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Noticias de KYTX
Eventos de KYTX
Kyverna Advances BLA Submission and Clinical Trials
"Kyverna continues to advance our rolling BLA submission for stiff person syndrome, progress commercial launch readiness activities and accelerate enrollment in our registrational trial in generalized myasthenia gravis, while advancing our pipeline," said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. "With three RMAT indications and the potential to deliver the first approved CAR T-cell therapy for autoimmune diseases, we are well positioned to achieve our goal of freeing patients from life-long disease burden and chronic immunotherapies with a single dose of miv-cel."
Kyverna and ElevateBio Sign Manufacturing Agreement for miv-cel
Kyverna Therapeutics and ElevateBio announced a manufacturing agreement for both U.S. commercial and global clinical supply of miv-cel, Kyverna's autologous CD19-directed CAR T-cell therapy. The new agreement provides Kyverna with flexible and scalable supply of miv-cel, supporting the company's potential launches in stiff person syndrome and generalized myasthenia gravis, as well as other ongoing clinical studies. Over the past three years, Kyverna and ElevateBio have built a strong clinical-stage partnership, delivering a track record of success in process development, quality systems, and cell product manufacturing optimization, supporting the SPS biologics license application, or BLA, and laying the foundation for future growth. Kyverna remains on track to complete the rolling BLA submission for miv-cel in SPS in the fourth quarter of 2026. If approved, miv-cel has the potential to become the first FDA-approved CAR T-cell therapy for an autoimmune disease and the first approved treatment for people living with SPS.
Cue Biopharma Appoints Dominic Borie as Chief Medical Officer
Cue Biopharma (CUE) announced the appointment of Dominic Borie as chief medical officer, and head of research and development. He reports to president and CEO Shao-Lee Lin. Most recently, he served as strategic advisor to the CEO and board of Kyverna Therapeutics (KYTX), where he previously served as president of research and development, and founding CEO.
Vera Therapeutics Chief Regulatory Officer William Turner Retires, Nancy Boman Succeeds
Vera Therapeutics (VERA) announced a planned transition of the chief regulatory officer position. William Turner, current chief regulatory officer of Vera Therapeutics, is planning to retire and transition to the role of strategic advisor in the third quarter of this year after a successful tenure at the company, including the recent accelerated approval of Vera Therapeutics' first therapy in IgA nephropathy, Trutakna. Nancy Boman will succeed Turner as chief regulatory officer of Vera Therapeutics. Most recently, she served as the chief regulatory officer at Kyverna Therapeutics (KYTX).
Kyverna Therapeutics Appoints Ritesh Srivastava as Chief Legal and Compliance Officer
Kyverna Therapeutics announced the appointment of Ritesh Srivastava as chief legal and compliance officer, effective June 22. Srivastava brings extensive experience spanning legal, corporate strategy, compliance, and risk management, which will further support Kyverna as it advances miv-cel towards a potential first approval in stiff person syndrome and transitions to a commercial-stage organization. Srivastava joins Kyverna from BPGbio, where he served as general counsel and provided legal and strategic counsel across research and development, commercialization planning, and business operations.
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