BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//OnCo//Catalyst calendar//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:OnCo oncology catalysts
X-WR-CALDESC:Regulatory decisions\, expected readouts\, advisory committees
 \, congresses and deal closings in oncology\, from onco.cc.
BEGIN:VEVENT
UID:onco-catalyst-c-zidesamtinib-pdufa@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20260918
DTEND;VALUE=DATE:20260919
SUMMARY:FDA decision: zidesamtinib in TKI-pretreated ROS1-positive NSCLC
DESCRIPTION:PDUFA target action date stated by Nuvalent when the FDA accept
 ed the new drug application. Nuvalent's first potential approval.\n\nCompa
 nies: Nuvalent\n\nhttps://onco.cc/catalysts/#c-zidesamtinib-pdufa
URL:https://investors.nuvalent.com/news-releases
CATEGORIES:Regulatory decision,confirmed
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-catalyst-c-galleri-pma-decision@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270101
DTEND;VALUE=DATE:20270102
SUMMARY:Expected 2027: FDA decision on the Galleri multi-cancer early detec
 tion test (premarket approval)
DESCRIPTION:Follows the 23 September 2026 advisory committee. PMA decisions
  typically come months after the panel\; no date has been announced.\n\nEd
 itorial estimate\; can slip by quarters.\n\nCompanies: GRAIL\n\nhttps://on
 co.cc/catalysts/#c-galleri-pma-decision\n\nTiming resolution: year. The ev
 ent is placed on the first day of the period.
URL:https://www.prnewswire.com/news-releases/grail-announces-fda-advisory-c
 ommittee-meeting-to-review-premarket-approval-application-for-the-galleri-
 multi-cancer-early-detection-test-302846154.html
CATEGORIES:Label or clearance decision,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-catalyst-c-harmoni-3-readout@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270101
DTEND;VALUE=DATE:20270102
SUMMARY:Expected 2027: HARMONi-3: ivonescimab plus chemotherapy versus pemb
 rolizumab plus chemotherapy\, first-line NSCLC
DESCRIPTION:The first head-to-head test of the PD-1 x VEGF bispecific again
 st pembrolizumab in a Western population. Timing is our estimate from the 
 registry record\; the sponsor has not given a date.\n\nEditorial estimate\
 ; can slip by quarters.\n\nCompanies: Summit Therapeutics\, Akeso\n\nhttps
 ://onco.cc/catalysts/#c-harmoni-3-readout\n\nTiming resolution: year. The 
 event is placed on the first day of the period.
URL:https://clinicaltrials.gov/study/NCT05899608
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-catalyst-c-sunray-01-readout@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270101
DTEND;VALUE=DATE:20270102
SUMMARY:Expected 2027: SUNRAY-01: olomorasib plus pembrolizumab\, first-lin
 e KRAS G12C NSCLC
DESCRIPTION:Phase 3 in first-line KRAS G12C-mutant NSCLC. Timing is a regis
 try-based estimate.\n\nEditorial estimate\; can slip by quarters.\n\nCompa
 nies: Eli Lilly (incl. Loxo)\n\nhttps://onco.cc/catalysts/#c-sunray-01-rea
 dout\n\nTiming resolution: year. The event is placed on the first day of t
 he period.
URL:https://clinicaltrials.gov/study/NCT06119581
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-catalyst-c-krascendo-1-readout@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270101
DTEND;VALUE=DATE:20270102
SUMMARY:Expected 2027: Krascendo 1: divarasib versus sotorasib or adagrasib
 \, previously treated KRAS G12C NSCLC
DESCRIPTION:The first phase 3 comparing KRAS G12C inhibitors head to head. 
 Timing is a registry-based estimate.\n\nEditorial estimate\; can slip by q
 uarters.\n\nCompanies: Roche / Genentech\n\nhttps://onco.cc/catalysts/#c-k
 rascendo-1-readout\n\nTiming resolution: year. The event is placed on the 
 first day of the period.
URL:https://clinicaltrials.gov/study/NCT06497556
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-catalyst-c-ideate-lung02-readout@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270101
DTEND;VALUE=DATE:20270102
SUMMARY:Expected 2027: IDeate-Lung02: ifinatamab deruxtecan versus chemothe
 rapy\, relapsed small-cell lung cancer
DESCRIPTION:Pivotal phase 3 for the B7-H3 ADC from the Merck and Daiichi Sa
 nkyo collaboration. Timing is a registry-based estimate.\n\nEditorial esti
 mate\; can slip by quarters.\n\nCompanies: Daiichi Sankyo\, Merck & Co. (M
 SD)\n\nhttps://onco.cc/catalysts/#c-ideate-lung02-readout\n\nTiming resolu
 tion: year. The event is placed on the first day of the period.
URL:https://clinicaltrials.gov/study/NCT06203210
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-catalyst-c-rejoice-ovarian01-readout@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270101
DTEND;VALUE=DATE:20270102
SUMMARY:Expected 2027: REJOICE-Ovarian01: raludotatug deruxtecan in platinu
 m-resistant ovarian cancer
DESCRIPTION:Phase 2/3 for the CDH6 ADC. Timing is a registry-based estimate
 .\n\nEditorial estimate\; can slip by quarters.\n\nCompanies: Daiichi Sank
 yo\, Merck & Co. (MSD)\n\nhttps://onco.cc/catalysts/#c-rejoice-ovarian01-r
 eadout\n\nTiming resolution: year. The event is placed on the first day of
  the period.
URL:https://clinicaltrials.gov/study/NCT06161025
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-catalyst-c-tropion-lung14-readout@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270101
DTEND;VALUE=DATE:20270102
SUMMARY:Expected 2027: TROPION-Lung14: datopotamab deruxtecan plus osimerti
 nib\, first-line EGFR-mutant NSCLC
DESCRIPTION:Would move the TROP2 ADC into the first-line EGFR-mutant settin
 g on top of the standard TKI. Timing is a registry-based estimate.\n\nEdit
 orial estimate\; can slip by quarters.\n\nCompanies: AstraZeneca\, Daiichi
  Sankyo\n\nhttps://onco.cc/catalysts/#c-tropion-lung14-readout\n\nTiming r
 esolution: year. The event is placed on the first day of the period.
URL:https://clinicaltrials.gov/study/NCT06350097
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-catalyst-c-ascent-07-readout@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270101
DTEND;VALUE=DATE:20270102
SUMMARY:Expected 2027: ASCENT-07: sacituzumab govitecan versus chemotherapy
 \, first-line HR-positive HER2-negative metastatic breast cancer
DESCRIPTION:Tests the ADC as the first chemotherapy after endocrine therapy
 . Timing is a registry-based estimate.\n\nEditorial estimate\; can slip by
  quarters.\n\nCompanies: Gilead Sciences (incl. Kite)\n\nhttps://onco.cc/c
 atalysts/#c-ascent-07-readout\n\nTiming resolution: year. The event is pla
 ced on the first day of the period.
URL:https://clinicaltrials.gov/study/NCT05840211
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-catalyst-c-pluvicto-mhspc-decision@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20260101
DTEND;VALUE=DATE:20260102
SUMMARY:Expected 2026: FDA decision on Pluvicto in metastatic hormone-sensi
 tive prostate cancer (PSMAddition)
DESCRIPTION:Novartis announced the supplemental filing after the PSMAdditio
 n results in 2025. No action date has been disclosed\; the year is our est
 imate.\n\nEditorial estimate\; can slip by quarters.\n\nCompanies: Novarti
 s\n\nhttps://onco.cc/catalysts/#c-pluvicto-mhspc-decision\n\nTiming resolu
 tion: year. The event is placed on the first day of the period.
URL:https://www.novartis.com/news
CATEGORIES:Regulatory decision,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-catalyst-c-intismeran-filing@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270101
DTEND;VALUE=DATE:20270102
SUMMARY:Expected 2027: Regulatory filings for intismeran autogene plus pemb
 rolizumab in adjuvant melanoma (INTerpath-001)
DESCRIPTION:The sponsors said filings would follow the positive topline res
 ult of August 2026 and the full data presentation. Timing is our estimate.
 \n\nEditorial estimate\; can slip by quarters.\n\nCompanies: Moderna\, Mer
 ck & Co. (MSD)\n\nhttps://onco.cc/catalysts/#c-intismeran-filing\n\nTiming
  resolution: year. The event is placed on the first day of the period.
URL:https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath
 -001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrenc
 e-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/
CATEGORIES:Filing,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-catalyst-c-tempus-personalis-close@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20261001
DTEND;VALUE=DATE:20261002
SUMMARY:Expected Q4 2026: Tempus completes the acquisition of Personalis
DESCRIPTION:All-stock deal at $16.25 per share announced July 2026\; the co
 mpanies guided to a close in late 2026 or early 2027.\n\nEditorial estimat
 e\; can slip by quarters.\n\nCompanies: Tempus AI\, Personalis (Tempus)\n\
 nhttps://onco.cc/catalysts/#c-tempus-personalis-close\n\nTiming resolution
 : quarter. The event is placed on the first day of the period.
URL:https://investors.tempus.com/news-releases/news-release-details/tempus-
 acquire-personalis-more-tightly-integrating-molecular
CATEGORIES:Deal closing,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-0@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20260923
DTEND;VALUE=DATE:20260924
SUMMARY:FDA advisory committee: Galleri multi-cancer early detection test (
 PMA)
DESCRIPTION:Molecular and Clinical Genetics Panel of the Medical Devices Ad
 visory Committee reviews GRAIL's premarket approval application. The first
  FDA-level judgement on a multi-cancer blood screening test.\n\nCompanies:
  GRAIL\n\nhttps://onco.cc/catalysts/#cal-0
URL:https://www.prnewswire.com/news-releases/grail-announces-fda-advisory-c
 ommittee-meeting-to-review-premarket-approval-application-for-the-galleri-
 multi-cancer-early-detection-test-302846154.html
CATEGORIES:Advisory committee,confirmed
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-1@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20261023
DTEND;VALUE=DATE:20261024
SUMMARY:ESMO Congress 2026\, Madrid (23–27 October)
DESCRIPTION:Europe's largest oncology congress. Watch for: TROPION-Breast05
 \, first-line ADC + IO data\, late-breaking radioligand and bispecific ADC
  results.\n\nhttps://onco.cc/catalysts/#cal-1
URL:https://www.esmo.org/meeting-calendar/esmo-congress-2026/registration
CATEGORIES:Congress,confirmed
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-2@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20261208
DTEND;VALUE=DATE:20261209
SUMMARY:San Antonio Breast Cancer Symposium 2026 (8–11 December)
DESCRIPTION:The breast cancer congress. Post-neoadjuvant TNBC ADC trials (A
 SCENT-05\, TROPION-Breast03) and sac-TMT first-line TNBC data are candidat
 es for presentation here or at ESMO.\n\nhttps://onco.cc/catalysts/#cal-2
URL:https://sabcs.org/media/future-symposia/
CATEGORIES:Congress,confirmed
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-3@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20261212
DTEND;VALUE=DATE:20261213
SUMMARY:ASH Annual Meeting 2026\, New Orleans (12–15 December)
DESCRIPTION:Haematology's main congress: CAR-T\, bispecifics\, menin inhibi
 tors\, BCL-2 combinations.\n\nhttps://onco.cc/catalysts/#cal-3
URL:https://www.hematology.org/meetings/annual-meeting
CATEGORIES:Congress,confirmed
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-4@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270402
DTEND;VALUE=DATE:20270403
SUMMARY:AACR Annual Meeting 2027\, Orlando (2–7 April)
DESCRIPTION:Early science and first-in-human data: next-generation ADC payl
 oads\, degraders\, in vivo CAR-T.\n\nhttps://onco.cc/catalysts/#cal-4
URL:https://www.aacr.org/meeting/aacr-annual-meeting-2027/
CATEGORIES:Congress,confirmed
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-5@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270604
DTEND;VALUE=DATE:20270605
SUMMARY:ASCO Annual Meeting 2027\, Chicago (4–8 June)
DESCRIPTION:Where most practice-changing phase 3 trials are first presented
 .\n\nhttps://onco.cc/catalysts/#cal-5
URL:https://www.asco.org/annual-meeting
CATEGORIES:Congress,confirmed
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-6@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20261001
DTEND;VALUE=DATE:20261002
SUMMARY:Expected Q4 2026: TROPION-Breast05: Dato-DXd ± durvalumab vs pembr
 olizumab + chemotherapy\, first-line PD-L1+ TNBC
DESCRIPTION:Primary completion per registry falls in 2026\; timing of topli
 ne is our estimate. Would complete the ADC + IO first-line picture alongsi
 de ASCENT-04.\n\nEditorial estimate\; can slip by quarters.\n\nCompanies: 
 Daiichi Sankyo\, AstraZeneca\n\nhttps://onco.cc/catalysts/#cal-6\n\nTiming
  resolution: quarter. The event is placed on the first day of the period.
URL:https://clinicaltrials.gov/study/NCT06103864
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-7@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20261001
DTEND;VALUE=DATE:20261002
SUMMARY:Expected Q4 2026: INTerpath-001 full data: intismeran autogene + pe
 mbrolizumab\, adjuvant melanoma
DESCRIPTION:Topline positive 19 August 2026\; hazard ratios and curves expe
 cted at a late-2026 congress (ESMO or SMR)\, with regulatory filings to fo
 llow.\n\nEditorial estimate\; can slip by quarters.\n\nCompanies: Moderna\
 , Merck & Co. (MSD)\n\nhttps://onco.cc/catalysts/#cal-7\n\nTiming resoluti
 on: quarter. The event is placed on the first day of the period.
URL:https://www.merck.com/news/merck-and-moderna-announce-phase-3-interpath
 -001-trial-of-intismeran-autogene-plus-keytruda-met-endpoints-of-recurrenc
 e-free-survival-rfs-and-distant-metastasis-free-survival-dmfs-in-patient/
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-8@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270101
DTEND;VALUE=DATE:20270102
SUMMARY:Expected Q1 2027: RASolute 302: daraxonrasib vs chemotherapy\, seco
 nd-line metastatic pancreatic cancer
DESCRIPTION:Fully enrolled\; event-driven OS endpoint. Sponsor has guided t
 o a 2026–27 readout. The first pivotal test of a pan-RAS inhibitor.\n\nE
 ditorial estimate\; can slip by quarters.\n\nCompanies: Revolution Medicin
 es\n\nhttps://onco.cc/catalysts/#cal-8\n\nTiming resolution: quarter. The 
 event is placed on the first day of the period.
URL:https://clinicaltrials.gov/study/NCT06625320
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-9@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270401
DTEND;VALUE=DATE:20270402
SUMMARY:Expected Q2 2027: IZABRIGHT-Breast01: iza-bren vs chemotherapy\, fi
 rst-line TNBC (PD-(L)1 ineligible)
DESCRIPTION:Global first-line trial of the EGFR×HER3 bispecific ADC\; timi
 ng is an estimate from enrolment start (2025).\n\nEditorial estimate\; can
  slip by quarters.\n\nCompanies: SystImmune / Sichuan Biokin\, Bristol Mye
 rs Squibb\n\nhttps://onco.cc/catalysts/#cal-9\n\nTiming resolution: quarte
 r. The event is placed on the first day of the period.
URL:https://clinicaltrials.gov/study/NCT06926868
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-10@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270101
DTEND;VALUE=DATE:20270102
SUMMARY:Expected 2027: US regulatory decision on sacituzumab tirumotecan (s
 ac-TMT) — first indication
DESCRIPTION:Merck holds a Commissioner's National Priority Voucher (July 20
 26) 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 n
 ot public.\n\nEditorial estimate\; can slip by quarters.\n\nCompanies: Sic
 huan Kelun-Biotech\, Merck & Co. (MSD)\n\nhttps://onco.cc/catalysts/#cal-1
 0\n\nTiming resolution: year. The event is placed on the first day of the 
 period.
URL:https://www.pharmacytimes.com/view/fda-grants-national-priority-voucher
 s-to-enlicitide-decanoate-sacituzumab-tirumotecan
CATEGORIES:Regulatory decision,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-11@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20270101
DTEND;VALUE=DATE:20270102
SUMMARY:Expected 2027: ASCENT-05 / OptimICE-RD: sacituzumab govitecan + pem
 brolizumab\, post-neoadjuvant residual TNBC
DESCRIPTION:Event-driven iDFS endpoint in patients with residual disease af
 ter KEYNOTE-522-type therapy. Would be the first ADC in the curative TNBC 
 setting.\n\nEditorial estimate\; can slip by quarters.\n\nCompanies: Gilea
 d Sciences (incl. Kite)\, Merck & Co. (MSD)\n\nhttps://onco.cc/catalysts/#
 cal-11\n\nTiming resolution: year. The event is placed on the first day of
  the period.
URL:https://clinicaltrials.gov/study/NCT05633654
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-12@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20271001
DTEND;VALUE=DATE:20271002
SUMMARY:Expected Q4 2027: TROPION-Breast03: Dato-DXd ± durvalumab\, post-n
 eoadjuvant residual TNBC
DESCRIPTION:Registry estimated primary completion 20 September 2027\; topli
 ne may lag.\n\nEditorial estimate\; can slip by quarters.\n\nCompanies: Da
 iichi Sankyo\, AstraZeneca\n\nhttps://onco.cc/catalysts/#cal-12\n\nTiming 
 resolution: quarter. The event is placed on the first day of the period.
URL:https://clinicaltrials.gov/study/NCT05629585
CATEGORIES:Expected readout,expected
TRANSP:TRANSPARENT
END:VEVENT
BEGIN:VEVENT
UID:onco-calendar-cal-13@onco.cc
DTSTAMP:20260910T083955Z
DTSTART;VALUE=DATE:20261001
DTEND;VALUE=DATE:20261002
SUMMARY:Expected Q4 2026: NHS England decision on Galleri rollout after ful
 l NHS-Galleri results
DESCRIPTION:Full results presented at ASCO 2026 (primary stage III–IV end
 point not met\; stage IV reduction reported). NHS England said it would wa
 it for final results before any rollout decision\; timing of a decision is
  not announced.\n\nEditorial estimate\; can slip by quarters.\n\nCompanies
 : GRAIL\n\nhttps://onco.cc/catalysts/#cal-13\n\nTiming resolution: quarter
 . The event is placed on the first day of the period.
URL:https://grail.com/press-releases/grail-reports-full-results-from-nhs-ga
 lleri-trial-demonstrating-substantial-reduction-in-stage-iv-cancer-diagnos
 es-at-2026-asco-annual-meeting/
CATEGORIES:Policy,expected
TRANSP:TRANSPARENT
END:VEVENT
END:VCALENDAR