Dyno Therapeutics Launches Dyno Psi-Phi, an Agentic AI Suite for Protein Binder Design, at NVIDIA GTC 2026




Dyno Therapeutics Launches Dyno Psi-Phi, an Agentic AI Suite for Protein Binder Design, at NVIDIA GTC 2026

Dyno’s Psi-Phi generative protein design and agentic interfaces provide versatile AI models and agents that connect physical outcomes with computational workflows

WATERTOWN, Mass.–(BUSINESS WIRE)–Dyno Therapeutics, Inc., a genetic technologies company applying AI to empower patients everywhere with genetic agency, today announced the launch of Dyno Psi-Phi (pronounced “sci-fi”), a suite of AI-powered protein design tools to help therapeutic developers create sequence-based medicines with the potential to transform patient lives. The announcement took place at NVIDIA GTC 2026 and arose from a collaboration between Dyno and NVIDIA to accelerate therapeutic discovery and design with high-performance computing.

AI technologies that can precisely design the amino acid sequences of protein molecules to bind therapeutic targets have the potential to dramatically accelerate the development of new medicines.

“Dyno’s Psi-Phi design suite is a step toward solving a major challenge in modern AI: connecting in silico benchmarks to real-world outcomes,” said Sam Sinai, Ph.D., Head of Machine Learning and Cofounder at Dyno Therapeutics. “Much of today’s progress is measured against a narrow set of computational filters. While effective, they can limit exploration of the broader functional space of proteins. With Psi-Phi, we democratize the filters that work, while introducing models that generate greater diversity and pair naturally with high-throughput experiments, so designs succeed not just at binding, but across downstream requirements.”

Dyno Psi-Phi is a suite of integrated tools:

Dyno Phi is a collection of filters that strongly predict real-world outcomes. Dyno iteratively calibrates and improves these filters with real-world experimental data to enable users to accurately assess the likelihood that resulting designs will validate in experimental settings. Furthermore, users can easily combine and modify the application of these filters to fit their design needs, balancing confidence in design success with diversity of designs. Dyno Phi can be used with any generative model to increase the confidence of translating designs to a wet-lab setting.

Dyno Psi-1 is the first open-weight model from the Dyno Psi protein design family. It is influenced by the NVIDIA La-Proteina family of models and trained on the NVIDIA DGX Cloud using NVIDIA Hopper GPUs. With a flow-matching backbone generative model optimized for scaling to complex multimeric interfaces, Psi-1 prioritizes structural diversity and controllability over pure in silico scoring objectives, producing more novel binders and demonstrating excellent experimental performance across common lab assays. The next-generation development of these models has already integrated the NVIDIA Transformer Engine to accelerate training and inference. To facilitate broader development of models within the community, Dyno is also openly releasing a curated dataset of synthetic domain interfaces (SDI) on which Dyno Psi-1 has been trained to improve the diversity of designed binders.

Dyno Psi-Phi APIs are a collection of community-tier REST APIs that provide programmatic access to Dyno Psi-1 for binder generation, and Dyno Phi for sequence filtering and experimental grounding. Developers can generate and evaluate protein designs through a unified interface without provisioning GPUs or building custom calibration pipelines, enabling structure-conditioned design and probabilistic estimation of real-world binding performance, and incorporating NVIDIA BioNeMo NIMs such as OpenFold3. These APIs are accessible at design.dynotx.com.

Dyno Psi-Phi Claude Code Skills are a one-click extension of the Psi-Phi platform that provide authenticated access to the same GPU-backed APIs directly within Anthropic’s Claude Code. They invoke inference and experimentally grounded filtering in real time, allowing scientists to iterate on protein design conversationally while leveraging Dyno’s computational infrastructure.

“Our collaboration with NVIDIA opens a new world of extraordinary AI leverage for Dyno’s partners, making frontier AI accessible to an even broader community of therapeutic developers,” said Eric Kelsic, Ph.D., Chief Executive Officer and Cofounder of Dyno Therapeutics. “Many genetic diseases can be treated by modulating protein binding, but historically it has been challenging to control and scale generative AI models for protein binder design. Our close technical partnership with NVIDIA, along with NVIDIA’s advanced hardware and software infrastructure, has enabled us to make rapid progress training Dyno Psi-1, and to create effective filtering methods with Dyno Phi agents. Now therapeutic developers can more confidently apply AI to create exceptionally effective new medicines for the patients who need them most.”

“Bridging the persistent gap between computational workflows and successful real-world experimental outcomes is critical for modern molecular design, and NVIDIA DGX Cloud equipped with H200 GPUs provides developers with the advanced infrastructure necessary to train complex generative models at scale,” said Anthony Costa, Director of Digital Biology at NVIDIA.

Dyno Psi-1 is available at https://huggingface.co/dynotx/dynopsi.

Dyno Phi is available at design.dynotx.com and through Claude Code.

Dyno SDI dataset is available at https://huggingface.co/datasets/dynotx/synthetic_dimers.

About Dyno Therapeutics

Dyno Therapeutics is on a mission to build high-performance genetic technologies that transform patients’ lives. Dyno applies AI to create better technologies for gene delivery and sequence design to increase “Genetic Agency” – a person’s ability to take action at the genetic level to live a healthier life – through safe, effective and widely accessible genetic medicines. Dyno partners across industries to ensure these life-transforming technologies can help as many patients as possible, including through strategic collaborations with leading gene therapy developers Astellas and Roche. Visit www.dynotx.com.

Contacts

Media Contact:

Thermal for Dyno Therapeutics

dynotx@thermalpr.com

QHP Announces $1.1 Billion Continuation Vehicle for Azurity Pharmaceuticals




QHP Announces $1.1 Billion Continuation Vehicle for Azurity Pharmaceuticals

The transaction provides liquidity option to existing investors and secures long-term capital to support continued growth.

RALEIGH, N.C.–(BUSINESS WIRE)–On February 13, 2026, QHP Capital, L.P. (“QHP”) announced the closing of a $1.1 Billion single-asset continuation vehicle for Azurity Pharmaceuticals, Inc. (“Azurity”). The transaction provides liquidity to existing limited partners while enabling QHP to maintain control and continue executing on Azurity’s long-term value creation plan.

The transaction was led by HarbourVest Partners, LLC (“HarbourVest”), with Pantheon Ventures, L.P. participating as a significant investor. Audax Strategic Capital (“ASC”) also participated through a separate structured growth investment. ASC also invested into the continuation vehicle as a syndicate investor.

The transaction offered the existing limited partners in the QHP selling fund the option to either capitalize on strong returns or roll their proceeds into the Continuation Vehicle (“CV”). There was strong participation from a broad set of limited partners, including existing limited partners of QHP. Other existing shareholders, including QHP’s subsequent fund, remain significant investors in Azurity and continue to support the company’s long-term strategy.

The new capital supports Azurity’s continued organic growth, business development and licensing, and potential strategic M&A. ASC provided additional acquisition capital to support the continued growth of Azurity.

Quotes:

“This CV reflects our strong conviction in Azurity’s strategy and leadership”, said Jeff Edwards, Partner at QHP. “We are pleased to partner with HarbourVest as lead investor alongside Pantheon and Audax Strategic Capital as well as other new investors, providing capital to support Azurity’s next phase of growth while offering liquidity to our existing LPs.”

“We are excited to continue our partnership with QHP and welcome our new investors as we enter the next phase of Azurity’s growth”, said Ronald Scarboro, CEO of Azurity. “This CV strengthens our ability to invest in our pipeline and expand our global reach while staying focused on delivering medicines to overlooked patients.”

“We are pleased to serve as the lead investor in the transaction which aligns with our strategy of partnering with what we believe are best-in-class general partners and their high performing portfolio companies,” said Nick Bellisario, Managing Director, HarbourVest Partners. “The QHP and Azurity teams have built an exceptional business, and we are excited to be investing alongside them in the company’s next chapter which will continue the mission of delivering innovative, high-quality medicine to overlooked patients.”

“Continuation vehicles are an increasingly important tool for high-quality assets, offering existing investors liquidity while providing new capital to support the next phase of growth,” said Kevin Dunwoodie, Partner at Pantheon. “Azurity has built a differentiated specialty pharmaceutical platform under QHP’s ownership, and we are pleased to partner with QHP, HarbourVest, Audax Strategic Capital and the management team to support the company’s continued development.”

Advisors

Goldman Sachs & Co. LLC (“GS”) acted as financial advisor to QHP, GS and Eaton Partners, a division of Stifel Nichols, both acted as placement agents, and Ropes & Gray, LLP acted as legal advisor on the transaction.

About Azurity Pharmaceuticals

Azurity Pharmaceuticals is a privately held company committed to delivering innovative, high-quality medicines for overlooked patients. Azurity’s global footprint is over 50 countries, with a diversified portfolio of 50+ medicines spanning 10 dosage forms and 10 key therapeutic areas. Powered by its Next-Gen Commercial Model, Azurity leverages data, analytics, and AI-driven digital tools to enhance market reach and stakeholder engagement. Azurity’s medicines have benefited millions of people. For more information, visit www.azurity.com.

About QHP Capital

Based in the Research Triangle Park of North Carolina, QHP Capital invests in life sciences and pharma services companies with proven products, services, and enabling technologies, utilizing a strategic platform to source, diligence, and create value. Led by a senior team of investment, healthcare, and research professionals, and rooted in the legacy of Quintiles (now IQVIA) and NovaQuest, QHP seeks to partner with founders and management teams to create long-term value. QHP Capital is the management company for NovaQuest Private Equity. For more information, please visit www.qhpcapital.com.

About HarbourVest Partners

HarbourVest is an independent, global private markets firm with over 43 years of experience and more than $146 billion of assets under management as of June 30, 2025. Our interwoven platform provides clients access to global primary funds, secondary transactions, direct co-investments, real assets and infrastructure, and private credit. Our strengths extend across strategies, enabled by our team of more than 1,250 employees, including more than 235 investment professionals across Asia, Europe, and the Americas. Across our private markets platform, our team has committed more than $63 billion to newly formed funds, completed over $64 billion in secondary purchases, and invested over $47 billion in direct operating companies. We partner strategically and plan our offerings innovatively to provide our clients with access, insight, and global opportunities.

About Pantheon

Pantheon has been at the forefront of private markets investing for more than 40 years, earning a reputation for providing innovative solutions covering the full lifecycle of investments, from primary fund commitments to co-investments and secondary purchases, across private equity, private credit, and real assets. For more information, please visit www.pantheon.com.

We have partnered globally with institutional investors of all sizes as well as a growing number of private wealth advisers and investors, with approximately $85bn in discretionary assets under management (as of September 30, 2025).

Leveraging our specialized experience and global team of professionals across Europe, the Americas, and Asia, we invest with purpose and lead with expertise to build secure financial futures.

For further information, please contact:

Pantheon

Mariella Reason, Pantheon Communications

Tel: +44 20 3473 3975 | Email: mariella.reason@pantheon.com

About Audax Strategic Capital

Based in New York and London, Audax Strategic Capital is a flexible partner to private equity sponsors seeking customized equity solutions to drive the continued growth of their portfolio companies. ASC is part of the Audax Private Equity platform, a capital partner to middle market companies with $19.5 billion of assets under management, as of January 2026, over 300 employees, and 100-plus investment professionals. For more information, visit www.AudaxStrategicCapital.com or follow ASC on LinkedIn.

Contacts

Media Contact
Silvia Cruz

silvia.cruz@qhpcapital.com

Mave Health Raises $2.1M to Launch Focus and Stress Regulation Wearable




Mave Health Raises $2.1M to Launch Focus and Stress Regulation Wearable

Blume Ventures leads seed round; Company completes 500 person beta

SAN FRANCISCO–(BUSINESS WIRE)–Mave Health, a neurotech company, announced $2.1 million in seed funding led by Blume Ventures with participation from other funds and angel investors, including Stanford Angels, Dhaval Shroff, and Raymond Russell. The company recently launched a non-invasive wearable headset built to improve focus, elevate mood, and regulate stress in just 20 minutes a day.

Mave debuted with over 500 beta customers ahead of its public release last month. Based on self-reported data collected after four weeks of use:

• 80% reported productivity gains exceeding 60%
• Users reported an average mood improvement of 77%
• 75% reported stress reductions above 50%

The wearable headset supports everyday mental health and cognitive performance. Its underlying technology, transcranial direct current stimulation (tDCS), has been studied for over 25 years, with more than 10,000 published papers globally. tDCS has an excellent safety profile and is well-suited for at-home use. Mave packages this science into a lightweight, consumer-friendly device.

“The brain is the most complex system we rely on every day, and modern life is constantly overloading it. We expect it to perform at peak levels without giving it the support it needs,” said Dhawal Jain, Co-founder and CEO of Mave Health. “Instead of chasing short-term boosts that come with long-term costs, we believe in strengthening the underlying systems that drive focus, mood, and stress regulation. Our approach is to use neurotechnology that is proven to be safe, effective, and easy to use.”

About the Product

The Mave headset delivers low-intensity electrical stimulation designed to strengthen the prefrontal cortex, the brain region associated with attention, emotional regulation, and stress response. Users wear the device for 20 minutes a day while working, reading, meditating, or going about their routine. There is no learning curve and no active effort required.

Most users report noticeable improvements within 15 to 20 days, with benefits compounding over time. The companion app allows users to log sessions, personalize protocols, and track progress without collecting any brain data.

Availability

Mave is available for pre-order at $495 and requires no subscription fees. Shipping begins in April 2026 to customers in the United States and India.

Technical Specifications

The Mave headset weighs 100 grams and lasts up to one month on a single charge with regular use. Each stimulation session lasts 20 minutes and uses an intensity of 1-2 mA, targeting the prefrontal cortex.

The headset does not collect brain data or require ongoing internet connectivity. The companion app can sync with popular fitness wearables to help users track correlations with sleep quality, heart rate variability, resting heart rate, and other related metrics.

Company Vision

“Most of us only think about mental health when something goes wrong,” said Dhawal Jain, Co-founder and CEO of Mave Health. “That is why my co-founders Jai Sharma, Aman Kumar, and I started Mave. We are giving people the ability to regain control over their focus, energy, and clarity so they can perform at their best and live more fully every day.”

About Mave Health

Mave Health exists to unlock the productivity and resilience that modern life often keeps out of reach. The company develops non-invasive wearable headsets to help people improve focus, mood and stress regulation. The product uses transcranial direct current stimulation (tDCS) to strengthen the prefrontal cortex in 20-minute daily sessions. Mave Health is a San Francisco and Bengaluru-based neurotechnology company founded in 2023 by Dhawal Jain, Jai Sharma, and Aman Kumar.

Contacts

Media Contact and Assets
Emily O’Brien, emily@emilyobrienconsulting.com
Press folder images and videos

Blue Matter Launches People and Organization Practice to Help Biopharma Navigate Structural Shift




Blue Matter Launches People and Organization Practice to Help Biopharma Navigate Structural Shift

NEW YORK–(BUSINESS WIRE)–Blue Matter today announced the launch of its People and Organization Practice, a dedicated capability designed to help life science companies build organizations that can perform through complexity – from enterprise transformation and M&A integration to talent strategy, learning, and workforce redesign.

The launch reflects a central conviction: the biopharma industry is not experiencing a cyclical downturn but a structural shift. With more than 42,700 jobs cut across the sector in 2024–2025, unprecedented policy uncertainty, accelerating AI adoption, and intensifying portfolio pressure, organizations must transform all functions simultaneously, not sequentially, to remain competitive.

A Proven Leader Across Transactions and Transformations

Stacey Petrey brings more than 25 years of experience and a track record spanning more than 75 completed transactions. Stacey served as a Partner in PwC’s Deals practice where she focused on integrations, separations, value creation, and change management. Prior to PwC, she held senior business, finance, and HR leadership roles at Bausch Health, Mylan (Viatris), Perrigo, Fidelity Investments, PerkinElmer, and Credit Suisse First Boston. She holds a doctorate from the University of Pennsylvania, a master’s from Cornell University, and a bachelor’s from Penn State University, and is a published thought leader on AI’s impact on biopharma organizational design and workforce architecture.

Four Integrated Capabilities

The People and Organization Practice operates across four service lines:

• Transformations & Transactions: Day 1 operating model design, synergy assessment, pre- and post-close integration and separation support, and change management
• Organization Design & Workflow Excellence: Best Practice Organization benchmarking, operating model design, organizational structure, role and decision rights redesign, AI use case prioritization, and governance
• Talent, Rewards & Performance Strategy: Career architecture, capability models, incentive compensation design, succession planning, and retention strategy
• Learning & Leadership Development: Salience Learning, learning strategy, leadership development, capability building, and measurement frameworks

The practice draws on Blue Matter’s deep functional expertise across Commercial, Medical Affairs, R&D, Market Access, and Enterprise Learning to deliver cross-functional solutions that work in practice, not just in theory.

According to Petrey, “Biopharma organizations must transform all functions at once, not sequentially, while keeping the portfolio pipeline moving and talent in place. That requires a partner who understands the science of the business, the deal dynamics, the incentive structures, and the human dynamics of change. That is what this practice is built to deliver.”

George Schmidt, Head of Consulting at Blue Matter, added, “We’ve spent years building deep expertise in how biopharma organizations operate. Stacey brings transactions and transformation experience to activate that expertise at scale, integrating organizational design, talent strategy, and learning into a single, connected offering. It is a meaningful step forward for our clients.”

About Blue Matter

Blue Matter (www.bluematterconsulting.com) is a global commercialization partner serving the life sciences industry. Operating from offices across North America, Europe, and Asia, Blue Matter serves a broad spectrum of biopharmaceutical organizations, from top-20 global companies to emerging biotech firms. The firm helps clients maximize value at the product, portfolio, and organization levels through market insights, strategic and operational consulting, and communications services.

Contacts

Media Contact
Craig Dunkley, Chief Marketing Officer

cdunkley@bluematterconsulting.com
+1 919 539 0658

Tiny Cargo and Bio-Sourcing Partner to Develop First-of-Its-Kind Oral Monoclonal Antibody Platform Using Goat-Milk Exosomes




Tiny Cargo and Bio-Sourcing Partner to Develop First-of-Its-Kind Oral Monoclonal Antibody Platform Using Goat-Milk Exosomes

Strategic US-EU alliance combines high-yield mAb production with industrial-scale exosome loading to eliminate the need for biologics by injection

ROANOKE, Va. & LIÈGE, Belgium–(BUSINESS WIRE)–The Tiny Cargo Company (“Tiny Cargo”) and Bio-Sourcing SA (‘Bio-Sourcing’) today announced a strategic partnership to develop an innovative oral delivery platform for monoclonal antibodies (mAbs). The collaboration utilizes goat-milk extracellular vesicles (EVs), specifically exosomes, to create a new class of shelf-stable, patient-friendly biologics.

The collaboration unites two proprietary technological breakthroughs:

• Tiny Cargo’s world-first, cGMP-compliant industrial platform built to isolate, purify, and load milk-derived exosomes with complex therapeutic payloads.
• Bio-Sourcing’s large-scale platform for producing high-potency mAbs and EVs directly in goat milk offers major cost savings and scalability benefits compared to traditional bioreactors.

While monoclonal antibodies are essential to modern medicine, their vulnerability to gastrointestinal breakdown has historically required delivery via injection or infusion. Milk-derived exosomes are evolutionarily designed to withstand the gut environment and transport molecular cargo into the bloodstream. By incorporating Bio-Sourcing-derived antibodies into these natural nanovesicles, the partners aim to eliminate the “needle barrier” altogether.

“By pairing Bio-Sourcing’s high-yield, sustainable production with Tiny Cargo’s sophisticated isolation and loading capabilities, we are positioned to unlock the ‘holy grail’ of biologics: true oral delivery,” said Bertrand Mérot, Founder and CEO of Bio-Sourcing SA. “This alliance not only advances our technical roadmap but strengthens our footprint in the U.S. market through a powerful transatlantic synergy.”

Bio-Sourcing’s platform uses a specific goat breed to produce mAbs at a lower cost than traditional methods. At the same time, Tiny Cargo’s unique purification techniques ensure these therapies meet pharmaceutical-grade standards for clinical use.

“Milk-derived exosomes are among the most resilient delivery systems in nature,” said Alan Gourdie, CEO of The Tiny Cargo Company. “The ability to source both the antibody and the delivery vehicle from the same biological starting point is a rare and powerful advantage. For the hundreds of millions of patients currently reliant on injectable mAbs, transitioning to an oral format would fundamentally transform how biologics are prescribed, distributed, and accessed globally.”

The joint venture will initially focus on assessing therapeutic applications and oral bioavailability. Currently, there are no FDA or EMA-approved oral mAbs, making this alliance a leader in pharmaceutical innovation.

About The Tiny Cargo Company

The Tiny Cargo Company, headquartered in Roanoke, Virginia, USA, is a biotechnology company pioneering the industrial-scale production of highly purified milk-derived exosomes. The company has developed proprietary technologies for isolating, purifying and loading exosomes with therapeutic and cosmetic cargoes, enabling applications across pharmaceuticals, nutraceuticals and advanced skincare.

Tiny Cargo’s world-first cGMP-ready manufacturing platform enables scalable production of exosome-based delivery systems for peptides, monoclonal antibodies, expression constructs and other biologics. The company’s platform is designed to integrate with multiple biologic production systems, allowing therapeutic molecules from diverse sources to be paired with milk-derived exosomes for advanced delivery applications.

Tiny Cargo is welcoming contacts and partnership enquiries via LinkedIn.

www.tinycargo.com

About Bio‑Sourcing

Bio‑Sourcing is developing a sustainable, scalable platform to produce biotherapeutics, including monoclonal antibodies in the milk – comprising EVs – of a particular breed of goats, creating industrial volumes at a drastically lower cost and capital expenditure versus conventional cell‑bioreactor systems. The platform supports both injectable and oral delivery formats. Building on the leadership of two international consortia, Bio‑Sourcing has twice been recognized by the European Union with competitive Eurostars funding; in 2024 it led a consortium to develop an oral adalimumab, and in 2026 alongside an EU partner, it was granted funding to advance an oral anti‑HER2 trastuzumab—reinforcing its position at the forefront of the oral delivery of mAbs.

Bio-Sourcing will be attending the Bio Europe Spring Conference and LSX in Lisbon, Portugal, on March 25 and 26, 2026, and is welcoming contacts via LinkedIn.

www.bio-sourcing.com| Bio-Sourcing – One pager | Trastuzumab (Eurostars 2026) |Nature research

Contacts

Keith Bowermaster, Mighty Spark Communications

k.bowermaster@mightysparkcommunications.com

Open Molecular Software Foundation’s OpenFold Consortium Launches Research Fellowship at the University of Washington’s Institute for Protein Design




Open Molecular Software Foundation’s OpenFold Consortium Launches Research Fellowship at the University of Washington’s Institute for Protein Design

BERKELEY, Calif.–(BUSINESS WIRE)–The Open Molecular Software Foundation (OMSF) today announced a new research fellowship between the OpenFold Consortium and the University of Washington Institute for Protein Design (IPD). Nobel Laureate David Baker is the Director of the IPD, a professor of biochemistry, and HHMI Investigator at UW Medicine. This fellowship is aimed at accelerating the development of open-source artificial intelligence tools for protein structure prediction and design ultimately to be used for new drug discovery.

The fellowship will support graduate students and postdoctoral scholars in the Baker Lab. With funding from the OpenFold Consortium fellows will focus on creating new state-of-the-art AI models for antibody-antigen design and structure prediction. Following an approach shared by OpenFold and the IPD, all resulting code from this collaboration will be released under permissive licenses for use by researchers and companies worldwide.

“The AI revolution in biology is built on a foundation of openness — researchers sharing data, code, and ideas freely so that others can build on them,” said Baker. “We’re excited to continue this tradition with OpenFold.”

“This collaboration with the Baker Lab marks a defining moment for open biomolecular AI,” said Dr. Woody Sherman, Chair of the OpenFold Consortium Executive Committee and Chief Innovation Officer at PsiThera. “This collaboration brings extraordinary depth across protein design, structure prediction, and large-scale experimental data generation. By building these capabilities as open, shared infrastructure, OpenFold is laying the foundation for a new era of biological discovery where AI models become community resources that accelerate innovation, enable entirely new classes of therapeutics, and deliver impact far beyond what any single organization could achieve.”

As part of this collaboration, the Baker Lab will conduct AI model development. To enhance the longevity and ease-of-use of new software, OpenFold engineers will provide technical support for packaging, documentation, and maintenance. All finished models developed with OMSF fellowship support will be shared publicly under permissive licenses.

About OMSF and OpenFold

The Open Molecular Software Foundation is a nonprofit 501(c)(3) organization supporting open, community-driven molecular software. The OpenFold project within OMSF advances open biomolecular AI by enabling shared infrastructure, evaluation, and community resources to accelerate scientific progress. OMSF is modeled after open source consortia in software technology such as the Linux Foundation.

The OpenFold Consortium is supported by a growing community of academic, industry, and philanthropic partners committed to building open scientific infrastructure for the next era of biology. OpenFold welcomes mission-aligned supporters interested in accelerating open innovation in biomolecular AI and drug discovery.

About the UW Institute for Protein Design

The Institute for Protein Design at the University of Washington creates new molecules that solve challenges in medicine, technology, and sustainability. Founded in 2012 by Nobel laureate David Baker, the Institute unites and trains experts in AI, biochemistry, medicine, and other disciplines. The IPD is building proteins to improve health, prevent pandemics, eliminate pollution, and organize matter at the atomic scale.

Contacts

Media Contact:

Mallory R. Tollefson, Ph. D.

Business Development and Project Manager

mallory.tollefson@omsf.io
https://openfold.io/

Niagen Bioscience to Present at the 38th Annual ROTH Conference




Niagen Bioscience to Present at the 38th Annual ROTH Conference

LOS ANGELES–(BUSINESS WIRE)–$NAGE #Biotech—Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announces that senior management will participate at the 38th Annual ROTH Conference, taking place at The Ritz-Carlton Laguna Niguel in Dana Point, California, from March 22 to 24, 2026.

Niagen Bioscience CEO, Rob Fried, will participate in the Technologies Advancing Healthy Aging Panel on Monday, March 23, at 2:00 PM PT (5:00 PM ET). The panel will be livestreamed and available at www.event.summitcast.com. Additionally, Niagen Bioscience’s CEO, Rob Fried, and CFO, Ozan Pamir, will attend one-on-one meetings with institutional investors in person throughout the day.

This year’s event will consist of one-on-one and small-group meetings, analyst-selected fireside chats, industry keynotes, and panels, with executive management from hundreds of private and public companies across a variety of growth sectors in attendance.

Investors interested in arranging one-on-one meetings should contact their ROTH representative. To learn more and submit a registration request, click here.

The Technologies Advancing Healthy Aging Panel will be livestreamed and available at www.event.summitcast.com.

For additional information on Niagen Bioscience, visit www.niagenbioscience.com.

About Niagen Bioscience:

Niagen Bioscience, Inc. (NASDAQ: NAGE) is the global leader in NAD+ (nicotinamide adenine dinucleotide) science and healthy-aging research. As a trusted pioneer of NAD+ discoveries, Niagen Bioscience^™ is dedicated to advancing healthspan through precision science and innovative NAD+-boosting solutions.

The Niagen Bioscience team, composed of world-renowned scientists, works with independent investigators from esteemed universities and research institutions around the globe to uncover the full potential of NAD+. A vital coenzyme found in every cell of the human body, NAD+ declines with age and exposure to everyday lifestyle stressors. NAD+ depletion is a key contributor to age-related changes in health and vitality.

Distinguished by state-of-the-art laboratories, rigorous scientific and quality protocols, and collaborations with leading research institutions worldwide, Niagen Bioscience sets the gold standard for research, quality, and innovation. There’s a better way to age.

At the heart of its clinically proven product portfolio is Niagen® (patented nicotinamide riboside, or NR), the most efficient, well-researched, and high-quality NAD+ booster available. Niagen powers the Company’s consumer supplement, Tru Niagen®, the number one NAD+ boosting oral supplement in the United States† (available at www.truniagen.com), and Niagen Plus™, featuring pharmaceutical-grade intravenous (IV) and injectable Niagen products (www.niagenplus.com). Pharmaceutical-grade Niagen IV and injections are compounded and distributed by U.S. FDA-registered 503B outsourcing facilities and are available exclusively at clinics with a prescription.

Niagen Bioscience’s robust patent portfolio protects NR and other NAD+ precursors. Niagen Bioscience maintains a website at www.niagenbioscience.com, where copies of press releases, news, and financial information are regularly published.

^†Based on revenue per largest U.S. e-commerce marketplace (Jan. 2025 – Dec. 2025)

About ROTH:

ROTH is a relationship-driven investment bank focused on serving growth companies and their investors. Their full service platform provides capital raising, high impact equity research, macroeconomics, sales and trading, technical insights, derivatives strategies, M&A advisory, and corporate access. Headquartered in Newport Beach, California, ROTH is a privately-held, employee owned organization and maintains offices throughout the U.S. For more information, please visit www.roth.com.

Contacts

Niagen Bioscience Media Contact:
Kendall Knysch, Senior Director of Media Relations & Partnerships

310.405.5227

kendall.knysch@niagenbio.com

Niagen Bioscience Investor Relations Contact:
Valter Pinto, Managing Director

KCSA Strategic Communications

212.896.1254

Niagen@kcsa.com

Crossbow Therapeutics Raises $77 Million in Series B Financing to Advance Development of TCR-mimetic Antibody Therapies to Treat Cancer




Crossbow Therapeutics Raises $77 Million in Series B Financing to Advance Development of TCR-mimetic Antibody Therapies to Treat Cancer

Financing co-led by Taiho Ventures and Arkin Bio Capital with significant participation from other new and existing investors

Investment enables continued clinical development of T-Bolt™ therapies, including completion of CBX-250 Phase 1 trial and initiation of CBX-663 clinical trial

Preclinical and translational updates on both programs to be presented at the American Association for Cancer Research (AACR) 2026 Annual Meeting

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Crossbow Therapeutics, Inc., a biotechnology company developing a novel class of potent and precise antibody therapies to treat a broad range of cancers, today announced it has raised $77 million in a Series B financing that will support the completion of the CROSSCHECK-001 Phase 1 clinical trial of the company’s lead program, CBX-250, and accelerate development of additional T-Bolt™ immunotherapies designed to extend the reach of antibody therapy across a broad range of cancers.

This Series B financing was co-led by Taiho Ventures and Arkin Bio Capital, with participation from new investors Sixty Degree Capital, Hamilton Square Partners Management LP, LifeLink Ventures, Libbs Ventures, and Blood Cancer United’s Therapy Acceleration Program^® (TAP), as well as existing investors MPM BioImpact, Pfizer Ventures, BVF Partners, Polaris Partners, Eli Lilly and Company, and Mirae Asset Venture Investment. As part of the financing, Sakae Asanuma, President & CEO of Taiho Ventures, and Pini Orbach, Managing Partner of Arkin Bio Capital, have joined Crossbow’s Board of Directors.

Crossbow is developing a broad portfolio of novel T-cell engager (TCE) therapies that potently target peptide human leukocyte antigen (pHLA) on cancer cells, using antibodies that mimic T-cell receptors (TCR-mimetics). These investigational products, known as T-Bolt^TM molecules, can be adapted to address a broad range of malignancies, potentially targeting the entire universe of cancer proteins.

“This financing not only strengthens our ability to advance CBX-250 through clinical development but also accelerates our mission to bring next-generation TCR-mimetic immunotherapies to patients who urgently need new options,” said Briggs Morrison, M.D., Chief Executive Officer of Crossbow Therapeutics. “We greatly appreciate our investors for sharing our conviction in the transformative potential of our T-Bolt^TM platform. We look forward to efficiently expanding our pipeline to address cancers that remain beyond the reach of today’s therapies.”

The Series B financing will allow Crossbow to complete a Phase 1 clinical trial of CBX-250, Crossbow’s first-in-class TCE therapy, which targets a pHLA specific to myeloid cancer cells. The ongoing Phase 1 study (CROSSCHECK-001) is evaluating CBX-250 in patients with relapsed and refractory myeloid malignancies including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), myelodysplastic syndromes (MDS), and chronic myelomonocytic leukemia (CMML). Initial clinical data from the CROSSCHECK-001 trial are expected around the end of 2026.

The financing will also enable submission of an Investigational New Drug (IND) application and initiation of a Phase 1 trial of CBX-663, a first-in-class TCE targeting a telomerase reverse transcriptase (TERT)-derived pHLA for the treatment of multiple hematologic and solid tumors. The initiation of the Phase 1 study evaluating CBX-663 is projected for Q3 2026.

Crossbow researchers will present preclinical findings for CBX-250 in myeloid malignancies as well as the characterization of CBX-663 in models of solid tumors at the upcoming American Association for Cancer Research (AACR) 2026 Annual Meeting in San Diego, Calif., which takes place April 17-22, 2026.

“Crossbow’s arsenal of T-cell engagers represents a differentiated and promising approach to anti-cancer immunotherapy by addressing the wide variety of intra-cellular targets and broadens the potentials of TCE modality,” commented Sakae Asanuma, President & CEO of Taiho Ventures and Crossbow board member. “The company’s experienced team and versatile platform position it to overcome the limitations of current treatments and deliver impact for patients in need. We are excited to continue supporting Crossbow as it advances its lead programs into the clinic.”

About Crossbow Therapeutics, Inc.

Crossbow Therapeutics, Inc., is a biotechnology company determined to improve the lives of people with cancer by unlocking the therapeutic potential of T-cell receptor (TCR)-mimetic antibodies. The company’s T-Bolt^TM therapies are next-generation, easily assembled immunotherapies directed with high precision at previously unreachable cancer cell targets. Crossbow’s efficient and selective approach is designed to target the entire universe of cancer proteins, dramatically expanding the potential of antibody therapy to address many types of cancer.

AACR 2026 Annual Meeting presentation details:

CBX-250 (Oral Presentation)

• Title: Preclinical evaluation and safety of CBX-250 in acute myeloid leukemia: A bispecific T cell engager targeting Cathepsin-G peptide/HLA Complex (abstract #4056)
• Presenting Author: Jennifer Helble, PhD
• Session Title: Advances in Therapeutic Antibodies
• Presentation Date/Time/Location: Monday Apr. 20, 2026, 3:50PM-4:05PM PDT, San Diego Convention Center – Ballroom 20 CD (Upper Level)
• Full text of the abstract is available here.

CBX-663 (Poster Presentation)

• Title: CBX-663, a first-in-class TCR-mimetic T-Cell Engager targeting the TERT peptide-HLA complex, mediates potent cytotoxicity in vitro and tumor inhibition in vivo in preclinical models of solid malignancies (abstract #1635)
• Session Title: T Cell Engagers 1
• Session Date/Time/Location: Monday Apr. 20, 2026, 9:00AM-12:00PM PDT, San Diego Convention Center, Poster Section 10, Poster Board Number 27
• Full text of the abstract is available here.

For additional details on the CROSSCHECK-001 Phase 1 trial, visit https://clinicaltrials.gov/study/NCT06994676.

For more information about Crossbow Therapeutics, visit www.crossbowtx.com.

About Taiho Ventures, LLC

Taiho Ventures, LLC is a strategic corporate venture capital arm of Taiho Pharmaceutical Co., Ltd., a Japanese specialty pharma focusing on oncology, allergy and immunology. Taiho Ventures is looking at early-stage preclinical oncology companies as well as platform technology companies for our core therapeutic areas. Taiho Ventures will review a wide variety of modalities, including both biologics and small molecules. The company will also consider option-type investments and spin-outs, in addition to the pure equity investments. For more information about Taiho Ventures, please visit https://www.taihoventures.com/.

About Arkin Bio Capital

Arkin Bio Capital is a global biotech fund dedicated to supporting clinical stage biotech companies approaching proof of concept in patients. Arkin Bio Capital leads investments alongside top global partners, driving robust growth and impactful advancements. Our team has a strong background in biopharmaceuticals, drug development, business development, and management, with a proven track record. Arkin Bio Capital seeks to invest in companies with innovative therapeutic candidates and experienced managements and is committed to nurturing promising opportunities and ensuring the success of each investment. For more information about Arkin Bio Capital, please visit https://arkin-capital.com/bio/.

Contacts

Investor Contact:
Crossbow Therapeutics, Inc.

Geraldine Paulus, Co-Founder, Senior Vice President and Head of Corporate Development and Business Operations

Geraldine.Paulus@crossbowtx.com

Media Contact:
SmithSolve

Alex Van Rees

Alex.VanRees@smithsolve.com

RevnaBio Secures Triple International Laboratory Accreditation to Expand Precision Medicine and Clinical Research Infrastructure in Africa




RevnaBio Secures Triple International Laboratory Accreditation to Expand Precision Medicine and Clinical Research Infrastructure in Africa

A2LA accreditation across ISO 15189, ISO 20387, and ISO/IEC 17043 strengthens diagnostic quality for patients while enabling global pharmaceutical and research partnerships.

ACCRA, Ghana–(BUSINESS WIRE)–#A2LA–RevnaBio today announced that it has received triple accreditation from the American Association for Laboratory Accreditation (A2LA), validating its laboratory and biobanking operations under three internationally recognized standards: ISO 15189 for medical laboratories, ISO 20387 for biobanking, and ISO/IEC 17043 for proficiency testing providers.

The combined accreditation confirms the strength of RevnaBio’s integrated quality systems across clinical diagnostics, biospecimen management, and laboratory performance monitoring. These capabilities support the delivery of reliable molecular testing for patients while providing a trusted platform for pharmaceutical companies, diagnostics developers, and research organizations conducting biomedical research in Africa.

The milestone represents a significant step toward expanding precision medicine infrastructure in West Africa and strengthening access to internationally accredited diagnostic services.

Improving Diagnostic Quality for Patients

Accurate and reliable diagnostics are essential for effective treatment selection, disease monitoring, and improved clinical outcomes.

Through its ISO 15189–accredited medical laboratory, RevnaBio provides molecular and genomic testing systems that meet internationally recognized standards for quality, accuracy, and traceability. These capabilities help clinicians make better-informed treatment decisions while expanding access to advanced molecular testing that historically required samples to be sent overseas.

By strengthening local diagnostic capacity, RevnaBio contributes to improving healthcare delivery and patient outcomes across Ghana.

Building Research Infrastructure for the Region

RevnaBio’s ISO 20387 biobanking accreditation validates the company’s governance and operational standards for collecting, processing, storing, and managing research-grade biospecimens.

These systems ensure that biological samples are linked to high-quality clinical and molecular data, supporting scientific research aimed at improving understanding of diseases affecting African populations and people of African descent globally.

Strengthening biospecimen infrastructure within Africa allows research involving African populations to be conducted with greater scientific rigor, representation, and ethical oversight.

Advancing Laboratory Quality Across West Africa

RevnaBio’s ISO/IEC 17043 accreditation authorizes the company to design and deliver accredited proficiency testing programs that help laboratories measure and improve their performance.

In regions where locally delivered external quality assessment programs remain limited, this capability enables RevnaBio to support laboratory networks through standardized benchmarking and quality monitoring.

Expanding access to accredited proficiency testing strengthens diagnostic reliability across healthcare systems, ultimately benefiting patients, clinicians, and public health programs throughout the region.

Supporting Global Biomedical Research and Drug Development

The accreditation also strengthens RevnaBio’s ability to collaborate with biopharmaceutical companies, diagnostics developers, and international research institutions seeking high-quality laboratory and biospecimen infrastructure in Africa.

Accredited diagnostics, validated biobanking systems, and reliable laboratory quality monitoring are essential for enabling biomarker discovery, pharmacogenomic research, and clinical studies involving diverse populations.

RevnaBio’s integrated platform helps facilitate research that advances precision medicine while ensuring that African populations are appropriately represented in global biomedical research.

Leadership Perspective

Commenting on the milestone, Dr. Derrick Akpalu, CEO and Co-Founder of RevnaBio, said: “This accreditation reflects our commitment to building laboratory systems that meet the highest international standards while serving the needs of patients and clinicians in Ghana. By strengthening diagnostic quality, biospecimen infrastructure, and laboratory performance monitoring, we aim to support improved healthcare locally while enabling meaningful collaboration with global research partners working to advance precision medicine.”

Ms. Jennifer Dent, a board member of the company, remarked, “I am incredibly proud to see the company achieve this important milestone. Receiving triple accreditation from the American Association for Laboratory Accreditation reflects RevnaBio’s commitment to quality, scientific excellence, and global laboratory best practices. The triple accreditation reflects the team’s commitment to quality, scientific excellence, and global standards. It also strengthens partnerships and supports African scientists and clinicians in leading impactful research.”

About Revna Biosciences (RevnaBio)

Revna Biosciences (RevnaBio) is a precision medicine company with an operational base in Accra, Ghana that provides genomic testing, clinical research services, and biobanking infrastructure across Africa. Founded in 2017 and domiciled in Delaware, RevnaBio partners with hospitals, research institutions, and global pharmaceutical companies to generate high-quality genomic and clinical datasets that reflect Africa’s genetic diversity, an essential foundation for precision-medicine discovery and drug development.

The company operates advanced laboratory and biospecimen infrastructure that supports molecular diagnostics, biomarker research, and clinical research programs across the region. Through these capabilities, RevnaBio enables pharmaceutical partners and academic researchers to conduct high-quality studies and develop therapies informed by African genomic data.

RevnaBio holds triple accreditation from the American Association for Laboratory Accreditation (A2LA) to ISO 15189:2022 (Medical Laboratories), ISO 20387:2018 (Biobanking), and ISO/IEC 17043 (Proficiency Testing Providers). This rare combination of accreditations confirms adherence to internationally recognized standards for diagnostic accuracy, biospecimen governance, and laboratory quality systems.

By building trusted biomedical infrastructure and generating globally relevant genomic data, RevnaBio is helping expand Africa’s role in precision medicine, clinical research, and pharmaceutical innovation.

Contacts

Media Contact
Revna Biosciences

Communications Office

Email: info@revnabio.com
Phone: +233-59-161-2549 / +233-59-900-9977

Website: www.revnabio.com

KERENDIA® (finerenone) Meets Primary Endpoint in Investigational Phase III FIND-CKD Study in Patients with Non-Diabetic Chronic Kidney Disease




KERENDIA® (finerenone) Meets Primary Endpoint in Investigational Phase III FIND-CKD Study in Patients with Non-Diabetic Chronic Kidney Disease

• KERENDIA^® (finerenone) met its primary endpoint demonstrating a statistically significant improvement vs. placebo in the estimated glomerular filtration rate (eGFR) slope from baseline to Month 32 – a surrogate endpoint for slowing kidney disease progression¹
• FIND-CKD is the fifth consecutive Phase III clinical trial where KERENDIA met its primary endpoint, adding to a clinical trial program of more than 20,000 patients across multiple patient populations with heart and kidney diseases
• FIND-CKD is the largest Phase III study to date focused on non-diabetic chronic kidney disease (CKD) and now expands KERENDIA’s clinical data in CKD to both diabetic and non-diabetic patients
• The clinical data from FIND-CKD will be presented at an upcoming scientific conference, and Bayer anticipates submitting the data to the U.S. Food and Drug Administration (FDA) to extend the indication of KERENDIA to this patient population
• KERENDIA is currently approved by the FDA for use in adults with CKD associated with type 2 diabetes (T2D) and heart failure with left ventricular ejection fraction (HF LVEF) ≥40%²

WHIPPANY, N.J.–(BUSINESS WIRE)–The Phase III study FIND-CKD (NCT05047263) — investigating the efficacy and safety of KERENDIA^® (finerenone) versus placebo when added to standard of care in adult patients with non-diabetic chronic kidney disease (CKD) — has met its primary endpoint.¹ The results demonstrated a statistically significant improvement versus placebo in the primary efficacy outcome of estimated glomerular filtration rate (eGFR) slope, defined as the mean annual rate of change from baseline to Month 32,¹ a validated surrogate endpoint for kidney disease progression.³ The safety profile of KERENDIA in the FIND-CKD study was consistent with its established safety profile.¹

The FIND-CKD clinical trial data will be presented at an upcoming scientific conference. Bayer anticipates submitting the data to the U.S. Food and Drug Administration (FDA) to extend the indication of KERENDIA to non-diabetic CKD patients.

“Patients with chronic kidney disease have substantial risk for cardiovascular events and kidney failure, so new treatments are needed to help slow kidney disease progression and improve outcomes,” said Hiddo L. Heerspink, Professor of Clinical Trials and Personalized Medicine, clinical trialist at the Department of Clinical Pharmacy and Pharmacology at the University Medical Center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee. “The FIND-CKD topline results are encouraging because they now provide evidence for finerenone in a non-diabetic chronic kidney disease population, on top of its established evidence in diabetic chronic kidney disease.”

Since 2021, KERENDIA has been approved to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), non-fatal myocardial infarction, sustained eGFR decline, and end-stage kidney disease in adult patients with CKD associated with type 2 diabetes (T2D). In July 2025, KERENDIA also received FDA approval for the treatment of heart failure with left ventricular ejection fraction (HF LVEF) ≥40%.²

Approximately 850 million people worldwide are living with CKD, and those with non-diabetic CKD represent more than half of these cases.^4,5,6 In the U.S., more than 35 million people are estimated to have CKD.⁷ In 2023, CKD accounted for over 1.4 million deaths, ranking as the ninth leading cause of death.⁸

“The FIND‑CKD findings mark the fifth consecutive Phase III trial in the KERENDIA clinical development program to meet its primary endpoint and represent a major milestone for people living with non-diabetic chronic kidney disease,” said Carolina Aldworth, M.D., MSc, Executive Medical Director at Bayer. “When considered alongside the growing evidence base, this important trial adds to our understanding of KERENDIA across multiple patient populations with heart and kidney diseases.”

KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys.² FIND-CKD is the largest Phase III study to date focused on non-diabetic CKD and investigated KERENDIA in a population spanning different etiologies of non-diabetic CKD.

About FIND-CKD

The Phase III FIND-CKD⁹ study investigated finerenone compared to placebo in addition to standard of care in more than 1,500 patients with non-diabetic CKD etiologies, of which etiologies included hypertension and chronic glomerulonephritis (inflammation of the kidneys’ blood filters). Patients were randomized to receive either finerenone 10mg or 20mg, based on serum potassium levels and eGFR, or placebo on top of individually tolerated maximum labeled doses of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). The primary endpoint was the mean annual rate of change in eGFR from baseline to 32 months. The safety endpoints were the occurrence of treatment-emergent adverse events (AEs), treatment-emergent serious AEs, and hyperkalemia AEs.

About KERENDIA’s Clinical Trial Program

KERENDIA’s clinical trial program—called FINEOVATE—currently comprises 10 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD (THUNDERBALL). The MOONRAKER program includes FINEARTS-HF¹⁰ as well as the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF,¹¹ CONFIRMATION-HF¹² and FINALITY-HF.¹³ The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD,¹⁴ FIGARO-DKD,¹⁵ FINE-ONE¹⁶ and FIND-CKD¹⁷ as well as the ongoing investigational studies, FIONA¹⁸ and FIONA-OLE.¹⁹

About Chronic Kidney Disease

CKD is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD affects 850 million people worldwide. In the U.S., 1 in 3 adults is at risk for the disease. At advanced stages of CKD, patients may need dialysis or a kidney transplant to stay alive. Healthy kidneys act as the body’s filter, removing waste products from the blood. They also control how much water and electrolytes are in the body, regulating blood pressure. As kidney function goes down, patients may experience a range of symptoms including leg swelling, tiredness in the day, nausea, muscle cramps, joint pain, confusion, trouble focusing and memory problems. Major underlying causes of CKD include diabetes, hypertension and glomerulonephritis such as immunoglobulin A nephropathy, focal segmental glomerulonephritis and membranous nephropathy.

About KERENDIA^® (finerenone)²

INDICATIONS:

KERENDIA (finerenone) is indicated to reduce the risk of:

• sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets)
• cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) ≥40% (10mg, 20mg, 40mg tablets)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

• Hypersensitivity to any component of this product
• Concomitant use with strong CYP3A4 inhibitors
• Patients with adrenal insufficiency

WARNINGS AND PRECAUTIONS:

• Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia.

  Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium.

• Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed.

  Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients with heart failure and an eGFR <25 mL/min/1.73 m² is not recommended. Measure eGFR periodically during maintenance treatment with KERENDIA in patients with heart failure. Consider delaying up-titration or interrupting treatment with KERENDIA in patients who develop clinically significant worsening of renal function.

MOST COMMON ADVERSE REACTIONS:

• CKD associated with T2D: From the pooled data of FIDELIO-DKD and FIGARO-DKD, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3%), and hyponatremia (1.3% vs 0.7%).
• HF LVEF ≥40%: From FINEARTS-HF, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (9.7% vs 4.2%), hypotension (7.6% vs 4.7%), and hyponatremia (1.9% vs 0.9%).²⁰ Events related to worsening renal function were reported more frequently in the KERENDIA group (18%) compared with placebo (12%).

DRUG INTERACTIONS:

• Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice.
• Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate.
• Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers.
• Sensitive CYP2C8 Substrates at KERENDIA 40mg: Monitor patients more frequently for adverse reactions caused by sensitive CYP2C8 substrates if KERENDIA 40mg is co-administered with such substrates, since minimal concentration changes may lead to serious adverse reactions.

USE IN SPECIFIC POPULATIONS:

• Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment.
• Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B).

Please see the Prescribing Information for KERENDIA.

About Bayer’s Commitment in Cardiovascular and Kidney Diseases

Bayer’s legacy in cardiovascular care spans decades of scientific innovation and patient-focused research. As a long-standing leader in cardiology, Bayer has consistently advanced therapies that address the complex interplay between the heart and kidneys—two organs deeply connected in both health and disease. Today, that heritage continues to guide our commitment to developing innovative treatments for patients facing high unmet medical needs. With a growing portfolio of approved therapies and promising compounds in development, Bayer is shaping the future of cardiovascular care through precision medicine, scientific rigor, and a deep sense of purpose.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer
Follow us on X: @BayerPharma

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports, which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

COR-KER-US-0185-1 3/26

Contacts

Media Contact:
Sarra Herzog

Bayer Media Relations

Sarra.Herzog@bayer.com
+1 862.460.8764