Biocatalystwatch
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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 1,611 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
EUPRAXIA PHARMACEUTICALS INC.EPRX
DrugEP-104GI
IndicationEosinophilic esophagitis (EoE)RESOLVE · dose escalation
Target—
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
DrugARO-MAPTsiRNA
IndicationEarly Alzheimer's diseaseAROMAPT-SC-1001NCT07221344
TargetTau (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
DrugOPGx-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 Rio

Near Normalization of Cone Sensitivity

BOfficial source
Current stage
PreINDP1P2P3FilingApproved
Price · 30D
$4.63-23.7%
30D · 10/09
Verastem, Inc.VSTM
DrugVS-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
Current stage
PreINDP1P2P3FilingApproved
Price · 30D
$8.24+8.1%
30D · 10/09
enGene Therapeutics Inc.ENGN
DrugDetalimogene voraplasmid (EG-70)non-viral gene therapy
IndicationNon-muscle-invasive bladder cancer (NMIBC)LEGEND · high-risk, BCG-unresponsive NMIBC patients with CIS · surfactant cohortNCT04752722
TargetRIG-I
Clinical dataPreclinical webinar · enrollment guidanceOct 15, 2026

LEGEND · Webinar on surfactant plus detalimogene preclinical data and cohort enrollment guidance

BOfficial source
Current stage
PreINDP1P2P3FilingApproved
Price · 30D
$1.77+0.0%
30D · 10/09
Pharming Group N.V.PHAR
DrugJoenja® (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 2026

leniolisib Phase 2 · Additional data will be presented

AOfficial source
All sources (2)
Current stage
PreINDP1P2P3FilingApproved
Price · 30D
$9.73-9.9%
30D · 10/09
EUPRAXIA PHARMACEUTICALS INC.EPRX
DrugEP-104GI
IndicationEosinophilic esophagitis (EoE)RESOLVE · dose escalation
Target—
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
DrugEP-104GI
IndicationEosinophilic esophagitis (EoE)RESOLVE · dose escalation
Target—
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
Achieve Life Sciences, Inc.ACHV
DrugCytisinicline
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 2026
Study details

ORCA-OL · new data evaluating the efficacy of 52 weeks of cytisinicline treatment for cigarette smoking and e-cigarette cessation will be presented

BOfficial source
All sources (2)
Current stage
PreINDP1P2P3FilingApproved
Price · 30D
$7.34+0.8%
30D · 10/09
Shattuck Labs, Inc.STTK
DrugSL-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 Week
Study 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

AOfficial source
All sources (4)
Current stage
PreINDP1P2P3FilingApproved
Price · 30D
$5.66-8.0%
30D · 10/09
Biohaven Ltd.BHVN
DrugBHV-1530antibody-drug conjugate
IndicationAdvanced solid tumorsBHV-1530 Phase 1NCT06874335
TargetFGFR3
Clinical dataPhase 1 dataOct 23, 2026ESMO

BHV-1530 Phase 1 · new Phase 1 data planned for ESMO

BOfficial source
Current stage
PreINDP1P2P3FilingApproved
Price · 30D
$12.13-5.2%
30D · 10/09
PERSPECTIVE THERAPEUTICS, INC.CATX
DrugVMT-α-NETpeptide radiopharmaceutical
IndicationSSTR2-positive neuroendocrine tumorsNCT05636618 · Cohorts 1–3NCT05636618
TargetSSTR2
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

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