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KYTX Touches New 52-Week Peak as KYV-101 Phase 2 SPS Data Looms
Kyverna Therapeutics, Inc. (KYTX) reached fresh heights today in anticipation of pivotal clinical results. The stock climbed to $10.38 during after-hours trading, marking an 18.22% jump and establishing a new 52-week high, after closing regular session at $8.78 with a 5.02% gain. Over the past 12 months, the biotech company’s shares have ranged from $1.78 to $9.75.
Breaking Ground in Rare Neurological Treatment
The catalyst driving investor enthusiasm is today’s announcement of topline findings from the KYSA-8 registrational trial, evaluating KYV-101 in patients suffering from stiff person syndrome (SPS). This rare progressive autoimmune neurological condition manifests as severe muscle stiffness and debilitating painful spasms, with existing therapeutic options proving inadequate and leaving patients with limited pathways toward sustained remission.
Mechanism Behind the Breakthrough Therapy
KYV-101 represents a fully human autologous CAR T-cell therapy engineered with CD28 co-stimulation functionality. The therapeutic approach operates by achieving profound B-cell depletion coupled with immune system restoration through a single administration, targeting the underlying autoimmune mechanisms. If successful, this strategy could potentially unlock drug-free and disease-free remission outcomes, representing a paradigm shift in autoimmune disease management.
Timeline and Financial Position
The company plans to submit a Biologics License Application (BLA) for KYV-101 in stiff person syndrome during the first half of 2026, contingent on positive trial outcomes. As of September 30, 2025, Kyverna maintains a robust financial position with $171.1 million in cash and cash equivalents. Additionally, the company drew an initial $25 million from a secured $150 million loan facility, extending operational runway into 2027 and providing substantial cushion for continued clinical development activities.