Lyell Immunopharma Begins PiNACLE - H2H Phase 3 Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 12 2026
0mins
Should l Buy LYEL?
Lyell Immunopharma announced that the first patient has been dosed in the PiNACLE - H2H Phase 3 trial evaluating rondecabtagene autoleucel compared to lisocabtagene maraleucel or axicabtagene ciloleucel for the treatment of patients with relapsed or refractory large B-cell lymphoma receiving treatment in the second-line setting. "Data from Lyell's single-arm pivotal PiNACLE trial in patients with later-stage large B-cell lymphoma are expected to be submitted for marketing approval to the FDA next year," said David Shook, MD, Lyell's Chief Medical Officer. "We are now pleased to have underway PiNACLE - H2H, the first-of-its-kind Phase 3 head-to-head randomized controlled CAR T-cell trial. This strategy demonstrates Lyell's confidence in ronde-cel's potential to be the best-in-class CAR T-cell treatment for patients with relapsed or refractory disease."
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy LYEL?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on LYEL
Wall Street analysts forecast LYEL stock price to rise
2 Analyst Rating
1 Buy
0 Hold
1 Sell
Hold
Current: 24.100
Low
12.00
Averages
28.50
High
45.00
Current: 24.100
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 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
GT Biopharma Advances GTB-3650 Clinical Trial to Cohort 4 with 10μg/kg/day Dosing
- Market Potential: The U.S. oncology market is projected to surge from $81 billion in 2025 to $212 billion by 2034, reflecting the rapid rise of precision therapies and immunotherapies, enhancing the investment outlook for companies like GT Biopharma.
- Clinical Trial Progress: GT Biopharma has advanced its GTB-3650 clinical trial to Cohort 4, where patients receive a dosing of 10μg/kg/day, indicating potential efficacy in treating resistant blood cancers and providing new treatment options for patients.
- Safety Confirmation: Six patients enrolled in Cohorts 1, 2, and 3 have successfully completed GTB-3650 treatment, establishing its safety profile with no dose-limiting toxicities observed across all completed cohorts, thereby boosting confidence in the clinical trial.
- Future Outlook: GT Biopharma plans to share its next trial update in Q1 2026, with expectations to continue assessing higher doses for efficacy, further driving innovation in the field of tumor immunotherapy.
See More
Lyell Immunopharma Soars Following Recent ASH Data and Immunotherapy Growth
Positive Market Reaction: Lyell Immunopharma's stock rose approximately 17% following the presentation of promising data on its CAR-T therapy for blood cancer at the American Society of Hematology Annual Meeting.
Encouraging CAR-T Therapy Results: New data revealed that the CAR-T therapy rondecabtagene autoleucel achieved an 83% overall response rate and a 61% complete response rate in patients with large B-cell lymphoma, with 70% of those who responded completely maintaining their response for six months or longer.
Strategic Acquisition: In November, Lyell acquired the rights to LYL273, a CAR-T treatment for metastatic colorectal cancer, enhancing its portfolio in the CAR-T therapy space.
Market Growth Projection: ResearchAndMarkets.com forecasts that the CAR-T therapy market will expand significantly, growing from $3.87 billion in 2024 to $13.25 billion by 2030.
See More
GT Biopharma Advances GTB-3650 Clinical Trial to Cohort 4 with 10μg/kg Dose
- FDA Approval Milestone: The FDA's November 2025 approval of the first bispecific antibody combination for second-line blood cancer treatment marks a significant shift from traditional chemotherapy, likely enhancing market share for companies like GT Biopharma.
- Clinical Trial Advancement: GT Biopharma has advanced its GTB-3650 clinical trial to Cohort 4, where patients receive a 10μg/kg/day dose, demonstrating a favorable safety profile and potential clinical efficacy, which could provide new options for patients with refractory blood cancers.
- Expansive Market Outlook: The CAR-T cell therapy market is projected to surge from $3.87 billion in 2024 to $13.25 billion by 2030, positioning GT Biopharma's innovative therapies to capture a significant share in this rapidly growing market.
- Future Plans: GT Biopharma plans to share its next clinical trial update in Q1 2026, continuing the dose escalation study of GTB-3650, which is expected to further validate its efficacy and expand patient benefit opportunities.
See More
GT Biopharma Advances GTB-3650 Clinical Trial to Cohort 4 with 10μg/kg/day Dosing
- FDA Approval Milestone: The FDA's November approval of the first bispecific antibody combination for second-line blood cancer treatment marks a significant shift from traditional chemotherapy, which is expected to enhance market performance for companies like GT Biopharma.
- Clinical Trial Advancement: GT Biopharma has advanced its GTB-3650 clinical trial to Cohort 4, where patients are receiving a dosing of 10μg/kg/day, indicating potential efficacy in patients with relapsed blood cancers, which could open new market opportunities for the company.
- Safety Validation: Six patients enrolled in Cohorts 1, 2, and 3 have successfully completed GTB-3650 treatment, establishing the therapy's safety profile across escalating doses, laying the groundwork for subsequent trials at higher doses.
- Future Outlook: The company anticipates sharing the next trial update in Q1 2026, and as dosing increases, clinical efficacy is expected to improve further, potentially attracting more 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
GT Biopharma Advances GTB-3650 Clinical Trial to Cohort 4 with 10μg/kg/day Dosing
- Market Potential: The U.S. oncology market is projected to surge from $81 billion in 2025 to $212 billion by 2034, reflecting the rapid rise of precision therapies and immunotherapies, enhancing the investment outlook for companies like GT Biopharma.
- Clinical Trial Progress: GT Biopharma has advanced its GTB-3650 clinical trial to Cohort 4, where patients receive a dosing of 10μg/kg/day, indicating potential efficacy in treating resistant blood cancers and providing new treatment options for patients.
- Safety Confirmation: Six patients enrolled in Cohorts 1, 2, and 3 have successfully completed GTB-3650 treatment, establishing its safety profile with no dose-limiting toxicities observed across all completed cohorts, thereby boosting confidence in the clinical trial.
- Future Outlook: GT Biopharma plans to share its next trial update in Q1 2026, with expectations to continue assessing higher doses for efficacy, further driving innovation in the field of tumor immunotherapy.
See More
Lyell Immunopharma Soars Following Recent ASH Data and Immunotherapy Growth
Positive Market Reaction: Lyell Immunopharma's stock rose approximately 17% following the presentation of promising data on its CAR-T therapy for blood cancer at the American Society of Hematology Annual Meeting.
Encouraging CAR-T Therapy Results: New data revealed that the CAR-T therapy rondecabtagene autoleucel achieved an 83% overall response rate and a 61% complete response rate in patients with large B-cell lymphoma, with 70% of those who responded completely maintaining their response for six months or longer.
Strategic Acquisition: In November, Lyell acquired the rights to LYL273, a CAR-T treatment for metastatic colorectal cancer, enhancing its portfolio in the CAR-T therapy space.
Market Growth Projection: ResearchAndMarkets.com forecasts that the CAR-T therapy market will expand significantly, growing from $3.87 billion in 2024 to $13.25 billion by 2030.
See More
GT Biopharma Advances GTB-3650 Clinical Trial to Cohort 4 with 10μg/kg Dose
- FDA Approval Milestone: The FDA's November 2025 approval of the first bispecific antibody combination for second-line blood cancer treatment marks a significant shift from traditional chemotherapy, likely enhancing market share for companies like GT Biopharma.
- Clinical Trial Advancement: GT Biopharma has advanced its GTB-3650 clinical trial to Cohort 4, where patients receive a 10μg/kg/day dose, demonstrating a favorable safety profile and potential clinical efficacy, which could provide new options for patients with refractory blood cancers.
- Expansive Market Outlook: The CAR-T cell therapy market is projected to surge from $3.87 billion in 2024 to $13.25 billion by 2030, positioning GT Biopharma's innovative therapies to capture a significant share in this rapidly growing market.
- Future Plans: GT Biopharma plans to share its next clinical trial update in Q1 2026, continuing the dose escalation study of GTB-3650, which is expected to further validate its efficacy and expand patient benefit opportunities.
See More
GT Biopharma Advances GTB-3650 Clinical Trial to Cohort 4 with 10μg/kg/day Dosing
- FDA Approval Milestone: The FDA's November approval of the first bispecific antibody combination for second-line blood cancer treatment marks a significant shift from traditional chemotherapy, which is expected to enhance market performance for companies like GT Biopharma.
- Clinical Trial Advancement: GT Biopharma has advanced its GTB-3650 clinical trial to Cohort 4, where patients are receiving a dosing of 10μg/kg/day, indicating potential efficacy in patients with relapsed blood cancers, which could open new market opportunities for the company.
- Safety Validation: Six patients enrolled in Cohorts 1, 2, and 3 have successfully completed GTB-3650 treatment, establishing the therapy's safety profile across escalating doses, laying the groundwork for subsequent trials at higher doses.
- Future Outlook: The company anticipates sharing the next trial update in Q1 2026, and as dosing increases, clinical efficacy is expected to improve further, potentially attracting more investor interest.
See More
