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Lyell's ronde-cel posts 77% complete response in pivotal lymphoma study; $80M placement announced

🇺🇸 Lyell Immunopharma, Inc. (LYEL) · Wed 04 Nov 2026

Lyell Immunopharma reported updated PiNACLE data in third-line-plus large B-cell lymphoma, with pivotal readout due mid-2027 and a BLA planned for the second half of that year.

Lyell Immunopharma reported third-quarter 2026 results on 4 November, alongside updated data for ronde-cel from the pivotal PiNACLE trial in third-line-plus relapsed or refractory large B-cell lymphoma (LBCL).

Among 44 evaluable patients, the overall response rate was 91% and the complete response rate was 77%, according to the company. The summary available does not give follow-up duration, safety findings or durability data.

Lyell expects pivotal data in mid-2027 and plans to follow with a Biologics License Application (BLA) submission to the US Food and Drug Administration in the second half of 2027.

On manufacturing, the company said it has completed the transfer of LYL273 production to its LyFE center after FDA review. Lyell also announced an $80.0 million private placement. No further terms of the financing were provided in the material available.

What it means for your team

  • The stated timeline points to pivotal data in mid-2027 and a US BLA filing in the second half of 2027, so regulatory teams tracking CAR-T competitors in LBCL have dates to watch.
  • The updated figures cover 44 evaluable patients; safety and durability data will matter for any benefit-risk assessment and are not included in the summary.
  • The completed LYL273 manufacturing transfer, following FDA review, is a reminder that site and process changes for cell therapies are subject to regulatory scrutiny.

Company's press release (SEC filing): Lyell Immunopharma, Inc. ↗

Article written by VigiEye from the official source (Lyell Immunopharma, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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