FDA Calendar
Upcoming clinical readouts, trial starts, and trial-progress milestones for U.S.-listed biotech, with official source links.
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35 of 1,612 scheduled catalysts · 26 of 429 companies with matching events
Evidence: A regulator/SEC/trial registry · B official company source · Market data is separate context.
Scheduled catalysts
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Next CatalystCompanyDrugPrice · 30DCurrent stage
Opus Genetics, Inc.IRDDrugOPGx-001AAV gene therapy
IndicationLCA5-associated inherited retinal disease (registered Phase 1/2)Children with LCA5
TargetFunctional LCA5 gene
Clinical dataPhase 1/2 dataOct 14, 2026Retina in RioNear Normalization of Cone Sensitivity
BOfficial source Current stagePreINDP1P2P3FilingApproved
Verastem, Inc.VSTMDrugVS-7375
Indicationadvanced KRAS G12D-mutated solid tumors / second-line advanced or metastatic pancreatic ductal carcinoma / first-line metastatic pancreatic ductal adenocarcinoma combination development / second- or third-line advanced KRAS G12D-mutated non-small cell lung cancer / first-line advanced non-small cell lung cancer / second-line or later metastatic colorectal cancer / first-line metastatic colorectal cancer combination development
TargetKRAS G12D
Clinical dataPhase 1/2 dataOct 14, 2026to present initial efficacy and updated safety and tolerability data
BOfficial sourceAll sources (8)
Current stagePreINDP1P2P3FilingApproved
Pharming Group N.V.PHARDrugJoenja® (leniolisib)small molecule
IndicationPrimary immunodeficiencies with immune dysregulationleniolisib Phase 2 · 13 subjects with genetically defined PIDs · dose escalation
TargetPI3Kδ
Clinical dataPhase 2 data · AdditionalOct 14-17, 2026ESID 2026leniolisib Phase 2 · Additional data will be presented
AOfficial sourceAll sources (2)
Current stagePreINDP1P2P3FilingApproved
Achieve Life Sciences, Inc.ACHVDrugCytisinicline
IndicationE-cigarette/vaping cessation / Cigarette smoking cessationORCA-OL · adults who previously participated in the ORCA-2, ORCA-3 or ORCA-V1 trials and were actively smoking cigarettes and/or vaping daily
Targetα4β2 nicotinic acetylcholine receptor / 5-HT3 receptor
Clinical dataPhase 2 dataOct 20, 2026CHEST 2026Study details
ORCA-OL · new data evaluating the efficacy of 52 weeks of cytisinicline treatment for cigarette smoking and e-cigarette cessation will be presented
All sources (2)
Current stagePreINDP1P2P3FilingApproved
Shattuck Labs, Inc.STTKDrugSL-846bispecific antibody
IndicationNon-human primates (IND-enabling GLP toxicology)SL-846 IND-enabling GLP toxicology study · non-human primates
TargetDR3 / IL-23R
Clinical dataPreclinical dataOct 17-20, 2026UEG WeekStudy details
SL-846 IND-enabling GLP toxicology study · Preclinical data for SL-846, including safety, pharmacokinetics, and receptor occupancy from the ongoing GLP toxicology study
All sources (4)
Current stagePreINDP1P2P3FilingApproved
PERSPECTIVE THERAPEUTICS, INC.CATXDrugVMT-α-NETpeptide radiopharmaceutical
IndicationSSTR2-positive neuroendocrine tumorsNCT05636618 · Cohorts 1–3NCT05636618 TargetSSTR2
Clinical dataPhase 1/2 dataOct 23, 2026European Society of Medical Oncology (ESMO) Congress 2026NCT05636618 · Cohort level safety and efficacy results
BOfficial sourceAll sources (4)
Current stagePreINDP1P2P3FilingApproved
EIKON THERAPEUTICS, INC.EIKNDrugEIK1003
IndicationAdvanced solid tumors, including breast, ovarian, prostate and pancreatic cancerNCT06253130 · Participants with advanced solid tumors; Cohort 1B includes patients with advanced prostate cancer · Cohorts 1A, 1B and 1CNCT06253130 TargetPARP1
Clinical dataPhase 1/2 dataOct 23, 2026ESMO Congress 2026NCT06253130 · will present clinical data from its ongoing Phase 1/2 trial of EIK1003
BOfficial sourceAll sources (3)
Current stagePreINDP1P2P3FilingApproved
EIKON THERAPEUTICS, INC.EIKNDrugEIK1004
IndicationAdvanced solid tumors with or without brain metastasesNCT06907043 · Patients with ovarian, breast, prostate, and pancreatic cancersNCT06907043 TargetPARP1
Clinical dataPhase 1/2 data · InitialOct 23, 2026ESMO Congress 2026NCT06907043 · will also present, for the first time, data from an ongoing Phase 1/2 trial
BOfficial source Current stagePreINDP1P2P3FilingApproved
EIKON THERAPEUTICS, INC.EIKNDrugEIK1005
IndicationAdvanced solid tumors including MSI-H tumorsNCT07262619 · Participants with advanced solid tumorsNCT07262619 TargetWRN
Clinical dataPhase 1/2 dataOct 23, 2026ESMO Congress 2026NCT07262619 · Preliminary safety, tolerability and pharmacokinetic data for EIK1005 will be presented
BOfficial source Current stagePreINDP1P2P3FilingApproved
ORIC PHARMACEUTICALS, INC.ORICDrugRinzimetostat (ORIC-944)small molecule
IndicationMetastatic castration-resistant prostate cancer previously treated with abirateroneHimalayas-1 · mCRPC patients previously treated with abiraterone acetate
TargetEED / PRC2
Clinical dataConference presentationOct 23, 2026global · ESMO Congress 2026Himalayas-1 · A Global Phase 3 Study in mCRPC Patients Previously Treated With Abiraterone Acetate (Himalayas-1)
BOfficial source Current stagePreINDP1P2P3FilingApproved
COMPASS THERAPEUTICS, INC.CMPXDrugCTX-009bispecific antibody
Indicationsecond-line unresectable advanced, metastatic or recurrent biliary tract cancerCOMPANION-002 · previously treated patients with advanced biliary tract cancer
TargetDLL4 / VEGF-A
Clinical dataPhase 2/3 dataOct 24, 2026ESMO CongressCOMPANION-002 · will highlight the results of the randomized, controlled Phase 2/3 COMPANION-002 clinical trial
BOfficial sourceAll sources (5)
Current stagePreINDP1P2P3FilingApproved
NovaBridge BiosciencesNBPDrugGivastomigbispecific antibody
IndicationAdvanced or metastatic solid tumors; gastroesophageal adenocarcinoma, pancreatic ductal adenocarcinoma and biliary tract cancer cohortsgivastomig Phase 1b · patients with first-line gastric cancer · dose expansion
TargetCLDN18.2 × 4-1BB
Clinical dataPhase 1 dataOct 25, 2026European Society for Medical Oncology (ESMO) Congress 2026givastomig Phase 1b · Poster presentation of Phase 1b combination dose expansion data
BOfficial sourceAll sources (2)
Current stagePreINDP1P2P3FilingApproved
Summit Therapeutics Inc.SMMTDrugivonescimab (SMT112)bispecific antibody
Indicationfirst-line treatment of patients with advanced biliary tract cancerHARMONi-GI1 · patients with advanced biliary tract cancer
TargetPD-1 / VEGF
Clinical dataPartner-led: Akeso, Inc. · China · Expected Phase 3 dataOct 25, 2026China · ESMO 2026Study details
HARMONi-GI1 · data from the Phase III HARMONi-GI1 trial, conducted in China and sponsored by Akeso, Inc., featuring the novel, potential first-in-class investigational bispecific antibody ivonescimab, will be featured
All sources (5)
Current stagePreINDP1P2P3FilingApproved
EIKON THERAPEUTICS, INC.EIKNDrugEIK1001
IndicationStage 4 non-small cell lung cancerTeLuRide-005 · Patients with NSCLCNCT06246110 TargetTLR7 / TLR8
Clinical dataPhase 2 dataOct 26, 2026ESMO Congress 2026TeLuRide-005 · will present comprehensive updated data from TeLuRide-005
BOfficial sourceAll sources (7)
Current stagePreINDP1P2P3FilingApproved
ORIC PHARMACEUTICALS, INC.ORICDrugEnozertinib (ORIC-114)small molecule
IndicationNSCLC with EGFR atypical mutationsEnozertinib Phase 1b · treatment-naive metastatic NSCLC with EGFR atypical mutationsNCT05315700 TargetEGFR / HER2
Clinical dataPhase 1 dataOct 26, 2026ESMO Congress 2026Study details
Enozertinib Phase 1b · Enozertinib (ORIC-114), a Brain Penetrant, Highly Selective EGFR Inhibitor, in Treatment-Naive Metastatic NSCLC with EGFR Atypical Mutations
Current stagePreINDP1P2P3FilingApproved
Generate Biomedicines, Inc.GENBDrugGB-4362ADC
IndicationPrevention or reduction of enfortumab vedotin-induced toxicity in advanced urothelial cancerGB-4362 Phase 1
TargetFree MMAE
Clinical dataConference presentationOct 23-27, 2026European Society for Medical Oncology (ESMO) Congress 2026GB-4362 Phase 1 · accepted for poster presentation
AOfficial source Current stagePreINDP1P2P3FilingApproved
IOVANCE BIOTHERAPEUTICS, INC.IOVADrugLifileucelautologous T cell therapy
IndicationUndifferentiated pleomorphic sarcoma and dedifferentiated liposarcomaSARATOGA · first six evaluable patients · registrational
Target—
Clinical dataPhase 2 dataOct 23-27, 2026European Society for Medical Oncology (ESMO)SARATOGA · Results will be highlighted
AOfficial source Current stagePreINDP1P2P3FilingApproved
MOLECULAR PARTNERS AGMOLNDrugMP0317multispecific protein therapeutic (DARPin)
IndicationAdvanced biliary tract cancer (cholangiocarcinoma)TACTIC · frontline settingNCT07036380 TargetCD40 / FAP
Clinical dataConference presentationOct 23-27, 2026France · European Society for Medical Oncology (ESMO) Congress 2026TACTIC · A trial-in-progress poster on the MP0317 Phase 2 study has been accepted for presentation
BOfficial sourceAll sources (2)
Current stagePreINDP1P2P3FilingApproved
Benitec Biopharma Inc.BNTCDrugBB-301AAV gene therapy vector
IndicationOculopharyngeal muscular dystrophy (OPMD) with dysphagiaBB-301 Phase 1b/2a · Cohort 1 and Cohort 2NCT06185673 TargetMutant PABPN1
Clinical dataInterim clinical dataOct 27-30, 202633rd Annual Congress of the European Society of Gene & Cell TherapyBB-301 Phase 1b/2a · Interim clinical results for Cohort 1 and Cohort 2 will be presented
BOfficial sourceAll sources (5)
Current stagePreINDP1P2P3FilingApproved
RECURSION PHARMACEUTICALS, INC.RXRXDrugREC-4881small molecule
IndicationFamilial adenomatous polyposis (FAP)TUPELO · familial adenomatous polyposis
TargetMEK1 (MAP2K1) / MEK2 (MAP2K2)
Clinical dataPhase 1/2 dataNov 2, 2026Collaborative Group of the Americas on Inherited Gastrointestinal Cancer (CGA-IGC) Annual MeetingTUPELO · Additional Phase 2 safety and efficacy data from the TUPELO clinical trial contextualized with real world data
BOfficial sourceAll sources (5)
Current stagePreINDP1P2P3FilingApproved
Inventiva S.A.IVADruglanifibranorsmall molecule
IndicationMASHlanifibranor Phase 2b
TargetPPARα / PPARδ / PPARγ
Clinical dataConference presentationNov 7, 2026AASLD The Liver Meeting ® 2026Study details
lanifibranor Phase 2b · Lanifibranor Improved Liver Sinusoidal Endothelial Cell Dysfunction and Vascular Alterations Across All Stages From MASH To Cirrhosis
All sources (2)
Current stagePreINDP1P2P3FilingApproved
FATE THERAPEUTICS INCFATEDrugFT839dual-CAR T-cell therapy
Indicationrheumatoid arthritisCOMPLETE Trial
TargetCD19 / CD38
Clinical dataConference presentationNov 8, 2026ACR Convergence 2026Study details
COMPLETE Trial · FT839: An Off-the-Shelf, Dual CAR T-Cell Therapy for the Comprehensive Elimination of Multicellular Drivers of Rheumatoid Arthritis
Current stagePreINDP1P2P3FilingApproved
Nkarta, Inc.NKTXDrugNKX019cell therapy
Indicationsystemic sclerosis / idiopathic inflammatory myopathy / ANCA-associated vasculitis / rheumatoid arthritisNtrust Phase 1/2 studies · Idiopathic Inflammatory Myopathy · Dose-Escalation/Optimization
TargetCD19
Clinical dataPhase 1/2 dataNov 8, 2026ACR Convergence 2026Ntrust Phase 1/2 studies · Preliminary Safety, PK/PD, and Clinical Activity
BOfficial sourceAll sources (2)
Current stagePreINDP1P2P3FilingApproved
Vir Biotechnology, Inc.VIRDrugElebsiran and tobevibart
IndicationChronic hepatitis deltaSOLSTICE · elebsiran + tobevibart · participants with chronic hepatitis delta infection
TargetHBV RNA transcripts / HBV RNA
Clinical dataPhase 2 dataNov 8, 2026American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2026SOLSTICE · Patterns of HDV RNA responses through Week 96
BOfficial source Current stagePreINDP1P2P3FilingApproved
Vir Biotechnology, Inc.VIRDrugElebsiran and tobevibart
IndicationChronic hepatitis deltaSOLSTICE · translational sub-study
TargetHBV RNA transcripts / HBV RNA
Clinical dataPhase 2 dataNov 8, 2026American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2026Study details
SOLSTICE · Intrahepatic NK cell remodelling with elebsiran and tobevibart in chronic hepatitis D - A translational sub-study of the SOLSTICE trial
Current stagePreINDP1P2P3FilingApproved
FATE THERAPEUTICS INCFATEDrugFT819CAR T-cell therapy
IndicationRefractory moderate-to-severe systemic lupus erythematosus with lupus nephritis
TargetCD19
Clinical dataPhase 2 dataNov 9, 2026ACR Convergence 2026Efficacy Reveals Biomarker Candidates for Fatigue in SLE
BOfficial source Current stagePreINDP1P2P3FilingApproved
Nkarta, Inc.NKTXDrugNKX019cell therapy
Indicationsystemic sclerosis / idiopathic inflammatory myopathy / ANCA-associated vasculitis / rheumatoid arthritisNtrust Phase 1/2 studies · Systemic Sclerosis · Dose-Escalation/Optimization
TargetCD19
Clinical dataPhase 1/2 dataNov 9, 2026ACR Convergence 2026Ntrust Phase 1/2 studies · Preliminary Safety, PK/PD, and Clinical Activity
BOfficial sourceAll sources (2)
Current stagePreINDP1P2P3FilingApproved
Showing 35 of 35 available events
