BEGIN:VCALENDAR VERSION:2.0 PRODID:-//app.biotechtracker.dev//Biotech Tracker//EN CALSCALE:GREGORIAN METHOD:PUBLISH X-WR-CALNAME:Biotech Tracker — catalysts BEGIN:VEVENT UID:549394e7f9221f71@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20261102 DTEND;VALUE=DATE:20261103 SUMMARY:RXRX Conference: REC-4881 TUPELO FAP data in Presidential Plenary a t CGA-IGC (Nov 2) DESCRIPTION:Recursion presents data on REC-4881 (MEK1/2 inhibitor) for fami lial adenomatous polyposis at a medical meeting on Nov 2\, 2026. New numbe rs at a conference can move the stock as much as a formal announcement.\n\ nRecursion Pharmaceuticals\, Inc.\nREC-4881 (MEK1/2 inhibitor) · familial adenomatous polyposis · Phase 1b/2\nSource: https://www.biospace.com/pre ss-releases/recursion-reports-second-quarter-financial-results-genentech-o ptions-first-neuroscience-target-into-early-discovery-program\nhttps://app .biotechtracker.dev/events/rxrx-conference-2026-11-02-rec-4881-tupelo-fap- data-in-presidential-plenary-at-c-549394e7f9221f71 URL:https://app.biotechtracker.dev/events/rxrx-conference-2026-11-02-rec-48 81-tupelo-fap-data-in-presidential-plenary-at-c-549394e7f9221f71 END:VEVENT BEGIN:VEVENT UID:2c22b4d971e4b62b@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20261114 DTEND;VALUE=DATE:20261115 SUMMARY:CYTK FDA decision: PDUFA date for aficamten sNDA (MAPLE-HCM\, monot herapy vs metoprolol) in oHCM DESCRIPTION:The FDA is due to decide by Nov 14\, 2026 whether to approve Cy tokinetics’ aficamten (MYQORZO) for obstructive hypertrophic cardiomyopa thy (label expansion based on MAPLE-HCM). Approval clears it for sale in t he US\; a rejection usually arrives as a letter listing what has to be fix ed first.\n\nCytokinetics\, Incorporated\naficamten (MYQORZO) · obstructi ve hypertrophic cardiomyopathy (label expansion based on MAPLE-HCM) · sND A under FDA review\nSource: https://www.biospace.com/press-releases/cytoki netics-reports-first-quarter-2026-financial-results-and-provides-business- update\nhttps://app.biotechtracker.dev/events/cytk-pdufa-2026-11-14-pdufa- date-for-aficamten-snda-maple-hcm-monotherapy-vs-met-2c22b4d971e4b62b URL:https://app.biotechtracker.dev/events/cytk-pdufa-2026-11-14-pdufa-date- for-aficamten-snda-maple-hcm-monotherapy-vs-met-2c22b4d971e4b62b END:VEVENT BEGIN:VEVENT UID:0385d38fb98099b2@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20261114 DTEND;VALUE=DATE:20261115 SUMMARY:SMMT FDA decision: PDUFA date for ivonescimab in EGFR-mutated NSCLC post-TKI DESCRIPTION:The FDA is due to decide by Nov 14\, 2026 whether to approve Su mmit’s Ivonescimab for EGFR-mutated locally advanced/metastatic non-squa mous NSCLC after 3rd-gen EGFR TKI (with chemotherapy). Approval clears it for sale in the US\; a rejection usually arrives as a letter listing what has to be fixed first.\n\nSummit Therapeutics Inc.\nIvonescimab · EGFR-mu tated locally advanced/metastatic non-squamous NSCLC after 3rd-gen EGFR TK I (with chemotherapy) · BLA under review\nSource: https://smmttx.com/news /press-releases/news-details/2026/Summit-Therapeutics-Announces-U-S--FDA-A cceptance-of-Biologics-License-Application-BLA-Seeking-Approval-for-Ivones cimab-in-Combination-with-Chemotherapy-in-Treatment-of-Patients-with-EGFRm -NSCLC-Post-TKI-Therapy/default.aspx\nhttps://app.biotechtracker.dev/event s/smmt-pdufa-2026-11-14-pdufa-date-for-ivonescimab-in-egfr-mutated-nsclc-p ost-tki-0385d38fb98099b2 URL:https://app.biotechtracker.dev/events/smmt-pdufa-2026-11-14-pdufa-date- for-ivonescimab-in-egfr-mutated-nsclc-post-tki-0385d38fb98099b2 END:VEVENT BEGIN:VEVENT UID:4ff316550f1386f2@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20261125 DTEND;VALUE=DATE:20261126 SUMMARY:SNY FDA decision: PDUFA for venglustat in type 3 Gaucher disease DESCRIPTION:The FDA is due to decide by Nov 25\, 2026 whether to approve Sa nofi’s Venglustat (glucosylceramide synthase inhibitor) for Type 3 Gauch er disease (GD3). Approval clears it for sale in the US\; a rejection usua lly arrives as a letter listing what has to be fixed first.\n\nSanofi\nVen glustat (glucosylceramide synthase inhibitor) · Type 3 Gaucher disease (G D3) · NDA under Priority Review\nSource: https://www.sanofi.com/assets/do tcom/pressreleases/2026/2026-07-30-05-30-00-3335767-en.pdf\nhttps://app.bi otechtracker.dev/events/sny-pdufa-2026-11-25-pdufa-for-venglustat-in-type- 3-gaucher-disease-4ff316550f1386f2 URL:https://app.biotechtracker.dev/events/sny-pdufa-2026-11-25-pdufa-for-ve nglustat-in-type-3-gaucher-disease-4ff316550f1386f2 END:VEVENT BEGIN:VEVENT UID:4b983368e811d09b@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20261130 DTEND;VALUE=DATE:20261201 SUMMARY:VRTX FDA decision: PDUFA date for povetacicept accelerated approval in IgA nephropathy DESCRIPTION:The FDA is due to decide by Nov 30\, 2026 whether to approve Ve rtex’s povetacicept (dual BAFF/APRIL inhibitor) for IgA nephropathy (acc elerated approval). Approval clears it for sale in the US\; a rejection us ually arrives as a letter listing what has to be fixed first.\n\nVertex Ph armaceuticals Incorporated\npovetacicept (dual BAFF/APRIL inhibitor) · Ig A nephropathy (accelerated approval) · BLA under FDA review (Phase 3 RAIN IER interim)\nSource: https://news.vrtx.com/news-releases/news-release-det ails/vertex-announces-us-fda-acceptance-biologics-license-application\nhtt ps://app.biotechtracker.dev/events/vrtx-pdufa-2026-11-30-pdufa-date-for-po vetacicept-accelerated-approval-in-iga-ne-4b983368e811d09b URL:https://app.biotechtracker.dev/events/vrtx-pdufa-2026-11-30-pdufa-date- for-povetacicept-accelerated-approval-in-iga-ne-4b983368e811d09b END:VEVENT BEGIN:VEVENT UID:d8e062cea901dc85@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20261203 DTEND;VALUE=DATE:20261204 SUMMARY:EXEL FDA decision: PDUFA date for zanzalintinib + atezolizumab in m etastatic colorectal cancer DESCRIPTION:The FDA is due to decide by Dec 3\, 2026 whether to approve Exe lixis’ Zanzalintinib (+ atezolizumab) for Previously treated non-MSI-hig h metastatic colorectal cancer. Approval clears it for sale in the US\; a rejection usually arrives as a letter listing what has to be fixed first.\ n\nExelixis\, Inc.\nZanzalintinib (+ atezolizumab) · Previously treated n on-MSI-high metastatic colorectal cancer · NDA under FDA review (standard review)\nSource: https://www.biospace.com/press-releases/exelixis-announc es-u-s-fda-accepted-the-new-drug-application-for-zanzalintinib-in-combinat ion-with-an-immune-checkpoint-inhibitor-for-patients-with-metastatic-color ectal-cancer\nhttps://app.biotechtracker.dev/events/exel-pdufa-2026-12-03- pdufa-date-for-zanzalintinib-atezolizumab-in-metastatic-co-d8e062cea901dc8 5 URL:https://app.biotechtracker.dev/events/exel-pdufa-2026-12-03-pdufa-date- for-zanzalintinib-atezolizumab-in-metastatic-co-d8e062cea901dc85 END:VEVENT BEGIN:VEVENT UID:8fce6e1ff695fb52@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20261211 DTEND;VALUE=DATE:20261212 SUMMARY:TAK Milestone: Takeda Capital Markets Day in Tokyo DESCRIPTION:Takeda Capital Markets Day in Tokyo\, expected on Dec 11\, 2026 . A company milestone for Takeda Pharmaceutical Company (Pipeline (ovepore xton\, rusfertide\, zasocitinib\, mezagitamab\, fazirsiran\, elritercept) for Corporate/pipeline strategy): a step in the program rather than a deci sion or a data readout.\n\nTakeda Pharmaceutical Company Limited\nPipeline (oveporexton\, rusfertide\, zasocitinib\, mezagitamab\, fazirsiran\, elri tercept) · Corporate/pipeline strategy · n/a\nSource: https://www.takeda .com/newsroom/newsreleases/2026/takeda-reports-first-quarter-fy2026-result s/\nhttps://app.biotechtracker.dev/events/tak-other-2026-12-11-takeda-capi tal-markets-day-in-tokyo-8fce6e1ff695fb52 URL:https://app.biotechtracker.dev/events/tak-other-2026-12-11-takeda-capit al-markets-day-in-tokyo-8fce6e1ff695fb52 END:VEVENT BEGIN:VEVENT UID:8ca721011ad5dd86@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20261223 DTEND;VALUE=DATE:20261224 SUMMARY:GILD FDA decision: PDUFA date for anito-cel in 4L+ relapsed/refract ory multiple myeloma DESCRIPTION:The FDA is due to decide by Dec 23\, 2026 whether to approve Gi lead Sciences’ anitocabtagene autoleucel (anito-cel) for Fourth-line+ re lapsed/refractory multiple myeloma. Approval clears it for sale in the US\ ; a rejection usually arrives as a letter listing what has to be fixed fir st.\n\nGilead Sciences\, Inc.\nanitocabtagene autoleucel (anito-cel) · Fo urth-line+ relapsed/refractory multiple myeloma · BLA under FDA review (p ivotal Phase 2 iMMagine-1)\nSource: https://www.gilead.com/news/news-detai ls/2026/gilead-sciences-to-acquire-arcellx-to-maximize-long-term-potential -of-anito-cel\nhttps://app.biotechtracker.dev/events/gild-pdufa-2026-12-23 -pdufa-date-for-anito-cel-in-4l-relapsed-refractory-multipl-8ca721011ad5dd 86 URL:https://app.biotechtracker.dev/events/gild-pdufa-2026-12-23-pdufa-date- for-anito-cel-in-4l-relapsed-refractory-multipl-8ca721011ad5dd86 END:VEVENT BEGIN:VEVENT UID:4ca4a23badc4477f@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20270202 DTEND;VALUE=DATE:20270203 SUMMARY:GILD FDA decision: PDUFA date for once-weekly oral Yeztugo (lenacap avir) for HIV PrEP DESCRIPTION:The FDA is due to decide by Feb 2\, 2027 whether to approve Gil ead Sciences’ Yeztugo (lenacapavir) 300-mg once-weekly oral tablets for HIV pre-exposure prophylaxis (PrEP). Approval clears it for sale in the US \; a rejection usually arrives as a letter listing what has to be fixed fi rst.\n\nGilead Sciences\, Inc.\nYeztugo (lenacapavir) 300-mg once-weekly o ral tablets · HIV pre-exposure prophylaxis (PrEP) · sNDA under FDA revie w\nSource: https://www.gilead.com/news/news-details/2026/gilead-sciences-a nnounces-second-quarter-2026-financial-results\nhttps://app.biotechtracker .dev/events/gild-pdufa-2027-02-02-pdufa-date-for-once-weekly-oral-yeztugo- lenacapavir-for-hi-4ca4a23badc4477f URL:https://app.biotechtracker.dev/events/gild-pdufa-2027-02-02-pdufa-date- for-once-weekly-oral-yeztugo-lenacapavir-for-hi-4ca4a23badc4477f END:VEVENT BEGIN:VEVENT UID:dc56985f8c4311c6@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20270228 DTEND;VALUE=DATE:20270301 SUMMARY:BMRN FDA decision: PDUFA date for VOXZOGO full-approval sNDA in ach ondroplasia DESCRIPTION:The FDA is due to decide by Feb 28\, 2027 whether to approve Bi oMarin’s VOXZOGO (vosoritide) for Achondroplasia in children (conversion of accelerated approval to full approval). Approval clears it for sale in the US\; a rejection usually arrives as a letter listing what has to be f ixed first.\n\nBioMarin Pharmaceutical Inc.\nVOXZOGO (vosoritide) · Achon droplasia in children (conversion of accelerated approval to full approval ) · sNDA under FDA review\nSource: https://investors.biomarin.com/news/ne ws-details/2026/U-S--Food-and-Drug-Administration-Accepts-BioMarins-Supple mental-New-Drug-Application-for-Full-Approval-of-VOXZOGO-vosoritide-for-Ch ildren-With-Achondroplasia/default.aspx\nhttps://app.biotechtracker.dev/ev ents/bmrn-pdufa-2027-02-28-pdufa-date-for-voxzogo-full-approval-snda-in-ac hondroplasi-dc56985f8c4311c6 URL:https://app.biotechtracker.dev/events/bmrn-pdufa-2027-02-28-pdufa-date- for-voxzogo-full-approval-snda-in-achondroplasi-dc56985f8c4311c6 END:VEVENT BEGIN:VEVENT UID:9c1532abe05d9797@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20270228 DTEND;VALUE=DATE:20270301 SUMMARY:SRPT FDA decision: PDUFA date for AMONDYS 45 and VYONDYS 53 sNDAs ( conversion to full approval) in DMD DESCRIPTION:The FDA is due to decide by Feb 28\, 2027 whether to approve Sa repta’s AMONDYS 45 (casimersen) / VYONDYS 53 (golodirsen) for Duchenne m uscular dystrophy (exon 45 / exon 53 skipping). Approval clears it for sal e in the US\; a rejection usually arrives as a letter listing what has to be fixed first.\n\nSarepta Therapeutics\, Inc.\nAMONDYS 45 (casimersen) / VYONDYS 53 (golodirsen) · Duchenne muscular dystrophy (exon 45 / exon 53 skipping) · sNDA under FDA review\nSource: https://investorrelations.sare pta.com/news-releases/news-release-details/sarepta-announces-fda-acceptanc e-sndas-amondys-45r-and-vyondys\nhttps://app.biotechtracker.dev/events/srp t-pdufa-2027-02-28-pdufa-date-for-amondys-45-and-vyondys-53-sndas-conversi on-9c1532abe05d9797 URL:https://app.biotechtracker.dev/events/srpt-pdufa-2027-02-28-pdufa-date- for-amondys-45-and-vyondys-53-sndas-conversion-9c1532abe05d9797 END:VEVENT BEGIN:VEVENT UID:2d96d45137de8f35@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20270501 DTEND;VALUE=DATE:20270502 SUMMARY:AXSM FDA decision: PDUFA date for AXS-12 in cataplexy associated wi th narcolepsy DESCRIPTION:The FDA is due to decide by May 1\, 2027 whether to approve Axs ome’s AXS-12 (reboxetine) for Cataplexy in narcolepsy. Approval clears i t for sale in the US\; a rejection usually arrives as a letter listing wha t has to be fixed first.\n\nAxsome Therapeutics\, Inc.\nAXS-12 (reboxetine ) · Cataplexy in narcolepsy · NDA under FDA review\nSource: https://www. globenewswire.com/news-release/2026/07/15/3327580/33090/en/axsome-therapeu tics-announces-fda-acceptance-of-new-drug-application-for-axs-12-for-the-t reatment-of-cataplexy-in-narcolepsy.html\nhttps://app.biotechtracker.dev/e vents/axsm-pdufa-2027-05-01-pdufa-date-for-axs-12-in-cataplexy-associated- with-narcole-2d96d45137de8f35 URL:https://app.biotechtracker.dev/events/axsm-pdufa-2027-05-01-pdufa-date- for-axs-12-in-cataplexy-associated-with-narcole-2d96d45137de8f35 END:VEVENT BEGIN:VEVENT UID:c1bb806072abc29d@app.biotechtracker.dev DTSTAMP:20261027T125627Z DTSTART;VALUE=DATE:20270513 DTEND;VALUE=DATE:20270514 SUMMARY:BMY FDA decision: PDUFA mezigdomide + carfilzomib/dex (MeziKd) in R RMM DESCRIPTION:The FDA is due to decide by May 13\, 2027 whether to approve Br istol-Myers Squibb Company’s mezigdomide for Relapsed or refractory mult iple myeloma (SUCCESSOR-2). Approval clears it for sale in the US\; a reje ction usually arrives as a letter listing what has to be fixed first.\n\nB ristol-Myers Squibb Company\nmezigdomide · Relapsed or refractory multipl e myeloma (SUCCESSOR-2) · NDA\nSource: https://news.bms.com/news/corporat e-financial/2026/U-S--Food-and-Drug-Administration-Accepts-Bristol-Myers-S quibbs-New-Drug-Application-for-Mezigdomide-in-Patients-with-Relapsed-or-R efractory-Multiple-Myeloma/default.aspx\nhttps://app.biotechtracker.dev/ev ents/bmy-pdufa-2027-05-13-pdufa-mezigdomide-carfilzomib-dex-mezikd-in-rrmm -c1bb806072abc29d URL:https://app.biotechtracker.dev/events/bmy-pdufa-2027-05-13-pdufa-mezigd omide-carfilzomib-dex-mezikd-in-rrmm-c1bb806072abc29d END:VEVENT END:VCALENDAR