Kyverna Therapeutics, Inc.
KYTX evidence brief
What we can confirm
- BioSniper Score:
- 7.1 / 10
- Market Cap:
- $454.5M
- Lead Asset:
- kyv-101 (Phase 2/Phase 3)
What it means
What to watch
Prepared research question
What matters most for KYTX—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · KYTX
Kyverna Therapeutics is a late-stage clinical biopharmaceutical company developing autologous anti-CD19 CAR T-cell therapies for autoimmune diseases, with its lead candidate miv-cel (KYV-101) targeting stiff person syndrome and generalized myasthenia gravis [sec_mda · as of 2026-08-11].
Key risk: No revenue until approval
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 6 clinical trials for Kyverna Therapeutics, Inc..
Kyverna Therapeutics is a late-stage clinical biopharmaceutical company developing autologous anti-CD19 CAR T-cell therapies for autoimmune diseases, with its lead candidate miv-cel (KYV-101) targeting stiff person syndrome and generalized myasthenia gravis [sec_mda · as of 2026-08-11].
- Cash and equivalents were $31.8M as of 2026-06-30 [sec].
- Net loss was -$38.3M for the period ended 2026-06-30 [sec].
- Shareholders' equity was $165.5M as of 2026-06-30 [sec].
- FDA granted RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis (naSPMS) as of 2026-08-11 [news · published 2026-08-11].
- Rolling BLA submission for miv-cel in stiff person syndrome (SPS) is on track for Q4 2026 [news · published 2026-08-11].
What works
- Lead candidate miv-cel has received FDA RMAT designation in naSPMS, ODD in SPS and MG, and Fast Track Designation, indicating regulatory support [sec_mda · as of 2026-08-11].
- The company reported transformative registrational data in SPS, a rare disease with no approved therapies, showing potential to improve mobility with a single dose [sec · filed 2026-04-13].
- A clinical and commercial supply agreement with ElevateBio BaseCamp was signed in July 2026 to support U.S. commercial and global clinical supply of miv-cel [sec_mda · as of 2026-08-11].
What to weigh
- The company expects to continue incurring substantial losses for the foreseeable future and may never achieve profitability [sec_mda · as of 2026-08-11].
- Kyverna does not expect to generate any revenue from commercial product sales unless and until it obtains regulatory approval for one or more product candidates [sec_mda · as of 2026-08-11].
- If adequate funding is not available when needed, the company could be forced to delay, scale back, or abandon development programs [sec_mda · as of 2026-08-11].
From the filings
Quoted directly from source documents.
FDA RMAT designation for miv-cel in naSPMS
“FDA grants RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis (naSPMS)”
News · August 11, 2026
BLA submission for miv-cel in SPS on track for Q4 2026
“On track to complete rolling BLA submission for miv-cel in stiff person syndrome (SPS) in Q4 2026”
News · August 11, 2026
Catalyst timeline
- 2022-12-01 · Phase2_Start: KYSA-3 — Phase 1/2 study of KYV-101 in refractory lupus nephritis initiated.
- 2023-04-28 · Phase2_Start: KYSA-1 — Phase 1/2 study of KYV-101 in refractory lupus nephritis initiated.
- 2024-08-06 · Phase2_Start: KYSA-5 — Phase 1/2 study of KYV-101 in systemic sclerosis initiated.
- 2024-08-28 · Phase3_Start: KYSA-6 — Phase 2/3 study of KYV-101 in generalized myasthenia gravis initiated.
Risks & what to watch (3)›
Key risks
- No revenue until approval — Kyverna expects no commercial revenue until regulatory approval of a product candidate [sec_mda · as of 2026-08-11].
- Continued net losses — The company expects substantial losses for the foreseeable future and may never become profitable [sec_mda · as of 2026-08-11].
- Funding dependency — If adequate funding is unavailable, development programs may be delayed or abandoned [sec_mda · as of 2026-08-11].
What to watch
- Completion of rolling BLA submission for miv-cel in SPS in Q4 2026 [news · published 2026-08-11].
- KYSA-8 12-month topline data expected in Q3 2026 [news · published 2026-08-11].
- Enrollment completion in KYSA-6 Phase 3 trial in gMG expected in mid-2027 [news · published 2026-08-11].
- Update on PMS development strategy expected by early 2027 [sec_mda · as of 2026-08-11].
Sources: Catalysts · News · SEC filings · SEC MD&A · Generated October 9, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.33 · 0% dilution
Lead: Phase 2/Phase 3
1 candidate
No upcoming catalysts tracked
No insider transactions in the last 180 days
Pipeline
Regulatory
Financials
Short Interest
as of Apr 20, 2026- % of float
- 8.2%
- Days to cover
- 6.2
- Shares short
- 4,212,602
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
KYTX short interestGovernance
Frequently asked questions
What is the AI investment thesis for Kyverna Therapeutics, Inc.?
Kyverna Therapeutics is a late-stage clinical biopharmaceutical company developing autologous anti-CD19 CAR T-cell therapies for autoimmune diseases, with its lead candidate miv-cel (KYV-101) targeting stiff person syndrome and generalized myasthenia gravis [sec_mda · as of 2026-08-11].
What is Kyverna Therapeutics, Inc.'s lead drug candidate?
Kyverna Therapeutics, Inc.'s most advanced tracked candidate is kyv-101 (Phase 2/Phase 3) for Refractory Lupus Nephritis; Myasthenia Gravis; Systemic Sclerosis.
Who is the CEO of Kyverna Therapeutics, Inc.?
Mr. Warner Biddle is the chief executive officer of Kyverna Therapeutics, Inc. (KYTX).
Where is Kyverna Therapeutics, Inc. headquartered?
Kyverna Therapeutics, Inc. (KYTX) is headquartered in EmeryVille, CA, United States.
What therapeutic areas does Kyverna Therapeutics, Inc. focus on?
Kyverna Therapeutics, Inc. develops therapies across Gene Therapy, Neurology, Immunology, Dermatology, Nephrology, Musculoskeletal.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.