Kyverna Therapeutics Conference Call Summary Company Overview - **Company**: Kyverna Therapeutics (NasdaqGS:KYTX) - **Focus**: Development of CAR-T therapies for autoimmune diseases, specifically targeting stiff person syndrome (SPS) with their lead product MIVCEL (mevalcaptagene autolysel) Key Industry Insights - **Industry**: Autoimmune therapies, particularly CAR-T cell therapies - **Market Opportunity**: Significant unmet medical need in SPS with no FDA-approved therapies currently available Core Points and Arguments 1. **Top-Line Data from KYZA-8 Trial**: - The trial met primary and all secondary endpoints with high statistical significance, demonstrating MIVCEL's effectiveness in reversing disability in SPS patients after a single dose [4][12][25] - MIVCEL showed a 74% improvement in the Timed 25-Foot Walk test, with patients' times improving from an average of 17.3 seconds to 4.5 seconds [8][18] 2. **Regulatory Pathway**: - BLA submission to the FDA is on track for the first half of 2026, supported by the trial's results and designations such as RMAT and orphan drug status [4][13][25] 3. **Patient Population**: - The trial included 26 patients with a median age of 56, all of whom had previously inadequate responses to off-label immunotherapies [15][16] - 88% of patients were GAD65 positive, the most common autoantibody associated with SPS [16] 4. **Efficacy and Safety**: - MIVCEL demonstrated deep and broad B-cell depletion, with durable efficacy beyond 24 months in some patients [10][11][31] - The safety profile was well-tolerated, with no high-grade CRS or ICANS observed [21][22] 5. **Market Dynamics**: - Approximately 6,000 diagnosed patients in the U.S. with SPS, with 2,000 to 2,500 patients identified as having the highest unmet need [26][27] - The company aims to establish MIVCEL as the first FDA-approved therapy for SPS, targeting patients with inadequate responses to current treatments [27][29] 6. **Commercial Strategy**: - Focused commercialization strategy leveraging existing CAR-T ecosystem and targeting academic centers where patients are concentrated [29][30] - Plans to expand into broader indications, including myasthenia gravis, following the potential approval of MIVCEL [5][26] Additional Important Insights - **Patient Impact**: The psychological and physical burden of SPS is significant, with many patients experiencing severe mobility issues and requiring walking aids [9][10] - **Transformative Potential**: MIVCEL's ability to eliminate the need for chronic immunotherapies and improve quality of life is emphasized as a game changer for SPS patients [19][24] - **Future Directions**: Kyverna is also exploring other autoimmune diseases, with promising early data in multiple sclerosis and rheumatoid arthritis [31][54] Conclusion - Kyverna Therapeutics is positioned to potentially lead the CAR-T therapy market for autoimmune diseases, with MIVCEL showing promising results in treating stiff person syndrome and a clear path towards regulatory approval and commercialization.

NEW YORK, Dec. 15, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Skye Bioscience, Inc. (NASDAQ: SKYE). Shareholders who purchased shares of SKYE during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/skye-bioscience-inc-loss-submission-form/?id=180162&from=4  CLASS PERIOD: Novem ...

Core Insights - Anixa Biosciences has completed the transfer of the Investigational New Drug application for its breast cancer vaccine from Cleveland Clinic, becoming the trial sponsor for its future development [1][2] - The company plans to advance the vaccine into a Phase 2 clinical trial after completing enrollment and observing encouraging immune response and safety data in the Phase 1 trial [2][4] - The breast cancer vaccine targets -lactalbumin, a protein that re-emerges in many forms of breast cancer, potentially offering therapeutic and preventive benefits [3] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes an ovarian cancer immunotherapy program developed in collaboration with Moffitt Cancer Center [5] - The company’s vaccine portfolio includes vaccines for breast and ovarian cancer, developed in collaboration with Cleveland Clinic, and aims to address various cancers by immunizing against "retired" proteins expressed in certain cancer forms [5] - Anixa's business model involves partnering with renowned research institutions to explore emerging technologies for further development and commercialization [5]

VICTORIA, British Columbia--(BUSINESS WIRE)--MindWalk (NASDAQ: HYFT), a BioNative AI biotherapeutic research and technology company combining in silico and wet lab operations for biologics discovery and development, today announced financial results for the second quarter of fiscal 2026 and provided updates on its AI driven asset pipeline and strategic initiatives. MindWalk operates a proprietary BioNative AI platform built on patented HYFT patterns—evolution shaped subsequence codes that link sequence, str ...

Adaptive Biotechnologies said on Monday it has signed two non-exclusive deals with Pfizer to support research in rheumatoid arthritis and other immune-related diseases. ...

Core Insights - Dren Bio has entered into a strategic collaboration with Sanofi to develop therapies for autoimmune diseases, with a deal valued at up to $1.7 billion [1] Company Summary - Dren Bio is a private biotech company focused on developing therapies for autoimmune diseases [1] - Sanofi is a global healthcare leader collaborating with Dren Bio for the development of these therapies [1] Financial Summary - The collaboration deal is worth up to $1.7 billion, indicating significant financial commitment from both companies [1]

WALTHAM, Mass.--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of Gibcoâ"¢ Bactoâ"¢ CD Supreme FPM Plus and Gibcoâ"¢ Bactoâ"¢ CD Supreme Feed (2X), two next-generation chemically-defined formulations that expand the Gibcoâ"¢ Bactoâ"¢ CD portfolio to enhance and simplify plasmid DNA and recombinant protein production using Escherichia coli (E. coli). As demand for plasmid DNA continues to surge to support expanding gene therapy and mRNA vaccin. ...

Silence Therapeutics is a global clinical-stage biotechnology company committed to transforming people's lives by silencing diseases through precision engineered medicines created with proprietary siRNA (short interfering RNA) technology. Silence leverages its mRNAi GOLDâ"¢ platform to create innovative siRNAs designed to precisely target and silence disease-associated genes in the liver, which represents a substantial opportunity. Silence focuses on areas of high unmet medical need with programs advancing ...

U.S. stock futures were higher this morning, with the Dow futures gaining around 200 points on Monday.Shares of argenx SE – ADR (NASDAQ:ARGX) fell sharply in pre-market trading after the company discontinued its Phase 3 UplighTED studies of efgartigimod SC in thyroid eye disease following a futility review.argenx shares dipped 6% to $825.00 in pre-market trading.Here are some other stocks moving lower in pre-market trading.TryHard Holdings Ltd (NASDAQ:THH) shares tumbled 15.2% to $13.16 in pre-market tradin ...

HOUSTON, Dec. 15, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics” or the “Company”), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced it has entered into definitive agreements for the issuance and sale of an aggregate of 5,227,275 shares of its common stock at an offering price of $0.33 per share ...