Lyell Immunopharma Releases New Data on Ronde-cel Therapy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5 days ago
0mins
Source: Newsfilter
- Clinical Trial Progress: As of May 5, 2026, a total of 108 patients with relapsed or refractory large B-cell lymphoma have been treated with ronde-cel, including 43 in the second-line and 65 in the third-line or later settings, demonstrating the therapy's efficacy in high-risk populations.
- Safety Analysis: No Grade 3 or higher cytokine release syndrome (CRS) events were reported among patients treated with ronde-cel, and among those receiving dexamethasone prophylaxis, Grade 1 CRS occurred in 56%, indicating a favorable safety profile that supports outpatient administration.
- Durable Responses: The study indicates that cytotoxic T cells with memory potential are more abundant in patients with durable responses, providing a biological rationale for the high rates of complete responses observed in patients with low antigen expression tumors, suggesting significant therapeutic potential.
- Future Outlook: The PiNACLE clinical trial is expected to update data in the second half of 2026, with pivotal data readout anticipated in mid-2027, followed by a Biologics License Application (BLA) submission in the second half of 2027, paving the way for market introduction of ronde-cel.
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Analyst Views on LYEL
Wall Street analysts forecast LYEL stock price to rise
2 Analyst Rating
1 Buy
0 Hold
1 Sell
Hold
Current: 12.440
Low
12.00
Averages
28.50
High
45.00
Current: 12.440
Low
12.00
Averages
28.50
High
45.00
About LYEL
Lyell Immunopharma, Inc. is a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with hematologic malignancies and solid tumors. The Company’s product candidates include LYL314 and LYL273. Its LYL314, which is in Phase I/II clinical development, is a dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to the approved CD19-targeted CAR T-cell therapies and is under evaluation trial for the treatment of patients with relapsed and/or refractory large B-cell lymphoma. The Company has acquired the global rights to LYL273 (formerly GCC19CART), a novel autologous guanylyl cyclase-C (GCC)-targeted CAR T-cell product candidate for the treatment of metastatic colorectal cancer (mCRC) and other GCC-expressing cancers.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Lyell Immunopharma Releases New Data on Ronde-cel Therapy
- Clinical Trial Progress: As of May 5, 2026, a total of 108 patients with relapsed or refractory large B-cell lymphoma have been treated with ronde-cel, including 43 in the second-line and 65 in the third-line or later settings, demonstrating the therapy's efficacy in high-risk populations.
- Safety Analysis: No Grade 3 or higher cytokine release syndrome (CRS) events were reported among patients treated with ronde-cel, and among those receiving dexamethasone prophylaxis, Grade 1 CRS occurred in 56%, indicating a favorable safety profile that supports outpatient administration.
- Durable Responses: The study indicates that cytotoxic T cells with memory potential are more abundant in patients with durable responses, providing a biological rationale for the high rates of complete responses observed in patients with low antigen expression tumors, suggesting significant therapeutic potential.
- Future Outlook: The PiNACLE clinical trial is expected to update data in the second half of 2026, with pivotal data readout anticipated in mid-2027, followed by a Biologics License Application (BLA) submission in the second half of 2027, paving the way for market introduction of ronde-cel.
See More
LYL273 Clinical Trial Safety Update
- Significant Safety Improvement: The incidence of Grade ≥ 2 diarrhea or colitis in patients receiving gastrointestinal prophylaxis dropped from 55% to 10%, demonstrating LYL273's ability to manage safety in relapsed metastatic colorectal cancer patients, potentially enhancing patient adherence to treatment.
- Trial Design Adjustment: The U.S. Phase 1 clinical trial has been amended to a Phase 1/2 design, allowing seamless expansion into a potential pivotal single-arm trial once the recommended Phase 2 dose is determined, which is expected to increase trial flexibility and efficiency.
- New Patient Cohorts Added: The amended trial design introduces a second-line cohort and a cohort evaluating a combination strategy with radiotherapy, with up to 60 patients expected to participate, further enriching the diversity and applicability of clinical data.
- FDA Fast Track Designation: LYL273 has received Fast Track designation from the FDA, indicating its potential clinical benefits in treating relapsed metastatic colorectal cancer, which may accelerate its market entry and enhance competitive positioning.
See More
Lyell Immunopharma Reports Reduced Q1 Net Loss
- Improved Net Loss: Lyell Immunopharma reported a net loss of $24.2 million for Q1 2026, a significant reduction from $52.2 million in the same period of 2025, indicating progress in cost control and operational efficiency.
- Increased Cash Reserves: As of March 31, 2026, the company's cash, cash equivalents, and marketable securities totaled $261 million, up from $247.2 million as of December 31, 2025, enhancing financial stability.
- Sufficient Funding: Lyell believes its current cash and cash equivalents will be adequate to meet working capital and capital expenditure needs into Q3 2027, providing a solid foundation for long-term growth.
- Enhanced Market Confidence: With the reduction in net loss and increase in cash reserves, investor confidence in Lyell Immunopharma is likely to improve, potentially attracting more attention to its future CAR-T therapy developments.
See More
Lyell Immunopharma Reports $140.7M Q4 Loss Amid Acquisition Costs
- Financial Performance: Lyell Immunopharma reported a net loss of $140.7 million for Q4 2025 and $274.4 million for the full year, an improvement from $191.9 million and $343.0 million in 2024, indicating efforts to control losses.
- R&D Expenses: The Q4 2025 loss included $66.3 million in acquired in-process R&D expenses related to the LYL273 license acquisition, highlighting the company's ongoing investment in drug development despite short-term financial strain.
- Non-GAAP Net Loss: The non-GAAP net loss for Q4 2025 was $33.1 million, down from $45.9 million in 2024, reflecting improved operational efficiency after excluding non-cash expenses, potentially laying the groundwork for future profitability.
- Market Reaction: Despite the reported losses, Lyell Immunopharma's stock rose following the release of positive ASH data, suggesting that the market remains optimistic about its immunotherapy prospects, which may attract further investor interest.
See More
Lyell Immunopharma Launches PiNACLE-H2H Clinical Trial for Ronde-cel
- Trial Launch: Lyell Immunopharma announced the dosing of the first patient in the PiNACLE-H2H trial, which will evaluate the efficacy of ronde-cel against other CD19 CAR T-cell therapies, aiming to provide data for treatment optimization for 400 patients.
- Promising Efficacy Data: In prior Phase 1/2 trials, ronde-cel demonstrated a 93% best overall response rate and a 76% complete response rate in 3L+ patients, indicating its potential to become the best-in-class treatment for relapsed or refractory large B-cell lymphoma.
- Market Approval Outlook: Lyell plans to submit a Biologics License Application (BLA) for ronde-cel to the FDA in 2027, which, if approved, could significantly enhance the company's market position and solidify its leadership in CAR T-cell therapies.
- Manufacturing Capacity Enhancement: Lyell's LyFE Manufacturing Center is capable of producing over 1,200 CAR T-cell doses annually, ensuring that the company can meet market demands during commercialization and support future business growth.
See More
Mineralys Therapeutics Shares Surge 203.4%, NDA Submission Expected in 2026
- Outstanding Stock Performance: Mineralys Therapeutics has seen its stock price soar by 203.4% in 2025, reflecting strong market confidence in its product candidate lorundrostat, which is expected to drive further growth in 2026.
- Successful Clinical Trials: In the first half of 2025, the pivotal Phase III Launch-HTN and Phase II Advance-HTN studies for lorundrostat met their primary efficacy endpoints, indicating its potential as a best-in-class treatment for resistant hypertension, which could significantly enhance the company's market position.
- NDA Submission Preparation: The company is gearing up to submit a New Drug Application (NDA) for lorundrostat in early 2026, paving the way for market entry and potentially boosting revenue and market share significantly.
- Multiple Research Advancements: Mineralys has also completed enrollment in the Phase II Explore-OSA study for lorundrostat in overweight and obese patients with moderate-to-severe OSA, with top-line data expected in Q1 2026, further strengthening its competitive edge in the market.
See More
Lyell Immunopharma Releases New Data on Ronde-cel Therapy
- Clinical Trial Progress: As of May 5, 2026, a total of 108 patients with relapsed or refractory large B-cell lymphoma have been treated with ronde-cel, including 43 in the second-line and 65 in the third-line or later settings, demonstrating the therapy's efficacy in high-risk populations.
- Safety Analysis: No Grade 3 or higher cytokine release syndrome (CRS) events were reported among patients treated with ronde-cel, and among those receiving dexamethasone prophylaxis, Grade 1 CRS occurred in 56%, indicating a favorable safety profile that supports outpatient administration.
- Durable Responses: The study indicates that cytotoxic T cells with memory potential are more abundant in patients with durable responses, providing a biological rationale for the high rates of complete responses observed in patients with low antigen expression tumors, suggesting significant therapeutic potential.
- Future Outlook: The PiNACLE clinical trial is expected to update data in the second half of 2026, with pivotal data readout anticipated in mid-2027, followed by a Biologics License Application (BLA) submission in the second half of 2027, paving the way for market introduction of ronde-cel.
See More
LYL273 Clinical Trial Safety Update
- Significant Safety Improvement: The incidence of Grade ≥ 2 diarrhea or colitis in patients receiving gastrointestinal prophylaxis dropped from 55% to 10%, demonstrating LYL273's ability to manage safety in relapsed metastatic colorectal cancer patients, potentially enhancing patient adherence to treatment.
- Trial Design Adjustment: The U.S. Phase 1 clinical trial has been amended to a Phase 1/2 design, allowing seamless expansion into a potential pivotal single-arm trial once the recommended Phase 2 dose is determined, which is expected to increase trial flexibility and efficiency.
- New Patient Cohorts Added: The amended trial design introduces a second-line cohort and a cohort evaluating a combination strategy with radiotherapy, with up to 60 patients expected to participate, further enriching the diversity and applicability of clinical data.
- FDA Fast Track Designation: LYL273 has received Fast Track designation from the FDA, indicating its potential clinical benefits in treating relapsed metastatic colorectal cancer, which may accelerate its market entry and enhance competitive positioning.
See More
Lyell Immunopharma Reports Reduced Q1 Net Loss
- Improved Net Loss: Lyell Immunopharma reported a net loss of $24.2 million for Q1 2026, a significant reduction from $52.2 million in the same period of 2025, indicating progress in cost control and operational efficiency.
- Increased Cash Reserves: As of March 31, 2026, the company's cash, cash equivalents, and marketable securities totaled $261 million, up from $247.2 million as of December 31, 2025, enhancing financial stability.
- Sufficient Funding: Lyell believes its current cash and cash equivalents will be adequate to meet working capital and capital expenditure needs into Q3 2027, providing a solid foundation for long-term growth.
- Enhanced Market Confidence: With the reduction in net loss and increase in cash reserves, investor confidence in Lyell Immunopharma is likely to improve, potentially attracting more attention to its future CAR-T therapy developments.
See More
Lyell Immunopharma Reports $140.7M Q4 Loss Amid Acquisition Costs
- Financial Performance: Lyell Immunopharma reported a net loss of $140.7 million for Q4 2025 and $274.4 million for the full year, an improvement from $191.9 million and $343.0 million in 2024, indicating efforts to control losses.
- R&D Expenses: The Q4 2025 loss included $66.3 million in acquired in-process R&D expenses related to the LYL273 license acquisition, highlighting the company's ongoing investment in drug development despite short-term financial strain.
- Non-GAAP Net Loss: The non-GAAP net loss for Q4 2025 was $33.1 million, down from $45.9 million in 2024, reflecting improved operational efficiency after excluding non-cash expenses, potentially laying the groundwork for future profitability.
- Market Reaction: Despite the reported losses, Lyell Immunopharma's stock rose following the release of positive ASH data, suggesting that the market remains optimistic about its immunotherapy prospects, which may attract further investor interest.
See More
Lyell Immunopharma Launches PiNACLE-H2H Clinical Trial for Ronde-cel
- Trial Launch: Lyell Immunopharma announced the dosing of the first patient in the PiNACLE-H2H trial, which will evaluate the efficacy of ronde-cel against other CD19 CAR T-cell therapies, aiming to provide data for treatment optimization for 400 patients.
- Promising Efficacy Data: In prior Phase 1/2 trials, ronde-cel demonstrated a 93% best overall response rate and a 76% complete response rate in 3L+ patients, indicating its potential to become the best-in-class treatment for relapsed or refractory large B-cell lymphoma.
- Market Approval Outlook: Lyell plans to submit a Biologics License Application (BLA) for ronde-cel to the FDA in 2027, which, if approved, could significantly enhance the company's market position and solidify its leadership in CAR T-cell therapies.
- Manufacturing Capacity Enhancement: Lyell's LyFE Manufacturing Center is capable of producing over 1,200 CAR T-cell doses annually, ensuring that the company can meet market demands during commercialization and support future business growth.
See More
Mineralys Therapeutics Shares Surge 203.4%, NDA Submission Expected in 2026
- Outstanding Stock Performance: Mineralys Therapeutics has seen its stock price soar by 203.4% in 2025, reflecting strong market confidence in its product candidate lorundrostat, which is expected to drive further growth in 2026.
- Successful Clinical Trials: In the first half of 2025, the pivotal Phase III Launch-HTN and Phase II Advance-HTN studies for lorundrostat met their primary efficacy endpoints, indicating its potential as a best-in-class treatment for resistant hypertension, which could significantly enhance the company's market position.
- NDA Submission Preparation: The company is gearing up to submit a New Drug Application (NDA) for lorundrostat in early 2026, paving the way for market entry and potentially boosting revenue and market share significantly.
- Multiple Research Advancements: Mineralys has also completed enrollment in the Phase II Explore-OSA study for lorundrostat in overweight and obese patients with moderate-to-severe OSA, with top-line data expected in Q1 2026, further strengthening its competitive edge in the market.
See More
