FDA Calendar

Upcoming clinical readouts, trial starts, and trial-progress milestones for U.S.-listed biotech, with official source links.

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15 of 1,611 scheduled catalysts · 10 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

EUPRAXIA PHARMACEUTICALS INC.EPRX

EP-104GI

Eosinophilic esophagitis (EoE)RESOLVE · dose escalation

—

Clinical dataConference presentationOct 12, 2026ACG 2026 Annual Scientific Meeting & Postgraduate Course

RESOLVE · Poster Presentation

AOfficial source

All sources (2)

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$7.46-7.0%

30D · 10/09

ARROWHEAD PHARMACEUTICALS, INC.ARWR

ARO-MAPTsiRNA

Early Alzheimer's diseaseAROMAPT-SC-1001NCT07221344

Tau (MAPT) / MAPT mRNA

Clinical dataInterim clinical dataOct 14, 2026

AROMAPT-SC-1001 · Interim Results from ARO-MAPT Phase 1/2a Study

BOfficial source

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$62.54-24.4%

30D · 10/09

Opus Genetics, Inc.IRD

OPGx-001AAV gene therapy

LCA5-associated inherited retinal disease (registered Phase 1/2)Children with LCA5

Functional LCA5 gene

Clinical dataPhase 1/2 dataOct 14, 2026Retina in Rio

Near Normalization of Cone Sensitivity

BOfficial source

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$4.63-23.7%

30D · 10/09

Verastem, Inc.VSTM

VS-7375

advanced 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

KRAS G12D

Clinical dataPhase 1/2 dataOct 14, 2026

to present initial efficacy and updated safety and tolerability data

BOfficial source

All sources (8)

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$8.24+8.1%

30D · 10/09

EUPRAXIA PHARMACEUTICALS INC.EPRX

EP-104GI

Eosinophilic esophagitis (EoE)RESOLVE · dose escalation

—

Clinical dataConference presentationOct 18, 2026UEG Week 2026

RESOLVE · Moderated Poster

AOfficial source

All sources (2)

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$7.46-7.0%

30D · 10/09

EUPRAXIA PHARMACEUTICALS INC.EPRX

EP-104GI

Eosinophilic esophagitis (EoE)RESOLVE · dose escalation

—

Clinical dataConference presentationOct 19, 2026UEG Week 2026

RESOLVE · Oral Abstract Session

AOfficial source

All sources (2)

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$7.46-7.0%

30D · 10/09

PERSPECTIVE THERAPEUTICS, INC.CATX

VMT-α-NETpeptide radiopharmaceutical

SSTR2-positive neuroendocrine tumorsNCT05636618 · Cohorts 1–3NCT05636618

SSTR2

Clinical dataPhase 1/2 dataOct 23, 2026European Society of Medical Oncology (ESMO) Congress 2026

NCT05636618 · Cohort level safety and efficacy results

BOfficial source

All sources (4)

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$2.66-4.0%

30D · 10/09

EIKON THERAPEUTICS, INC.EIKN

EIK1003

Advanced 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

PARP1

Clinical dataPhase 1/2 dataOct 23, 2026ESMO Congress 2026

NCT06253130 · will present clinical data from its ongoing Phase 1/2 trial of EIK1003

BOfficial source

All sources (3)

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$7.55-18.0%

30D · 10/09

EIKON THERAPEUTICS, INC.EIKN

EIK1004

Advanced solid tumors with or without brain metastasesNCT06907043 · Patients with ovarian, breast, prostate, and pancreatic cancersNCT06907043

PARP1

Clinical dataPhase 1/2 data · InitialOct 23, 2026ESMO Congress 2026

NCT06907043 · will also present, for the first time, data from an ongoing Phase 1/2 trial

BOfficial source

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$7.55-18.0%

30D · 10/09

EIKON THERAPEUTICS, INC.EIKN

EIK1005

Advanced solid tumors including MSI-H tumorsNCT07262619 · Participants with advanced solid tumorsNCT07262619

WRN

Clinical dataPhase 1/2 dataOct 23, 2026ESMO Congress 2026

NCT07262619 · Preliminary safety, tolerability and pharmacokinetic data for EIK1005 will be presented

BOfficial source

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$7.55-18.0%

30D · 10/09

Benitec Biopharma Inc.BNTC

BB-301AAV gene therapy vector

Oculopharyngeal muscular dystrophy (OPMD) with dysphagiaBB-301 Phase 1b/2a · Cohort 1 and Cohort 2NCT06185673

Mutant PABPN1

Clinical dataInterim clinical dataOct 27-30, 202633rd Annual Congress of the European Society of Gene & Cell Therapy

BB-301 Phase 1b/2a · Interim clinical results for Cohort 1 and Cohort 2 will be presented

BOfficial source

All sources (5)

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$8.93-26.9%

30D · 10/09

RECURSION PHARMACEUTICALS, INC.RXRX

REC-4881small molecule

Familial adenomatous polyposis (FAP)TUPELO · familial adenomatous polyposis

MEK1 (MAP2K1) / MEK2 (MAP2K2)

Clinical dataPhase 1/2 dataNov 2, 2026Collaborative Group of the Americas on Inherited Gastrointestinal Cancer (CGA-IGC) Annual Meeting

TUPELO · Additional Phase 2 safety and efficacy data from the TUPELO clinical trial contextualized with real world data

BOfficial source

All sources (5)

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$4.39+38.8%

30D · 10/09

FATE THERAPEUTICS INCFATE

FT839dual-CAR T-cell therapy

rheumatoid arthritisCOMPLETE Trial

CD19 / CD38

Clinical dataConference presentationNov 8, 2026ACR Convergence 2026

Study details

COMPLETE Trial · FT839: An Off-the-Shelf, Dual CAR T-Cell Therapy for the Comprehensive Elimination of Multicellular Drivers of Rheumatoid Arthritis

BOfficial source

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$2.21-5.4%

30D · 10/09

Nkarta, Inc.NKTX

NKX019cell therapy

systemic sclerosis / idiopathic inflammatory myopathy / ANCA-associated vasculitis / rheumatoid arthritisNtrust Phase 1/2 studies · Idiopathic Inflammatory Myopathy · Dose-Escalation/Optimization

CD19

Clinical dataPhase 1/2 dataNov 8, 2026ACR Convergence 2026

Ntrust Phase 1/2 studies · Preliminary Safety, PK/PD, and Clinical Activity

BOfficial source

All sources (2)

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$2.18-22.4%

30D · 10/09

Nkarta, Inc.NKTX

NKX019cell therapy

systemic sclerosis / idiopathic inflammatory myopathy / ANCA-associated vasculitis / rheumatoid arthritisNtrust Phase 1/2 studies · Systemic Sclerosis · Dose-Escalation/Optimization

CD19

Clinical dataPhase 1/2 dataNov 9, 2026ACR Convergence 2026

Ntrust Phase 1/2 studies · Preliminary Safety, PK/PD, and Clinical Activity

BOfficial source

All sources (2)

Current stage

PreINDP1P2P3FilingApproved

Price · 30D

$2.18-22.4%

30D · 10/09

Showing 15 of 15 available events