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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6 of 1,611 scheduled catalysts · 6 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
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
NovaBridge BiosciencesNBP
DrugGivastomigbispecific 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 2026

givastomig Phase 1b · Poster presentation of Phase 1b combination dose expansion data

BOfficial source
All sources (2)
Current stage
PreINDP1P2P3FilingApproved
Price · 30D
$1.41-16.9%
30D · 10/09
ALNYLAM PHARMACEUTICALS, INC.ALNY
DrugALN-HTT02RNAi therapeutic
IndicationHuntington's disease
TargetHTT
Clinical dataConference presentationOct 26, 2026

Up next…

BOfficial source
Current stage
PreINDP1P2P3FilingApproved
Price · 30D
$231.37-6.5%
30D · 10/09
ORIC PHARMACEUTICALS, INC.ORIC
DrugEnozertinib (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 2026
Study details

Enozertinib Phase 1b · Enozertinib (ORIC-114), a Brain Penetrant, Highly Selective EGFR Inhibitor, in Treatment-Naive Metastatic NSCLC with EGFR Atypical Mutations

BOfficial source
Current stage
PreINDP1P2P3FilingApproved
Price · 30D
$12.25+1.5%
30D · 10/09
Generate Biomedicines, Inc.GENB
DrugGB-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 2026

GB-4362 Phase 1 · accepted for poster presentation

AOfficial source
Current stage
PreINDP1P2P3FilingApproved
Price · 30D
$14.48-5.9%
30D · 10/09
CULLINAN THERAPEUTICS, INC.CGEM
DrugVelinotamig (GR-1803)bispecific T-cell engager
Indicationsystemic lupus erythematosus (SLE)Velinotamig Phase 1 · dose escalation
TargetBCMA / CD3
Clinical dataPartner-led: Genrix Bio · Region not stated · Expected Phase 1 dataNov 8, 2026ACR Convergence 2026
Study details

Velinotamig Phase 1 · Multi-dose regimen data from the ongoing Genrix Bio Phase 1 dose escalation study in SLE to be shared

BOfficial source
Current stage
PreINDP1P2P3FilingApproved
Price · 30D
$15.84-24.6%
30D · 10/09

Showing 6 of 6 available events