Kyverna Therapeutics Provides Corporate Update and Outlines 2026 Strategic Priorities at the J.P. Morgan Healthcare Conference
Rhea-AI Summary
Kyverna Therapeutics (NASDAQ: KYTX) provided a corporate update and 2026 priorities on Jan 12, 2026, highlighting late‑stage progress for its CAR T candidate miv‑cel. Key items: Kyverna plans to file a BLA for stiff person syndrome (SPS) in 1H 2026 after positive registrational topline data; the first patient has enrolled in the Phase 3 portion of the gMG KYSA‑6 trial; an IND for KYV‑102 was accepted by FDA in Jan 2026; a December 2025 follow‑on offering raised approximately $105M, and cash, cash equivalents, and marketable securities were ~$279M as of Dec 31, 2025, extending runway into 2028. Christi Shaw was appointed Executive Chairperson to strengthen CAR T commercialization experience.
Positive
- Raised approximately $105M in December 2025 follow‑on offering
- Estimated cash and securities of ~$279M as of Dec 31, 2025
- Planned BLA submission for SPS in 1H 2026 following registrational data
- First patient enrolled in Phase 3 gMG KYSA‑6 trial
- FDA accepted IND for KYV‑102 in January 2026
- Appointed Christi Shaw as Executive Chairperson to bolster commercialization
Negative
- BLA for SPS is planned but not yet approved
- Phase 3 gMG outcomes remain pending and will affect approval timelines
- Near‑term execution depends on timely enrollment and regulatory reviews
News Market Reaction
On the day this news was published, KYTX declined 1.08%, reflecting a mild negative market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $5M from the company's valuation, bringing the market cap to $454M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
KYTX slipped 1.54% with light volume while key CAR T/autoimmune peers CABA, CRBU, ELTX and TLSA also declined between 2–5%, and NTHI was roughly flat. With no peers in the momentum scanner and mixed individual moves, trading appeared more company-specific than a clear sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 05 | Conference appearance | Neutral | -7.3% | Announced CEO presentation at J.P. Morgan 2026 Healthcare Conference. |
| Dec 17 | Equity offering priced | Negative | -32.5% | Priced $100M underwritten stock offering under effective Form S‑3 shelf. |
| Dec 15 | Equity offering proposed | Negative | +23.2% | Proposed $100M common stock offering following SPS data disclosure. |
| Dec 15 | Clinical data update | Positive | +23.2% | Reported positive registrational KYSA‑8 SPS topline data for miv‑cel. |
| Dec 14 | Earnings/date update | Neutral | +23.2% | Scheduled webcast to discuss upcoming KYSA‑8 SPS topline results. |
Dilutive offerings have drawn sharp selloffs, while positive SPS and gMG data or financing tied to clinical progress have often coincided with strong upside moves.
Over the past few months, Kyverna has moved from anticipation of SPS data to confirming positive registrational KYSA‑8 results and then financing its late-stage plans. On Dec 15, 2025, SPS topline data and a webcast announcement aligned with a +23.23% reaction. Subsequent proposed and priced equity offerings in mid‑December funded operations through 2028 but produced contrasting moves, including a -32.52% drop on the final pricing. The latest JPM conference appearance on Jan 05, 2026 saw a modest pullback.
Market Pulse Summary
This announcement outlines Kyverna’s transition toward late-stage development and potential commercialization, with a planned SPS BLA in 1H 2026, first patient enrolled in a Phase 3 gMG trial, and estimated cash of $279 million extending runway into 2028. Investors may track progress on SPS launch readiness by year-end 2026, updated gMG data, KYV‑102 development, and additional autoimmune indications as key milestones.
Key Terms
stiff person syndrome medical
generalized myasthenia gravis medical
biologics license application (bla) regulatory
car t medical
car t-cell therapy medical
phase 3 medical
phase 2 medical
investigational new drug (ind) regulatory
AI-generated analysis. Not financial advice.
Advancing valuable commercial opportunity in stiff person syndrome (SPS) following landmark registrational data; Biologics License Application (BLA) submission anticipated in 1H 2026
First patient enrolled in registrational Phase 3 trial in generalized myasthenia gravis (gMG)
Completed follow-on offering extends cash runway into 2028, expected to fully fund SPS BLA filing, commercial launch, and Phase 3 gMG trial
Kyverna Board member, Christi Shaw, appointed as Executive Chairperson, further bolstering Company’s CAR T commercialization experience; Ian Clark, former Chairperson, to remain on Board
EMERYVILLE, Calif., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Kyverna, Nasdaq: KYTX), a clinical-stage biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, provided today a corporate update and outlined its strategic priorities for 2026.
“Our strong execution in 2025 solidifies our leadership position in autoimmune CAR T with unprecedented clinical trial results for miv-cel, positioning us to be first-to-market with a valuable commercial opportunity in stiff person syndrome, followed by myasthenia gravis,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “Looking ahead, we remain focused on preparing for our BLA filing with a clear regulatory path forward and the potential near-term launch in SPS, while executing on our Phase 3 gMG trial. These priorities are underpinned by our strong financial position, which will enable us to achieve key milestones across our late-stage programs.”
Mr. Biddle continued, “In addition, we are pleased to share that Christi Shaw has been appointed as the Executive Chairperson of our Board. An industry veteran with a proven track record in CAR T, Christi further strengthens our CAR T leadership team experience, and her appointment comes at an important time as we actively prepare our organization to be launch-ready by the end of this year.”
“I’m excited to step into this expanded role as Kyverna advances towards delivering the first potential commercial CAR T-cell therapy in autoimmune disease,” added Ms. Shaw. “Kyverna has made strong progress demonstrating miv-cel’s potential in stiff person syndrome and myasthenia gravis. I look forward to building on this momentum with Warner and the team to bring the transformative promise of CAR T-cell therapy to patients with neuroimmunology conditions.”
Recent Corporate Updates
- Initiated Phase 3 registrational trial in gMG: In December 2025, Kyverna enrolled its first patient in the Phase 3 portion of the FDA-aligned KYSA-6 clinical trial of miv-cel (mivocabtagene autoleucel, KYV-101) in gMG.
- Strengthened financial position with follow-on offering: In December 2025, the Company raised approximately
$105 million in gross proceeds from a public follow-on offering, extending expected cash runway into 2028. Estimated, preliminary, and unaudited cash, cash equivalents, and marketable securities as of December 31, 2025 were approximately$279 million . - Advanced KYV-102, Kyverna’s whole blood rapid manufacturing process: In January 2026, the Company’s Investigational New Drug (IND) application for KYV-102 was accepted by the U.S. FDA following the filing in December 2025.
- Independent Director Christi Shaw Appointed Executive Chairperson of the Board: Ian Clark, who served as Kyverna’s Board Chairman, will remain as a Director on the Board. Ms. Shaw brings significant CAR T-cell therapy experience, having served as the Chief Executive Officer of Kite, a Gilead Company. Under Christi’s leadership, Kite became the global leader in CAR T with multiple approved blood cancer indications in over 20 countries. In addition, Ms. Shaw brings deep immunology and neurology experience from her time at Eli Lilly and Company and Novartis Pharmaceutical Corporation.
2026 Strategic Priorities and Anticipated Milestones
- File BLA for miv-cel in SPS in 1H 2026: Following positive topline data from the KYSA-8 registrational trial in SPS, Kyverna intends to submit its first BLA to the FDA in the first half of 2026. In addition, the Company plans to report its full registrational data in 1H 2026.
- Achieve SPS launch readiness by year-end 2026: Kyverna will continue to build its commercialization infrastructure and execute on its launch-readiness strategy to enable efficient market entry and rapid adoption of miv-cel, the first potential FDA-approved therapy for SPS.
- Execute on Phase 3 gMG trial: Building on unprecedented interim Phase 2 data, Kyverna will continue to advance enrollment for the Phase 3 portion of the KYSA-6 clinical trial. In addition, the Company expects to report updated Phase 2 data from the gMG trial in 2026.
- Evaluate additional pipeline opportunities in a capital-efficient manner: In 2026, the Company expects to report Phase 2 investigator-initiated trial (IIT) data in rheumatoid arthritis, additional Phase 1 IIT data in multiple sclerosis, Phase 1 data in lupus nephritis and share the development strategy for KYV-102. Further, Kyverna will continue to explore miv-cel with no lymphodepletion (LD) or alternative LD regimen as well as outpatient administration.
Presentation at the J.P. Morgan Healthcare Conference
Kyverna will be presenting at the J.P. Morgan 2026 Healthcare Conference on Wednesday, January 14, 2025 at 9:45 am PT. A live webcast of the presentation will be available on the Investors section of Kyverna's website, www.kyvernatx.com. A replay of the webcast will be available on Kyverna's website for approximately 30 days following the conference.
About miv-cel (mivocabtagene autoleucel, KYV-101)
Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, which is under investigation for B-cell-driven autoimmune diseases. With a single administration, miv-cel has potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases.
About Kyverna Therapeutics
Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a clinical-stage biopharmaceutical company focused on liberating autoimmune patients through the curative potential of cell therapy. Kyverna’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its recently completed registrational trial in stiff person syndrome and an ongoing registrational trial for generalized myasthenia gravis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications. Additionally, its next generation pipeline includes CAR T-cell therapies deploying novel innovations to improve patient access and experience. For more information, please visit https://kyvernatx.com.
Forward-Looking Statements
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: Kyverna’s strategic priorities; opportunities related to miv-cel and SPS, including the potential to be first to market, the potential to be the first FDA approved therapy for SPS, the regulatory path forward and the potential near-term commercial opportunity and launch; Kyverna’s continued build out of its commercialization infrastructure and ability to execute on its launch-readiness strategy to enable efficient market entry and rapid adoption of miv-cel; anticipated timing of BLA submission for miv-cel in SPS; expected cash runway; Kyverna’s transition to a commercial stage company; the Phase 3 gmG trial, including enrollment and anticipated timing for reporting data; the anticipated timing for reporting data from Phase 2 IIT data in rheumatoid arthritis, additional Phase 1 IIT data in multiple sclerosis, and Phase 1 data in lupus nephritis; the anticipated timing for sharing the development strategy for KYV-102; Kyverna’s exploration of miv-cel with no LD or alternative LD regimen and outpatient administration; Kyverna’s expected future financial performance; and Kyverna’s presentation at the J.P. Morgan 2026 Healthcare Conference. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, the possibility that results from prior clinical trials, named-patient access activities and preclinical studies may not necessarily be predictive of future results; the possibility that the FDA or other regulatory agencies may require additional trials or studies to support its intended BLA submission; intellectual property rights; and other factors discussed in the “Risk Factors” section of Kyverna’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that Kyverna has filed or may subsequently file with the U.S. Securities and Exchange Commission. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Contact:
Investors: InvestorRelations@kyvernatx.com
Media: media@kyvernatx.com
FAQ
When will Kyverna (KYTX) file the BLA for miv‑cel in stiff person syndrome (SPS)?
How much cash did Kyverna (KYTX) report as of December 31, 2025 and how long is the runway?
What is the status of Kyverna’s Phase 3 trial in generalized myasthenia gravis (gMG)?
Did the FDA accept any Kyverna INDs recently for KYV‑102?
What was the size and purpose of Kyverna’s December 2025 follow‑on offering (KYTX)?
Who is the new Executive Chairperson of Kyverna’s board and why is it significant for KYTX investors?
