Accelerating clinical path to commercialization in stiff person syndrome, myasthenia gravis and lupus nephritis Aligned with the U.S. Food and Drug Administration (FDA) on a registrational Phase 2 trial design for ongoing KYSA-8 trial in stiff person syndrome; 70% of study enrolled with topline data expected in 1H 2026; Biologics License Application (BLA) filing targeted for 2026 Clinical data in myasthenia gravis and lupus... Read More

EMERYVILLE, Calif. , March 3, 2025 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna, Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced that Warner Biddle , Chief Executive Officer of Kyverna, will present at the Leerink Partners Global Biopharma Conference in Miami, FL on Monday, March 10, 2025 , at 3:00 p.m. ET . A live... Read More

Dr. Gehchan brings decades of successful late-stage clinical development and commercial experience to role, further enhancing Kyverna's senior leadership team to execute Company's next wave of growth EMERYVILLE, Calif. , Jan. 21, 2025 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna, NASDAQ: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today... Read More

Extending Company's leadership position in autoimmune CAR T with prioritized indication strategy; pivoting to late-stage development and commercialization First-to-market opportunity with KYV-101 in stiff person syndrome; 40% enrolled in pivotal Phase 2 trial with first BLA filing targeted for 2026; fast-follow indications in myasthenia gravis and lupus nephritis Efficiently expanding into broader autoimmune indications and... Read More

SANTA CRUZ, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Unnatural Products, Inc. (UNP), a biotech developing orally-delivered macrocyclic peptides to address previously undruggable targets, announced today the appointment of Abbas Kazimi and Mert Aktar to its Board of Directors. "We are honored to welcome Abbas and Mert to our Board of Directors," said Cameron Pye, Ph.D., CEO and Co-Founder of Unnatural Products. "Abbas has an... Read More

EMERYVILLE, Calif. , Jan. 6, 2025 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna, NASDAQ: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, announced that the Company will participate at the 43rd Annual J.P. Morgan Healthcare Conference. Warner Biddle , Chief Executive Officer of Kyverna, will present its 2025 strategic priorities and key... Read More

Key Leadership Appointments Bring New Skills and Capabilities to Organization EMERYVILLE, Calif. , Dec. 13, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, announced the recent appointments of Dan Maziasz as Chief Business Officer, Cara Bauer as Chief Human Resources Officer, and Tracy Rossin as... Read More

Positive Sustained Efficacy and Durability at >6-month Follow-Up Observed in Patients With Severe Lupus Nephritis (LN) Treated With KYV-101 Target Dose KYV-101 Treatment Continues to Demonstrate Robust Safety and Tolerability With No High-Grade CRS or ICANS Observed EMERYVILLE, Calif. , Nov. 14, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a clinical-stage biopharmaceutical company focused on developing cell... Read More

Multiple Key Leadership Appointments, Including Warner Biddle as CEO, Bringing Clinical, Commercial and Strategic Expertise in Cell Therapy Continuing to Advance Broad KYSA Clinical Development Program: Presented Clinical Data Highlighting Potential for KYV-101 in SPS, MG and MS at ECTRIMS and Plan to Share Updated Clinical Data in LN at Company Symposium at ACR Convergence 2024 Strong Financial Position; Ended the Quarter... Read More

Enriches Board's expertise in corporate strategy and business development, with vast experience leading biopharmaceutical companies through rapid growth and creating value across innovative therapeutic platforms, including cell therapy EMERYVILLE, Calif. , Oct. 21, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for... Read More

Company symposium to highlight case reports from 11 patients with stiff-person syndrome, myasthenia gravis and multiple sclerosis reinforcing KYV-101's initial efficacy and safety profile and broad potential in B cell-driven neuroinflammatory diseases Key biomarkers indicate potential for KYV-101 to durably modify neuroinflammatory diseases with immune system reset Kyverna to present posters on design and methods for... Read More

Warner Biddle Appointed as Chief Executive Officer and to Board of Directors, Bringing Over 30 Years of Commercial, Product Planning and Franchise Leadership Experience, Including Successful Launches for CAR T Pioneer in Hematology Christi Shaw , Life Sciences Leader at Multiple Major Pharmaceutical and Biotech Companies and Across Therapeutic Areas, Appointed to Board of Directors Together Strengthen Leadership as... Read More

EMERYVILLE, Calif. , Aug. 21, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc . (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announced today that the company's executives will participate in the following investor events: Investor Conference Details: Morgan Stanley Global Healthcare Conference in New York, NY on... Read More

Actively recruiting clinical trials in neurology and rheumatology with KYV-101 No severe ICANS or CRS reported in first 36 autoimmune disease patients treated with KYV-101 Received FDA RMAT Designation for KYV-101 for treatment of patients with Stiff-Person Syndrome Received FDA RMAT Designation for KYV-101 for treatment of patients with Myasthenia Gravis Reported clinical experience with first KYV-101 patient disease-free... Read More

The application was evaluated based on the positive clinical outcomes in patients treated in Germany under the named-patient program The Regenerative Medicine Advanced Therapies designation allows Kyverna to leverage on more expedited meetings and more senior FDA leadership involvement throughout the development cycle for KYV-101 EMERYVILLE, Calif. , Aug. 12, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a... Read More

The application was evaluated based on the positive clinical outcomes of KYV-101 in patients treated in Germany under a named-patient treatment option The Regenerative Medicine Advanced Therapies designation will allow Kyverna to receive expert guidance on efficient drug development and use of surrogate endpoints from senior FDA officials EMERYVILLE, Calif. , July 15, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc.... Read More

This IND clearance expands the use of KYV-101 CAR T-cell therapy in a Phase 2, open-label KYSA-8 clinical trial targeting a devastating neuroimmunological autoimmune disease KYV-101 is a fully human anti-CD19 CAR T-cell therapy designed for use in patients with B cell-driven autoimmune diseases EMERYVILLE, Calif. , June 20, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage... Read More

Patient received KYV-101, a fully human anti-CD19 CAR T-cell product candidate, as part of a named-patient treatment option after failure to respond to conventional therapies Significant improvement in walking distance and 40% reduction in GABAergic medications were among the reported results Well-tolerated treatment with low-grade CRS and no ICANS supports continued exploration of KYV-101 in neuroimmunological disease... Read More

Promising results from early clinical experience with anti-CD19 CAR T cells in patients with autoimmune diseases Optimal CAR construct design contributing to an acceptable safety profile, and potential for lasting immune reset are key for treatment adoption Kyverna is currently recruiting for multiple KYSA trials where the company's product candidate KYV-101 is used to treat patients suffering from myasthenia gravis,... Read More

Data to include insights from 12 indications from more than 15 CAR T centers in US and Europe KYV-101 experience in Rheumatological disease spans 9 patients, with 7 lupus nephritis and 2 systemic sclerosis patients Kyverna to host a press conference on June 14 at 5pm CEST EMERYVILLE, Calif. , June 7, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company... Read More

Advanced clinical development in two broad areas of autoimmune disease: rheumatology and neurology Treated 30 patients cumulatively as of May 14, 2024 , including eight patients with myasthenia gravis, seven patients with lupus nephritis, and four patients with multiple sclerosis Strong balance sheet, bolstered by recent public offering EMERYVILLE, Calif. , May 14, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc . (Nasdaq:... Read More

Poster #14-006 describes the first successful treatment of concomitant myasthenia gravis and Lambert- Eaton myasthenic syndrome with autologous CD19-targeted CAR-T cells Kyverna to host a conference call on April 16 to review recent named-patient experience in patients suffering from multiple sclerosis and myasthenia gravis EMERYVILLE, Calif. , April 11, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a... Read More

Two patients were treated with KYV-101, a fully human anti-CD19 CAR T-cell product candidate, in Germany as part of a named patient program after failure to respond to conventional therapies The treatment resulted in an acceptable safety profile, with no observed clinical signs of early neurotoxicity, warranting larger clinical studies in subjects with multiple sclerosis EMERYVILLE, Calif. , March 29, 2024 /PRNewswire/ --... Read More

Advanced clinical development in two broad areas of autoimmune disease: rheumatology and neurology Strong balance sheet, bolstered by recent public offering, expected to fund operations into 2026 EMERYVILLE, Calif. , March 26, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune... Read More

The Investigator-Initiated Trial will assess the safety, tolerability, and clinical activity of KYV-101, a fully human anti CD19 CAR T-cell therapy in up to 12 study participants The clinical study will be supported by cutting edge correlative studies funded through a parallel research collaboration between Kyverna and Stanford University The agreements further expand the scale of ongoing clinical studies assessing the... Read More