Gilead has agreed to acquire Arcellx in a deal worth $7.8bn, as the drugmaker looks to add a CAR T-cell therapy for blood cancer treatment on the cusp of approval to its portfolio. As per the agreement, Gilead will pay $115 per share, as well as a one contingent value right of $5 each. The deal is expected to close in Q2 2026. The acquisition marks the culmination of a period of collaboration between the two companies. In 2022, Gilead, via its subsidiary Kite, entered a research and development partners ...

SOUTH SAN FRANCISCO, Calif., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced that members of its senior management team will present and participate in the following investor conferences: TD Cowen 46th Annual Health Care Conference on Monday, March 2, 2026, in Boston, Massachusetts; presentation at 9:10am Eastern TimeLeerink An ...

Core Insights - Dispatch Bio and CARsgen Therapeutics announced a clinical collaboration to conduct a Phase 1 trial in China, set to begin in 2026, focusing on solid tumors [1][2] Company Overview - Dispatch Bio is engineering a universal treatment for solid tumors using its Flare platform, which combines immunotherapy with a tumor-specific virus [7] - CARsgen Therapeutics specializes in developing innovative CAR T-cell therapies, addressing unmet clinical needs in hematologic malignancies and solid tumors [8] Clinical Trial Details - The trial will evaluate DISP-11, which utilizes Dispatch's Flare platform and CARsgen's zevorcabtagene autoleucel (zevor-cel), targeting patients with solid tumors [2][3] - Zevor-cel is an autologous BCMA-targeting CAR T-cell therapy approved in China for multiple myeloma [2][6] Strategic Collaboration - The collaboration aims to enhance the application of CAR T technologies for solid tumors, particularly those lacking specific targets [3] - This partnership is seen as a significant step in addressing the unmet medical needs in oncology and expanding the impact of the Flare platform [4] Technological Innovation - Dispatch's Flare platform addresses challenges in solid tumors by delivering a tumor-specific virus that creates a universal synthetic antigen, enhancing T cell recognition and reshaping the tumor microenvironment [5] - Preclinical findings presented at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting support the safety and therapeutic promise of the Flare platform [5]

Core Insights - Kyverna Therapeutics is advancing its commercial opportunity in stiff person syndrome (SPS) with a Biologics License Application (BLA) submission anticipated in the first half of 2026 [1][4] - The company has enrolled its first patient in a registrational Phase 3 trial for generalized myasthenia gravis (gMG) [1][5] - A follow-on offering has extended the company's cash runway into 2028, which is expected to fully fund the SPS BLA filing, commercial launch, and Phase 3 gMG trial [1][5] Recent Corporate Updates - Kyverna's CEO, Warner Biddle, emphasized the company's strong execution in 2025, positioning it to be first-to-market in SPS and gMG [2] - Christi Shaw has been appointed as Executive Chairperson, enhancing the company's CAR T commercialization experience [2][5] - The company plans to report full registrational data in the first half of 2026 [6] 2026 Strategic Priorities and Anticipated Milestones - The company aims to file the BLA for miv-cel in SPS in the first half of 2026 following positive topline data from the KYSA-8 trial [4] - Kyverna has initiated the Phase 3 registrational trial in gMG, enrolling its first patient in December 2025 [5] - The company raised approximately $105 million in gross proceeds from a public follow-on offering, with estimated cash and equivalents of approximately $279 million as of December 31, 2025 [5] - Kyverna's IND application for KYV-102 was accepted by the U.S. FDA in January 2026 [5] Future Plans - The company plans to achieve SPS launch readiness by the end of 2026 and continue advancing the Phase 3 gMG trial [11] - Kyverna will evaluate additional pipeline opportunities and report Phase 2 investigator-initiated trial data in rheumatoid arthritis and Phase 1 data in multiple sclerosis and lupus nephritis in 2026 [11]

Core Insights - Kyverna Therapeutics (KYTX) shares increased by 23.2% following the announcement of positive top-line data from a mid-stage study of mivocabtagene autoleucel (miv-cel) for treating stiff person syndrome (SPS) [1][5] - Miv-cel is a fully human, autologous CD19-targeting CAR T-cell therapy that could become the first FDA-approved CAR T therapy for an autoimmune disease [1] Phase II SPS Study Data - In the Phase II KYSA-8 study, miv-cel met its primary efficacy endpoint, showing a median improvement of 46% in the timed 25-foot walk (T25FW) at week 16, with 81% of patients achieving over a 20% improvement [2][5] - The therapy also demonstrated consistent and statistically significant benefits across all secondary efficacy endpoints, indicating broad functional and symptom relief [3] Patient Outcomes - 67% of patients who required walking aids at baseline no longer needed assistance by Week 16, and all patients remained free of immunotherapies without requiring rescue treatment [4][7] - The therapy's safety profile was generally well tolerated, with no high-grade cytokine release syndrome or neurotoxicity reported, although some patients experienced manageable grade 3/4 neutropenia [7] Market Context - SPS is a rare autoimmune disorder with no FDA-approved therapies, leaving patients inadequately served by existing treatments [8] - Kyverna Therapeutics aims to fill this gap with miv-cel, which has shown significant potential in improving mobility and reducing stiffness [9] Future Developments - Following the positive results, Kyverna Therapeutics plans to file a biologics license application with the FDA for miv-cel in SPS in the first half of 2026 [10] - The company is also exploring miv-cel for other autoimmune conditions, including myasthenia gravis and multiple sclerosis, across various early to mid-stage studies [11]

Core Insights - Mivocabtagene autoleucel (miv-cel) has shown transformative results in treating stiff person syndrome (SPS), potentially becoming the first FDA-approved CAR T-cell therapy for autoimmune diseases [1][3][5] - The company plans to submit a Biologics License Application (BLA) for miv-cel in the first half of 2026 [1][5][8] Efficacy - Miv-cel demonstrated statistically significant improvements in all primary and secondary endpoints, reversing disability and eliminating the need for immunotherapies after a single dose [1][5][6] - The primary endpoint, the timed 25-foot walk (T25FW), showed a median improvement of 46% at Week 16 compared to baseline, with 81% of patients exceeding a 20% improvement [6][12] - Secondary endpoints also showed highly statistically significant benefits, with all p-values <0.0001, including improvements in the Modified Rankin Scale (mRS) and Hauser Ambulation Index (HAI) [6][12] Safety - Miv-cel was well-tolerated, with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) observed [1][14] - Grade 3/4 neutropenia was noted but was manageable, indicating a favorable safety profile [14] Clinical Trial Overview - The KYSA-8 trial is a single-arm registrational Phase 2 study involving 26 patients with SPS who had inadequate responses to non-approved treatments [4][11] - Patients received a single dose of miv-cel after lymphodepletion with cyclophosphamide and fludarabine, with follow-up for one year [12] Company Background - Kyverna Therapeutics is focused on developing cell therapies for autoimmune diseases, with miv-cel as its lead candidate [17] - The company has received Regenerative Medicine Advanced Therapy and Orphan Drug designations for miv-cel in the context of SPS [8][18]

Core Insights - Kyverna Therapeutics is advancing its lead CAR T-cell therapy, KYV-101, for autoimmune disorders, with plans for IND filing in Q4 2025 and a BLA submission in H1 2026 [1][3][4] Group 1: Clinical Development - KYV-101 is being explored in multiple autoimmune disorders, including multiple sclerosis and rheumatoid arthritis, through both company-led trials and investigator-initiated studies [1] - Positive interim Phase 2 data from the KYSA-6 trial for generalized myasthenia gravis showed 100% of patients experienced immediate and sustained improvement at 24 weeks, with all patients ceasing immunosuppressive medications [2] - The company anticipates topline data from the registrational trial in stiff person syndrome by early 2026 [3] Group 2: Financial Position - Kyverna reported a net loss of $36.8 million but secured a $150 million loan facility to support its pipeline and pre-launch activities, with an initial draw of $25 million [6] - The company had $171.1 million in cash and equivalents at the end of Q3 2025, which is expected to fund operations until 2027 [6] Group 3: Market Performance - Kyverna's stock has increased by 108% year-to-date, significantly outperforming the S&P 500 Index, which gained 17% [4] - Analysts are bullish on Kyverna, with six out of seven rating the stock as a "Strong Buy" and an average price target suggesting a potential upside of 208% [8]

Summary of Lyell Immunopharma Conference Call Company Overview - **Company**: Lyell Immunopharma (NasdaqGS:LYEL) - **Focus**: Development of next-generation autologous CAR T-cell therapies for cancer treatment, targeting both hematologic malignancies and solid tumors [4][5] Key Highlights from the Call Clinical Data Presentation - **Ronacabtagene Autoleucel (Rona-cel)**: New clinical and translational data presented at the 67th American Society of Hematology (ASH) annual meeting [2][6] - **Target Indication**: Rona-cel is a dual-targeting CD19/CD20 CAR T-cell candidate aimed at treating relapsed or refractory large B-cell lymphoma [5][6] - **Clinical Trial Results**: - **Third or Later Line Setting**: - Overall response rate: 93% - Complete response rate: 76% - Median progression-free survival: 18 months [11][12] - **Second Line Setting**: - Overall response rate: 83% - Complete response rate: 61% - 70% of patients with complete response remained in complete response for six months or longer [11][24] Safety Profile - Rona-cel demonstrated a safety profile suitable for outpatient administration: - No grade 3 or higher cytokine release syndrome (CRS) reported - Grade 3 or higher immune effector cell-associated neurotoxicity syndrome (ICANS) rate was less than 5% with dexamethasone prophylaxis [11][29] Competitive Landscape - Rona-cel's clinical data suggests it may disrupt the current CD19 CAR T-cell market, which is valued at nearly $3 billion and projected to grow to over $5 billion [13][14] - Comparison with existing therapies (Yescarta and Breyanzi): - Yescarta: 72% overall response rate, 51% complete response rate, median progression-free survival of 6-7 months - Rona-cel: 93% overall response rate, 76% complete response rate, median progression-free survival of 18 months [12][14] Pipeline Expansion - **LYL273**: A new CAR T-cell candidate targeting guanylyl cyclase C (GCC) for metastatic colorectal cancer, currently in phase 1 clinical development: - Overall response rate: 67% - Disease control rate: 83% at the highest dose evaluated [39][40] - GCC is expressed in over 95% of colorectal cancers, representing a significant market opportunity projected to reach $12 billion by 2032 [43] Manufacturing and Scalability - Lyell operates its own manufacturing facility capable of producing over 1,200 CAR T-cell doses per year, ensuring scalability for clinical and commercial needs [9][40] Future Milestones - Ongoing pivotal trials for Rona-cel (Pinnacle and Pinnacle Head-to-Head) expected to provide further insights into its efficacy and safety compared to existing therapies [30][48] Additional Insights - The importance of CD62L enrichment in Rona-cel manufacturing was emphasized, leading to improved T-cell characteristics and sustained functional capacity post-infusion [31][36] - The call highlighted the need for next-generation CAR T-cell therapies to address limitations of existing treatments, particularly in high-risk patient populations [16][17] This summary encapsulates the critical points discussed during the conference call, focusing on Lyell Immunopharma's advancements in CAR T-cell therapy and its competitive positioning in the oncology market.

Core Insights - Lyell Immunopharma, Inc. reported financial results and business highlights for Q3 2025, focusing on its advanced CAR T-cell therapies for cancer treatment [1] Clinical Programs - The lead clinical program, rondecabtagene autoleucel (ronde-cel), is in pivotal trials for relapsed and/or refractory large B-cell lymphoma (LBCL) [2] - Ronde-cel has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for both second-line and third-line settings [2][8] - Lyell acquired global rights to LYL273, a CAR T-cell product candidate for refractory metastatic colorectal cancer (mCRC), which showed a 67% overall response rate in a Phase 1 trial [3][5] Financial Performance - The company reported a net loss of $38.8 million for Q3 2025, an improvement from a net loss of $44.6 million in Q3 2024 [12] - Research and development expenses decreased to $28.2 million in Q3 2025 from $39.5 million in Q3 2024, primarily due to reduced personnel costs [13] - Cash, cash equivalents, and marketable securities were approximately $320 million as of September 30, 2025, expected to support operations into 2027 [16] Upcoming Developments - Two pivotal trials, PiNACLE and PiNACLE – H2H, are set to advance, with patient enrollment for PiNACLE – H2H expected to begin by early 2026 [4][10] - New clinical data for ronde-cel will be presented at the upcoming ASH meeting in December 2025 [5][10] Pipeline and Manufacturing - Lyell's pipeline includes next-generation CAR T-cell therapies targeting significant unmet needs in cancer treatment [5] - The LyFE Manufacturing Center™ has the capacity to produce over 1,200 CAR T-cell doses, supporting both clinical trials and potential commercial launches [17]

Core Insights - The top 20 global biopharmaceutical companies saw a 4% increase in combined market capitalisation from $3.7 trillion on June 30, 2025, to $3.8 trillion on September 30, 2025, despite challenges from tariffs and drug pricing pressures [1] Company Performances - UCB experienced the largest market capitalisation growth of 40.9%, reaching $59.8 billion in Q3 2025, driven by the competitive positioning of its drug Bimzelx in hidradenitis suppurativa [2] - Alnylam Pharmaceuticals recorded a 40.6% increase in market capitalisation, attributed to strong sales of its RNAi therapeutic Amvuttra, which saw a 59% quarter-on-quarter increase in global sales to $492 million in Q2 2025 [3] - AbbVie reported a 24.7% rise in market capitalisation, bolstered by its $2.1 billion acquisition of Capstan Therapeutics and plans to invest $195 million in a new manufacturing facility in North Chicago [4] - Johnson & Johnson's market capitalisation grew by 21.5%, supported by a 5.8% sales growth in Q2 and FDA approval of its monoclonal antibody Tremfya for paediatric patients [5]