Biotech PDUFA & catalyst calendar 2026
Next 90 days of PDUFA, AdCom, and readouts — cash status on every row. Tap for the thesis board.
2026-08-229dCAPRPDUFA — deramiocel DMD
Confirmedok
2026-08-2916dNVOPDUFA — Mim8
Confirmedok
2026-09-0119dCRSPCommercial / access update
Company-guidedok
2026-09-0523dVRTXSCD access update
Company-guidedok
2026-09-1028dALNYTTR franchise update
Company-guidedok
2026-09-1230dJNJMyeloma franchise update
Company-guidedok
2026-09-1533dVKTXPhase 3 start / design
Company-guidedok
2026-09-1836dMRKADC Phase 3 update
Company-guidedok
2026-09-2038dEDITUpdated SCD dataset
Company-guidedok
2026-09-2543dMRKLung IO label / combo update
Company-guidedok
2026-09-2846dSNYPDUFA — tolebrutinib
Confirmedok
2026-09-3048dLLYBroader access update
Company-guidedok
2026-09-3048dPFEmCRPC franchise update
Estimatedok
2026-10-0149dBMRNCommercial update
Company-guidedok
2026-10-0250dMRKCRC IO franchise update
Company-guidedok
2026-10-0553dMRUSExpansion cohort data
Company-guidedok
2026-10-0856dAZNBreast ADC label / earlier-line update
Company-guidedok
2026-10-1058dNVOPhase 3 combo data
Company-guidedok
2026-10-1260dAZNLung franchise / combo update
Company-guidedok
2026-10-1563dBLUETreatment center expansion
Estimatedok
2026-10-1866dLEGNEarlier-line myeloma update
Company-guidedok
2026-10-2068dBIIBSubcutaneous / label update
Company-guidedok
2026-10-2573dAKROPhase 3 histology
Company-guidedok
2026-10-2876dJANXJANX007 prostate update
Company-guidedok
2026-10-3078dNTLAPivotal ATTR update
Company-guidedok
2026-11-0180dLLYPhase 3 obesity readout
Company-guidedok
2026-11-0180dMDGLLabel / real-world update
Company-guidedok
2026-11-0584dBMYCAR-T myeloma competitive update
Company-guidedok
2026-11-0887dDAWNBreast / solid tumor ADC update
Estimatedok
FAQ
What is a PDUFA date?
A PDUFA date is the FDA’s target action date for a drug application. BioFin lists upcoming PDUFA, AdCom, and trial-readout dates for tracked biotechs over the next 90 days.
What does Confirmed vs Estimated mean?
Confirmed means a dated source is linked. Company-guided is management timing. Estimated is editorial scaffolding — do not trade on it.
How does Survive-to-Event show on the calendar?
Each row shows whether that ticker’s curated cash is OK, TIGHT, or BROKEN versus that catalyst date. Tap the row to open the thesis board.