MindWalk Applies HYFT® Technology to Detect Functional Adjacency Linked to Portfolio Risk in AI-Designed Therapeutics

MindWalk Applies HYFT® Technology to Detect Functional Adjacency Linked to Portfolio Risk in AI-Designed Therapeutics




MindWalk Applies HYFT® Technology to Detect Functional Adjacency Linked to Portfolio Risk in AI-Designed Therapeutics

AUSTIN, Texas–(BUSINESS WIRE)–MindWalk Holdings Corp. (NASDAQ:HYFT) (“MindWalk” or the “Company”), a Bio-Native AI therapeutic research and technology company, today announced an application of its proprietary HYFT® technology designed to identify functional adjacency – meaning different molecules can produce the same therapeutic effect even when sequence comparisons suggest they are unrelated – an emerging source of competitive, legal, and valuation risk in modern drug discovery that sequence-alignment-based analysis often fails to capture.


Using HYFT® technology, MindWalk found a shared biological “signature” in influenza that stays consistent even when the virus’s genetic code changes a lot. This supports MindWalk’s approach to designing vaccine targets aimed at broader protection across strains and shows how HYFT identifies meaningful similarities in biology even when molecules do not look alike at first glance.

“Functional adjacency is now one of the most under-appreciated risks in pharmaceutical R&D,” said Jennifer Bath, Ph.D., Chief Executive Officer of MindWalk. “If two molecules deliver the same biological effect, they may compete for the same patient, pursue similar regulatory labels, and undermine perceived differentiation even if their sequences appear unrelated. As AI accelerates protein design, teams can generate many distinct sequences that converge on the same functional outcome, increasing the likelihood of competitive overlap, IP vulnerability, and valuation compression. HYFT is intended to help identify this convergence early by evaluating similarity at the functional level, not only at the sequence level.”

The Functional Adjacency Problem: An Emerging IP Risk for Pharma

Functional adjacency, where distinct molecular entities produce the same biological effect despite limited or no sequence similarity, has emerged as a material legal, competitive, and valuation risk in pharmaceutical development. Recent U.S. patent decisions have increased scrutiny on broadly drafted, functionally defined claim scope and underscore the need for disclosure and support proportional to what a patent claims.

In Amgen v. Sanofi, the U.S. Supreme Court found certain broad, functionally defined antibody claims directed to PCSK9 inhibition invalid for lack of enablement, meaning the patent did not teach others how to make and use the full claimed scope without undue experimentation. The decision reinforced a critical reality for biologics, competitive overlap often follows functional equivalence, not sequence similarity, and durable patent protection requires enabling disclosure consistent with the breadth of the claim.

Similarly, in Juno Therapeutics v. Kite Pharma, the Federal Circuit found certain CAR-T claims invalid for lack of written description, meaning the patent did not adequately describe the full claimed class of binding elements. The court’s analysis highlighted the risk of claiming broad functional territory without sufficient support, such as representative examples and shared defining features, across the claimed range.

Together, these decisions reflect an industry shift:

  • Multiple molecules achieve the same therapeutic effect through different sequences
  • Sequence novelty alone often proves insufficient as a proxy for competitive or legal differentiation
  • Competitive landscapes, deal valuations, and IP strategies built primarily on sequence similarity may face increasing fragility

As AI-driven protein design accelerates, this challenge intensifies. High-throughput platforms rapidly explore functional space and produce diverse sequences that converge on similar activity, creating blind spots in competitive intelligence and asset valuation when evaluation relies heavily on sequence similarity alone. Functional adjacency is no longer theoretical; it is increasingly recognized as an economically material risk, and recent case law underscores its IP implications.

HYFT Technology: Functional Intelligence Beyond Sequence Alignment

HYFT technology is designed to help close this gap by identifying conserved functional patterns shaped by biophysical constraints such as structure, charge, and binding interactions, even when evolutionary relationships are unclear and sequence similarity is low.

“HYFT technology lets us step outside sequence thinking and identify a functional constraint influenza appears to preserve for infection,” said Dirk Van Hyfte, MD, Ph.D., Chief Technology Officer of MindWalk.

In MindWalk’s influenza study, HYFT-based analysis identified functional architecture that persisted despite viral mutation, showing how influenza can change its sequence while preserving features required for infection. The same principle applies to AI-designed therapeutics, where optimization can generate diverse sequences that converge on similar functional outcomes.

HYFT technology is designed to help organizations evaluate competition, IP exposure, and portfolio risk based on functional similarity, where clinical and commercial overlap often occurs.

Strategic Implications for Pharma and Investors

The influenza observation, together with MindWalk’s previously disclosed HYFT-enabled dengue epitope program, shows HYFT as a cross-pathogen platform for identifying conserved functional design rules in biology, even when targets look different at the sequence level.

Taken together, these programs support the view that HYFT is not a single-asset discovery tool. It is positioned as a scalable strategic intelligence capability within MindWalk’s broader data management and biological reasoning platform.

As deployed, HYFT is intended to help pharmaceutical and biotechnology organizations:

  • Identify potential functional competitors earlier, including AI-designed or convergently evolved assets that sequence-based comparisons may miss
  • Strengthen in-licensing and M&A diligence efforts by assessing functional overlap, not only sequence similarity
  • Inform patent strategy under heightened scrutiny of function-based claims by grounding how functional space is characterized and supported
  • Improve R&D portfolio choices and capital allocation by prioritizing differentiated opportunities and identifying crowded functional areas earlier

MindWalk plans to engage pharmaceutical, biotechnology, and other organizations to explore collaborations and commercial arrangements that deploy HYFT-based functional intelligence across discovery, diligence, and portfolio decision workflows. This is designed to integrate with MindWalk’s end-to-end data platform, which unifies sequence, structure, function, and literature within a single operational framework.

This approach is designed to shift organizations from backward-looking analysis to forward-looking functional decision-making, aligning scientific discovery, competitive intelligence, IP strategy, and capital deployment as AI accelerates therapeutic design.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of applicable United States and Canadian securities laws. Forward-looking statements are often identified by words such as “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “targets,” “seeks,” “potential,” or similar expressions, or by statements that certain actions, events, or results are expected to occur or be achieved.

Forward-looking statements in this press release include, without limitation, statements regarding: the interpretation and significance of observations derived from the application of the Company’s HYFT® technology; the identification, characterization, and relevance of conserved functional patterns and functional adjacency; the hypothesis that such patterns may support rational design toward broadly protective influenza immunogens; the relevance of functional adjacency to competitive intelligence, intellectual property strategy, business development, and portfolio decision-making; the intended role of HYFT-based analysis in evaluating functional competition, IP exposure, or portfolio risk; the integration of HYFT within the Company’s broader data management and biological reasoning platform; the scope, timing, and outcome of potential future validation activities; and the Company’s ability to pursue, structure, or complete strategic investments, collaborations, commercial arrangements, partnering transactions, or licensing opportunities related to HYFT-based technologies or programs.

Forward-looking statements are based on management’s current expectations, assumptions, and projections about future events and Company performance. Forward-looking statements involve known and unknown risks, uncertainties, and other factors that cause actual results, performance, or achievements to differ materially from those expressed or implied. These factors include, among others: the preliminary and exploratory nature of computational analyses and in silico observations; limitations in available data, inputs, or analytical assumptions; the risk that subsequent laboratory, experimental, or validation studies do not replicate or support the reported observations; uncertainty regarding the biological relevance, robustness, or generalizability of identified functional patterns; risks inherent in therapeutic research and development, including challenges related to translation, validation, manufacturability, safety, immunogenicity, breadth, durability, or efficacy; the risk that future development decisions are delayed, modified, or discontinued; regulatory requirements and uncertainties; dependence on third-party collaborators, laboratories, service providers, and data sources; intellectual property risks, including the ability to obtain, maintain, defend, and enforce patent and other proprietary rights; competitive developments; the availability, timing, and terms of strategic investments or other financing alternatives; the ability to enter into, maintain, or enforce collaborations, partnering arrangements, or commercial agreements on acceptable terms; and broader economic, market, geopolitical, or regulatory conditions.

Additional information about these and other risks and uncertainties is set out in the Company’s Annual Report on Form 20-F, as amended, for the fiscal year ended April 30, 2025, available on the Company’s SEDAR+ profile at www.sedarplus.ca and EDGAR profile at www.sec.gov/edgar.

Readers are cautioned not to place undue reliance on forward-looking statements. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or otherwise.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities.

Contacts

Investor Contact

Louie Toma, CPA, CFA

Managing Director, CoreIR

investors@mindwalkAI.com

A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products | 1-Day Online Training Course (May 7, 2026) – Master EU CMC Requirements for Veterinary Pharmaceuticals – ResearchAndMarkets.com

A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products | 1-Day Online Training Course (May 7, 2026) – Master EU CMC Requirements for Veterinary Pharmaceuticals – ResearchAndMarkets.com




A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products | 1-Day Online Training Course (May 7, 2026) – Master EU CMC Requirements for Veterinary Pharmaceuticals – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products Training Course (May 7, 2026)” has been added to ResearchAndMarkets.com’s offering.


Understanding the chemistry, manufacturing and controls (CMC) requirements for veterinary pharmaceuticals is essential to support successful registration in the EU.

Regulations for CMC of veterinary pharmaceuticals are complex and are regularly updated, making pharmaceutical product development challenging. Information presented in the CMC section (Part 2) of the veterinary pharmaceutical dossier enables you to demonstrate successful pharmaceutical development and support post approval change management.

This course is designed to guide you through the essential steps in the development of the formulation and manufacturing process, in a manner that will ensure regulatory compliance for clinical trial applications and marketing authorization applications. Requirements for a range of veterinary dosage forms will be addressed with reference to guidance and legislation applied by EU regulators. Pharmaceutical development, manufacturing activities and the content of the CMC (Part 2) regulatory submission will be covered with consideration of VICH and EU provisions.

Benefits of Attending

  • Understand the EU regulatory framework governing CMC aspects of veterinary pharmaceutical development
  • Gain a detailed review of product development steps to fulfill requirements for Development Pharmaceutics
  • Confirm the manufacturing and stability protocol to meet EU regulatory expectations
  • Review the impact of the CMC data package on post-approval change management
  • Learn from experienced CMC regulatory experts and gain an understanding of the complexities and opportunities in the development of veterinary pharmaceutical products

Certifications

  • CPD: 6 hours for your records
  • Certificate of completion

Who Should Attend

This course will be beneficial to personnel in the following departments and roles:

  • Regulatory affairs
  • Quality assurance and manufacturing
  • Research and development
  • CMC technical writers

Agenda

EU CMC guidelines for veterinary pharmaceuticals

  • EU legal requirements for CMC
  • EMA CMC guidelines
  • EMA Scientific Advice for CMC

Development requirements for the active substance

  • New substance: process development and production of clinical and regulatory batches
  • Supplier qualification
  • Transfer of test methods
  • Setting the specification

Development pharmaceutics – part 1 – formulation and analytical development

  • Dosage form selection
  • Excipient selection and compatibility
  • Preliminary stability
  • Antimicrobial preservatives and antioxidants
  • Packaging selection
  • Analytical method development and validation

Development pharmaceutics – part 2 – process development

  • Quality by Design
  • Scale-up pilot scale to engineering batch
  • Developing in-process controls
  • Selection of sterilization method
  • Process validation protocol

Manufacturing and stability considerations for EU regulations

  • Scheduling for submission batches
  • Stability protocol
  • Bracketing and matrixing

Part 2 – dossier and expert report preparation

  • Data requirements for the Part 2 dossier
  • Presentation of the CMC development package
  • Specification for starting materials
  • Specification for dosage form
  • Method validation
  • Shelf life and in-use shelf life

For more information about this training visit https://www.researchandmarkets.com/r/gwq89z

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./ CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Serenity Mental Health Centers Offers Breakthrough Ketamine Therapy in Las Vegas

Serenity Mental Health Centers Offers Breakthrough Ketamine Therapy in Las Vegas




Serenity Mental Health Centers Offers Breakthrough Ketamine Therapy in Las Vegas

Mental health clinic provides ketamine infusion therapy to heal residents

LAS VEGAS–(BUSINESS WIRE)–Serenity Mental Health Centers, a leader in psychiatric care and one of the fastest growing mental health providers in the nation, today announced the expansion of its ketamine infusion therapy in Las Vegas.




Serenity’s board-certified psychiatrists and psychiatric mental health nurse practitioners provide full-spectrum mental health services tailored to each patient’s needs. Treatments include psychiatric evaluations, medication management, Transcranial Magnetic Stimulation (TMS), and ketamine infusion therapy for conditions such as depression, anxiety, PTSD, OCD, and more. These evidence-based approaches are designed for patients seeking both traditional support and non-medication treatment options.

“For patients who feel like they’ve exhausted traditional approaches, ketamine therapy in Las Vegas can offer a new path forward,” said Tricia Pease, COO and co-founder of Serenity Mental Health Centers. “Our goal is to provide this treatment in a safe, supportive clinical setting where patients are guided by experienced psychiatric providers.”

Serenity’s outpatient model includes flexible scheduling and same-day appointments, breaking down barriers that often prevent patients from receiving timely care. Serenity is committed to providing patient-first psychiatry and to becoming the go-to destination for ketamine therapy in Las Vegas.

To book an appointment, visit http://serenitymentalhealthcenters.com/nevada-psychitry-clinics/las-vegas/ or call 725-201-1842.

About Serenity Mental Health Centers

Serenity Mental Health Centers is a leading provider of comprehensive mental health services, dedicated to transforming the lives of patients through compassionate, innovative, and evidence-based care. With 35 locations across the country, Serenity offers a wide range of treatments tailored to address various mental health conditions, including depression, anxiety, OCD, and PTSD. Our highly skilled team of psychiatrists, nurse practitioners and mental health specialists combine innovative therapies like Transcranial Magnetic Stimulation (TMS) and ketamine infusion with personalized care to help patients achieve lasting wellness. Serenity is committed to expanding access to quality mental health care and fostering hope and recovery for individuals and families in the communities we serve. For more information, go to serenitymentalhealthcenters.com.

Contacts

For more information, contact:
Jillian DiMarco

jdimarco@serenityhealthcare.com

Prospera™ Featured in Landmark Interventional Study Advancing Lung Transplant Care

Prospera™ Featured in Landmark Interventional Study Advancing Lung Transplant Care




Prospera™ Featured in Landmark Interventional Study Advancing Lung Transplant Care

New publication shows that Prospera-guided care helped >75% of low-risk patients safely avoid routine transbronchial biopsies performed at 9 months

AUSTIN, Texas–(BUSINESS WIRE)–Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced the publication of a new prospective clinical trial in Transplantation Direct. The study, which was conducted by The Ohio State University Wexner Medical Center (OSU-WMC), was initiated to explore whether donor-derived cell-free DNA (dd-cfDNA) surveillance, and specifically Prospera-guided monitoring, could reduce the number of invasive biopsies for patients following lung transplantation.


Lung transplant patients are typically monitored with transbronchial biopsies – at one, three, six, nine, and 12 months after transplantation. These procedures are invasive, costly and associated with significant morbidity¹.

As transplant volumes increased at OSU-WMC, the center launched a quality assurance and performance improvement (QAPI) initiative to evaluate whether the Prospera test could allow them to safely eliminate the 9-month surveillance biopsy.

In the study, 78 lung-transplant recipients were monitored with the Prospera test for one year post-transplant. Prospera testing was incorporated at approximately 8 months to categorize patients as low risk (<1.0 % dd-cfDNA) or high risk (≥1.0 %) for rejection. Physicians could then choose to forgo the 9-month surveillance biopsy for low-risk, clinically stable patients. All participants were recommended for a protocol biopsy at 12 months post-transplant.

Key findings included:

  • Physicians chose to omit the 9-month biopsy in ~75% of patients with low-risk Prospera results. For these patients over the ensuing 3 months, there was no significant difference in acute rejection rates, spirometry indices, or donor-specific antibodies compared to patients who underwent the procedure.
  • At one year post-transplant, approximately 95% of patients who omitted the 9-month biopsy did not have acute rejection that needed any treatment.
  • Patients who omitted the 9-month biopsy maintained lung function and immunologic stability similar to those who underwent the procedure.

“This study highlights how monitoring with Prospera can improve both the patient experience and the sustainability of transplant programs,” said Justin Rosenheck, D.O., clinical assistant professor of internal medicine at The Ohio State University Wexner Medical Center and principal investigator of the study. “These compelling results support our goal of providing more personalized and efficient medical care without compromising patient safety or outcomes.”

“The Prospera test provided actionable patient risk assessments within a structured QAPI framework,” said David Ross, M.D., senior medical director of lung transplantation and molecular diagnostics at Natera. “These data support fewer routine biopsies during dd-cfDNA surveillance while maintaining lung function and immune response. We believe that future clinical studies could further support the safe omission of protocol biopsies implementing the Prospera Lung test, ultimately reducing invasive procedural risks and burdens with optimized health.”

References

  1. Huo J, Xu Y, Sheu T, Volk RJ, Shih Y-CT. Complication Rates and Downstream Medical Costs Associated With Invasive Diagnostic Procedures for Lung Abnormalities in the Community Setting. JAMA Internal Medicine. 2019;179(3):324-332.

About Natera

Natera™ is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 350 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Genethon Advances Groundbreaking Gene Therapies for Patients with Rare Genetic Diseases

Genethon Advances Groundbreaking Gene Therapies for Patients with Rare Genetic Diseases




Genethon Advances Groundbreaking Gene Therapies for Patients with Rare Genetic Diseases

Genethon’s Newsletter highlights the latest developments in gene therapies for diseases once considered incurable, including Duchenne muscular dystrophy

PARIS–(BUSINESS WIRE)–Genethon, a unique non-profit gene therapy R&D organization founded by the French Muscular Dystrophy Association (AFM-Telethon), began the new year with an R&D licensing deal for its gene therapy approach to Pompe disease and continues pivotal clinical trials of its best-in-class low dose micro-dystrophin gene therapy (GNT0004) for Duchenne muscular dystrophy (DMD). Read about these and other advances in Genethon’s latest Newsletter.


In his CEO Commentary, Frederic Revah, Ph.D., underscores the dedication, expertise and successes of Genethon’s 240 scientists and professional staff as they pursue new gene therapy treatments for rare genetic diseases, which disproportionately affect children worldwide.

Other Newsletter highlights:

  • Genethon’s license agreement with AskBio, a gene therapy subsidiary of Bayer AG, for a proprietary technology developed by Genethon and integrated into AskBio’s gene therapy clinical trial candidate for Pompe disease.
  • An update on Genethon’s pivotal clinical trial of its gene therapy for DMD.
  • A research discovery that could lead to a combination treatment with gene therapy for DMD.
  • Interviews with Dr. Revah in two global publications.

Read the full Newsletter and learn more about Genethon on its website (www.genethon.com).

About Genethon

A pioneer in the discovery and development of gene therapies for rare diseases, Genethon is a non-profit laboratory created by the AFM-Telethon. The first gene therapy drug, to which Genethon contributed, has been approved for marketing for spinal muscular atrophy. With more than 240 scientists and professionals, Genethon’s goal is to develop innovative therapies that change the lives of patients suffering from rare genetic diseases. Thirteen gene therapy products resulting from Genethon’s research, or to which Genethon has contributed, are currently undergoing clinical trials for diseases of the liver, blood, immune system, muscles, and eyes. Others are in preparation for clinical trials over the next five years. More information at www.genethon.com.

Contacts

Media Contact
Stephanie Bardon

SBARDON@afm-telethon.fr

Aesyra Demonstrates Significant Sleep Bruxism Reduction in Clinical Study

Aesyra Demonstrates Significant Sleep Bruxism Reduction in Clinical Study




Aesyra Demonstrates Significant Sleep Bruxism Reduction in Clinical Study

LAUSANNE, Switzerland–(BUSINESS WIRE)–#aesybiteAesyra SA, a Swiss medtech company developing innovative digital therapeutics for dental and sleep-related disorders, today announced the successful completion of its clinical investigation evaluating the efficacy and safety of AesyBite™ Active, an intelligent oral appliance designed to treat and prevent sleep bruxism through biofeedback.




The clinical investigation demonstrated that AesyBite™ Active achieved a statistically significant and clinically meaningful reduction in sleep bruxism activity, exceeding the predefined performance target.

Strong and robust clinical outcomes

In the study (Identifier: NCT06153810), involving 26 adult patients with confirmed sleep bruxism, activation of the AesyBite Active biofeedback system resulted in a 60.6% reduction in total sleep bruxism duration per hour compared to baseline (95% CI: 55.8%–64.9%, p < 0.001). This reduction exceeded the study’s predefined efficacy threshold, confirming the device’s ability to meaningfully reduce bruxism activity during sleep.

In addition to the primary endpoint, statistically significant improvements were observed across multiple secondary measures, including:

  • Reduced number of bruxism episodes per hour
  • Shorter bruxism episode duration
  • Lower intensity of bruxism episodes
  • No negative impact on sleep duration

The therapeutic effect was consistent regardless of baseline bruxism severity and independent of the timing of biofeedback activation.

Positive safety and usability profile

No adverse events were reported during the investigation. Patient-reported outcomes showed progressive improvements in orofacial pain, as well as improved comfort and acceptance of the device over time, supporting its suitability for long-term nightly use.

A differentiated approach to treating sleep bruxism

Unlike conventional passive splints, AesyBite™ Active combines a customized oral appliance with embedded sensors and active biofeedback, enabling real-time detection and reduction of bruxism activity without disturbing sleep.

“These results represent a major milestone for Aesyra,” said Marco Letizia, co-founder and CEO of Aesyra SA. “Demonstrating a consistent and robust reduction in sleep bruxism activity, together with an excellent safety profile, strongly supports the clinical value of AesyBite Active and its potential to change how sleep bruxism is treated.”

“The magnitude and consistency of the effect observed in this investigation are particularly encouraging,” added Prof. Marcello Maddalone, Principal Investigator, University of Milano-Bicocca.

“The data support AesyBite Active as an effective and well-tolerated therapeutic option for patients suffering from sleep bruxism.”

Next steps

The study results will support global regulatory submissions and future commercialization efforts. FDA submission has been initiated and regulatory approval in the USA is targeted for 2026. European regulatory approval is planned thereafter. In 2026 Aesyra plans to initiate go-to-market activities with existing partners and will seek additional partners for other commercial activities and to expand clinical indications of its platform technology.

About Aesyra SA

Aesyra SA is a Swiss spin-off from EPFL (École Polytechnique Fédérale de Lausanne) focused on developing smart, data-driven oral medical devices for the diagnosis and treatment of sleep-related dental conditions using its proprietary platform technology.

Its flagship product, AesyBite™ Active, integrates digital sensing and biofeedback to address sleep bruxism in a novel and clinically validated way.

Building on the same technological platform, Aesyra is also developing AesyBite™ Custom, a next-generation digital dentistry solution that leverages patient-specific intraoral 3D scans and additive manufacturing to enhance personalization and wearing comfort in bruxism therapy.

For more information, visit: www.aesyra.com

Contacts

Media: info@aesyra.com

Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results

Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results




Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results

  • In its first financial results announcement after the spin-off, Samsung Bioepis recorded FY2025 revenue of KRW 1.672 trillion, highest annual revenue in its 14-year history
  • Excluding milestone revenue, annual sales revenue grew 28% year-over-year (YoY), recording KRW 1.626 trillion, with 101% YoY growth in operating profit to KRW 330.8 billion

 


INCHEON, Korea–(BUSINESS WIRE)–#ADCs–Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced financial results for the fourth quarter and fiscal year 2025.

“We are very pleased to report strong year-to-date sales growth in our first financial results following the spin-off. Our organic growth has been driven by solid performance across our biosimilars portfolio,” said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We are continuing to make meaningful progress in our regulatory and commercial milestones with our existing biosimilars portfolio, while strategically investing in our future pipeline with a disciplined, long-term approach. We aim to drive sustainable growth and create long-term value for our shareholders, so that we can remain committed to improving patient access worldwide.”

Samsung Bioepis Fourth Quarter & Fiscal Year 2025 Results

In the fourth quarter of 2025, Samsung Bioepis achieved a consolidated revenue of KRW 429.4 billion with an operating profit of KRW 29.2 billion. Revenue and operating profit based on product sales (excluding milestone revenue) in the fourth quarter increased by 23% and 14% year-over-year (YoY), respectively.

Full-year 2025 (FY2025) revenue reached KRW 1.672 trillion (+9%) while operating profit stood at KRW 375.9 billion (-14%). Excluding milestone revenue, sales revenue and operating profit stood at KRW 1.626 trillion (+28%) and KRW 330.8 billion (+101%), respectively.

[Consolidated Earnings, KRW billion]

 

Q4’23

Q4’24

Q4’25

YoY Change

FY23

FY24

FY25

YoY Change

Revenue

288.9

397.4

429.4

+32.01

(+8%)

1,020.3

1,537.7

1,672.0

+134.31

(+9%)

 

Excluding Milestone Revenue

288.9

347.0

425.2

+78.2

(+23%)

1,008.3

1,266.8

1,626.9

+360.1

(+28%)

Operating Profit

78.2

72.3

29.2

-43.1

(-60%)

205.4

435.4

375.9

-59.5

(-14%)

 

Excluding Milestone Revenue

78.2

21.9

25.0

+3.1

(+14%)

193.4

164.5

330.8

+166.3

(+101%)

The growth was driven by Samsung Bioepis’ continued global expansion through product launches, regulatory approvals, and new partnerships.

  • EPYSQLI™ (SB12), a biosimilar to Soliris2 (eculizumab), indicated for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and generalized Myasthenia Gravis (gMG), was launched in the United States (US) in April 2025 through its commercialization partner Teva Pharmaceuticals, improving access for patients with rare diseases.
  • OBODENCE™ / OSPOMYV™3 (SB16), a biosimilar to Prolia4 (denosumab), and XBRYK™ (SB16), a biosimilar to Xgeva3 (denosumab), were approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in February 2025. In Europe, OBODENCE was launched in December 2025, consequently followed by the launch of XBRYK in January 2026. As of January 2026, four products are directly commercialized by Samsung Bioepis in Europe, namely EPYSQLI (eculizumab), OBODENCE (denosumab), XBRYK (denosumab), and BYOOVIZ™ (ranibizumab).5
  • PYZCHIVA™ (SB17), a biosimilar to Stelara6 (ustekinumab), was launched in the US in partnership with Sandoz in February 2025. PYZCHIVA has also been available as private label brands since the second and third quarter of 2025. In Japan, SB17 was approved as Ustekinumab BS Subcutaneous Injection 45mg Syringes 「NIPRO」 by Pharmaceuticals and Medical Devices Agency (PMDA) in December 2025. It is the first product to gain marketing approval in Japan under the partnership with NIPRO CORPORATION entered in June 2025.
  • Samsung Bioepis entered into a partnership agreement with Harrow for commercialization of BYOOVIZ (SB11), a biosimilar referencing Lucentis7 (ranibizumab) and OPUVIZ™ (SB15), a biosimilar referencing Eylea8 (aflibercept), in the US.

Fiscal Year 2026 Outlook

Samsung Epis Holdings is actively supporting its subsidiaries’ core businesses under the holding company structure, with a goal of increasing global biosimilar sales by more than 10% compared YoY. Samsung Bioepis plans to secure 20 biosimilars in its portfolio by 2030, including dupilumab, guselkumab, ixekizumab, trastuzumab deruxtecan, vedolizumab, and ocrelizumab.

Beyond biosimilars, the company has also embarked on its novel therapeutic development. It plans to have one novel therapeutic candidate enter into clinical study every year, starting with SBE303. SBE303 is Samsung Bioepis’ first novel antibody-drug conjugate (ADC) engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including bladder cancer, urothelial cancer, lung cancer, and breast cancer.9 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year.

Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform.

About Samsung Epis Holdings Co., Ltd.

As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: www.samsungepisholdings.com.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

About Epis NexLab Co., Ltd.

Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: www.samsungepisholdings.com.

 
1

The year-over-year (YoY) change in operating profit is reflective of the ‘milestone payment’ – a payment system that pays out upon completion of specific milestones within a project’s development.

2

Soliris is a trademark of Alexion Pharmaceuticals, Inc.

3

SB16 was approved under different names in Europe and the US; OBODENCE in Europe and OSPOMYV in the US

4

Prolia and Xgeva are trademarks of Amgen Inc.

5

In Europe, Samsung Bioepis has assumed full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen back to Samsung Bioepis, effective as of January 2026.

6

Stelara is a trademark of Johnson & Johnson Corporation.

7

Lucentis is a trademark of Genentech Inc.

8

Eylea is a trademark of Regeneron Pharmaceuticals, Inc

9

Li K, Zhou Y, Zang M, Jin X, Li X. Therapeutic prospects of nectin-4 in cancer: applications and value. Front Oncol. 2024 Mar 28;14:1354543. doi: 10.3389/fonc.2024.1354543. PMID: 38606099; PMCID: PMC11007101.

 

Contacts

Media Contact
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com

Merz Therapeutics Submits Application to the European Medicines Agency for New Indication of XEOMIN® in Pediatric Spasticity

Merz Therapeutics Submits Application to the European Medicines Agency for New Indication of XEOMIN® in Pediatric Spasticity




Merz Therapeutics Submits Application to the European Medicines Agency for New Indication of XEOMIN® in Pediatric Spasticity

FRANKFURT AM MAIN, Germany–(BUSINESS WIRE)–Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that it has completed the regulatory submission for XEOMIN® (incobotulinumtoxinA) for the treatment of spasticity of the lower and upper limb in children and adolescents aged 2–17 years in the European Union (EU) and European Economic Area (EEA). If approved, the indication would expand access to an established botulinum neurotoxin therapy for some of the youngest and most vulnerable patients across Europe.


Spasticity is a common and often debilitating condition in children and adolescents with certain neurological conditions, leading to increased muscle tone that can significantly limit movement, function and independence. One of the most common underlying causes of spasticity in children is cerebral palsy (CP), the most frequent motor disability in childhood, with spastic forms accounting for approximately 80% of all cases. In more severe cases, spasticity associated with CP can also affect speech, swallowing and fine motor skills.1,2

“We have made the conscious and ethical decision to advance our pediatric spasticity program. The submission of this important application for an indication extension in Europe represents another milestone in our long‑term commitment to improving standards of care for children and adolescents living with spasticity,” said Dr. Stefan Albrecht, Chief Scientific and Medical Officer, Merz Therapeutics.

Submission based on comprehensive clinical dossier update

The regulatory package submitted to the European Medicines Agency includes a comprehensive update of the clinical dossier, with data from the Phase 3 ELLIE study and prior pediatric spasticity investigations evaluating multipattern treatment of the lower limb, and, where appropriate, concomitant upper‑limb treatment.

The positive results of the prospective, randomized, placebo-controlled, two-stage, double-blind, multicenter, 28-week Phase 3 clinical trial ELLIE were recently presented at the TOXINS 2026 8th International Congress on Neurotoxins from January 14 to 17, 2026. The Phase 3 trial investigated incobotulinumtoxinA in the treatment of lower limb spasticity in children and adolescents with CP and showed how incobotulinumtoxinA significantly improved lower limb spasticity in children and adolescents with CP, while demonstrating a favorable safety and tolerability profile.3

About Merz Therapeutics

Merz Therapeutics GmbH is dedicated to delivering better outcomes for more patients. With science as its foundation and the patient experience as its focus, the company relentlessly pursues innovative treatments and partnerships to address unmet needs in movement disorders, neurodegenerative conditions, liver disease, and other health conditions that severely impact patients’ quality of life.

Merz Therapeutics is headquartered in Frankfurt am Main, Germany, and is active in more than 80 countries. Merz Therapeutics GmbH is part of the Merz Group, a privately held, family-owned company with a 118-year legacy. With passion and purpose, Merz Therapeutics continues to advance care in specialty neurology in ways that benefit both patients and society.

Please visit www.merztherapeutics.com.

References:

1 Cerebral Palsy Guide. Spastic cerebral palsy. https://www.cerebralpalsyguide.com/cerebral-palsy/types/spastic/. Last accessed: 19.01.2026.

2 Centers For Disease Control and Prevention. Data and Statics for Cerebral Palsy. https://archive.cdc.gov/www_cdc_gov/ncbddd/cp/data.html. Last accessed: 19.01.2026.

3 Banach M et al. IncobotulinumtoxinA for treatment of lower limb spasticity in children/adolescents with CP (ELLIE). Toxicon. 2026;271(S1):7. Abstract 0076.

Contacts

Press Contact:

Merz Therapeutics GmbH

Luke Anthony Mircea-Willats

Head of Global Communications & Strategic Affairs

merztherapeutics@merz.com

Flunitrazepam (CAS 1622-62-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com

Flunitrazepam (CAS 1622-62-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com




Flunitrazepam (CAS 1622-62-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Flunitrazepam (CAS 1622-62-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecast to 2029” report has been added to ResearchAndMarkets.com’s offering.


This report on Flunitrazepam provides comprehensive insights, including general information, synonyms, chemical composition, safety, hazards, handling, storage, and toxicological and ecological details, along with transport information. This in-depth study serves as a vital resource for understanding the Flunitrazepam market landscape and its growth potential worldwide.

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  • Flunitrazepam market drivers and challenges
  • Flunitrazepam manufacturers and distributors
  • Flunitrazepam prices
  • Flunitrazepam end-users
  • Flunitrazepam downstream industries trends

Key questions answered in the report:

  • What were the main trends of the global Flunitrazepam market in 2019-2024?
  • What was the size of the global Flunitrazepam market in 2019-2024?
  • Who are the main players in the global Flunitrazepam market?
  • Which drivers and challenges will determine the development of the global Flunitrazepam market during 2025-2029?
  • What will the CAGRs be for the global product industry?

Key Topics Covered:

1. FLUNITRAZEPAM

1.1. General information, synonyms

1.2. Composition, chemical structure

1.3. Safety information

1.4. Hazards identification

1.5. Handling and storage

1.6. Toxicological & ecological information

1.7. Transport information

2. FLUNITRAZEPAM APPLICATIONS

3. FLUNITRAZEPAM MANUFACTURING METHODS

4. FLUNITRAZEPAM PATENTS

5. FLUNITRAZEPAM WORLD MARKET ANALYSIS

5.1. Flunitrazepam market constraints, drivers and opportunities in 2019-2024

5.2. Flunitrazepam supply/demand in 2019-2024

5.3. Flunitrazepam market overview by region – Europe, Asia, North America, etc.

6. MANUFACTURERS OF FLUNITRAZEPAM

6.1. Flunitrazepam manufacturers in Europe

6.2. Flunitrazepam manufacturers in Asia

6.3. Flunitrazepam manufacturers in North America

6.4. Flunitrazepam manufacturers in RoW

7. SUPPLIERS OF FLUNITRAZEPAM

7.1. Flunitrazepam suppliers in Europe

7.2. Flunitrazepam suppliers in Asia

7.3. Flunitrazepam suppliers in North America

7.4. Flunitrazepam suppliers in RoW

8. FLUNITRAZEPAM WORLD MARKET FORECAST

8.1. Future trends in global Flunitrazepam market

8.2. Flunitrazepam supply/demand forecast to 2029

8.3. Flunitrazepam market forecast to 2029 by region (Europe, Asia, North America, etc.)

9. FLUNITRAZEPAM MARKET PRICES

9.1. Flunitrazepam prices in Europe

9.2. Flunitrazepam prices in Asia

9.3. Flunitrazepam prices in North America

9.4. Flunitrazepam prices in RoW

10. FLUNITRAZEPAM END-USE SECTOR

For more information about this report visit https://www.researchandmarkets.com/r/sakwc2

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Flumazenil (CAS 78755-81-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com

Flumazenil (CAS 78755-81-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com




Flumazenil (CAS 78755-81-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecasts 2025-2029 – Applications, Manufacturing Method, Patents, Suppliers, Prices, End-users – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Flumazenil (CAS 78755-81-4) Industry Research 2025: Global and Regional Market Trends 2019-2024 and Forecast to 2029” report has been added to ResearchAndMarkets.com’s offering.


This report on Flumazenil provides comprehensive insights, including general information, synonyms, chemical composition, safety, hazards, handling, storage, and toxicological and ecological details, along with transport information. This in-depth study serves as a vital resource for understanding the Flumazenil market landscape and its growth potential worldwide.

It explores various applications and examines manufacturing methods, supported by an analysis of relevant patents. The global market analysis covers constraints, drivers, and opportunities from 2019 to 2024, supply and demand dynamics, suppliers and regional overviews across Europe, Asia, North America, and other regions.

The report forecasts future trends and supply-demand scenarios up to 2029, with detailed market predictions by region. Additionally, it analyzes market prices across different regions and evaluates the end-use sectors for Flumazenil.

The Flumazenil global market report covers the following key points:

  • Flumazenil description, applications and related patterns
  • Flumazenil market drivers and challenges
  • Flumazenil manufacturers and distributors
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  • Flumazenil end-users
  • Flumazenil downstream industries trends

Key questions answered in the report:

  • What were the main trends of the global Flumazenil market in 2019-2024?
  • What was the size of the global Flumazenil market in 2019-2024?
  • Who are the main players in the global Flumazenil market?
  • Which drivers and challenges will determine the development of the global Flumazenil market during 2025-2029?
  • What will the CAGRs be for the global product industry?

Key Topics Covered:

1. FLUMAZENIL

1.1. General information, synonyms

1.2. Composition, chemical structure

1.3. Safety information

1.4. Hazards identification

1.5. Handling and storage

1.6. Toxicological & ecological information

1.7. Transport information

2. FLUMAZENIL APPLICATIONS

3. FLUMAZENIL MANUFACTURING METHODS

4. FLUMAZENIL PATENTS

5. FLUMAZENIL WORLD MARKET ANALYSIS

5.1. Flumazenil market constraints, drivers and opportunities in 2019-2024

5.2. Flumazenil supply/demand in 2019-2024

5.3. Flumazenil market overview by region – Europe, Asia, North America, etc.

6. MANUFACTURERS OF FLUMAZENIL

6.1. Flumazenil manufacturers in Europe

6.2. Flumazenil manufacturers in Asia

6.3. Flumazenil manufacturers in North America

6.4. Flumazenil manufacturers in RoW

7. SUPPLIERS OF FLUMAZENIL

7.1. Flumazenil suppliers in Europe

7.2. Flumazenil suppliers in Asia

7.3. Flumazenil suppliers in North America

7.4. Flumazenil suppliers in RoW

8. FLUMAZENIL WORLD MARKET FORECAST

8.1. Future trends in global Flumazenil market

8.2. Flumazenil supply/demand forecast to 2029

8.3. Flumazenil market forecast to 2029 by region (Europe, Asia, North America, etc.)

9. FLUMAZENIL MARKET PRICES

9.1. Flumazenil prices in Europe

9.2. Flumazenil prices in Asia

9.3. Flumazenil prices in North America

9.4. Flumazenil prices in RoW

10. FLUMAZENIL END-USE SECTOR

For more information about this report visit https://www.researchandmarkets.com/r/9qmow7

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ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

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For E.S.T Office Hours Call 1-917-300-0470

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