“We are pleased to report an exceptional start to the year, marked by rapid execution against our focused strategy to advance development of KYV-101 and build Kyverna into a robust clinical and commercial-ready organization,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics (KYTX). “Importantly, we have now aligned with the FDA on the registrational pathway for our two lead indications, SPS and MG, laying the foundation for accelerating our potential first-in-class neuroinflammation franchise. Having recently completed enrollment in KYSA-8, our registrational study in SPS, we now anticipate filing our first BLA in the first half of 2026 and are strategically investing in pre-launch activities. We are working with a sense of urgency given SPS is a debilitating and progressive disease with no currently approved therapies.” Kyverna reported $242.6M in cash, cash equivalents, and available-for-sale marketable securities as of March 31, 2025. The company expects this to provide a cash runway into 2027, which supports its first BLA filing, MG Phase 3 trial and pre-launch activities.
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