients with residual disease after KEYNOTE-522-type therapy. Would be the first ADC in the curative TNBC setting.