Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling




Tempus Receives IVDR Certification for xR RNA Sequencing for Solid Tumor Profiling

CHICAGO–(BUSINESS WIRE)–Tempus AI, Inc. (NASDAQ: TEM) today announced that its xR assay has received certification under the European Union’s In Vitro Diagnostic Regulation (IVDR) as a Class C in vitro diagnostic device. The certification covers Tempus’ quality management system for “next-generation sequencing devices for cancer genomic profiling to support clinical management.”

xR detects gene rearrangements and specific splice variants in solid tumor tissue to support clinical management. A published study demonstrated that combining Tempus RNA and DNA testing increases detection of clinically actionable gene fusions compared with DNA testing alone.

IVDR certification supports continued access to xR in the EU beyond 2028, the transition deadline for eligible legacy Class C devices, and provides biopharma partners with an IVDR-certified testing platform to support clinical studies.

“Securing our European IVDR certification for xR reinforces our commitment to meeting the highest regulatory standards globally,” said Lauren Silvis, SVP of External Affairs at Tempus. “This achievement establishes a strong regulatory foundation in Europe as we work to expand access to our advanced RNA sequencing tools for healthcare providers, biopharma partners and cancer patients across the region.”

About Tempus

Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the expected outcomes and benefits of Tempus xR and IVDR certification. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.

You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission (“SEC”) on February 24, 2026, as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.

Contacts

Hanah Heintzelman

media@tempus.com

Spotlight Medical Announces Successful Independent Evaluation of Its Digital Slide-Based Test for Assessing Recurrence Risk in Early Breast Cancer




Spotlight Medical Announces Successful Independent Evaluation of Its Digital Slide-Based Test for Assessing Recurrence Risk in Early Breast Cancer

An independent, blinded evaluation of 620 patients from the phase III PANTHER trial identified nearly one-quarter as Low Risk despite clinically high-risk breast cancer, with favorable ten-year outcomes.

PARIS–(BUSINESS WIRE)–Spotlight Medical, a company developing AI-powered prognostic tests in oncology, today announced results from an independent evaluation of myStage Dx, its CE-IVDR-marked test for assessing recurrence risk in patients with hormone receptor-positive, HER2-negative early breast cancer. The study was conducted by researchers at Karolinska Institutet in Sweden.

Independent, Blinded Evaluation Using Phase III Trial Data

The study used data from 620 patients enrolled in PANTHER, an international randomized phase III trial comparing dose-dense with standard chemotherapy. myStage Dx predictions were generated blinded to clinical outcomes. Researchers at Karolinska Institutet linked the predictions to patient outcomes and independently assessed prognostic performance according to a prespecified protocol and statistical analysis plan.

Within this clinically high-risk population, myStage Dx identified two groups with markedly different long-term outcomes. The Low Risk group comprised 23.5% of patients. At ten years, the estimated proportion alive and free from breast cancer recurrence was 96.1% in the Low Risk group, compared with 76.6% in the Not Low Risk group. The difference remained statistically significant after adjustment for standard clinicopathological prognostic factors. These findings build on earlier evidence from the CANTO and UNIRAD trial cohorts, published in the Journal of Clinical Oncology in 2025.

“Confidence in a clinical test has to be earned through independent scrutiny. We chose a blinded evaluation of myStage Dx by an independent research team, accepting that the results were outside our control. These findings are consistent with our previous studies and reinforce the test’s ability to address a concrete clinical problem: identifying patients with a favorable prognosis despite clinically high-risk disease, with a clear risk classification to inform treatment discussions,” says Dr. Marvin Lerousseau, co-founder and CSO of Spotlight Medical.

Refining Recurrence Risk Assessment to Support Clinical Decision-Making

Patients considered clinically high-risk may be eligible for additional treatment, including CDK4/6 inhibitors, yet their individual recurrence risks can vary substantially. In PANTHER, patients received chemotherapy and endocrine therapy without CDK4/6 inhibitors. By identifying a subgroup with favorable long-term outcomes under those treatment conditions, myStage Dx provides prognostic information to inform discussions about treatment strategy. These discussions should consider individual recurrence risk, the expected benefits and risks of additional treatment, and patient preferences, consistent with ASCO guidance.

“As ASCO guidelines highlight, accurately assessing recurrence risk is essential to treatment decisions. For patients, additional therapies can mean up to three more years of treatment, with side effects, anxiety, and a real impact on daily life. We are proud to show how myStage Dx can help oncologists better assess individual risk and support more informed clinical decisions, with the aim of improving patient care,” said Sylvain Berlemont, co-founder and CEO of Spotlight Medical.

About Spotlight Medical

Spotlight Medical is an oncology diagnostics company developing evidence-driven, clinical-grade AI tests to support more precise cancer care. The company combines routine pathology, clinical data and explainable AI to develop prognostic assays designed for practical adoption in oncology workflows.

About myStage Dx

myStage Dx is a software-only in vitro diagnostic medical device that has received CE marking under the European Union IVDR. It combines the analysis of a digitized histopathology slide with routinely available clinicopathological data to generate a prognostic classification intended for use by qualified healthcare professionals.

Contacts

Media
press@spotlightmedical.com
spotlightmedical.com | mystagedx.com

BeOne Medicines to Announce Third Quarter 2026 Financial Results on November 5




BeOne Medicines to Announce Third Quarter 2026 Financial Results on November 5

SAN CARLOS, Calif.–(BUSINESS WIRE)–$ONC #BeOne–BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will report its third quarter 2026 financial results on Thursday, November 5, 2026, before the financial markets open. Following the release of the financials, the Company will host a live webcast with management at 8:00 a.m. ET.

The live webcast of this event can be accessed from the investors section of the Company’s website at https://ir.beonemedicines.com.To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the Company’s website.

About BeOne Medicines

BeOne Medicines is a global oncology company that is discovering and developing innovative treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. The Company has a growing global team spanning six continents who are driven by scientific excellence and exceptional speed to reach more patients than ever before.

To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeOne’s plans, commitments, aspirations and goals related to BeOne’s medicines and drug candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors which are discussed in the section entitled “Risk Factors” in BeOne’s most recent periodic report filed with the U.S. Securities and Exchange Commission (“SEC”) as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the SEC. All information in this press release is as of the date hereof, and BeOne undertakes no duty to update such information unless required by law.

Contacts

Investor Contact:
Liza Heapes

Tel:+1 857-302-5663

ir@beonemed.com

Media Contact:
Kyle Blankenship

Tel:+1 667-351-5176

media@beonemed.com

Ivonescimab Data Sets across Multiple Tumor Types to Be Featured at ESMO 2026




Ivonescimab Data Sets across Multiple Tumor Types to Be Featured at ESMO 2026

Highlights Include Phase II Data Supporting Clinical Development Expansion for Ivonescimab

MIAMI–(BUSINESS WIRE)–Summit Therapeutics Inc. (NASDAQ: SMMT) today announced that ivonescimab data will be featured in numerous presentations at the European Society for Medical Oncology 2026 Congress (ESMO 2026), taking place October 23-27, 2026, in Madrid, Spain.

Across 10 presentations at ESMO 2026, ivonescimab data will span a broad range of tumor types, led by positive overall survival findings from Akeso Inc.’s Phase III HARMONi-GI1 study of ivonescimab plus chemotherapy compared to durvalumab plus chemotherapy in first-line advanced biliary tract cancer, which is selected as a Late-Breaking Abstract for the Presidential Symposium. HARMONi-GI1 is a multi-center, Phase III study conducted in China and sponsored by Akeso, with all relevant data exclusively generated, managed, and analyzed by Akeso. On October 21, Summit and ECOG-ACRIN Cancer Research Group announced the initiation of the open-label Phase II/III EA2251 study, which plans to enroll patients in the U.S. who will be randomized to receive ivonescimab in combination with gemcitabine and cisplatin, or pembrolizumab or durvalumab in combination with gemcitabine and cisplatin as the established standard-of-care comparator regimen. Activation of clinical trial sites is expected to begin in the fourth quarter of 2026.

Additional data include findings from investigator-sponsored trials (ISTs). A rapid oral presentation and a proffered paper will feature ivonescimab-based regimens in first-line recurrent/metastatic thymic carcinoma and advanced renal cell carcinoma, respectively. The program also highlights emerging endometrial cancer (EC) data, alongside continued development in gastrointestinal cancers such as esophageal, gastric/GEJ, and pancreatic cancers; glioblastoma; and head and neck squamous cell carcinoma.

In a Phase II study in EC conducted at Memorial Sloan Kettering Cancer Center in New York, NY, ivonescimab monotherapy met the study’s primary endpoint for objective response rate with a manageable safety profile without new safety signals in previously treated patients with second-line and later EC. The strength of these results supported expansion of the IST led by Drs. Maria Rubinstein, MD, and Vicky Makker, MD, and provided a meaningful signal to inform opportunities for further development of ivonescimab in EC.

“The breadth of the ivonescimab data at ESMO underscores the expanding body of clinical evidence across a diverse range of tumor types and treatment settings,” said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit Therapeutics. “Our ambition for ivonescimab extends beyond any single indication. We are focused on advancing a rigorous clinical development program to determine where this novel IO bispecific antibody could make a meaningful difference for patients. We look forward to engaging with the global oncology community on these data at ESMO 2026.”

The ESMO 2026 ivonescimab presentations are listed below by tumor type:

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was initially approved for marketing authorization in China in May 2024.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, North America, South America, Europe, the Middle East, Africa, and Japan, and as AK112 outside of Summit’s license territories, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. By design, ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity to PD-1 when in the presence of VEGF.

This design is intended to differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Summit believes ivonescimab’s specifically engineered tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the TME (Zhong, et al, iScience, 2025). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of ivonescimab’s design, together with a half-life of 6 to 7 days after the first dose (Zhong, et al, iScience, 2025) increasing to approximately 10 days at steady state dosing, is to improve upon previously established efficacy thresholds, side effects, and safety profiles associated with prior approved drugs to these targets.

Ivonescimab was invented by Akeso Inc. (HKEX Code: 9926.HK) and is currently utilized in multiple Phase III clinical trials. Over 5,000 patients have been treated with ivonescimab in clinical studies globally and over 100,000 patients when considering those treated in a commercial setting in China, as noted by Akeso.

There are currently 17 Phase III clinical studies that are either announced, ongoing, or have been completed studying ivonescimab, five of which are Summit-sponsored global studies, two of which are studies sponsored by cooperative groups, and 10 of which are being or have been conducted in China by Akeso. Summit began its clinical development of ivonescimab in NSCLC and expanded its sponsored Phase III clinical development program into colorectal cancer (CRC) and urothelial carcinoma (bladder cancer).

About Summit Therapeutics Inc.

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase potential duration of life, and resolve serious unmet medical needs.

Summit was founded in 2003 and the company’s shares are listed on the Nasdaq Global Market (symbol “SMMT”). Summit is headquartered in Miami, Florida, with additional offices in Palo Alto, California, Princeton, New Jersey, Dublin, Ireland, and Oxford, UK.

For more information, please visit https://www.smmttx.com and follow Summit on X @SMMT_TX.

Summit Forward-Looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including but not limited to, statements about the risk that the private placement does not close on the anticipated timeline or at all, including because required regulatory clearances are not obtained or other closing conditions are not satisfied, dilution to existing stockholders, and potential adverse effects on the market price of the Company’s common stock, including from future sales by AstraZeneca, the Company’s broad discretion over the use of proceeds, and the possibility that the proceeds will not be sufficient to fund operations as long as anticipated, AstraZeneca’s ownership and contractual rights, including Third Party acquisition participation, and registration rights, and potential conflicts of interest, the completion of the Private Placement does not depend on the parties entering into a definitive collaboration agreement, the Company’s reliance on AstraZeneca for the supply of AstraZeneca’s products and other contributions to the clinical trials, the clinical and preclinical development of the Company’s product candidates, entry into and actions related to the Company’s partnership with Akeso Inc. and other collaborations, the intended use of the net proceeds from the private placements, the Company’s anticipated spending and cash runway, the therapeutic potential of the Company’s product candidates, the potential commercialization of the Company’s product candidates, the timing of initiation, completion and availability of data from clinical trials, the potential submission of applications for marketing approvals, the expected timing of BLA submissions or FDA decisions, potential acquisitions, statements about the previously disclosed At-The-Market equity offering program (“ATM Program”), the expected proceeds and uses thereof, the Company’s estimates regarding stock-based compensation, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the Company’s ability to sell shares of our common stock under the ATM Program, the conditions affecting the capital markets, general economic, industry, or political conditions, including the effects of geopolitical developments, domestic and foreign trade policies, and monetary policies, the results of our evaluation of the underlying data in connection with the development and commercialization activities for ivonescimab, the outcome of discussions with regulatory authorities, including the Food and Drug Administration, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials, the results of such trials, and their success, global public health crises, that may affect timing and status of our clinical trials and operations, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, whether business development opportunities to expand the Company’s pipeline of drug candidates, including without limitation, through potential acquisitions of, and/or collaborations with, other entities occur, expectations for regulatory approvals, laws and regulations affecting government contracts and funding awards, availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of filings that the Company makes with the Securities and Exchange Commission. Summit defines a “positive study” as a clinical study with one or more prespecified primary endpoints in which one of those endpoints achieves a statistically significant benefit according to the protocol or statistical analysis plan. Any change to our ongoing trials could cause delays, affect our future expenses, and add uncertainty to our commercialization efforts, as well as to affect the likelihood of the successful completion of clinical development of ivonescimab. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

Summit Therapeutics and the Summit Therapeutics logo are registered trademarks of Summit Therapeutics Inc. and/or its affiliates. Copyright 2026, Summit Therapeutics Inc. All Rights Reserved.

Contacts

Summit Therapeutics’ Media & Investor Contacts:
Nathan LiaBraaten

Senior Director, Investor Relations

Tracy Jones

Director, Media & Public Relations

investors@smmttx.com
media@smmttx.com

Prilenia and Ferrer Announce Authorization for EU Initiation of Confirmatory PRECISE-HD Study of Pridopidine in Huntington’s Disease




Prilenia and Ferrer Announce Authorization for EU Initiation of Confirmatory PRECISE-HD Study of Pridopidine in Huntington’s Disease

Recruitment is expected to start this month, rolling out to upwards of 31 sites across nine EU countries, and joining the ongoing enrollment in the US and UK, with Canada set to follow

Prilenia and Ferrer will share new data analyses and clinical trial updates at the European Huntington’s Disease Network (EHDN) Clinical Research Congress

NAARDEN, Netherlands & WALTHAM, Mass. & BARCELONA, Spain–(BUSINESS WIRE)–#HD—Prilenia Therapeutics B.V. and Ferrerⁱ today announced that the confirmatory Phase 3 PRECISE-HD study of investigational pridopidine in Huntington’s disease (HD) has received authorization to begin in participating EU Member States (clinicaltrialsregister.eu 2026-526093-16-00, clinicaltrials.gov NCT07609108). Recruitment in the EU is expected to commence this month, joining currently recruiting sites in the US and UK, with Canada to follow.

Designed to evaluate the efficacy and safety of pridopidine (administered as an oral capsule twice a day), and to generate data for regulatory evaluation, the global, approximately 400-participant, randomized, double-blind, placebo-controlled PRECISE-HD study will assess the clinical effect of the investigational treatment on disease progression, functional capacity, motor function, cognition, speech and quality of life.

“The initiation of PRECISE-HD in Europe marks a milestone for the Huntington’s disease research community. This confirmatory Phase 3 study has been designed to build on learnings from previous research and to rigorously evaluate the efficacy and safety of pridopidine in people living with HD. As investigators, we look forward to working with participating centers and the HD community to generate robust evidence that can help us better understand the potential role of the study treatment in HD,” said Dr. Ralf Reilmann, Principal Investigator and member of the PRECISE-HD Steering Committee.

“For people living with Huntington’s disease and their families, every step toward a better understanding of the disease and potential treatment options matters. We welcome the involvement of European centers in PRECISE-HD and the continued focus on outcomes that reflect the realities and priorities of people living with HD and their families,” said Astri Arnesen, President of the European Huntington Association.

EHDN 2026 Clinical Research Congress

Prilenia and Ferrer will participate at the European Huntington’s Disease Network (EHDN) Clinical Research Congress 2026, taking place October 22–24, 2026, in Kraków, Poland, with Prilenia’s Chief Executive Officer, Dr. Michael R. Hayden, giving an oral presentation on clinical trial design and determination of clinical meaningfulness, in addition to four poster presentations, describing clinically meaningful change in early manifest HD, placebo response in the PROOF-HD clinical trial, and the designs of the PREVAiLS and PRECISE-HD studies of pridopidine in ALS and HD respectively.

[This press release is intended for informational purposes only. Pridopidine is an investigational medicine and is not approved for commercial use by any regulatory authority. Its safety and efficacy have not been established. Information contained herein does not constitute medical advice. Patients should consult their healthcare provider for guidance regarding diagnosis or treatment options. Local regulations may vary; this release is not intended to promote or advertise any product.]

About HD

Huntington’s disease (HD) is a rare, inherited, autosomal dominant, neurodegenerative disease that results in functional, motor, cognitive and behavioral symptoms, and ultimately leads to death. HD is caused by a mutation in the huntingtin (HTT) geneⁱⁱ, and each child of a parent with HD has a 50 percent chance of developing the diseaseⁱⁱⁱ.

Across the world an estimated 100,000 people have HD^iv, with an additional 300,000 people at risk of developing HD^v,vi. It is usually diagnosed between the ages of 35 and 55^{vii viii}, although HD can occur at any age, including in children and young adults (known as juvenile onset HD or JHD). The disease progresses slowly over 10 to 30^ix years, with patients slowly losing their ability to work, communicate, manage day-to-day life and take care of themselves. This increasing disability leads to full reliance on a caregiver and, ultimately, death.

The only currently available treatments for HD focus on symptomatic relief and palliative care, with no approved therapies shown to impact measures of overall disease progression.

About pridopidine

Pridopidine is an investigational highly selective, oral sigma-1 receptor (S1R) agonist. S1R has been shown to play a role in stimulating multiple neuroprotective pathways impaired in neurodegenerative diseases, such as Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS)^x.

In clinical studies to date, pridopidine (taken as an oral capsule twice a day) has shown a generally favorable safety and tolerability profile, with data from more than 1,600 people (mostly from HD studies), some of whom have received active treatment for up to seven years^xi.

Pridopidine is currently in late-stage clinical development for HD and ALS. It has Orphan Drug Designation in HD and ALS in the US and EU, and FDA Fast Track designation in the US for the treatment of HD. These designations do not imply that pridopidine has been approved or that safety and efficacy have been established.

About the PRECISE-HD Study

PRECISE-HD (Pridopidine Phase 3 Study to Establish Clinical Impact and Safety in Huntington’s Disease) is a confirmatory, global, 400-participant, randomized, double-blind, placebo-controlled study designed to further evaluate the efficacy and safety of pridopidine, an investigational medicinal product, in people living with Huntington’s disease (HD), from early to mid-stage disease (TFC 7-13).

Focused on generating data to further support regulatory evaluation, the study will assess the clinical effect of pridopidine on disease progression, functional capacity, motor function, cognition, speech and quality of life. It incorporates learnings from prior research, advice and input from the HD patient and research community, and regulatory authorities.

PRECISE-HD comprises two consecutive stages: a 52-week placebo-controlled stage, with participants randomized to receive either pridopidine or placebo on a 1:1 basis, followed by a 104-week open-label extension stage in which all eligible participants will receive pridopidine. The primary endpoint is the change from baseline to Week 52 in the combined Unified Huntington’s Disease Rating Scale (cUHDRS) score.

PRECISE-HD will be undertaken at up to 75 sites globally, including sites in the United States, European Union, United Kingdom and Canada. Further details are available at clinicaltrials.gov (NCT07609108) and clinicaltrialsregister.eu (2026-526093-16-00).

About Prilenia

Prilenia is a private biopharmaceutical company driven by an unwavering commitment to scientific excellence and accelerating progress for people affected by Huntington’s disease (HD), amyotrophic lateral sclerosis (ALS) and other neurodegenerative disorders. Our mission is simple but urgent: to develop and provide sustainable access to transformative medicines for people affected by devastating neurodegenerative diseases.

Prilenia is incorporated in the Netherlands and backed by leading life sciences investors.

Prilenia and Ferrer are partners in co-development and commercialisation of pridopidine.

For more information, please visit www.prilenia.com, and connect with us on LinkedIn, X or Instagram.

About Ferrer

At Ferrer, we use business to fight for social justice. We have long been a company that wants to do things differently; instead of maximizing shareholder returns, we reinvest much of our profit in initiatives that give back to society. Back where it belongs. We go beyond compliance and are guided by the highest standards of sustainability, ethics and integrity. As such, since 2022, we are a B Corp.

Founded in Barcelona in 1959, Ferrer offers transformative solutions for life-threatening diseases in more than one hundred countries. In line with our purpose, we have an increasing focus on pulmonary vascular and interstitial lung diseases and rare neurological disorders. Our 1,800-strong team is driven by a clear conviction: our business is not an end in itself, but a way to change lives.

We are Ferrer. Ferrer for good. www.ferrer.com

ⁱ In April 2025, Prilenia and Ferrer signed a commercialization and co-development agreement for pridopidine. https://news.prilenia.com/press-releases/press-release-details/2025/Prilenia-Enters-into-a-Collaboration-and-License-Agreement-with-Ferrer-for-the-Commercialization-and-Co-Development-of-Pridopidine-in-Europe-and-Other-Select-Markets/default.aspx
ⁱⁱ Eddings CR, Arbez N, Akimov S, Geva M, Hayden MR, Ross CA. Pridopidine protects neurons from mutant-huntingtin toxicity via the sigma-1 receptor. Neurobiol Dis. 2019 Sep;129:118-129. doi: 10.1016/j.nbd.2019.05.009. Epub 2019 May 17. PMID: 31108174; PMCID: PMC6996243.

ⁱⁱⁱ Myers RH. Huntington’s disease genetics. NeuroRx. 2004 Apr;1(2):255-62. doi: 10.1602/neurorx.1.2.255. PMID: 15717026; PMCID: PMC534940.)

^iv Pringsheim T, Wiltshire K, Day L, Dykeman J, Steeves T, Jette N. The incidence and prevalence of Huntington’s disease: a systematic review and meta-analysis. Mov Disord. 2012 Aug;27(9):1083-91. doi: 10.1002/mds.25075. Epub 2012 Jun 12. PMID: 22692795.

^v Medina et al., Prevalence and Incidence of Huntington’s Disease: An Updated Systematic Review and Meta-Analysis. Mov Disord. 2022 Dec;37(12):2327-2335.

^vi Jiang, A., Handley, R. R., Lehnert, K., & Snell, R. G. (2023). From Pathogenesis to Therapeutics: A Review of 150 Years of Huntington’s Disease Research. International Journal of Molecular Sciences, 24(16), 13021. https://doi.org/10.3390/ijms241613021
^vii EHDN. About Huntington’s Disease. April 2024. Available at: https://ehdn.org/about-hd/ (accessed April 2025).

^viii Petracca M, et al. Clinical and genetic characteristics of late-onset Huntington’s disease in a large European cohort. Eur J Neurol. 2022;29:1940–51. ​

^ix Mayo Clinic. Huntington’s disease. Available at: https://www.mayoclinic.org/diseases-conditions/huntingtons-disease/symptoms-causes/syc-20356117
^x Lachance V, Bélanger S-M, Hay C, Le Corvec V, Banouvong V, Lapalme M, Tarmoun K, Beaucaire G, Lussier MP, Kourrich S. Overview of Sigma-1R Subcellular Specific Biological Functions and Role in Neuroprotection. International Journal of Molecular Sciences. 2023; 24(3):1971. https://doi.org/10.3390/ijms24031971
^xi Goldberg YP, Navon-Perry L, Cruz-Herranz A, Chen K, Hecker-Barth G, Spiegel K, Cohen Y, Niethammer M, Tan AM, Schuring H, Geva M, Hayden MR. The Safety Profile of Pridopidine, a Novel Sigma-1 Receptor Agonist for the Treatment of Huntington’s Disease. CNS Drugs. 2025 May;39(5):485-498. doi: 10.1007/s40263-025-01171-x. Epub 2025 Mar 7. PMID: 40055280; PMCID: PMC11982116.

Contacts

Media Contacts:

Prilenia Contact
Rob Cohen, Head of Corporate Communications

rob.cohen@prilenia.com

Ferrer Contact

Alba Soler, Director of Communication

asolerc@ferrer.com

Bonerge Lifescience to Launch BonFusion™ and BonVesio™ Precision Delivery Platforms at SupplySide Global 2026




Bonerge Lifescience to Launch BonFusion™ and BonVesio™ Precision Delivery Platforms at SupplySide Global 2026

Preclinical data show 3x higher bioavailability for water-dispersible urolithin A; liposomal S-equol reaches >85% encapsulation efficiency, PDI <0.2

NEW YORK–(BUSINESS WIRE)–#Bioavailability–Bonerge Lifescience today announced BonFusion™ and BonVesio™, two complementary technology platforms designed to address formulation challenges associated with poorly water-soluble nutritional ingredients. The company will introduce the platforms at SupplySide Global 2026 in Las Vegas (October 28–30, Booth 7911-2), showcasing delivery solutions for urolithin A, fisetin and S-equol.

As the nutritional ingredients industry advances, formulation performance is becoming an increasingly important consideration alongside ingredient quality and dosage. Solubility, gastrointestinal stability, absorption and metabolism can all influence how an active compound behaves in the body. Bonerge’s two platforms address these challenges through molecule-specific delivery design and measurable formulation quality attributes.

BonFusion™: A molecule-first approach to delivery design

BonFusion™ evaluates the physicochemical properties and formulation challenges of individual ingredients to guide the selection and integration of complementary delivery technologies. Rather than relying on a single approach for every compound, the platform is designed to accommodate different ingredients and finished-product formats.

For urolithin A and fisetin, BonFusion™ incorporates the ingredients into lipid-based submicron dispersions designed to improve aqueous dispersibility and dissolution performance. Target particle sizes are approximately 200–300 nm, with formulations being developed for applications across capsules, tablets, sachets, oral liquids and beverages.

In a preclinical pharmacokinetic study, BonFusion™ water-dispersible urolithin A demonstrated threefold higher bioavailability than conventional urolithin A powder. These findings support further investigation of the formulation’s potential to improve oral delivery performance.

BonVesio™: Engineering measurable liposomal performance

BonVesio™ specializes in liposomal delivery systems, emphasizing the characterization of critical quality attributes rather than relying on the liposomal designation alone.

One application is BonVesio™ liposomal S-equol. S-equol, a bioactive metabolite of the soy isoflavone daidzein, presents formulation challenges related to its limited aqueous solubility.

The formulation features an encapsulation efficiency above 85%, with a particle size of 100–200 nm and a polydispersity index (PDI) below 0.2. These parameters reflect high encapsulation and a uniform vesicle size distribution, supporting systematic formulation characterization and quality control.

“Delivery performance should be evaluated through measurable parameters and appropriate supporting data,” said Orin Chou, R&D Director of Bonerge Lifescience. “Through BonFusion and BonVesio, we aim to give our partners a more systematic approach to formulation development, from selecting suitable delivery technologies to characterizing the resulting systems.”

Meet Bonerge at SupplySide Global 2026

Bonerge invites supplement brands, formulators and ingredient buyers to visit Booth 7911-2 to explore the two platforms, review supporting formulation data and discuss opportunities for next-generation nutritional products.

About Bonerge Lifescience

Bonerge Lifescience develops functional ingredients and advanced formulation solutions for the global nutrition and dietary supplement industries. Its portfolio spans healthy aging, women’s health, sleep and metabolic wellness, combining ingredient development, formulation technology and clinical research to support next-generation nutritional products.

Contacts

Media Contact
Cecilia Yang

sales@bonerge.com
www.bonerge.com

Ferrer and Prilenia Announce Authorization for EU Initiation of Confirmatory PRECISE-HD Study of Pridopidine in Huntington’s Disease




Ferrer and Prilenia Announce Authorization for EU Initiation of Confirmatory PRECISE-HD Study of Pridopidine in Huntington’s Disease

BARCELONA, Spain–(BUSINESS WIRE)–Ferrerⁱ and Prilenia Therapeutics B.V. today announced that the confirmatory Phase 3 PRECISE-HD study of investigational pridopidine in Huntington’s disease (HD) has received authorization to begin in participating EU Member States (EU CT number: 2026-526093-16-00, NCT07609108). Recruitment in the EU is expected to commence this month, joining currently recruiting sites in the US and UK, with Canada to follow.

Designed to evaluate the efficacy and safety of pridopidine (administered as an oral capsule twice a day), and to generate data for regulatory evaluation, the global, approximately 400-participant, randomized, double-blind, placebo-controlled PRECISE-HD study will assess the clinical effect of the investigational treatment on disease progression, functional capacity, motor function, cognition, speech and quality of life.

“The initiation of PRECISE-HD in Europe marks a milestone for the Huntington’s disease research community. This confirmatory Phase 3 study has been designed to build on learnings from previous research and to rigorously evaluate the efficacy and safety of pridopidine in people living with HD. As investigators, we look forward to working with participating centers and the HD community to generate robust evidence that can help us better understand the potential role of the study treatment in HD,” said Dr. Ralf Reilmann, Principal Investigator and member of the PRECISE-HD Steering Committee.

“For people living with Huntington’s disease and their families, every step toward a better understanding of the disease and potential treatment options matters. We welcome the involvement of European centers in PRECISE-HD and the continued focus on outcomes that reflect the realities and priorities of people living with HD and their families,” said Astri Arnesen, President of the European Huntington Association.

“At Ferrer, putting our purpose into practice also means taking on complex scientific challenges, while recognizing the uncertainty inherent in research. The authorization to initiate PRECISE-HD in participating EU Member States is a further step in our work with Prilenia. We approach that work with a clear sense of responsibility: to conduct research with integrity and let the evidence lead the way,” said Oscar Pérez, Chief Scientific Officer at Ferrer.

About HD

Huntington’s disease (HD) is a rare, inherited, autosomal dominant, neurodegenerative disease that results in functional, motor, cognitive and behavioral symptoms, and ultimately leads to death. HD is caused by a mutation in the huntingtin (HTT) geneⁱⁱ, and each child of a parent with HD has a 50 percent chance of developing the diseaseⁱⁱⁱ.

Across the world an estimated 100,000 people have HD^iv, with an additional 300,000 people at risk of developing HD^v,vi. It is usually diagnosed between the ages of 35 and 55^{vii viii}, although HD can occur at any age, including in children and young adults (known as juvenile onset HD or JHD). The disease progresses slowly over 10 to 30^ix years, with patients slowly losing their ability to work, communicate, manage day-to-day life and take care of themselves. This increasing disability leads to full reliance on a caregiver and, ultimately, death.

The only currently available treatments for HD focus on symptomatic relief and palliative care, with no approved therapies shown to impact measures of overall disease progression.

About pridopidine

Pridopidine is an investigational highly selective, oral sigma-1 receptor (S1R) agonist. S1R has been shown to play a role in stimulating multiple neuroprotective pathways impaired in neurodegenerative diseases, such as Huntington’s disease (HD) and amyotrophic lateral sclerosis (ALS)^x.

In clinical studies to date, pridopidine (taken as an oral capsule twice a day) has shown a generally favorable safety and tolerability profile, with data from more than 1,600 people (mostly from HD studies), some of whom have received active treatment for up to seven years^xi.

Pridopidine is currently in late-stage clinical development for HD and ALS. It has Orphan Drug Designation in HD and ALS in the US and EU, and FDA Fast Track designation in the US for the treatment of HD. These designations do not imply that pridopidine has been approved or that safety and efficacy have been established.

About the PRECISE-HD Study

PRECISE-HD (Pridopidine Phase 3 Study to Establish Clinical Impact and Safety in Huntington’s Disease) is a confirmatory, global, 400-participant, randomized, double-blind, placebo-controlled study designed to further evaluate the efficacy and safety of pridopidine, an investigational medicinal product, in people living with Huntington’s disease (HD), from early to mid-stage disease (TFC 7-13).

Focused on generating data to further support regulatory evaluation, the study will assess the clinical effect of pridopidine on disease progression, functional capacity, motor function, cognition, speech and quality of life. It incorporates learnings from prior research, advice and input from the HD patient and research community, and regulatory authorities.

PRECISE-HD comprises two consecutive stages: a 52-week placebo-controlled stage, with participants randomized to receive either pridopidine or placebo on a 1:1 basis, followed by a 104-week open-label extension stage in which all eligible participants will receive pridopidine. The primary endpoint is the change from baseline to Week 52 in the combined Unified Huntington’s Disease Rating Scale (cUHDRS) score.

PRECISE-HD will be undertaken at up to 75 sites globally, including sites in the United States, European Union, United Kingdom and Canada. Further details are available at www.clinicaltrials.gov (NCT07609108), www.clinicaltrialsregister.eu/ (EU CT number: 2026-526093-16-00).

About Ferrer

At Ferrer, we use business to fight for social justice. We have long been a company that wants to do things differently; instead of maximizing shareholder returns, we reinvest much of our profit in initiatives that give back to society. Back where it belongs. We go beyond compliance and are guided by the highest standards of sustainability, ethics and integrity. As such, since 2022, we are a B Corp.

Founded in Barcelona in 1959, Ferrer offers transformative solutions for life-threatening diseases in more than one hundred countries. In line with our purpose, we have an increasing focus on rare pulmonary and neurological diseases. Our 1,800-strong team is driven by a clear conviction: our business is not an end in itself, but a way to change lives.

We are Ferrer. Ferrer for good. www.ferrer.com

ⁱ In April 2025, Prilenia and Ferrer signed a commercialization and co-development agreement for pridopidine. https://news.prilenia.com/press-releases/press-release-details/2025/Prilenia-Enters-into-a-Collaboration-and-License-Agreement-with-Ferrer-for-the-Commercialization-and-Co-Development-of-Pridopidine-in-Europe-and-Other-Select-Markets/default.aspx
ⁱⁱ Eddings CR, Arbez N, Akimov S, Geva M, Hayden MR, Ross CA. Pridopidine protects neurons from mutant-huntingtin toxicity via the sigma-1 receptor. Neurobiol Dis. 2019 Sep;129:118-129. doi: 10.1016/j.nbd.2019.05.009. Epub 2019 May 17. PMID: 31108174; PMCID: PMC6996243.

ⁱⁱⁱ Myers RH. Huntington’s disease genetics. NeuroRx. 2004 Apr;1(2):255-62. doi: 10.1602/neurorx.1.2.255. PMID: 15717026; PMCID: PMC534940.)

^iv Pringsheim T, Wiltshire K, Day L, Dykeman J, Steeves T, Jette N. The incidence and prevalence of Huntington’s disease: a systematic review and meta-analysis. Mov Disord. 2012 Aug;27(9):1083-91. doi: 10.1002/mds.25075. Epub 2012 Jun 12. PMID: 22692795.

^v Medina et al., Prevalence and Incidence of Huntington’s Disease: An Updated Systematic Review and Meta-Analysis. Mov Disord. 2022 Dec;37(12):2327-2335.

^vi Jiang, A., Handley, R. R., Lehnert, K., & Snell, R. G. (2023). From Pathogenesis to Therapeutics: A Review of 150 Years of Huntington’s Disease Research. International Journal of Molecular Sciences, 24(16), 13021. https://doi.org/10.3390/ijms241613021
^vii EHDN. About Huntington’s Disease. April 2024. Available at: https://ehdn.org/about-hd/ (accessed April 2025).

^viii Petracca M, et al. Clinical and genetic characteristics of late-onset Huntington’s disease in a large European cohort. Eur J Neurol. 2022;29:1940–51. ​

^ix Mayo Clinic. Huntington’s disease. Available at: https://www.mayoclinic.org/diseases-conditions/huntingtons-disease/symptoms-causes/syc-20356117
^x Lachance V, Bélanger S-M, Hay C, Le Corvec V, Banouvong V, Lapalme M, Tarmoun K, Beaucaire G, Lussier MP, Kourrich S. Overview of Sigma-1R Subcellular Specific Biological Functions and Role in Neuroprotection. International Journal of Molecular Sciences. 2023; 24(3):1971. https://doi.org/10.3390/ijms24031971
^xi Goldberg YP, Navon-Perry L, Cruz-Herranz A, Chen K, Hecker-Barth G, Spiegel K, Cohen Y, Niethammer M, Tan AM, Schuring H, Geva M, Hayden MR. The Safety Profile of Pridopidine, a Novel Sigma-1 Receptor Agonist for the Treatment of Huntington’s Disease. CNS Drugs. 2025 May;39(5):485-498. doi: 10.1007/s40263-025-01171-x. Epub 2025 Mar 7. PMID: 40055280; PMCID: PMC11982116.

Contacts

Ferrer media:

Alba Soler, Director of Communication

asolerc@ferrer.com
Paula Bonet

pbonetg@ferrer.com