Every 8-K that Kyverna Therapeutics (KYTX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow KYTX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full KYTX filings page.
Kyverna Therapeutics reported second quarter 2026 results and a business update centered on its lead CAR T-cell therapy miv-cel. The FDA granted RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis, expanding its regulatory momentum across neuroimmunology.
The company has begun a rolling BLA for stiff person syndrome, submitted the CMC module, and expects to complete the filing in Q4 2026 while planning to seek priority review and preparing for a potential 2027 commercial launch. Enrollment continues in the Phase 3 KYSA-6 trial in generalized myasthenia gravis, with completion targeted by mid-2027 and additional Phase 2 data expected in Q3 2026.
Kyverna reported $199.4 million in cash, cash equivalents and marketable securities as of June 30, 2026, which together with its loan facility is expected to fund operations into 2028. In Q2 2026, R&D expenses were $24.8 million, G&A expenses were $14.8 million, and net loss was $38.3 million, or $0.63 per share.
Kyverna Therapeutics entered a new Clinical and Commercial Supply Agreement with ElevateBio that replaces their prior development and manufacturing arrangement for miv-cel, its autologous CD19-directed CAR T-cell therapy for autoimmune diseases. ElevateBio will provide development, clinical and commercial manufacturing under statements of work, and Kyverna agreed to order at least certain minimum quantities of miv-cel in specified years and after regulatory approvals.
The agreement runs for an initial term of five years, then automatically renews for successive one-year periods, and includes annual price and fee adjustments tied to the Producer Price Index for Pharmaceutical Preparation Manufacturing, along with customary quality, audit and confidentiality provisions. A joint press release notes ElevateBio’s clinical manufacturing success rate of more than 98% for miv-cel and states that Kyverna remains on track to complete its rolling Biologics License Application submission for stiff person syndrome in the fourth quarter of 2026, supporting potential launches in stiff person syndrome and generalized myasthenia gravis and other ongoing studies.
Kyverna Therapeutics, Inc. amended its existing non-dilutive term loan facility with Oxford Finance, which provides up to $150.0 million in multiple tranches. The company previously drew $25.0 million from Term A and now has extended access to the remaining $15.0 million of Term A Loans through December 31, 2026 in exchange for an upfront fee of $187,500.
If Kyverna does not use the full remaining Term A amount by that date, it will pay a 1.0% non‑utilization fee on the undrawn balance. Contingent on drawing the remaining Term A funds, availability periods for the Term B Loan of $5.0 million to $20.0 million and two $20.0 million Term C tranches will be extended or restructured around specific clinical and revenue milestones.
Under those same conditions, Kyverna will also become subject to minimum revenue covenants beginning with a quarter ending as early as June 30, 2027, with the start date tied to how much cash it raises from other capital sources over certain periods.
Kyverna Therapeutics, Inc. reported results from its 2026 annual stockholder meeting. Of 60,530,293 common shares outstanding as of March 30, 2026, 43,987,007 shares were represented, about 73% of shares entitled to vote, which was sufficient to constitute a quorum.
Stockholders elected Class II directors Ian Clark and Christi Shaw to serve until the 2029 annual meeting or until their successors are elected and qualified. Clark received 31,505,902 votes for and 3,255,231 votes withheld, while Shaw received 34,528,865 votes for and 232,268 votes withheld, with 9,225,874 broker non-votes on each nominee.
Stockholders also ratified the Audit Committee’s appointment of BDO USA, P.C. as the independent registered public accounting firm and independent auditor for the year ending December 31, 2026, with 43,830,300 votes for, 80,223 votes against, and 76,484 abstentions.
Kyverna Therapeutics, Inc. appointed Gregory (Greg) Martini as Chief Financial Officer, effective May 18, 2026, succeeding Marc Grasso, M.D., who will remain as a strategic advisor through August 1, 2026 to support a smooth transition. Martini becomes Kyverna’s principal financial and accounting officer.
Under his offer letter, Martini receives a $525,000 base salary, an annual bonus opportunity equal to 40% of salary (pro‑rated for 2026), and a $300,000 sign‑on bonus, split into two $150,000 payments tied to his start date and first anniversary. He will also be granted a stock option to purchase 325,000 shares of common stock under Kyverna’s 2024 Inducement Equity Incentive Plan, vesting over four years, along with severance and change‑in‑control protections.
Kyverna states that Grasso’s transition is not due to any disagreement over operations or financial reporting. The accompanying press release highlights Martini’s prior CFO role at Ironwood Pharmaceuticals and frames his hire as supporting Kyverna’s evolution into a commercial‑stage company as it advances its CAR T‑cell therapy candidate miv‑cel toward potential approval in autoimmune diseases.
Kyverna Therapeutics initiated a rolling biologics license application (BLA) submission for its CAR T-cell therapy miv-cel in stiff person syndrome (SPS) after a positive pre-BLA meeting with the FDA confirming that the single-arm KYSA-8 trial can support the filing and potential priority review under its RMAT designation. The company reported robust, durable SPS data with all patients off immunotherapies through last follow-up, and encouraging results across generalized myasthenia gravis and progressive multiple sclerosis programs.
For the quarter ended March 31, 2026, Kyverna reported a net loss of $39.7 million, or $0.66 per share, on operating expenses of $41.4 million. Cash, cash equivalents and marketable securities were $236.4 million, and management continues to expect a cash runway into 2028 while advancing launch readiness for a potential SPS commercial rollout.
Kyverna Therapeutics, Inc. appointed veteran commercial leader Nadia Dac as Chief Commercial Officer, effective May 4, 2026. She will lead commercial strategy and execution for miv-cel (mivocabtagene autoleucel, KYV-101), a CD19-targeting CAR T-cell therapy being developed for stiff person syndrome and other B‑cell-driven autoimmune diseases.
In connection with her appointment, Kyverna will grant Ms. Dac an option to purchase 300,000 shares of common stock under its Amended and Restated 2024 Inducement Equity Incentive Plan, as an inducement award under Nasdaq Listing Rule 5635(c)(4). The option will have an exercise price equal to the closing price on May 4, 2026 and will vest over four years, with 25% vesting on the one-year anniversary of her appointment and the remainder vesting in equal monthly installments thereafter, subject to continued service.
Kyverna Therapeutics reported strong clinical data for its autoimmune CAR T therapy miv-cel (KYV‑101) in two registrational programs, stiff person syndrome (SPS) and generalized myasthenia gravis (gMG). The results were highlighted in a presentation tied to a conference call and recent press releases.
In the SPS Phase 2 KYSA‑8 registrational trial (n=26), patients had a 46% median improvement in the timed 25‑foot walk at week 16, with 81% achieving at least a 20% improvement and all remaining off SPS immunomodulatory or immunosuppressive therapies through last follow‑up. Secondary measures of disability, stiffness, and hypersensitivity all improved significantly, and no high‑grade cytokine release syndrome (CRS) or ICANS occurred.
In the gMG Phase 2 KYSA‑6 trial (n=7), a single miv‑cel dose produced rapid, durable reductions in MG‑ADL and QMG scores out to 52 weeks, with 100% of patients achieving clinically meaningful responses and 57% reaching minimal symptom expression. All patients were free of immunotherapies through 24 weeks, with a favorable safety profile and evidence of deep B‑cell depletion, autoantibody reduction, and preserved humoral immunity. The company is preparing a BLA for SPS and advancing a global Phase 3 trial in gMG.
Kyverna Therapeutics reported positive primary analysis results from its registrational Phase 2 KYSA-8 trial of miv-cel (KYV-101) in stiff person syndrome (SPS). A single dose of 1×108 CAR T cells in 26 patients led to rapid, statistically significant and clinically meaningful improvements in walking speed, disability, stiffness, hypersensitivity, and mobility at 16 weeks, with a median 46% improvement in the Timed 25-Foot Walk and 81% of patients achieving at least a 20% improvement.
All patients discontinued chronic immunotherapies by Week 16, and two-thirds of those who needed walking aids at baseline no longer required them. Miv-cel showed a favorable safety profile with no high-grade CRS or ICANS and manageable Grade 3/4 neutropenia, supporting Kyverna’s plans to prepare a BLA submission for SPS.
Kyverna Therapeutics reported longer-term Phase 2 data from its KYSA-6 registrational trial of miv-cel (KYV-101) in generalized myasthenia gravis. Seven patients with moderate-to-severe disease received a single dose, showing deep, durable responses across key clinical scores and reduced treatment burden.
At 24 weeks, all patients had rapid, clinically meaningful improvements in MG-ADL and QMG scores, with many maintaining benefits out to 52 weeks. All were free of nonsteroidal immunosuppressants, high-dose steroids, and FcRn or complement inhibitors at 24 weeks, and safety was favorable with no high-grade CRS or ICANS.
Kyverna Therapeutics reported its fourth quarter and full year 2025 results while highlighting major progress for its lead autoimmune CAR T therapy, miv-cel. The company is preparing a Biologics License Application for stiff person syndrome in the first half of 2026 and aims to be launch-ready by year-end 2026.
Kyverna is also advancing an FDA-aligned Phase 3 trial in generalized myasthenia gravis and reported encouraging data from investigator-initiated studies in progressive multiple sclerosis and rheumatoid arthritis. The company strengthened its balance sheet through $147.5 million in financings and ended 2025 with $279 million in cash, expecting runway into 2028 despite a 2025 net loss of $161.3 million.
Kyverna Therapeutics appointed two new independent directors as it refreshes its board. Andrew Miller, Ph.D., founder and former R&D president of Karuna Therapeutics, joins as a Class III director and member of the Audit and Science and Technology Committees. He will receive annual cash retainers for board and committee service and initial equity awards sized at $262,000 in stock options and $87,500 in restricted stock units, subject to service-based vesting and full vesting on a Change in Control.
Sravan Emany, CFO of Beam Therapeutics and former CFO/COO of Ironwood Pharmaceuticals, joins as a Class I director, Chair of the Audit Committee and member of the Nominating and Corporate Governance Committee, with similar cash and equity compensation levels and change-in-control vesting. Director Daniel Spiegelman resigned effective February 24, 2026, and the company states his resignation was not due to any disagreement with operations, policies or practices.
Kyverna Therapeutics, Inc. reported a leadership transition and a change to its inducement equity plan. Karen Walker notified the company on January 29, 2026 that she will retire and step down as Chief Technology Officer, effective February 9, 2026. The company noted that her resignation is not due to any disagreement regarding operations, policies, or practices.
On the same date, the board’s Compensation Committee amended and restated the 2024 Inducement Equity Incentive Plan to increase the shares of common stock available for grant by 1,000,000, bringing the aggregate to 5,000,000 shares. This change was adopted without stockholder approval under Nasdaq Listing Rule 5635(c)(4) and maintains the plan’s focus on equity awards used as material inducements for new or rehired employees. The company also announced the appointment of Mayo Pujols as Chief Technology Officer, effective February 9, 2026.
Kyverna Therapeutics appointed Christi Shaw as Executive Chairperson of its Board, effective January 12, 2026. She will replace Ian Clark as Chairperson, who will continue to serve as a director. Shaw will be employed on an at-will basis with an initial annual salary of $400,000.
As part of her compensation, Shaw will receive an option to purchase 185,000 shares of common stock and 30,000 restricted stock units, each vesting over four years, along with performance RSUs equal to $200,000 divided by the grant-date fair market value, which vest upon achieving specified stock price targets. If a change in control occurs during her employment, all of her unvested equity awards will fully vest, with performance targets deemed achieved at the target level.
The company also furnished a press release providing a corporate update, strategic priorities for 2026, and preliminary unaudited financial information for the year ended December 31, 2025, which may change upon completion of year-end procedures.
Kyverna Therapeutics, Inc. entered into an underwriting agreement for an underwritten public offering of 13,333,333 shares of common stock at a public offering price of $7.50 per share. Underwriters will purchase the shares at $7.05 per share and have a 30-day option to buy up to an additional 1,999,999 shares at the public offering price, less underwriting discounts and commissions.
The company expects gross proceeds of approximately $100 million, before deducting underwriting discounts, commissions and offering expenses. Kyverna intends to use the net proceeds for general corporate purposes, which may include funding research and development, capital expenditures, working capital and general and administrative expenses. Closing is expected on or about December 18, 2025, subject to customary conditions, and directors, executive officers and certain affiliated stockholders are subject to lock-up agreements generally through January 31, 2026.
Kyverna Therapeutics, Inc. announced positive topline data from KYSA-8, a registrational Phase 2 trial of its fully human, autologous CD19 CAR T-cell therapy mivocabtagene autoleucel (miv-cel, formerly KYV-101) in stiff person syndrome.
The company is hosting a conference call at 8:00 a.m. Eastern Time on December 15, 2025 to review the results and has provided an investor slide presentation as Exhibit 99.1, which is furnished rather than filed under federal securities law provisions.
Kyverna Therapeutics reported positive topline data from KYSA-8, its registrational Phase 2 trial of mivocabtagene autoleucel (miv-cel, formerly KYV-101), a fully human, autologous CD19 CAR T-cell therapy with CD28 co-stimulation, in stiff person syndrome.
The company also stated it will host a conference call at 8:00 a.m. Eastern Time on December 15, 2025 to review the results, and made a detailed press release available describing the KYSA-8 data and its implications for the miv-cel program.
Kyverna Therapeutics, Inc. (KYTX) furnished an 8-K announcing it issued a press release with a business update and financial results for the quarter ended September 30, 2025. The press release is included as Exhibit 99.1.
The company states the information under Item 2.02 and Exhibit 99.1 is furnished, not filed, under the Exchange Act and will not be incorporated by reference into Securities Act or Exchange Act filings unless specifically referenced. The report was signed by Chief Financial Officer Marc Grasso, M.D.
Kyverna Therapeutics (KYTX) entered a non-dilutive term loan facility of up to $150.0 million with Oxford Finance, structured in multiple tranches. The facility includes an initial $40.0 million tranche and two additional tranches totaling $60.0 million, with a discretionary fourth tranche of $50.0 million. The company expects to draw $25.0 million from the first tranche on November 3, 2025.
The loan matures on October 1, 2030 and bears a floating rate equal to the greater of the 1‑Month CME Term SOFR or 3.75%, plus 5.00%. Kyverna will make interest-only payments until November 1, 2028 or, at its option upon meeting certain milestones, until November 1, 2029, after which principal and interest are due monthly. The agreement is secured by substantially all assets, including intellectual property, and includes customary events of default.
The company also announced it now expects to report topline registrational data for its Phase 2 KYV‑101 trial in stiff person syndrome in early 2026.
Kyverna Therapeutics (KYTX) announced positive interim data from the Phase 2 portion of its KYSA-6 Phase 2/3 trial of KYV-101 in generalized myasthenia gravis. The company will host a conference call at 8:00 a.m. Eastern Time on October 29, 2025 to review the results.
Slides for the call are furnished as Exhibit 99.1. The information was furnished under Item 7.01 and is not deemed “filed” under the Exchange Act.
Kyverna Therapeutics (KYTX) announced positive interim data from the Phase 2 portion of its KYSA-6 Phase 2/3 trial evaluating KYV-101 in generalized myasthenia gravis. The company scheduled a conference call at 8:00 a.m. Eastern Time on October 29, 2025 to review the results. The announcement was provided under Regulation FD to ensure broad, simultaneous disclosure.
The details were furnished as Exhibit 99.1 and, consistent with Regulation FD practice, are not deemed “filed” for purposes of Section 18 of the Exchange Act. This signals a clinical program update rather than a change to financial statements or guidance. The filing lists the press release and the Inline XBRL cover page as exhibits.
Kyverna Therapeutics, Inc. reported a change in its board leadership. Steve Liapis, Ph.D. notified the company on September 19, 2025 that he will resign as a member of the board of directors and all related committees, effective September 30, 2025. The company states that his resignation is not due to any disagreement with its operations, policies, or practices.
After his departure, the size of the board will be reduced from eight to seven directors. The board has appointed current director Christi Shaw to the Audit Committee to fill the vacancy created by Dr. Liapis’ resignation. The board also expressed appreciation for Dr. Liapis’ years of service and contributions.
Kyverna Therapeutics, Inc. furnished a press release providing a business update and reporting financial results for the quarter ended June 30, 2025. The press release is attached to the report as Exhibit 99.1.
The company notes this information is furnished, not filed, and therefore is not subject to Section 18 liability and is not automatically incorporated by reference into registration statements. Kyverna's common stock trades on Nasdaq under the symbol KYTX, and the registrant is identified as an emerging growth company.