The Emergence of Blood Purification Devices to Treat Cardiovascular Disease

Sigyn Therapeutics, Inc.

/ Key word(s): Manufacturing

The Emergence of Blood Purification Devices to Treat Cardiovascular Disease

06.01.2026 / 22:54 CET/CEST

The issuer is solely responsible for the content of this announcement.


Dear Readers, 

For more than a century, cardiovascular disease has been the leading cause of death in the United States.

While single-target drugs have been a therapeutic focal point, cardiovascular disease is fueled by a multitude of circulating factors, including inflammatory and cholesterol targets that are not addressed with drug therapies.

While not broadly recognized, multi-target blood purification devices to lower LDL-cholesterol (LDL-C) and Lipoprotein(a) levels, otherwise known as Lipoprotein Apheresis, can reduce major adverse cardiovascular events (MACE) by 75-95% (American Heart Association). Whereas, LDL-C lowering statins, (e.g., Lipitor, Crestor), the leading class of drugs to treat cardiovascular disease, are limited to average MACE reductions of 25%.

When considering this variance between device and drug treatment benefit, Lipoprotein Apheresis provides compelling efficacy evidence that supports the clinical advancement of CardioDialysis. 

As compared to Lipoprotein Apheresis, CardioDialysis addresses a wider range of cardiovascular disease targets and is supported by a vastly larger global delivery infrastructure.  

In additional to targeting LDL-C and Lipoprotein(a), in vitro studies of CardioDialysis have demonstrated its ability to address a broad-spectrum of inflammatory factors that are also implicated in cardiovascular disease progression.

In regard to global delivery infrastructure, CardioDialysis is deployed for use on dialysis machines already located in hospitals and clinics around the world.  This is an important strategic advantage as the delivery of Lipoprotein Apheresis is limited to plasma separation machines located in specialized apheresis centers.  

To provide some perspective, there are more than 7,500 dialysis clinics in the United States, while geographical access to Lipoprotein Apheresis is limited to fewer than 60 apheresis center locations. Globally, there are approximately 50,000 dialysis clinics, yet less than 800 apheresis center locations.

Regardless of distribution constraint, the demand for Lipoprotein Apheresis continues to grow. The global market for the therapy was estimated at $300 million in 2024 and is projected to reach $650 million in 2033. Thus, further supporting our rationale to clinically advance CardioDialysis. 

Beyond our strategic distribution advantage, the deployment of CardioDialysis on dialysis machines provides an early clinical opportunity to address cardiovascular disease in end-stage renal disease (ESRD) patients who rely on kidney dialysis for survival.

Globally, more than four million ESRD patients receive approximately 640 million dialysis treatments each year.  Once on dialysis, their median length of survival is 3-5 years. Cardiovascular disease accounts for approximately 67% of ESRD patient deaths.

Unfortunately, drug therapies have not been found to improve survival or reduce cardiovascular events in this patient population.  As a result, the treatment of cardiovascular disease in ESRD patients remains a significant unmet need in global health. 

Unlike Lipoprotein Apheresis, CardioDialysis can be conveniently administered during regularly scheduled dialysis treatments to combat cardiovascular disease progression. Beyond providing potential patient benefit, CardioDialysis could have a significant impact on dialysis industry revenues.  In the United States, there is an estimated 550,00 ESRD patients on dialysis.  Extending the lives of these patients by just one month would boost top-line U.S. dialysis industry revenues by approximately $2.8 billion. What if the lives of ESRD patients could be extended by years? 

Our clinical plan to initially treat cardiovascular disease in ESRD patients is far more than a niche market opportunity.  Consider that the $300 million market for Lipoprotein Apheresis in 2024 was based on the treatment of approximately 5,500 individuals worldwide. That number is the equivalent of just 1% of the U.S. dialysis patient population and slightly more than 1/10th of one percent of the global population of ESRD patients on dialysis. 

Now consider that a vast majority of ESRD dialysis patients suffer from cardiovascular disease; approximately two thirds will die from the condition; and drug therapies provide little if any benefit. Thus, further reinforcing the potential value of CardioDialysis. 

Thank you for reading my note. If you have questions or comments, please reach out at jj@sigyntherapeutics.com

Sincerely, Jim 

About Sigyn Therapeutics™

Sigyn Therapeutics is developing dialysis-like therapies to address cardiovascular disease and cancer. The Company’s therapeutic candidates are designed to improve and extend the quality of patient lives, and their successful clinical advancement offers to provide strategic value to the dialysis and biopharmaceutical industry.

Sigyn CardioDialysis™ is a first-in-industry medical device to treat cardiovascular disease, the leading cause of death globally. CardioDialysis™ aims to reduce the circulating presence of inflammatory molecules that fuel cardiovascular disease progression while simultaneously lowing levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE). Based on its broad-spectrum mechanism, CardioDialysis™ offers to reduce the incidence of MACE by overcoming the inherent limitations of single-target drugs.

The Company’s development pipeline is comprised of ImmunePrep™ to optimize the delivery of immunotherapeutic antibodies to treat cancer; ChemoPrep™ to enhance the targeted delivery of chemotherapy; and ChemoPure™ to reduce the toxicity of chemotherapy.

To learn more about Sigyn Therapeutics, visit: www.SigynTherapeutics.com

CONTACT:
Sigyn Therapeutics, Inc.
Jim Joyce
Inventor CEO
Email: jj@SigynTherapeutics.com

Cautionary Note Regarding Forward-Looking Statements

This information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties. All statements contained in this summary are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as “may,” “believe,” “anticipate,” “expect,” “intend,” “plan,” “project,” “will,” “projections,” “estimate,” “potentially” or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties, and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Sigyn’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences may include, without limitation, the Company’s ability to clinically advance Sigyn Therapy in human studies required for market clearance, the Company’s ability to manufacture Sigyn Therapy, the Company’s ability to raise capital resources, and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K, and in the Company’s other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this report speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

 

News Source: Sigyn Therapeutics, Inc.


06.01.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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2255686  06.01.2026 CET/CEST

aap successfully places a 5.7% capital increase from authorised capital at EUR 1.34, excluding subscription rights

aap Implantate AG

/ Key word(s): Capital Increase

aap successfully places a 5.7% capital increase from authorised capital at EUR 1.34, excluding subscription rights

06.01.2026 / 10:00 CET/CEST

The issuer is solely responsible for the content of this announcement.


  • The cash inflow will strengthen investments in the approval of innovative antibacterial implant technology

aap Implantate AG (“aap” or “Company”) successfully completed the 5.7% capital increase announced on 4 December 2025, excluding subscription rights, at a placement price of EUR 1.34. This will provide the Company with cash proceeds of EUR 1,056,121.00. This cash inflow will strengthen investments in the approval costs for the innovative antibacterial implant technology. The capital increase was oversubscribed.

 

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aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German stock exchanges –

 

About aap Implantate AG

aap Implantate AG is a global medical technology company based in Berlin, Germany. The company develops, manufactures and markets products for traumatology. In addition to the innovative LOQTEQ® anatomical plate system, its IP-protected portfolio includes a wide range of screw plates. Furthermore, aap Implantate AG has an innovation pipeline with promising development projects, such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical problems in traumatology that have not yet been adequately solved. aap Implantate AG sells its products in Germany directly to hospitals, purchasing groups and hospital networks, while at the international level it primarily uses a broad network of distributors in around 31 countries. In the USA, the company relies on a sales strategy via distribution agents through its subsidiary aap Implants Inc. The shares of aap Implantate AG are listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at www.aap.de.

The figures presented in this press release may contain technical rounding differences that do not affect the overall statement.

 

Forward-looking statements

This press release may contain forward-looking statements based on the current expectations, assumptions and forecasts of the Management Board and the information currently available to it. Forward-looking statements are not guarantees of future developments and results. Various known and unknown risks, uncertainties and other factors could lead to the actual results, financial position, development or performance of the company differing materially from the estimates given here. These factors also include those described by aap in published reports. Forward-looking statements are therefore only valid on the day they are made. We undertake no obligation to update the forward-looking statements made in this announcement or to adapt them to future events or developments.

 

If you have any questions, please contact: aap Implantate AG; Rubino Di Girolamo, Chairman of the Executive Board/CEO, Lorenzweg 5; 12099 Berlin

Tel.: +49 (0)30 75019 – 170 ; Fax : +49 (0)30 75019 – 290 ; Email : r.digirolamo@aap.de

 


06.01.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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Language: English
Company: aap Implantate AG
Lorenzweg 5
12099 Berlin
Germany
Phone: +49 (0) 30 75 019-0
Fax: +49 (0) 30 75 019-111
E-mail: info@aap.de
Internet: www.aap.de
ISIN: DE000A3H2101
WKN: A3H210
Listed: Regulated Market in Frankfurt (General Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 2254990

 
End of News EQS News Service

2254990  06.01.2026 CET/CEST

Newron Further Expands Intellectual Property Portfolio for Evenamide with New EU Composition of Matter Patent

Newron Pharmaceuticals S.p.A.

/ Key word(s): Patent

Newron Further Expands Intellectual Property Portfolio for Evenamide with New EU Composition of Matter Patent

06.01.2026 / 07:00 CET/CEST

The issuer is solely responsible for the content of this announcement.


Newron Further Expands Intellectual Property Portfolio for Evenamide with New EU Composition of Matter Patent

EP4615820 – “Crystalline Forms of Evenamide” is expected to extend asset exclusivity in EU into 2044

  • Evenamide is currently being investigated in Newron’s global ENIGMA-TRS Phase III development program, enrolling at least 1,000 schizophrenia patients with topline results expected in Q4-2026
  • Evenamide is a first-in-class glutamate modulator with a novel mechanism of action for patients who do not respond adequately, or are resistant to, existing antipsychotic therapies
  • ENIGMA-TRS program aims to establish evenamide as the first approved add-on therapy for treatment resistant schizophrenia (TRS), a patient population with high morbidity and mortality

Milan, Italy, and Morristown, NJ, USA, January 6, 2026, 07:00 am CET Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced that the European Patent Office (EPO) has issued the decision to grant an additional patent covering its lead development compound, evenamide. This composition of matter patent EP4615820 claims crystalline forms of evenamide, processes for their preparation, and their uses. The patent has a scheduled term of 2044.

“This European Patent Office decision is evidence of our comprehensive strategy to continuously strengthen the intellectual property protecting our key assets,” stated Elena Barbanti, Newron’s Senior Director Intellectual Property (IP).

Stefan Weber, Newron’s CEO, added: “This is an important milestone for Newron and a testament to the outstanding work of our IP team. We expect this new patent will extend the exclusivity runway for evenamide, supporting our efforts to maximize its therapeutic and commercial potential. This drug candidate, which is currently progressing through pivotal clinical studies, has the potential to become the first add-on therapy for schizophrenia patients who do not respond adequately, or are resistant to, existing antipsychotic therapies, in our assessment constituting the vast majority of patients suffering from schizophrenia.”

Newron has completed the entry into national phases for counterpart patent applications to EP4615820 in all key countries. This new composition of matter patent adds to the current extensive IP protection around evenamide.

About treatment-resistant schizophrenia (TRS)

A significant proportion of patients with schizophrenia show virtually little to no beneficial response to currently available antipsychotic (AP) treatments, leading to a diagnosis of treatment-resistant schizophrenia (TRS). TRS is defined as no or inadequate symptom relief despite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period. It is estimated that approximately 15% of patients develop TRS from the onset of illness, and about one-third to 50% of patients with schizophrenia overall. Emerging scientific evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, to explain the lack of clinical benefit of most typical and atypical antipsychotics, which act primarily on dopamine receptors. These insights underline the need for novel therapeutic approaches that target the underlying glutamatergic dysfunction in schizophrenia, offering hope for patients who currently have limited or no effective treatment options.

About evenamide

Evenamide is a novel, orally available new chemical entity with a unique mechanism of action distinct from all currently marketed antipsychotics. It acts by selectively blocking voltage-gated sodium channels (VGSCs) and exhibits no biological activity at more than 130 other central nervous system (CNS) targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of subtherapeutic doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide meaningful benefits for patients who do not adequately respond to current APs, including those on clozapine. A recent study conducted at University of Pittsburg suggests that evenamide’s efficacy in downregulating the hyperdopaminergic state, social deficits, and memory impairment may result from its ability to attenuate vHipp hyperexcitability (Neuropsychopharmacology; https://doi.org/10.1038/s41386-025-02188-y). Importantly, the benefits seemed to persist for a substantial time after evenamide had been degraded, also suggesting neural plasticity possibly explaining accumulating long-term effects observed in clinical studies 014/015. While the exact causes of TRS are complex and multifactorial, hippocampal dysfunction rooted in impaired neural plasticity is considered a strong contributing factor. Through its novel glutamatergic modulation, evenamide represents a first-in-class approach aimed at addressing the unmet needs of patients with schizophrenia who are resistant to existing treatments.

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of innovative therapies for patients with diseases of the central and peripheral nervous system. Headquartered in Bresso near Milan, Italy, the Company has a strong track record of advancing neuroscience-based treatments from discovery to market. Newron’s lead compound, evenamide, is a first-in-class glutamate modulator and has the potential to be the first add-on therapy for treatment-resistant schizophrenia (TRS) and for poorly responding patients with schizophrenia. Evenamide is currently developed in the global pivotal ENIGMA-TRS Phase III development program. Clinical trial results to date demonstrate the benefits of this drug candidate in the TRS as well as poorly responding patient population, with significant improvements across key efficacy measures increasing over time, as well as a favorable safety profile, which is uncommon for available antipsychotic medications. Newron has signed development and commercialization agreements for evenamide with EA Pharma (a subsidiary of Eisai) for Japan and other Asian territories, as well as Myung In Pharm for South Korea. Newron’s first marketed product, Xadago®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea. The product is commercialized by Newron’s partner Zambon, with Supernus Pharmaceuticals holding marketing rights in the U.S., and Meiji Seika responsible for development and commercialization in Japan and other key Asian territories. For more information, please visit: www.newron.com

For more information, please contact:

Newron
Stefan Weber – CEO; +39 02 6103 46 26, pr@newron.com

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting; +44 20 3727 1000, SCnewron@fticonsulting.com 

Switzerland
Valentin Handschin, IRF; +41 43 244 81 54, handschin@irf-reputation.ch

Germany/Europe
Anne Hennecke / Maximilian Schur, MC Services; +49 211 52925227, newron@mc-services.eu

USA
Paul Sagan, LaVoieHealthScience; +1 617 865 0041, psagan@lavoiehealthscience.com

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron’s strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron’s research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.


06.01.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
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The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Newron Pharmaceuticals S.p.A.
via Antonio Meucci 3
20091 Bresso
Italy
Phone: +39 02 610 3461
Fax: +39 02 610 34654
E-mail: pr@newron.com
Internet: www.newron.com
ISIN: IT0004147952
WKN: A0LF18
Listed: Regulated Unofficial Market in Dusseldorf (Primärmarkt); SIX
EQS News ID: 2254824

 
End of News EQS News Service

2254824  06.01.2026 CET/CEST

Mainz Biomed Provides Review of 2025 Highlights

Issuer: Mainz BioMed N.V.

/ Key word(s): Miscellaneous

Mainz Biomed Provides Review of 2025 Highlights

05.01.2026 / 14:15 CET/CEST

The issuer is solely responsible for the content of this announcement.


Mainz Biomed Provides Review of 2025 Highlights

Initiation of eAArly DETECT 2 – U.S. Clinical Study to Evaluate Performance of Next Generation Test on Advanced Adenomas over Large Patient Population in Preparation for ReconAAsense U.S. FDA Pivotal Trial

Results from Feasibility Study of Biomarker Panel in Pancreatic Cancer Project Study Demonstrated a Sensitivity of 100% and Specificity of 95%

BERKELEY, US – MAINZ, Germany – January 5, 2026 — Mainz Biomed N.V. (NASDAQ:MYNZ) (“Mainz Biomed” or the “Company”), a molecular genetics diagnostic company specializing in the early detection of cancer, today reviewed its major accomplishments for the year ended December 31, 2025. The Company expects to release its year-end financial results in March 2026.

Key Highlights During 2025

Colorectal Cancer Business Highlights

  • Mainz Biomed launched eAArly DETECT 2, a US feasibility study to evaluate the Company’s next generation colorectal cancer (CRC) test, integrating its proprietary mRNA biomarkers, AI developed algorithm and FIT test, over a population of approximately 2,000 patients, all of average risk, to validate the leading results of previous feasibility studies, which included average risk and identified risk patients.
  • ColoAlert®, the Company’s DNA-based colorectal cancer (CRC) screening test, received official registration with the Medicines and Healthcare products Regulatory Agency (MHRA) and is now authorized for marketing in the United Kingdom.
  • ColoAlert® has also been officially registered and approved for distribution by Swissmedic, the Swiss regulatory and supervisory authority for medicinal products and medical devices.
  • The Company entered into a strategic partnership with labor team w ag, a renowned diagnostic laboratory based in Goldach, Switzerland. This collaboration introduces ColoAlert®, a DNA-based colorectal cancer screening test to the Swiss market for the very first time, marking Mainz Biomed’s initial footprint in Switzerland.
  • Mainz Biomed signed a Memorandum of Understanding (“MOU”) with OncoVanguard8, a distributor of oncological innovations. The collaboration aims to introduce ColoAlert® to South America, starting with Peru.
  • Mainz Biomed collaborated with CARE diagnostica Laborreagenzien GmbH (“CARE”). CARE is currently working with more than 15 statutory health insurance companies as part of special online-based screening concepts based on the widely used fecal immunochemical test (FIT). Thanks to the cooperation with Mainz Biomed, the range of services for risk groups could potentially be expanded to include the ColoAlert® test, which uses molecular genetic analysis of biomarkers in stool using PCR to increase the detection rate, particularly in the early stages of the disease.
  • Mainz Biomed also announced that ColoAlert® has been added to the portfolio of DoctorBox, one of Germany’s leading pioneers in digital health. This marks another important milestone in Mainz Biomed’s European growth strategy and highlights the increasing importance of innovative, personalized solutions in preventive medicine. Laboratory analysis will be performed by Mainz Biomed’s long-standing partner, the European Oncology Lab, led by Dr. med. Annette Buhlmann in St. Ingbert, Germany.

Pancreatic Cancer Business Highlights

  • In March 2025 the Company entered into a License and Option Agreement with Liquid Biosciences (“Liquid”) to access a portfolio of novel mRNA biomarkers for the non-invasive detection of pancreatic cancer with a blood test. The parties, under the Agreement, plan to develop this blood-based test for potential future FDA applications. The discovery process included multiple independent pancreatic cancer study cohorts. Liquid used their proprietary EMERGE platform to identify a panel of clinically relevant mRNA biomarkers from a blood-based cohort of 285 subjects with 35 pancreatic cancer patients. In the analysis, the biomarkers coupled with the proprietary algorithm developed by Liquid achieved overall sensitivity of 95% and a 98% specificity for the detection of pancreatic cancer. If the statistical results are replicable after the integration into a new product, it has the potential to ultimately position Mainz Biomed’s test to be the most robust and accurate screening test for pancreatic cancer on the market.
  • In October 2025 the Company announced positive topline results from its feasibility study, examining a non-invasive blood-based screening test for the early detection of pancreatic cancer, initiated earlier in 2025. The study confirmed the strong clinical accuracy and utility of licensed proprietary biomarkers from Liquid Biosciences for developing an innovative screening test for pancreatic cancer. Researchers evaluated 18 licensed biomarkers across multiple candidate panels to streamline assay complexity. The leading panel achieved 100% sensitivity and 95% specificity, successfully distinguishing pancreatic cancer patients from healthy controls in a 30-subject cohort, reflecting different stages of the disease as well as precursors.
  • Mainz Biomed announced that its pancreatic cancer project will receive public funding from the Investitions- und Strukturbank Rheinland-Pfalz (ISB), the development bank of the German federal state of Rheinland-Pfalz. Under the ISB’s Innovation and Technology Support Program (Innovations- und Technologieförderungsprogramm), the state will fund up to 50% of the project’s total costs. This direct governmental support represents a strong endorsement of the scientific and societal value of the Company’s non-invasive, blood-based screening test for the early detection of pancreatic cancer and will accelerate its development.

“I’m extremely pleased with the achievements of our team during 2025 as we advance our ambitious growth strategy, driven by our eAArly DETECT 2 study and continued progress in our pancreatic cancer screening program,” commented Guido Baechler, Chief Executive Officer of Mainz Biomed. “Looking ahead to the first half of 2026, we expect to complete our eAArly DETECT 2 feasibility study, which will be the launching point for our ReconAAsense US FDA pivotal colorectal cancer study in 2026, and to announce our next steps in advancing our blood-based screening test for the early detection of pancreatic cancer.”

Please visit Mainz Biomed’s official website for investors at mainzbiomed.com/investors/ for more information

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About Mainz Biomed NV
Mainz Biomed develops market-ready molecular genetic diagnostic solutions for life-threatening conditions. The Company’s flagship product is ColoAlert®, an accurate, non-invasive and easy-to-use, early-detection diagnostic test for colorectal cancer. ColoAlert® is marketed across Europe. The Company is currently running its eAArly DETECT 2 clinical study in preparation for its pivotal FDA study for US regulatory approval. Mainz Biomed’s product candidate portfolio also includes PancAlert, an early-stage pancreatic cancer screening test based on real-time Polymerase Chain Reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in blood and stool samples. To learn more, visit mainzbiomed.com or follow us on LinkedIn, Twitter and Facebook.

For media inquiries as to Mainz Biomed:

MC Services AG
Maximilian Schur / Simone Neeten
+49 211 529252 20
mainzbiomed@mc-services.eu

For investor inquiries, please contact ir@mainzbiomed.com 

Forward-Looking Statements
Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements reflect the current analysis of existing information and are subject to various risks and uncertainties. As a result, caution must be exercised in relying on forward-looking statements. Due to known and unknown risks, actual results may differ materially from the Company’s expectations or projections. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: (i) the failure to meet projected development and related targets; (ii) changes in applicable laws or regulations; (iii) the effect of the COVID-19 pandemic on the Company and its current or intended markets; and (iv) other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in other reports and other public filings with the Securities and Exchange Commission (the “SEC”) by the Company. Additional information concerning these and other factors that may impact the Company’s expectations and projections can be found in its initial filings with the SEC, including its annual report on Form 20-F filed on March 31, 2025 and its mid-year report on Form 6-K filed on September 26, 2025. The Company’s SEC filings are available publicly on the SEC’s website at www.sec.gov. Any forward-looking statement made by us in this press release is based only on information currently available to Mainz Biomed and speaks only as of the date on which it is made. Mainz Biomed undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, except as required by law.


Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

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Language: English
Company: Mainz BioMed N.V.
Robert-Koch-Strasse 50
55129 Mainz
Germany
Internet: mainzbiomed.com
EQS News ID: 2254080

 
End of News EQS News Service

O3 Holding GmbH (KD Pharma Group) acquires food-grade oil business from dsm- firmenich financed through shareholder loan

O3 Holding GmbH / Key word(s): Miscellaneous

O3 Holding GmbH (KD Pharma Group) acquires food-grade oil business from dsm- firmenich financed through shareholder loan

02-Jan-2026 / 08:30 CET/CEST

Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News – a service of EQS Group.

The issuer is solely responsible for the content of this announcement.


Disclosure of an inside Information under Article 17 of Regulation (EU) No 5G6/2014

 

O3 Holding GmbH (KD Pharma Group) acquires food-grade oil business from dsm- firmenich financed through shareholder loan

BEXBACH, GERMANY – 31 December 2025 – Today, O3 Holding GmbH (the Company), the holding company of KD Pharma Group, through its subsidiary KD Swiss GmbH, signed agreements with dsm-firmenich to acquire the distribution and supply of the

food-grade oil business from dsm-firmenich. The acquisition will be financed through a shareholder loan.

Closing of the transaction is expected for today and not subject to any condition’s precedent.

 

ABOUT KD PHARMA GROUP

KD Pharma Group is a CDMO that creates health solutions in the pharmaceutical and nutraceutical space. It is also the worldwide leading producer Omega-3 fatty acids for the pharmaceutical and nutraceutical markets, formulation and encapsulation

services, with about 700 employees and a presence in Norway, Germany, Switzerland, Canada, Peru and the US. The KD Pharma Group employs state-of-the-art technology which is protected by numerous patents. Visit www.kdpharmagroup.com to learn more.

IMPORTANT INFORMATION

This release contains forward-looking statements. These statements are based on plans, estimates and projections currently available to KD Pharma Group. Forward- looking statements therefore speak only as of the date they are made. KD Pharma

Group assumes no obligation to update such statements in light of new information or future events. By their nature, forward-looking statements involve risks and

uncertainties. A variety of important factors could cause actual results to differ materially from those in forward-looking statements.

End of Inside Information


02-Jan-2026 CET/CEST The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: O3 Holding GmbH
Am Kraftwerk 6
66450 Bexbach
Germany
Phone: +49 (0)68 26 97 97 00
E-mail: investor.relations@kdpharmagroup.com
Internet: https://kdpharmagroup.com
ISIN: NO0013360552
WKN: A383V0
Listed: Regulated Unofficial Market in Frankfurt
EQS News ID: 2253476

 
End of Announcement EQS News Service

2253476  02-Jan-2026 CET/CEST

Evotec appoints Dr. Sarah Fakih as EVP, Head of Global Communications and Investor Relations

Evotec SE

/ Key word(s): Personnel

Evotec appoints Dr. Sarah Fakih as EVP, Head of Global Communications and Investor Relations

01.01.2026 / 07:30 CET/CEST

The issuer is solely responsible for the content of this announcement.


Evotec appoints Dr. Sarah Fakih as EVP, Head of Global Communications and Investor Relations

  • Creation of new Executive Vice President role integrating Global Communications and Investor Relations to strengthen strategic messaging and stakeholder alignment

Hamburg, Germany, January 1, 2026:
Evotec SE (NASDAQ: EVO; Frankfurt Prime Standard: EVT) today announced the appointment of Dr. Sarah Fakih as Executive Vice President, Head of Global Communications and Investor Relations. In this strategic role, Dr. Fakih will lead Evotec’s newly integrated Global Communications and Investor Relations function.

Reporting directly to CEO Dr. Christian Wojczewski, she will bring together both teams to strengthen alignment, clarity and engagement across stakeholders. The integration of Communications and Investor Relations supports Evotec’s focus on a clear and consistent articulation of its strategy, scientific leadership and value creation. The appointment follows the departure of Volker Braun, who successfully led Evotec’s Investor Relations and ESG function over the past five years.

Dr. Christian Wojczewski, Chief Executive Officer of Evotec, said: “Clear and credible communication is essential as we continue to execute our strategy. Sarah’s extensive experience across science, investor relations and corporate communications makes her ideally suited to this role. I would like to thank Volker for his dedicated contributions to our investor relations and ESG during the past five years and wish him all the best for the future.”

Dr. Fakih brings more than 15 years of experience in life sciences, with a strong leadership track record in capital markets strategy and corporate messaging. She has held senior roles at U.S. listed companies, including QIAGEN, MorphoSys, and most recently at CureVac. She holds a PhD in Chemistry.

 

About Evotec SE
Evotec is a life science company that is pioneering the future of drug discovery and development. By integrating breakthrough science with AI-driven innovation and advanced technologies, we accelerate the journey from concept to cure — faster, smarter, and with greater precision.

Our expertise spans small molecules, biologics, cell therapies and associated modalities, supported by proprietary platforms such as Molecular Patient Databases, PanOmics and iPSC-based disease modeling.

With flexible partnering models tailored to our customers’ needs, we work with all Top 20 Pharma companies, over 800 biotechs, academic institutions, and healthcare stakeholders. Our offerings range from standalone services to fully integrated R&D programs and long-term strategic partnerships, combining scientific excellence with operational agility.

Through Just – Evotec Biologics, we redefine biologics development and manufacturing to improve accessibility and affordability.

With a strong portfolio of over 100 proprietary R&D assets, most of them being co-owned, we focus on key therapeutic areas including oncology, cardiovascular and metabolic diseases, neurology, and immunology.

Evotec’s global team of more than 4,800 experts operates from sites in Europe and the U.S., offering complementary technologies and services as synergistic centers of excellence. Learn more at www.evotec.com and follow us on LinkedIn and X/Twitter @Evotec.

Forward-looking statements
This announcement contains forward-looking statements concerning future events, including the proposed offering and listing of Evotec’s securities. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and variations of such words and similar expressions are intended to identify forward-looking statements. Such statements include comments regarding Evotec’s expectations for revenues, Group EBITDA and unpartnered R&D expenses. These forward-looking statements are based on the information available to, and the expectations and assumptions deemed reasonable by Evotec at the time these statements were made. No assurance can be given that such expectations will prove to have been correct. These statements involve known and unknown risks and are based upon a number of assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond the control of Evotec. Evotec expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Evotec’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.

 

For further information, please contact:

Investor Relations and Media Contact

Dr. Sarah Fakih
EVP Head of Global Communications & Investor Relations
Sarah.Fakih@evotec.com


01.01.2026 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Evotec SE
Manfred Eigen Campus / Essener Bogen 7
22419 Hamburg
Germany
Phone: +49 (0)40 560 81-0
Fax: +49 (0)40 560 81-222
E-mail: info@evotec.com
Internet: www.evotec.com
ISIN: DE0005664809
WKN: 566480
Indices: SDAX, TecDAX
Listed: Regulated Market in Berlin, Frankfurt (Prime Standard); Regulated Unofficial Market in Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange; Nasdaq
EQS News ID: 2252248

 
End of News EQS News Service

2252248  01.01.2026 CET/CEST

Update on Ongoing Transactions with Pharmaceutical Company Grupo Landsteiner and the NASDAQ Listing of VERAXA Biotech AG

Grupo Landsteiner

Xlife Sciences AG today announced, following the completion of its internal information processes, the twelve project companies that will be partnered with Grupo Landsteiner. The transaction establishes a company with a scalable structure that combines an innovative portfolio with industrial expertise and is designed to accelerate the development and partnering of the projects.

As part of the transaction, the technology platform companies Inventum Genetics GmbH and inflamed pharma GmbH; the biotechnology and therapy companies alytas therapeutics GmbH, Baliopharm AG, Lysatpharma GmbH and Firstgene Life Sciences GmbH; the medical technology companies Axenoll Life Sciences AG, novaxomx GmbH, saniva diagnostics GmbH, x-kidney diagnostics GmbH and x-nuclear diagnostics GmbH; and the artificial intelligence focused company FUSE-AI AG will be partnered.

Xlife Sciences AG and Grupo Landsteiner are currently working together to define the corporate and legal structure of the US company to be established. In parallel, the required accounting, organizational and regulatory frameworks are being implemented to support a planned NASDAQ listing in 2026.

The transaction is not expected to result in any operational changes for the involved project companies. All parties involved welcome the additional expertise, industrial experience and international reach that Grupo Landsteiner is expected to contribute to the respective project companies.

 

VERAXA Biotech AG

VERAXA Biotech AG has successfully resolved all outstanding matters with the commercial register and the auditors. The distribution of invitations for the extraordinary general meeting is planned for January 2026. In the meantime, the VERAXA team is looking forward to a full and engaging schedule surrounding the JP Morgan Health Care Conference in San Francisco.

Oliver R. Baumann, CEO of Xlife Sciences AG, commented: «Both transactions represent major milestones for Xlife Sciences AG. The entire team is working with full commitment to ensure the fastest possible execution. We look ahead to 2026 and would like to thank our shareholders, partners and colleagues for the trust they have placed in us.»

 

Financial calendar

Annual Report 2025                                                                                      28 April 2026

Annual Shareholders Meeting 2026                                                              26 June 2026

Half-Year Report 2026                                                                                   24 September 2026

 

Contact

Information for investors and journalists: Xlife Sciences AG, Dr. Dennis Fink, dennis.fink@xlifesciences.ch

Uni-Bio Science Joins Forces with WMU NERC and Ouhai District Government to Build Growth Factor Innovation Ecosystem and Accelerate Regenerative Medicine Strategy Layout

EQS Newswire / 30/12/2025 / 17:36 UTC+8

[Hong Kong, December 30th, 2025] Uni-Bio Science Group Limited (“Uni-Bio Science Group”, “Uni-Bio” or “the Group”) is pleased to announce the official signing of a tripartite strategic cooperation agreement in Wenzhou, Zhejiang, with the National Engineering Research Center for Cell Growth Factor Drugs and Protein Formulations of Wenzhou Medical University (“WMU NERC”) and the People’s Government of Ouhai District, Wenzhou. The parties also explored the subsequent co-establishment of the “Uni-Bio – WMU Joint Innovation Laboratory for Translational Medicine.”  This collaboration marks a key step for Uni-Bio in deeply integrating with a national-level research platform and a regional industrial ecosystem. Through a synergistic “government-university-enterprise” model, the three parties will focus on the core regenerative medicine field of growth factors to establish an end-to-end innovation system spanning basic research, clinical translation, and industrial application. This represents a milestone for the Group in consolidating its R&D pipeline and accelerating its strategic execution.

updated image
Photo: Strategic cooperation signing ceremony group photo

Focusing on Growth Factor Frontiers, Unleashing “1+1>2” Clinical and Market Potential

Growth factors are key signaling molecules that regulate cell proliferation, migration, and tissue repair, representing some of the most transformative bioactive substances in regenerative medicine. Both EGF (Epidermal Growth Factor) and FGF (Fibroblast Growth Factor) have demonstrated significant efficacy across major indications, including wound healing, ophthalmic diseases, and metabolic disorders, underscoring their substantial market potential.

Uni-Bio possesses deep expertise in the EGF field, with its flagship products GeneTime® and GeneSoft® achieving large-scale production and nationwide commercial coverage. Concurrently, under the leadership of Academician Li Xiaokun, the WMU NERC has been a global pioneer in FGF drug R&D, having successfully translated several Class I New Drugs – including Recombinant Human Basic Fibroblast Growth Factor – and has accumulated substantial clinical data and authoritative expert consensus in trauma and metabolic diseases.

Building on this foundation, the three parties will initiate collaborative research on combined EGF/FGF therapies for key areas, including burns, dermatology, and ophthalmology. The goal is to unlock powerful therapeutic synergies, develop superior combination products and advance delivery systems, set new treatment benchmarks, and establish a leadership position in shaping this multi-billion Yuan sector.

 

Empowered by Academician Leadership & Platform, Creating a Fast Track from R&D to Production

The WMU NERC is an independent legal entity established by Wenzhou Medical University based on the national-level platform, the National Engineering Research Center for Cell Growth Factor Drugs and Protein Preparations. It undertakes downstream functions including engineering technology research and development, transformation of scientific and technological achievements, and technical services. In synergistic collaboration with the National Key Laboratory for Macromolecular Drugs and Large-Scale Preparation, which focuses on upstream basic research, the Center has built a next-generation growth factor drug pipeline targeting multiple systems such as metabolism and dermatology. Through the ongoing research of Academician Li Xiaokun’s team, the Center has achieved internationally leading breakthroughs in key technologies, including long-acting Modification, targeted delivery, and aerosol inhalation.

The planned “Uni-Bio – WMU Joint Innovation Laboratory for Translational Medicine” will conduct in-depth research into the synergistic mechanisms of Epidermal Growth Factor (EGF) and Fibroblast Growth Factor (FGF) in regulating metabolic homeostasis, improving insulin sensitivity, and promoting tissue repair. It aims to develop novel compound formulations and drug delivery systems targeting conditions such as endocrine diseases represented by non-alcoholic steatohepatitis (NASH), respiratory diseases represented by asthma, as well as bone tissue repair. These diseases affect a large global patient population, yet there remains a significant unmet clinical need for innovative therapies. Through this collaboration, it is expected to address treatment gaps in multiple specific indications, further unlocking clinical and commercial value in the broad chronic disease market.

The “Government-University-Enterprise ” Trinity, Systematically Strengthening Full-Chain Capabilities

This collaboration extends beyond technological synergy to ecosystem co-development. The People’s Government of Ouhai District, Wenzhou, is a key facilitator and supporter of this strategic cooperation, committed to building a first-class biomedical industry ecosystem. Its core platform, the “China Gene Valley,” will provide comprehensive spatial support and specialized policy assistance for the cooperative projects across all stages – from R&D and pilot-scale testing to industrialization.

For Uni-Bio, this tripartite cooperation delivers threefold empowerment:

  • R&D Front: Direct access to the National Engineering Research Center’s source innovation and core technologies, elevating the starting point of R&D.
  • Clinical Front: Collaboration with Wenzhou Medical University’s affiliated hospital network to accelerate clinical validation and indication expansion.
  • Commercialization Front: Leveraging the advanced manufacturing capabilities and regional policy benefits of the China Gene Valley to ensure efficient project implementation and facilitate market access.

 

This strategic partnership is a crucial step in the Group’s pursuit of its vision “To Be the Global Leader in Regenerative Medicine, Redefining How Science Restores and Extends Human Life” Moving forward, the Group will continue to deepen collaborations with national scientific institutions and local governments, driving the translation of more cutting-edge research into clinical and market value. This will further consolidate and enhance its comprehensive competitiveness and leadership in regenerative medicine.

 

 

End

 

About Uni-Bio Science:

Uni-Bio Science Group Limited is an innovative biopharmaceutical enterprise listed on the Main Board of The Stock Exchange of Hong Kong Limited in 2001(Stock Code: 00690.HK). The Group is committed to powering the advancement of regenerative medicine with next-generation synthetic biology and complex peptide innovation. Focusing on four core research areas—muscular-skeletal regeneration, skin regeneration, ocular regeneration, and ENT regeneration—the Group has built a diversified product pipeline encompassing innovative biologics, high-value generic drugs, and medical aesthetics. The Group operates GMP-compliant production bases in Beijing, Dongguan, and Shenzhen, with fully integrated capabilities spanning R&D, manufacturing, and commercial sales. Uni-Bio Science Group is dedicated to becoming a global leader in regenerative medicine, redefining how science restores and extends human life.

About the National Engineering Research Center for Cell Growth Factor Drugs and Protein Formulations of Wenzhou Medical University:

The WMU NERC is an independent legal entity established by Wenzhou Medical University based on the national-level platform, the National Engineering Research Center for Cell Growth Factor Drugs and Protein Preparations. It undertakes downstream functions including engineering technology research and development, transformation of scientific and technological achievements, and technical services. Under the leadership of Chinese Academy of Engineering Academician Li Xiaokun, the Center has long been engaged in foundational research and novel drug discovery for cell growth factor drugs, holding a globally leading position. It brings together top-tier scientific teams, undertakes major national science and technology projects, and has successfully developed a series of innovative FGF drugs with independent intellectual property rights. Through synergistic collaboration with the National Key Laboratory for Macromolecular Drugs and Large‑Scale Preparation, the Center forms a complete innovation chain from source discovery and key technological breakthroughs to industrial translation. As the important R&D engine of the China Gene Valley, it continuously promotes the incubation and translation of several original new drug candidates, including a long-acting FGF21 variant.

About the People’s Government of Ouhai District, Wenzhou:

The People’s Government of Ouhai District, Wenzhou, is a key facilitator and supporter of this strategic cooperation, committed to building a first-class biomedical industry ecosystem. Its core platform, the “China Gene Valley,” will provide comprehensive spatial support and specialized policy assistance for the cooperative projects across all stages – from R&D and pilot-scale testing to industrialization. Through specialized industrial policies, “full-cycle escort” services, and clinical resource coordination, Ouhai District empowers the implementation and growth of innovation projects, serving as a vital driver for regional biomedical industry innovation and development.

30/12/2025 Dissemination of a Financial Press Release, transmitted by EQS News.
The issuer is solely responsible for the content of this announcement.

Media archive at www.todayir.com

AEVIS VICTORIA SA successfully completes major Group-wide refinancing

AEVIS VICTORIA SA

/ Key word(s): Financing

AEVIS VICTORIA SA successfully completes major Group-wide refinancing

29.12.2025 / 07:00 CET/CEST


Press release

Fribourg, 29 December 2025

AEVIS VICTORIA SA successfully completes major Group-wide refinancing

AEVIS VICTORIA SA (“AEVIS”) announces the successful completion of a comprehensive refinancing program across multiple levels of the Group, as part of its ongoing efforts to optimize its capital and financing structure.

At the holding company level, AEVIS arranged a new syndicated financing facility, enhancing the Group’s overall financial flexibility and liquidity profile.

Within the real estate segment, AEVIS completed the refinancing of an interim facility originally put in place in 2020 to finance the acquisition of several hotel assets. This interim financing has been replaced with long-term, traditional mortgage financings, further strengthening the stability of the Group’s balance sheet. In addition, AEVIS successfully secured a new financing facility for L’Oscar Hotel in London.

Collectively, these transactions extend and diversify the Group’s debt maturity profile and, together with the significant reduction of the Group’s consolidated debt by more than CHF 100 million in H1 2025, are expected to materially reduce the Group’s cost of debt and financial expenses, resulting in interest expense savings in the high single-digit million range on an annualized basis.

For further information:
AEVIS VICTORIA SA Media and Investor Relations: c/o Dynamics Group, Zurich
Philippe R. Blangey, prb@dynamicsgroup.ch, +41 (0) 43 268 32 35 or +41 (0) 79 785 46 32
Séverine Van der Schueren, svanderschueren@aevis.com, +41 (0) 79 635 04 10

AEVIS VICTORIA SA – Investing for a better life
AEVIS VICTORIA SA invests in healthcare, hospitality & lifestyle and infrastructure. AEVIS′s main shareholdings are Swiss Medical Network Holding SA (76.3%, directly and indirectly), the only Swiss private network of hospitals present in the country’s three main language regions, MRH Switzerland AG, a luxury hotel group managing eleven hotels in Switzerland and abroad, Infracore SA (30%, directly and indirectly), a real estate company dedicated to healthcare-related infrastructure, Swiss Hotel Properties SA, a hospitality real estate division, and NESCENS SA, a brand dedicated to better aging. AEVIS is listed on the Swiss Reporting Standard of the SIX Swiss Exchange (AEVS.SW). www.aevis.com.


End of Media Release


2250980  29.12.2025 CET/CEST

FDA approves another interchangeable Ranibizumab Biosimilar, Nufymco® – Strengthening US Presence with Zydus as Commercialization Partner

Formycon AG

/ Key word(s): Regulatory Approval/Alliance

FDA approves another interchangeable Ranibizumab Biosimilar, Nufymco® – Strengthening US Presence with Zydus as Commercialization Partner

23.12.2025 / 14:02 CET/CEST

The issuer is solely responsible for the content of this announcement.


 

Press Release // December 23, 2025

FDA approves another interchangeable Ranibizumab Biosimilar, Nufymco® Strengthening US Presence with Zydus as Commercialization Partner 

  • FDA approves Biologics License Application (BLA) for additional ranibizumab biosimilar under the trade name Nufymco®
  • Zydus becomes commercialization partner for Nufymco® in the US
  • Targeted strategy to maximize market penetration for ranibizumab biosimilars by building further on existing partnerships
     

Planegg-Martinsried, Germany – Formycon AG (FWB: FYB, Prime Standard, “Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco®1 (ranibizumab-leyk), an interchangeable biosimilar to Lucentis®2. With its second FDA-approved ranibizumab biosimilar in the US, the companies are further underscoring their pioneering position in high-quality biosimilar development.

Zydus Lifesciences Limited (including its subsidiaries and affiliates; “Zydus”) has been secured as another strong commercialization partner for the US market. The company has proven expertise with medically administered drugs (known as Medical Part B), a category that includes Nufymco®. Recently, Zydus also obtained exclusive rights to Formycon’s Keytruda®3 biosimilar FYB206 for the US and Canada – a strong testament to the attractiveness of and confidence in Formycon’s development platform.

Nufymco® is an interchangeable biosimilar to Lucentis®, developed by Formycon, and will be available in the US for all approved indications, expanding access to essential retinal therapies by offering a more affordable treatment option for patients.

“Our FDA approval for Nufymco® marks an important milestone for Formycon and reaffirms our role as an innovative leader in biosimilar development. With two strong and internationally established partners, we are ideally positioned to expand access to high-quality and affordable ranibizumab biosimilars for ophthalmic patients in the US. This expanded market coverage opens new growth opportunities by enabling a differentiated approach within the complex US healthcare and reimbursement landscape, supporting sustainable market penetration,” comments Dr. Stefan Glombitza, CEO of Formycon AG.

Nufymco® is FDA approved for the treatment of patients with age-related neovascular (wet) macular degeneration (AMD) and other serious eye diseases such as diabetic macular edema (DME), diabetic retinopathy (DR), macular edema due to retinal vein occlusion (RVO), and myopic choroidal neovascularization (mCNV).

1) Nufymco® is a registered trademark of Formycon AG
2) Lucentis® is a registered trademark of Genentech, Inc.
3) Keytruda
® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, (NYSE: MRK) Rahway, NJ/USA.

About Formycon:
Formycon AG (FSE: FYB) is a leading, independent developer of high-quality biosimilars, follow-on products of biopharmaceutical medicines. The company focuses on therapies in ophthalmology, immunology, immuno-oncology and other key disease areas, covering almost the entire value chain from technical development through clinical trials to approval by the regulatory authorities. For commercialization of its biosimilars, Formycon relies on strong, well-trusted and long-term partnerships worldwide. With FYB201/ranibizumab and FYB202/ustekinumab, Formycon already has two biosimilars on the market. Another biosimilar, FYB203/aflibercept, has been approved by the FDA, EMA, and MHRA. Four pipeline candidates – including FYB208/dupilumab – are currently in development. With its biosimilars, Formycon is making an important contribution to providing as many patients as possible with access to highly effective and affordable medicines.

Formycon AG is headquartered in Munich, listed in the Prime Standard of the Frankfurt Stock Exchange: FYB / ISIN: DE000A1EWVY8 / WKN: A1EWVY. Further information can be found at: https://www.formycon.com/

About Bioeq:
Bioeq is a Swiss biopharmaceutical joint venture between the Polpharma Biologics Group and Formycon AG. Bioeq develops, licenses, and markets biosimilars. www.bioeq.ch

About Zydus Lifesciences Limited:
Zydus Lifesciences Limited is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness, supported by an emerging MedTech franchise and a global footprint across the United States, India and other international markets. As of September 30, 2025, the group employs 27,000 people worldwide, including 1,500 scientists engaged in R&D, and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit www.zyduslife.com

About Biosimilars:
Since their introduction in the 1980s, biopharmaceutical drugs have revolutionized the treatment of serious and chronic diseases. By 2032, many of these drugs will lose their patent protection – including 45 blockbusters with an estimated total annual global turnover of more than 200 billion US dollars. Biosimilars are successor products to biopharmaceutical drugs for which market exclusivity has expired. They are approved in highly regulated markets such as the EU, the USA, Canada, Japan and Australia in accordance with strict regulatory procedures. Biosimilars create competition and thus give more patients access to biopharmaceutical therapies. At the same time, they reduce costs for healthcare systems. Global sales of biosimilars currently amount to around 21 billion US dollars. Analysts assume that sales could rise to over 74 billion US dollars by 2030.

 
Contact:

Sabrina Müller,
Director Investor Relations & Corporate Communications,
Formycon AG
Fraunhoferstr. 15
82152 Planegg-Martinsried
Germany

Tel.: +49 (0) 89 – 86 46 67 149
Fax: + 49 (0) 89 – 86 46 67 110

Sabrina.Mueller@formycon.com

 

Disclaimer:
This press release may contain forward-looking statements and information which are based on Formycon’s current expectations and certain assumptions. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, performance of the company, development of the products and the estimates given here. Such known and unknown risks and uncertainties comprise, among others, the research and development, the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality, patient safety, patent litigation, contractual risks and dependencies from third parties. With respect to pipeline products, Formycon AG does not provide any representation, warranties or any other guarantees that the products will receive the necessary regulatory approvals or that they will prove to be commercially exploitable and/or successful. Formycon AG assumes no obligation to update these forward-looking statements or to correct them in case of developments which differ from those anticipated. This document neither constitutes an offer to sell nor a solicitation of an offer to buy or subscribe for securities of Formycon AG. No public offering of securities of Formycon AG will be made nor is a public offering intended. This document and the information contained therein may not be distributed in or into the United States of America, Canada, Australia, Japan or any other jurisdictions, in which such offer or such solicitation would be prohibited. This document does not constitute an offer for the sale of securities in the United States.


23.12.2025 CET/CEST Dissemination of a Corporate News, transmitted by EQS News – a service of EQS Group.
The issuer is solely responsible for the content of this announcement.

The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.


Language: English
Company: Formycon AG
Fraunhoferstraße 15
82152 Planegg-Martinsried
Germany
Phone: +49 89 864667 100
Fax: +49 89 864667 110
E-mail: ir@formycon.com
Internet: www.formycon.com
ISIN: DE000A1EWVY8, NO0013586024
WKN: A1EWVY, A4DFJH
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange; Oslo
EQS News ID: 2250924

 
End of News EQS News Service

2250924  23.12.2025 CET/CEST