Welcome to our dedicated page for Kyverna Therapeutics news (Ticker: KYTX), a resource for investors and traders seeking the latest updates and insights on Kyverna Therapeutics stock.
Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on developing CD19-targeting CAR T-cell therapies for autoimmune diseases, and its news flow reflects this focus. Company updates frequently highlight progress with its lead autologous CAR T-cell therapy candidate, mivocabtagene autoleucel (miv-cel, KYV-101), in B-cell-driven autoimmune conditions.
Visitors to this KYTX news page can review announcements on Kyverna’s registrational trials in stiff person syndrome (SPS) and generalized myasthenia gravis (gMG). Recent press releases describe positive topline data from the KYSA-8 registrational Phase 2 trial in SPS and interim Phase 2 data from the KYSA-6 registrational Phase 2/3 trial in gMG, including reported effects on disability, mobility, and disease activity scores, as well as safety outcomes such as the absence of high-grade cytokine release syndrome or ICANS in the reported datasets.
News items also cover Kyverna’s broader development and financing activities. These include business updates and quarterly financial results, a loan facility with Oxford Finance LLC, and public equity offerings under an effective shelf registration statement on Form S-3. Additional releases describe investigator-initiated trials in multiple sclerosis and rheumatoid arthritis, Phase 1/2 trials in lupus nephritis, and the advancement of KYV-102, which the company characterizes as using a whole blood rapid manufacturing process.
Investors and followers of KYTX can use this page to track Kyverna’s press releases on clinical milestones, regulatory plans such as an anticipated BLA submission for SPS, corporate presentations at healthcare conferences, leadership and governance changes, and capital-raising transactions. Checking this feed provides a consolidated view of how the company reports its progress in autoimmune CAR T-cell therapy and related corporate developments.
Kyverna Therapeutics (Nasdaq: KYTX) reported Phase 1 investigator-initiated trial results for KYV-101 in difficult-to-treat rheumatoid arthritis presented at ACR Convergence 2025.
In six ACPA-positive, treatment-refractory patients given a single 1×108 KYV-101 infusion (follow-up 28–175 days), CAR T cells expanded rapidly (peak 14–21 days), B cells were depleted in all patients, and profound reductions in ACPA and RF-IgM were observed. Four of six achieved ACR20 and two achieved ACR50. Safety showed no high-grade CRS or ICANS. These data supported initiation of the randomized Phase 2 portion, with enrollment completed.
Kyverna Therapeutics (Nasdaq: KYTX) will host a conference call on Wednesday, October 29, 2025 at 8:00 AM ET to discuss interim Phase 2 data from the KYSA-6 study of KYV-101 in generalized myasthenia gravis (gMG). The interim data will also be presented at the American Association of Neuromuscular and Electrodiagnostic Medicine Annual Meeting in San Francisco on October 29–November 1, 2025.
The AANEM presentation, titled "Update on the Phase 2 Part of KYSA-6," will be given by Srikanth Muppidi, M.D. on Wednesday, October 29, 2025 at 11:00 AM PT. The call requires registration to receive dial-in and PIN; a live webcast, presentation materials, and archived replay will be available on Kyverna's Investor Relations "Events & Presentations" page at ir.kyvernatx.com.
Kyverna Therapeutics (Nasdaq: KYTX) announced updated Phase 1 data for KYV-101 in progressive multiple sclerosis (MS) to be presented at the 2025 ECTRIMS Congress. The data comes from investigator-initiated trials at Stanford Medicine and UCSF.
Key findings include: robust CAR T-cell penetration into the central nervous system, improved disability status scores (EDSS), and a tolerable safety profile with no high-grade adverse events. Stanford's trial enrolled 6 patients (4 treated) while UCSF's study included 2 patients, all showing disease stabilization or improvement. The therapy demonstrated successful immune reset potential, evidenced by B-cell reconstitution to a naive phenotype in multiple patients.
Kyverna Therapeutics (Nasdaq: KYTX) announced it will present interim Phase 2 data from its KYSA-6 study of KYV-101 in myasthenia gravis (MG) at the AANEM Annual Meeting in October 2025. The presentation will include topline efficacy and safety data for 6 patients with up to 9 months of follow-up.
The company has successfully transformed the Phase 2 open-label study into a registrational Phase 2/3 trial following FDA alignment. Kyverna plans to initiate the Phase 3 portion by year-end 2025. The study evaluates KYV-101, a CD19 CAR T-cell therapy designed to achieve durable drug-free, disease-free remission with a single dose in patients with generalized myasthenia gravis (gMG).
Kyverna Therapeutics (Nasdaq: KYTX) announced details of its Phase 3 registrational trial design for KYV-101, a CD19-directed CAR T-cell therapy, in myasthenia gravis (MG). The KYSA-6 Phase 2/3 trial will enroll approximately 60 patients randomized 1:1 to receive either KYV-101 or standard-of-care therapy.
The trial aims to demonstrate KYV-101's potential to deliver durable, drug-free, disease-free remission in MG patients. Key endpoints include changes in MG-ADL and QMG scores at 24 weeks. The company expects to initiate Phase 3 enrollment by year-end 2025 and will report interim Phase 2 data in Q4 2025.
The therapy is also being developed for stiff person syndrome (SPS), with positive longer-term follow-up data reported from compassionate use patients in both indications.
Kyverna Therapeutics (Nasdaq: KYTX), a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases, has announced its participation in three major investor conferences in September 2025.
CEO Warner Biddle will participate in fireside chat presentations at the 2025 Wells Fargo Healthcare Conference (September 3rd, 11:00 a.m. ET), the Morgan Stanley 23rd Annual Global Healthcare Conference (September 8th, 4:05 p.m. ET), and the H.C. Wainwright 27th Annual Global Investment Conference (September 9th, 11:00 a.m. ET).
Investors can access live webcasts through Kyverna's investor relations website, with replays available for 90 days post-events.
Kyverna Therapeutics (Nasdaq: KYTX) reported Q2 2025 financial results and provided key business updates. The company maintains a strong cash position of $211.7 million, expected to fund operations into 2027. Key highlights include completion of patient enrollment in the registrational Phase 2 trial for stiff person syndrome (SPS), with topline data and BLA submission anticipated in 1H 2026.
The company plans to initiate a Phase 3 registrational trial for myasthenia gravis (MG) by year-end 2025, involving approximately 60 patients, with interim Phase 2 data expected in Q4 2025. For Q2 2025, Kyverna reported a net loss of $42.1 million ($0.97 per share), compared to $28.8 million ($0.67 per share) in Q2 2024. R&D expenses increased to $35.8 million from $27.3 million year-over-year.
Kyverna Therapeutics (Nasdaq: KYTX) announced a virtual Key Opinion Leader (KOL) event scheduled for August 28, 2025, from 11:00am to 1:30pm ET. The event will focus on the company's neuroimmunology CAR T franchise, featuring presentations from distinguished medical experts and management team members.
The webcast will highlight KYV-101's potential in treating myasthenia gravis (MG) and stiff person syndrome (SPS), including the Phase 3 registrational trial in MG. Key topics will cover treatment landscapes, patient experiences, unmet needs, and the company's commercial strategy. The event will conclude with a Q&A session and will be accessible through the company's investor relations website.
Kyverna Therapeutics (Nasdaq: KYTX), a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases, has appointed Dr. Marc Grasso as its new Chief Financial Officer, effective June 30, 2025. Dr. Grasso brings over 25 years of experience in public company operations, capital markets, and investment banking.
Dr. Grasso previously served as CFO of Alector, Inc. and held the position of CFO and Chief Business Officer at Kura Oncology. His extensive background includes managing director roles at prominent institutions including Stifel, UBS, and Leerink Swann. He succeeds Ryan Jones, who will transition to a strategic advisor role.
As part of his appointment, Dr. Grasso will receive an inducement grant of options to purchase 450,000 shares of Kyverna's common stock, vesting over four years with 25% vesting after one year and the remainder vesting monthly thereafter.
Kyverna Therapeutics (NASDAQ: KYTX), a clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases, announced that CEO Warner Biddle will present at the Jefferies Global Healthcare Conference in New York. The presentation is scheduled for June 4, 2025, at 4:55 p.m. ET. Investors can access the live webcast through Kyverna's investor relations website at ir.kyvernatx.com, with a replay available for 30 days after the event.
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