KYTX

Positive pre-BLA meeting with FDA alignment reached on KYSA-8 single-arm trial in stiff person syndrome (SPS); rolling BLA submission initiated Miv-cel pivotal trial primary analysis results in SPS demonstrated robust, durable effect in indication with no approved therapies; launch preparations continue with appointment of Nadia Dac as Chief Commercial Officer Enrollment advances in Phase 3 trial in generalized myasthenia gravis (gMG), further derisked by Phase 2 longer-term follow-up data demonstrating durable efficacy out to one year EMERYVILLE, Calif., May 12, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported business and portfolio progress, and financial results for the first quarter ended March 31, 2026. "As the first company to submit a BLA for an autoimmune CAR T therapy, gaining alignment with the FDA on a single-arm trial and a clear path to submission for miv-cel is a significant milestone for not only Kyverna but also the field," said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. "This achievement underscores both the hard work and dedication of our entire organization and the promising potential of miv-cel, starting with stiff person syndrome. As we execute our rolling BLA submission and prepare for launch in 2027, we are laying the foundation for a multi-indication neuroimmunology franchise that reinforces our leadership position in autoimmune CAR T. More broadly, we are well positioned to establish a new therapeutic paradigm, delivering durable drug-free, disease-free remission for patients." Recent Progress in Neuroimmunology CAR T Franchise FDA Alignment on SPS BLA submission: Kyverna held a positive pre-BLA meeting with the FDA, in which the company gained alignment on its regulatory path for miv-cel in SPS, including a rolling BLA submission and all core components of its BLA package: KYSA-8 single-arm pivotal Phase 2 trial is sufficient to support the BLA submission Primary endpoint measurement is the Timed 25-foot Walk (T2FW) test at 16 weeks Clinical safety package Preclinical package Chemistry, Manufacturing, and Controls (CMC) package In addition, the Company will include additional analysis of its completed natural history study presented at the 2026 American Aca...

Advancing first-to-market autoimmune CAR T opportunity in stiff person syndrome (SPS) with key launch preparation activities underway; BLA submission anticipated in 1H 2026 Progressing enrollment for FDA-aligned Phase 3 trial in generalized myasthenia gravis (gMG) Positive progressive multiple sclerosis data underscore valuable pipeline-in-a-product opportunity with miv-cel Cash and cash equivalents of $279 million provide expected runway into 2028, funding SPS BLA filing, commercial launch, and Phase 3 gMG trial EMERYVILLE, Calif., March 26, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported its business highlights and financial results for the fourth quarter and full year ended December 31, 2025. “We continue to cement our leadership in autoimmune CAR T supported by our unique construct and a growing body of transformative clinical data that reinforces miv-cel’s differentiated profile,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “We are advancing the first CAR T for stiff person syndrome, a serious and debilitating disease with no FDA-approved treatments, representing a significant unmet need and meaningful commercial opportunity. Our market entry will establish the foundation for our neuroimmunology franchise with expansion into generalized myasthenia gravis and potentially other indications, such as progressive multiple sclerosis, where miv-cel has shown promising clinical benefit.” Fourth Quarter 2025 Highlights and Recent Business Updates Neuroimmunology CAR T Franchise KYSA-8 Registrational Phase 2 Clinical Trial for SPS In December 2025, Kyverna reported landmark topline data for miv-cel (mivocabtagene autoleucel, KYV-101) in SPS. Miv-cel achieved highly statistically significant clinical benefit across all primary and secondary endpoints, including reversing disability. It was generally well-tolerated with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) observed, supporting the potential for outpatient administration. Kyverna anticipates submitting its first Biologics License Application (BLA) in the first half of 2026. The primary analysis from the Company’s registrational trial will be shared as a late-bre...

Topline data from registrational trial in stiff person syndrome (SPS) now expected in early 2026; narrowed from previous guidance of first half 2026; BLA submission anticipated in 1H 2026 Positive interim Phase 2 data in generalized myasthenia gravis (gMG); on-track to enroll first patient for registrational Phase 3 portion of trial by year-end 2025 Strengthened financial flexibility with up to $150M loan facility to support the continued advancement of the Company’s late-stage indications in gMG and SPS, while also accelerating pre-launch activities EMERYVILLE, Calif., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported its business highlights and financial results for the quarter ended September 30, 2025. “Kyverna’s execution across significant clinical and corporate milestones provides us with strong momentum heading into the new year,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “We are very pleased to have reinforced our market opportunity in generalized myasthenia gravis with unprecedented Phase 2 interim data, demonstrated KYV-101’s potential in multiple sclerosis and rheumatoid arthritis with promising IIT data, and strengthened our financial flexibility with non-dilutive financing. Looking ahead, we remain focused on executing our neuroimmunology CAR T-cell franchise strategy, with topline registrational stiff person syndrome data expected ahead of schedule in early 2026.” Third Quarter 2025 Highlights and Recent Business Updates Neuroimmunology CAR T Franchise: Kyverna is advancing its first-in-class neuroimmunology CAR T franchise for indications with high unmet need, including stiff person syndrome and myasthenia gravis. KYSA-8 Registrational Phase 2 Trial for Stiff Person Syndrome (SPS) Kyverna narrowed its previously announced guidance for reporting topline data from this trial from the first half of 2026 to early 2026. The Company remains on track to submit its first BLA in the first half of 2026. KYSA-6 Registrational Phase 2/3 Trial for Generalized Myasthenia Gravis (gMG) Kyverna presented positive interim data from the Phase 2 portion of its registrational KYSA-6 clinical trial at the American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM)...

Topline data for registrational Phase 2 trial of KYV-101 in stiff person syndrome (SPS) and BLA submission anticipated in 1H 2026 Registrational Phase 3 KYV-101 trial in myasthenia gravis (MG) to include ~60 patients with enrollment to initiate by year-end 2025; interim Phase 2 data expected in Q4 2025 Strong cash position to support upcoming milestones EMERYVILLE, Calif., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported its business highlights and financial results for the quarter ended June 30, 2025. “The second quarter was marked by continued strong execution of our focused strategy, as we achieved key clinical and regulatory milestones to advance our potential first-in-class neuroimmunology CAR T franchise,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “We anticipate this momentum will continue in the second half of the year with the initiation of our Phase 3 registrational trial in MG. We believe this is an efficient and well-powered trial given the substantial clinical effect size that has been observed in this patient population treated with KYV-101. More broadly, we are well-positioned to deliver on multiple near-term value-creating milestones with our interim Phase 2 MG data readout expected in the fourth quarter of this year as well as anticipated topline registrational data for SPS and BLA filing in the first half of next year. We look forward to sharing more details on these programs at our upcoming KOL event, where we will highlight KYV-101’s differentiated clinical profile, our Phase 3 trial design for MG and the market opportunity for our neuroimmunology franchise.” Second Quarter 2025 Highlights and Recent Business Updates KYSA-8 Registrational Phase 2 Trial for Stiff Person Syndrome (SPS) Patient enrollment for the registrational trial was completed in the second quarter of 2025. Kyverna remains on track to report topline data from this study and submit its first BLA in the first half of 2026. KYSA-6 Registrational Phase 2/3 Trial for Myasthenia Gravis (MG) Following a successful end-of-Phase 2 meeting with the FDA, Kyverna is expanding its existing KYSA-6 trial to include a Phase 3 portion, which the Company expects to begin enrolling by year-end 2025. The P...

Enrollment complete in registrational Phase 2 KYV-101 trial in stiff person syndrome (SPS); on track for topline data in 1H 2026; biologics license application (BLA) filing now anticipated in 1H 2026 Advancing into registrational Phase 3 KYV-101 trial in myasthenia gravis (MG) following successful end-of-Phase 2 meeting with U.S. Food and Drug Administration (FDA); Phase 2 MG data anticipated in 2H 2025 Company to host KOL event in Q3 2025, spotlighting its accelerating neuroinflammation franchise Strong financial position; cash runway into 2027 supports first BLA filing, MG Phase 3 trial and pre-launch activities EMERYVILLE, Calif., May 13, 2025 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported its business highlights and financial results for the quarter ended March 31, 2025. "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. "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." First Quarter 2025 Highlights and Recent Business Updates KYV-101: Autologous, fully human CD19 CAR T-cell product candidate, incorporating highly potent CD28 co-stimulation. KYV-101 is currently being evaluated in company-sponsored KYSA trials and investigator-initiated trials in numerous B cell mediated autoimmune diseases with a prioritized focus in stiff person syndrome, myasthenia gravis and lupus nephritis. Stiff Person Syndrome (SPS) Kyverna has completed patient enrollment in KYSA-8, its pivotal Phase 2 trial for KYV-101 in SPS. As previously announced, the Company has aligned with the FDA for KYSA-8 to serv...

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 nephritis expected in 2H 2025 Strong balance sheet extends cash runway into 2027 through key clinical and regulatory catalysts EMERYVILLE, Calif., March 27, 2025 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported its business highlights and financial results for the full year 2024. "Kyverna's first year as a public company was a transformative one, as we demonstrated our leadership position in autoimmune CAR T. We have treated the most CAR T patients in neuroinflammatory and rheumatologic diseases with our differentiated construct, and our clinical experience to date highlights the potential for profound clinical outcomes in autoimmune patients," said Warner Biddle, Chief Executive Officer of Kyverna. "Kyverna has entered 2025 and its next phase of growth with the right strategy and a strong team in place to advance late-stage development of KYV-101 in our three priority indications – stiff person syndrome, myasthenia gravis and lupus nephritis – each with a clear and rapid path to market. We are pleased with our progress in our lead indication, stiff person syndrome, following alignment with the FDA on our registrational trial, KYSA-8, which is an important milestone as we advance KYV-101 toward its first BLA filing in 2026." Fourth Quarter 2024 Highlights and Recent Business Updates KYV-101: Autologous, fully human CD19 CAR T-cell product candidate, incorporating highly potent CD28 co-stimulation. KYV-101 is currently being evaluated in company-sponsored KYSA trials and investigator-initiated trials in numerous B cell mediated autoimmune diseases with a prioritized focus in stiff person syndrome, myasthenia gravis and lupus nephritis. Stiff Person Syndrome (SPS) Kyverna has aligned with the FDA on a registrational Phase 2 design for its ongoing KYSA-8 trial in SPS, which has enrolled 70% of study...