Lyell's Ronde-cel Demonstrates Long-lasting Complete Responses and Acceptable Safety in High-Risk LBCL Patients
Clinical Trial Results: Lyell Immunopharma presented promising data from its Phase 1/2 trial of Ronde-cel for relapsed or refractory large B-cell lymphoma, showing a 93% overall response rate in the third-line setting and an 83% response rate in the second-line setting.
Safety Profile: The trial reported favorable safety outcomes, with no severe cytokine release syndrome and low rates of neurotoxicity, further improved by prophylactic dexamethasone.
Ongoing Trials: Two pivotal trials, PiNACLE and PiNACLE-H2H, are currently underway to further evaluate Ronde-cel's efficacy against existing therapies in large B-cell lymphoma.
Financial Status: As of September 30, 2025, Lyell had a cash balance of approximately $320 million, which is expected to support its clinical pipeline through 2027.
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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.

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.






