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Kyverna shares phase 1 data on miv-cel for progressive MS

Fri, 23 Oct 2026 10:30:34 -0400

Kyverna Therapeutics (Nasdaq: KYTX) presented updated data from a Phase 1 investigator-initiated trial of miv-cel (mivocabtagene autoleucel) in patients with progressive multiple sclerosis at the MS Toronto 2026 joint ACTRIMS-ECTRIMS meeting.

The trial, conducted at Stanford University, enrolled six patients with non-relapsing progressive multiple sclerosis — either secondary progressive or primary progressive — who received a single dose of miv-cel at either 33 million or 100 million CAR T-cell dose levels using a bendamustine lymphodepleting regimen.

Efficacy data were available for five patients. All five showed stable to improved expanded disability status scale scores at last follow-up, with four of five sustaining

Kyverna shares phase 1 data on miv-cel for progressive MS

Fri, 23 Oct 2026 10:30:34 -0400

Efficacy data were available for five patients. All five showed stable to improved expanded disability status scale scores at last follow-up, with four of five sustaining

Kyverna Therapeutics Highlights Promising Updated Clinical Data with Miv-cel in Progressive Multiple Sclerosis at MS Toronto 2026

Fri, 23 Oct 2026 10:30:00 -0400

Single-dose miv-cel continues to demonstrate promising clinical benefit in progressive multiple sclerosis, achieving robust CAR T-cell penetration in the central nervous system (CNS) and improving disability scores while removing the need for chronic immunotherapies

Durable results extending beyond two years in the first patient treated

Consistent, well-tolerated safety profile with no high-grade CRS and no cases of ICANS or IEC-HS

RMAT designation granted in treatment of non-active secondary progressive multiple sclerosis (naSPMS); update on development strategy expected by early 2027

EMERYVILLE, Calif., Oct. 23, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics,

Kyverna Therapeutics Highlights Promising Updated Clinical Data with Miv-cel in Progressive Multiple Sclerosis at MS Toronto 2026

Fri, 23 Oct 2026 10:30:00 -0400

Durable results extending beyond two years in the first patient treated

Consistent, well-tolerated safety profile with no high-grade CRS and no cases of ICANS or IEC-HS

RMAT designation granted in treatment of non-active secondary progressive multiple sclerosis (naSPMS); update on development strategy expected by early 2027

EMERYVILLE, Calif., Oct. 23, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics,

H.C. Wainwright Reiterates Buy Rating on Kyverna Therapeutics Inc (KYTX)

Thu, 22 Oct 2026 08:09:47 -0400

H.C. Wainwright analyst Mitchell S. Kapoor reiterated a Buy rating and $25.00 price target on Kyverna Therapeutics Inc (NASDAQ: KYTX).

The analyst commented: "Full year KYSA-8 data strengthens rolling SPS BLA with additional functional and quality-of-life evidence. On October 21, Kyverna Therapeutics released the full one-year dataset from KYSA-8, its single-arm registrational Phase 2 trial of miv-cel (mivocabtagene autoleucel) in 26 adults with stiff person syndrome (SPS) who had an inadequate response to at least one prior immunotherapy. The release preceded a scheduled 4:30-6:30 PM ET poster presentation at MS Toronto 2026, the joint ACTRIMS-ECTRIMS meeting. September’s topline carried the walking-speed,

Kyverna's miv-cel shows one-year durability in stiff person syndrome

Wed, 21 Oct 2026 07:15:58 -0400

Kyverna Therapeutics (Nasdaq: KYTX) presented one-year data from KYSA-8, its registrational Phase 2 trial of miv-cel (mivocabtagene autoleucel) in stiff person syndrome (SPS), at the MS Toronto 2026 joint ACTRIMS-ECTRIMS meeting on October 21, 2026.

The trial enrolled 26 adult SPS patients who had an inadequate response to at least one prior immunotherapy. All patients received a single dose of miv-cel. The primary endpoint measured change from baseline in the timed 25-Foot Walk (T25FW) at 16 weeks.

At one year, median improvement in T25FW from baseline was 49%, compared with 46% at the 16-week primary endpoint, with statistical significance reported at p

Kyverna's miv-cel shows one-year durability in stiff person syndrome

Wed, 21 Oct 2026 07:15:58 -0400

At one year, median improvement in T25FW from baseline was 49%, compared with 46% at the 16-week primary endpoint, with statistical significance reported at p

Kyverna Therapeutics Presents Full One-Year Registrational Data Set Demonstrating Sustained Clinical Benefit of Miv-cel in Stiff Person Syndrome at MS Toronto

Wed, 21 Oct 2026 07:15:00 -0400

Miv-cel reversed disability and achieved durable efficacy across all primary and secondary endpoints through one year, with nearly all patients remaining off chronic immunotherapies

Deep B-cell depletion demonstrated with a single dose supports the potential for broad immune reset enabled by miv-cel's unique construct

Consistent, well-tolerated safety profile with no high-grade CRS or ICANS, and no cases of IEC-HS in one-year follow-up

Data further strengthens SPS BLA package and supports potential for miv-cel to be the first approved therapy in SPS and first approved CAR T-cell therapy for autoimmune diseases

EMERYVILLE, Calif.,

Kyverna Therapeutics Presents Full One-Year Registrational Data Set Demonstrating Sustained Clinical Benefit of Miv-cel in Stiff Person Syndrome at MS Toronto

Wed, 21 Oct 2026 07:15:00 -0400

Miv-cel reversed disability and achieved durable efficacy across all primary and secondary endpoints through one year, with nearly all patients remaining off chronic immunotherapies

Deep B-cell depletion demonstrated with a single dose supports the potential for broad immune reset enabled by miv-cel's unique construct

Consistent, well-tolerated safety profile with no high-grade CRS or ICANS, and no cases of IEC-HS in one-year follow-up

Data further strengthens SPS BLA package and supports potential for miv-cel to be the first approved therapy in SPS and first approved CAR T-cell therapy for autoimmune diseases

EMERYVILLE, Calif.,

Form SCHEDULE 13G Kyverna Therapeutics, Filed by: HIRSCHMAN ORIN

Mon, 19 Oct 2026 14:29:00 -0400

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Kyverna Therapeutics to Present Positive Data in Stiff Person Syndrome and Progressive Multiple Sclerosis at MSToronto2026

Wed, 07 Oct 2026 08:00:00 -0400

Full one-year results from the KYSA-8 registrational trial in stiff person syndrome to be reported, demonstrating sustained clinical benefit and a well-tolerated safety profile with no high-grade CRS or ICANS and no cases of IEC-HS

Updated Phase 1 investigator-initiated trial data to be presented, continuing to highlight encouraging clinical activity and a well-tolerated safety profile in progressive multiple sclerosis

EMERYVILLE, Calif., Oct. 07, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical immunology company pioneering transformative therapies for people with neurologic autoimmune diseases, today announced two abstracts selected for presentation

Kyverna Therapeutics to Present Positive Data in Stiff Person Syndrome and Progressive Multiple Sclerosis at MSToronto2026

Wed, 07 Oct 2026 08:00:00 -0400

Updated Phase 1 investigator-initiated trial data to be presented, continuing to highlight encouraging clinical activity and a well-tolerated safety profile in progressive multiple sclerosis

H.C. Wainwright Reiterates Buy Rating on Kyverna Therapeutics Inc (KYTX)

Fri, 25 Sep 2026 06:48:01 -0400

H.C. Wainwright analyst Mitchell S. Kapoor reiterated a Buy rating and $25.00 price target on Kyverna Therapeutics Inc (NASDAQ: KYTX).

The analyst commented: "Kyverna reported that all 26 KYSA-8 patients reached one-year follow-up, with a 49% median T25FW improvement from baseline vs. 46% at Week 16; 95% of the 81% who initially achieved a ≥20% improvement retained that benefit, eight of 12 baseline walking-aid users remained unassisted, and 24/26 patients remained off protocol-defined stiff-person syndrome (SPS) immunotherapies. We believe the dataset answers the durability question that had been the principal clinical variable ahead of rolling Biologics License Application (BLA) completion, yet

Kyverna stock jumps on positive one-year therapy data

Thu, 24 Sep 2026 09:43:31 -0400

Investing.com -- Kyverna Therapeutics Inc (NASDAQ:KYTX) shares rose nearly 10% in early trade Thursday following the release of positive one-year durability data for its miv-cel therapy in stiff person syndrome and generalized myasthenia gravis.

The company reported that sustained clinical benefit and reversal of disability through one year support the potential for miv-cel to be the first approved therapy in SPS and first approved CAR T-cell therapy for autoimmune disease. The rolling BLA submission remains on track for completion in the fourth quarter of 2026.

In the KYSA-8 SPS registrational trial, 12-month follow-up data

Kyverna stock jumps on positive one-year therapy data

Thu, 24 Sep 2026 09:43:31 -0400

In the KYSA-8 SPS registrational trial, 12-month follow-up data

Form 8-K Kyverna Therapeutics, For: Sep 24

Thu, 24 Sep 2026 06:02:00 -0400

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Kyverna reports one-year durability data for miv-cel in SPS and gMG

Thu, 24 Sep 2026 06:01:54 -0400

Kyverna Therapeutics (Nasdaq: KYTX) released one-year topline data from its KYSA-8 registrational trial of miv-cel (mivocabtagene autoleucel) in stiff person syndrome (SPS) and longer-term follow-up data from the Phase 2 portion of its KYSA-6 trial in generalized myasthenia gravis (gMG), according to a company statement.

In the KYSA-8 trial, 26 adult SPS patients received a single dose of miv-cel. As of a database lock in July 2026, the timed 25-foot walk showed a median improvement from baseline of 49% at month 12, compared with 46% at week 16. Of 12 patients who required a walking aid prior to treatment, 67% continued

Kyverna reports one-year durability data for miv-cel in SPS and gMG

Thu, 24 Sep 2026 06:01:54 -0400

Kyverna reports one-year durability data for miv-cel in SPS and gMG

Thu, 24 Sep 2026 06:01:54 -0400

Kyverna Therapeutics Reports Positive One-Year Data Demonstrating Durable Clinical Responses and Favorable Safety Profile for Miv-cel in Stiff Person Syndrome and Generalized Myasthenia Gravis

Thu, 24 Sep 2026 06:00:00 -0400

Topline durability data reinforce potential for single-dose miv-cel to free patients from life-long disease burden and chronic immunotherapies, further highlighting miv-cel’s differentiated construct

Sustained clinical benefit and reversal of disability through one year support the potential to be the first approved therapy in SPS and first approved CAR T-cell therapy for autoimmune disease; rolling BLA submission on track for completion in Q4 2026

Longer-term Phase 2 follow-up in gMG demonstrate robust and durable effects sustained for up to 1.5 years, with majority of patients maintaining MSE;
Phase 3 enrollment expected to be completed

Kyverna Therapeutics Reports Positive One-Year Data Demonstrating Durable Clinical Responses and Favorable Safety Profile for Miv-cel in Stiff Person Syndrome and Generalized Myasthenia Gravis

Thu, 24 Sep 2026 06:00:00 -0400

Topline durability data reinforce potential for single-dose miv-cel to free patients from life-long disease burden and chronic immunotherapies, further highlighting miv-cel’s differentiated construct

Sustained clinical benefit and reversal of disability through one year support the potential to be the first approved therapy in SPS and first approved CAR T-cell therapy for autoimmune disease; rolling BLA submission on track for completion in Q4 2026

Longer-term Phase 2 follow-up in gMG demonstrate robust and durable effects sustained for up to 1.5 years, with majority of patients maintaining MSE;
Phase 3 enrollment expected to be completed

Kyverna Therapeutics to Present at Upcoming Investor Conferences

Wed, 02 Sep 2026 16:05:00 -0400

EMERYVILLE, Calif., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical immunology company pioneering transformative therapies for people with neurologic autoimmune diseases, today announced that company management will present at the following upcoming conferences:

2026 Wells Fargo Healthcare Conference
Format: Fireside chat and investor meetings
Date: Wednesday, September 9^th, 2026
Time: 4:30 p.m. ET

Morgan Stanley 24^th Annual Global Healthcare Conference
Format: Fireside chat and investor meetings
Date: Monday, September 14^th, 2026
Time: 4:05 p.m. ET

H.C. Wainwright 28^th Annual Global Investment Conference
Format: Fireside chat and investor meetings
Date:

Kyverna Therapeutics to Present at Upcoming Investor Conferences

Wed, 02 Sep 2026 16:05:00 -0400

EMERYVILLE, Calif., Sept. 02, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical immunology company pioneering transformative therapies for people with neurologic autoimmune diseases, today announced that company management will present at the following upcoming conferences:

2026 Wells Fargo Healthcare Conference
Format: Fireside chat and investor meetings
Date: Wednesday, September 9^th, 2026
Time: 4:30 p.m. ET

Morgan Stanley 24^th Annual Global Healthcare Conference
Format: Fireside chat and investor meetings
Date: Monday, September 14^th, 2026
Time: 4:05 p.m. ET

H.C. Wainwright 28^th Annual Global Investment Conference
Format: Fireside chat and investor meetings
Date:

Form SCHEDULE 13G/A Kyverna Therapeutics, Filed by: Bain Capital Life Sciences Opportunities III, LP

Fri, 14 Aug 2026 07:00:00 -0400
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Form SCHEDULE 13G/A Kyverna Therapeutics, Filed by: Bain Capital Life Sciences Opportunities III, LP

Fri, 14 Aug 2026 07:00:00 -0400
si-local-file:///var/storage/secattach/20260814/26924416.html