Kyverna Therapeutics, Inc. KYTX

Chief executive Warner Biddle said the therapy’s durability “exceeded even our expectations.”

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.

Kyverna Therapeutics (NASDAQ:KYTX) reported one-year topline data from its KYSA-8 registrational trial of miv-cel, or mivocabtagene autoleucel, in stiff person syndrome (SPS), alongside longer-term follow-up results from the Phase 2 portion of its KYSA-6 trial in generalized myasthenia gravis (gMG). The company said the latest results provide follow-up on clinical outcomes and safety measures after patients received a single dose of the investigational cell therapy.

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 demonstrat

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 ConferenceFormat: Fireside chat and investor meetingsDate: Wednesday, September 9th, 2026Time: 4:30 p.m. ET Morgan Stanley 24th Annual Global Healthcare Conf

Wall Street analysts believe that a more cautious approach to manufacturing, study enrollment and side effect management could help developers avoid future safety hazards.

FDA grants RMAT designation for miv-cel in non-active secondary progressive multiple sclerosis (naSPMS) based on compelling clinical data, further expanding the therapy’s potential across neuroimmunology On track to complete rolling BLA submission for miv-cel in stiff person syndrome (SPS) in Q4 2026; KYSA-8 12-month topline data expected in Q3 2026 Enrollment in KYSA-6 Phase 3 trial in generalized myasthenia gravis (gMG) expected to be completed in mid-2027; longer-term follow-up Phase 2 toplin

New agreement secures flexible and scalable manufacturing to support the U.S. commercial and global clinical supply of miv-celEMERYVILLE, Calif., and WALTHAM, Mass., July 27, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company developing cell therapies for patients with autoimmune diseases, and ElevateBio, a technology-driven advanced therapy contract development and manufacturing organization (CDMO), today announced a manufacturing

A single analyst note sent Kyverna Therapeutics tumbling despite a clinical milestone that had investors cheering just weeks ago, and the question now is whether the selloff marks a buying opportunity or the start of a painful unwind.

Jacob Funds, a mutual fund company, released its first-quarter 2026 investor letter. A copy of the letter can be downloaded here. The recent quarter began against the backdrop of the war in the Middle East and concerns about AI disruption in the tech space. However, these concerns eased, leading investors to focus more on AI winners […]

EMERYVILLE, Calif., June 22, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company developing cell therapies for patients with autoimmune diseases, today announced the appointment of Ritesh Srivastava as Chief Legal and Compliance Officer, effective June 22, 2026. Mr. Srivastava brings extensive experience spanning legal, corporate strategy, compliance, and risk management, which will further support Kyverna as it advances miv-cel (mi

Majority of patients met the American College of Rheumatology improvement criteria (ACR70) response by Week 36 Single-dose of miv-cel delivered deep B-cell depletion with evidence of immune reset Miv-cel continues to demonstrate a well-tolerated safety profile, consistent with observations from over 100 patients treated to date1 Data reinforce miv-cel’s differentiated clinical profile and opportunity to change the treatment paradigm across a variety of autoimmune diseases EMERYVILLE, Calif., Jun

Veteran biopharma leader joins to help lead Kyverna’s next phase of commercial growthEMERYVILLE, Calif., May 18, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company developing cell therapies for patients with autoimmune diseases, today announced the appointment of Greg Martini as Chief Financial Officer (CFO), effective May 18, 2026. Mr. Martini succeeds Dr. Marc Grasso who will be consulting for the Company to ensure a seamless tra

KYV-101 presents key market opportunities in autoimmune diseases like SPS and gMG through regulatory advancements, promising clinical efficacy, and unmet needs for novel therapies. It offers potential as a disruptor with first-to-market status in rare indications, supported by strong strategic positioning and development capabilities.Dublin, May 15, 2026 (GLOBE NEWSWIRE) -- The "KYV-101 Sales Forecast and Market Size Analysis - 2034" has been added to ResearchAndMarkets.com's offering. The KYV-1

Assertio’s latest offer represents a roughly 31% premium over an initial acquisition proposal. Elsewhere, Kyverna is readying a first-of-its-kind approval application and AC Immune is swapping CEOs.