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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RESOLVE · Poster Presentation
AOfficial sourceAll sources (2)
AROMAPT-SC-1001 · Interim Results from ARO-MAPT Phase 1/2a Study
BOfficial source
Near Normalization of Cone Sensitivity
BOfficial source
to present initial efficacy and updated safety and tolerability data
BOfficial source
LEGEND · Webinar on surfactant plus detalimogene preclinical data and cohort enrollment guidance
BOfficial source
leniolisib Phase 2 · Additional data will be presented
AOfficial sourceAll sources (2)
RESOLVE · Moderated Poster
AOfficial sourceAll sources (2)
RESOLVE · Oral Abstract Session
AOfficial sourceAll sources (2)
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
All sources (2)
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
BHV-1530 Phase 1 · new Phase 1 data planned for ESMO
BOfficial source
NCT05636618 · Cohort level safety and efficacy results
BOfficial source
NCT06253130 · will present clinical data from its ongoing Phase 1/2 trial of EIK1003
BOfficial sourceNCT06907043 · will also present, for the first time, data from an ongoing Phase 1/2 trial
BOfficial sourceNCT07262619 · Preliminary safety, tolerability and pharmacokinetic data for EIK1005 will be presented
BOfficial source
Himalayas-1 · A Global Phase 3 Study in mCRPC Patients Previously Treated With Abiraterone Acetate (Himalayas-1)
BOfficial source
COMPANION-002 · will highlight the results of the randomized, controlled Phase 2/3 COMPANION-002 clinical trial
BOfficial source
givastomig Phase 1b · Poster presentation of Phase 1b combination dose expansion data
BOfficial sourceAll sources (2)
Study 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
TeLuRide-005 · will present comprehensive updated data from TeLuRide-005
BOfficial sourceStudy details
Enozertinib Phase 1b · Enozertinib (ORIC-114), a Brain Penetrant, Highly Selective EGFR Inhibitor, in Treatment-Naive Metastatic NSCLC with EGFR Atypical Mutations
GB-4362 Phase 1 · accepted for poster presentation
AOfficial source
SARATOGA · Results will be highlighted
AOfficial source