Key Takeaway: Lyell Immunopharma reported positive updates regarding its pivotal clinical trial for ronde-cel in patients with LBCL. The trial is on schedule to provide additional data in the latter part of 2026, with pivotal results expected by mid-2027. A Biologics License Application (BLA) submission is projected for the second half of 2027.
Market Sentiment Analysis
POSITIVE FACTORS
Pivotal clinical trial for ronde-cel is on track.
Additional data expected in the second half of 2026.
BLA submission anticipated in the second half of 2027.
Updated data presented in over 100 patients.
BiopharmaWatch Analysis
From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+37%
120-day peak, hindsight
Typical move
6.4%
average across 5 past catalysts
Cash runway
~17 mo
Low dilution risk
Lead asset
rondecabtagene autoleucel
Phase 3 · Large B-cell Lymphoma
Full Press Release Details
PiNACLE pivotal clinical trial evaluating ronde-cel in 3L+ patients with LBCL on track to report additional data in second half of 2026, with pivotal data expected mid-2027 and BLA submission expected to follow in the second half of 2027 Presented updated ronde-cel data in more than 100 patients
Frequently Asked Questions
What is the status of the ronde-cel clinical trial?
The ronde-cel pivotal clinical trial is on track to report additional data in late 2026.
When is the BLA submission expected?
The BLA submission for ronde-cel is anticipated in the second half of 2027.
How many patients were included in the updated ronde-cel data?
Updated ronde-cel data was presented in more than 100 patients.
What type of patients is the ronde-cel trial evaluating?
The trial evaluates ronde-cel in 3L+ patients with LBCL.