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Kyverna’s KYV-101 Receives U.S. FDA RMAT Designation for KYV-101 in the Treatment of Patients With Refractory Stiff-Person Syndrome

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2 years ago

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The application was evaluated based on the positive clinical outcomes of KYV-101 in patients treated in Germany under a named-patient treatment option

The Regenerative Medicine Advanced Therapies designation will allow Kyverna to receive expert guidance on efficient drug development and use of surrogate endpoints from senior FDA officials

EMERYVILLE, Calif., July 15, 2024 /PRNewswire/ — Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announced today the designation as Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of patients suffering from refractory stiff-person syndrome. 

“Stiff-person syndrome has devastating and life-altering effects on patients suffering from this rare autoimmune disease,” said Amanda Piquet, M.D., director of the Autoimmune Neurology Program at CU Anschutz Medical Campus, Aurora, CO. “I look forward to the data that will emerge from the KYSA-8 trial as this trial could drastically change the treatment landscape for SPS.”

“We are eager to begin generating data from our sponsored trial to advance the knowledge on a potential immunological reset of the patient’s immune system,” said Peter Maag, Ph.D., chief executive officer at Kyverna. “We are humbled by the resilience of the SPS patients and their hope for a potential paradigm-shifting treatment option that could provide durable, immunosuppressant-free remission.”

About Stiff Person Syndrome (SPS) 
SPS is a rare, progressive neurological autoimmune disorder causing debilitating muscle stiffness in the torso, arms, and legs, impacting the ability to walk or move. Patients typically present with muscle spasms and stiffness, resulting in difficulty turning and bending. When stiffness is severe, the patients’ posture resembles a statue. Muscle spasms and stiffness can be precipitated by unexpected stimuli, including sounds, like a phone ring or a siren, sudden touches or conditions triggering anxiety and emotional upset which, when severe, are misdiagnosed as a primary anxiety disorder1. 

About KYV-101
KYV-101 is an autologous, fully human CD19 CAR T-cell product candidate for use in B cell-driven autoimmune diseases. The CAR in KYV-101 was designed by the National Institutes of Health (NIH) to improve tolerability and tested in a 20-patient Phase 1 trial in oncology. Results were published by the NIH in Nature Medicine2.

KYV-101 is currently being evaluated in sponsored, open-label, Phase 1/2 and Phase 2 trials of KYV-101 in the United States and Germany across two broad areas of autoimmune disease: rheumatology and neurology.

With 50 patients treated so far with the CAR in KYV-101 in both oncological and autoimmune conditions at more than 15 locations in Europe and the U.S., we believe that the differentiated properties of KYV-101 are critical for the potential success of CAR T cells as autoimmune disease therapies.

KYV-101 is also being evaluated in investigator-initiated trials for multiple indications in multiple geographies.

About Kyverna Therapeutics
Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. 

Our lead CAR T-cell therapy candidate, KYV-101 is advancing through clinical development with sponsored clinical trials across two broad areas of autoimmune disease: rheumatology and neurology, including Phase 2 trials for stiff person syndrome, multiple sclerosis and myasthenia gravis, a Phase 1/2 trial for systemic sclerosis, and two ongoing multi-center, open-label Phase 1/2 trials in the United States and Germany for patients with lupus nephritis. 

Kyverna’s pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats with properties intended to be well suited for use in B cell-driven autoimmune diseases.

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: the potential impact of named-patient case studies; Kyverna’s goals to develop certain paradigm-shifting treatment options; Kyverna’s beliefs about the differentiated properties of KYV-101; and Kyverna’s clinical trials. 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, 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. 

For more information, please visit https://kyvernatx.com. 

Investor Contact:
George Thampy
Kyverna Therapeutics
InvestorRelations@kyvernatx.com 

Kyverna Media Contact:
Consort Partners for Kyverna
kyvernatx@consortpartners.com 

1 Dalakas, M.C., Neurotherapeutics 2022; 19, 832–847.
2 Brudno et al., Nature Medicine 2020; 26:270-280. 

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SOURCE Kyverna Therapeutics

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ZKH Group Limited to Announce First Quarter 2026 Financial Results on Thursday, May 21, 2026

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May 7, 2026

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SHANGHAI, May 7, 2026 /PRNewswire/ — ZKH Group Limited (“ZKH” or the “Company”) (NYSE: ZKH), a leading maintenance, repair and operations (“MRO”) procurement service platform in China, today announced that it will release its unaudited financial results for the first quarter 2026, on Thursday, May 21, 2026, before the open of the U.S. markets.

The Company’s management will hold an earnings conference call on Thursday, May 21, 2026 at 7:00 A.M. U.S. Eastern Time (7:00 P.M. Beijing/Hong Kong Time) to discuss the financial results. Listeners may access the call by dialing the following numbers:

United States (toll free):

+1-888-317-6003

International:

+1-412-317-6061

Mainland China (toll free):

400-120-6115

Hong Kong (toll free):

800-963-976

Hong Kong:

+852-5808-1995

Access Code:

2335796

A replay of the conference call will be accessible by phone one hour after the conclusion of the live call at the following numbers, until May 28, 2026:

United States:

+1-855-669-9658

International:

+1-412-317-0088

Replay Access Code:

6840038

A live and archived webcast of the conference call will also be available on the Company’s investor relations website at https://ir.zkh.com.

About ZKH Group Limited

ZKH Group Limited (NYSE: ZKH) is a leading MRO procurement service platform in China, underpinned by robust supply chain capabilities and dedicated to serving customers globally through a product-led, agentic AI-driven approach. Through its primary online platforms, the ZKH platform, the GBB platform and the Northsky platform, along with innovative technology and extensive industry expertise, the Company provides bespoke MRO procurement solutions to a diverse and loyal customer base. These solutions encompass hyper-personalized product curation from a comprehensive selection of quality products at competitive prices. Additionally, the Company ensures timely and reliable product delivery through professional fulfillment services. By focusing on reducing procurement costs and addressing management efficiency challenges, ZKH is transforming the opaque MRO procurement process and empowering all stakeholders across the value chain.

For more information, please visit: https://ir.zkh.com.

For investor and media inquiries, please contact:

ZKH Group Limited
IR Department
E-mail: IR@zkh.com

Christensen Advisory
Email: zkh@christensencomms.com

View original content:https://www.prnewswire.com/news-releases/zkh-group-limited-to-announce-first-quarter-2026-financial-results-on-thursday-may-21-2026-302765384.html

SOURCE ZKH Group Limited

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Goldman Sachs, J.P. Morgan, TD Securities, Morgan Stanley, and Bank of America Join LTX in Bid to Unlock Greater Liquidity in Corporate Bonds

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12 minutes ago

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May 7, 2026

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Broadridge-backed LTX to add Representatives from J.P. Morgan and TD Securities to its Board of Directors

NEW YORK, May 7, 2026 /PRNewswire/ — LTX, an AI-powered corporate bond e-trading venue backed by global Fintech leader, Broadridge Financial Solutions, Inc. (NYSE:BR), today announced that Goldman Sachs, J.P. Morgan, TD Securities (through its subsidiary, TD Financial Products LLC), Morgan Stanley, and Bank of America have joined LTX as fully integrated liquidity providers. This major milestone underscores the participants’ commitment to serving buy-side clients by delivering increased choice and improving liquidity in fixed income markets. J.P. Morgan and TD Securities will each appoint a representative to LTX’s Board of Directors.

The AI-powered LTX corporate bond e-trading platform offers investors access to a suite of innovative trading tools including the award-winning BondGPTSM solution. These leading dealers will provide investment grade and high yield bond liquidity on the platform, joining 40+ liquidity providers and 100+ buy-side investors already on LTX.

Patrick Whelan, Global Head of FICC Digital Markets at JP Morgan, said, “In a competitive market, we’re committed to supporting new entrants and fostering greater competition in the US credit multi-dealer platform landscape. Our collaboration with LTX leverages innovative technology to broaden investor access, enhance liquidity, and streamline execution—empowering clients with more choice and driving industry advancement.”

“We’ve been impressed by LTX’s commitment to deliver innovative execution and artificial intelligence solutions to both sell-side and buy-side participants,” said Marty Mannion, Co-Head of TD Financial Products.  “We are excited to enter into this strategic partnership and accelerate these efforts to drive greater efficiencies in the corporate bond market.”

“We are excited to welcome these five leading dealers as fully integrated liquidity providers and look forward to working with them to drive increased liquidity and execution in the fixed income marketplace,” said Chris Perry, President of Broadridge. “Broadridge’s commitment to helping our clients innovate and grow through cost effective technology solutions is further reinforced by the inclusion of these premier institutions. I’m also excited to welcome J.P. Morgan and TD Bank to the Board of LTX.”

“We’re thrilled to be working with Goldman Sachs, J.P. Morgan, TD Securities, Morgan Stanley, and Bank of America as liquidity providers on LTX,” said Jim Kwiatkowski, CEO of LTX. “The combination of LTX’s innovative trading tools and AI-powered workflows with the deep liquidity and market expertise of these leading institutions positions us to help transform corporate bond trading. Together, we are unlocking liquidity, optimizing efficiency, and helping drive down trading costs for the market. It’s an exciting time for LTX, for our growing list of buyside clients, and for the future of corporate bond trading.”

Backed by Broadridge, LTX was created to address corporate bond market challenges that have slowed the growth in adoption of electronic trading compared to other markets by offering certain benefits. These include facilitating essential dealer-client relationships, lower trading and data costs, and better e-trading options for large sized trades. Partnering with some of the leading market participants, LTX is uniquely positioned to address these industry pain points by using patented AI and execution protocols to deliver improved liquidity at a lower cost, while facilitating relationships between dealers and buy-side clients through direct, fully disclosed trading. The addition of these liquidity providers underscores LTX’s position as a dynamic marketplace for buy- and sell-side corporate bond market participants.

LTX’s latest  innovation, BondGPT Intelligence, brings GenAI-powered insights directly into investing and trading workflows, anticipating traders’ needs and helping them identify opportunities and execute trades more efficiently. Using patented technology for the methods and systems behind BondGPT including the large language model (LLM) orchestration of machine learning agents, these milestones build on LTX’s legacy of harnessing innovation to further electronify the corporate bond market and reinforce Broadridge’s commitment to advancing intelligent trading solutions.

About LTX
LTX is an electronic trading platform that enables corporate bond market participants to trade smarter, combining powerful, patented artificial intelligence with innovative e-trading protocols to improve liquidity, efficiency, and execution. The Liquidity Cloud is LTX’s secure network of actionable disclosed sell-side axes and anonymous buy-side indications of interest (IOIs). LTX leverages Broadridge Business Process Outsourcing, LLC as its broker dealer.

For more information about LTX, please visit www.ltxtrading.com.

About Broadridge
Broadridge Financial Solutions (NYSE: BR) is a global technology leader with trusted expertise and transformative technology, helping clients and the financial services industry operate, innovate, and grow. We power investing, governance, and communications for our clients – driving operational resiliency, elevating business performance, and transforming investor experiences.

Our technology and operations platforms process and generate over 7 billion communications annually and underpin the daily average trading of over $15 trillion in tokenized and traditional securities globally. A certified Great Place to Work®, Broadridge is part of the S&P 500® Index, employing over 15,000 associates in 21 countries.

For more information about us, please visit www.broadridge.com 

Broadridge Contacts:

Investors:
broadridgeir@broadridge.com           
Media:
Gregg.Rosenberg@broadridge.com 

 

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SOURCE Broadridge Financial Solutions, Inc.

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Electric Era Teams with WEX to Drive Customers and Revenue to Retail-Based Charging Locations

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12 minutes ago

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May 7, 2026

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SEATTLE, May 7, 2026 /PRNewswire/ — Electric Era, America’s leading retail-first EV charging company, today announced the addition of WEX® fleet payment processing services to their retail-based EV fast charging systems across the U.S.

Adding WEX fleet cards as a payment option underscores Electric Era’s unique strategy to design DC fast charging systems that function as marketing platforms for retailers to draw-in customers to grow sales revenues. With WEX, Electric Era’s chargers are available to WEX Fleet EV drivers to use at prominent fuel retailers in the Skycharger Network, Plaid Pantry and Space Age locations, and will be rolling out across Electric Era stations at Love’s Travel Stops, Giant Eagle and more soon.

“Our vision is to make EV charging as ubiquitous as traditional petroleum fueling with equally dependable charging stations located in safe, accessible locations to drive traffic and revenues to retail and food establishments,” said Quincy Lee, Electric Era CEO and founder. “By adding WEX, we’re creating new opportunities to drive even more store traffic to our retail customers, while simplifying payment processing for EV drivers and fleet operators.”

With the addition of WEX, commercial EV drivers will be able to use their WEX EV RFID or WEX DriverDash® mobile app to charge at Electric Era EV charging sites, and utilize WEX’s proprietary payment network to process payments, while simultaneously capturing charging data, driver ID, locations and vehicle mileage. This allows fleet managers to simplify billing, controls and expense tracking for both their electric-powered and internal combustion engine (ICE) fleet vehicles simultaneously.

“We’re focused on making mixed-energy fleet management seamless for fleet operators, and this is an important step toward making that happen,” said Sarah Booth, senior director, WEX Connected Fleet. “This collaboration with Electric Era adds reliable, retail adjacent EV fast charging to our growing network and will help our customers efficiently manage both electric and traditional fueled vehicles within a single account.”

Simple and easy to use, Electric Era’s EV chargers are available to all EV drivers and do not require special apps or accounts to use them. Simply tap a valid credit, debit or – and now a WEX RFID card – to pay for charging. EV fleet drivers can also pay via the WEX DriverDash mobile app.

A Retail-First EV Charging Platform
Founded by a SpaceX engineer, Electric Era reimagines high-power EV charging systems from the ground up to break down the barriers to rapid deployment of highly reliable DC fast charging systems. To make level-3 DC fast charging a profitable, market-driven solution, Electric Era designed their chargers specific for retail businesses to leverage retail adjacency and utilize the charging kiosks as an extension of company brand and retail space.

Electric Era’s patented battery-backed power architecture and energy management system enables their chargers to be installed as fast as 60-days, while delivering 400 kW max charge output with 99.8% per-port reliability – the new industry standard.

To help convenience stores and fuel retailers leverage the unique revenue-driving opportunities of DC fast charging systems, Electric Era provides complete start-to-finish, turn-key installations of their retailer-branded chargers – including successfully coordinating grant funding that reduces upfront CapEx costs to de-risk deployments and generate faster ROI.

About Electric Era
Electric Era is the only full-service EV charging solutions provider focused on the rapid deployment of highly reliable Level-3 DCFC systems at retail locations to grow and extend their retail space. Electric Era’s patented battery-backed charging architecture and bespoke, retail-first charging solutions deliver industry-leading power and reliability in a package that dramatically reduces installation time and energy costs.

For more information and the latest Electric Era updates, go to electricera.tech or follow us on
X: @ElectricEraTech LinkedIn: Electric-Era Facbook: ElectricEraTechnologies and YouTube: electricera.tech

SIDEBAR

HED: Electric Era + WEX® Opening Doors to Fleet Productivity and Retail Opportunities

As transportation-centric businesses accelerate EV adoption to reduce carbon emissions and lower operating costs, the Electric Era + WEX alliance enables fleet operators to:

Simplify company/driver-specific dashboards to simultaneously track both petro-fuel and electric charging platformsTrack EV specific expenses as a line item in familiar report formats – with similar levels of oversight and control as petroleum refuelingAllow retailers to gain access to WEX’s customer base to help attract new customers and increase store traffic for additional retail revenuesOpens the door to future QSR/fuel retailer loyalty program offerings via Electric Era’s EV charging systemsFurther strengthens Electric Era’s retail-first EV charging systems for retail and QSR/refueling locations and leader in public/private funded installations

View original content to download multimedia:https://www.prnewswire.com/news-releases/electric-era-teams-with-wex-to-drive-customers-and-revenue-to-retail-based-charging-locations-302764939.html

SOURCE Electric Era

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