Nxera Pharma Submits Marketing Authorization Application for Daridorexant in South Korea

Nxera Pharma Submits Marketing Authorization Application for Daridorexant in South Korea




Nxera Pharma Submits Marketing Authorization Application for Daridorexant in South Korea

  • Daridorexant is a dual orexin receptor antagonist being developed in South Korea by Nxera for the treatment of adult patients with insomnia and is approved and marketed in Japan as QUVIVIQ®
  • Phase 3 trial of daridorexant in South Korea met both primary and secondary efficacy endpoints of subjective total sleep time (sTST), subjective latency to sleep onset (sLSO) and subjective wake after sleep onset (sWASO)

Tokyo, Japan and Cambridge, UK, 4 March 2026 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) announces that it has submitted a marketing authorisation application (MAA) to the Ministry of Food and Drug Safety (MFDS) in South Korea for daridorexant, a dual orexin receptor antagonist, for the treatment of adult patients with insomnia. This submission follows positive data from the Phase 3 trial of daridorexant in South Korea which met both primary and secondary efficacy endpoints (Link).

Insomnia, characterized by difficulties in sleep onset and/or sleep maintenance, impacts both physical and mental health. The condition is highly prevalent in South Korea, affecting 15-25% of the adult population, or approximately 6.5-11 million people1,2.

Mr. MinBok Lee, President and Representative Director of Nxera Pharma Korea, commented: “This submission represents a key milestone in our efforts to expand access to daridorexant in South Korea. With the medicine already approved and marketed in Japan, we look forward to sharing further progress as it advances through the regulatory review process in South Korea towards anticipated approval in 2027.”

Daridorexant is approved and marketed in Japan as QUVIVIQ® under a commercialization agreement between Nxera and Shionogi. QUVIVIQ®, discovered by Idorsia Pharmaceuticals, is marketed by Idorsia in the US, Canada, and multiple European countries, and marketed by Simcere in China and Hong Kong.

–END–

Notes to Editors

About Insomnia Disorder
Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. As defined this impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep.

Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. The disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Research has shown that poor quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels.

The goal of treatments for insomnia is to improve sleep quality and quantity, as well as daytime functioning, while avoiding adverse events and next-morning residual effects. Current recommended treatment of insomnia includes sleep hygiene therapy, cognitive behavioral therapy, and pharmacotherapy.

According to multiple epidemiological studies, insomnia affects around 15% to 25% of the adult population in South Korea, or approximately 6.5-11 million people1,2. The condition is notably more prevalent among women and older adults. Recent data from Korea’s Health Insurance Review and Assessment Service (HIRA) revealed that the number of chronic insomnia patients treated has increased by 21% from 597,529 in 2018 to 722,440 in 2022. Of these patients, 50% are aged 60 or above, and 61% are women.

1Epidemiology of Insomnia in Korean Adults: Prevalence and Associated Factors (Print ISSN 1738-6586 / On-line ISSN 2005-5013)
2The Prevalence and Incidence of Insomnia in Korea during 2005 to 2013 / Print ISSN 1738-3684 / On-line ISSN 1976-3026)

About the Orexin system
Wake and sleep signaling is regulated by intricate neural circuitry in the brain. One key component of this process is the orexin system, which helps promote wakefulness. There are two forms of orexin neuropeptides – small protein-like molecules used by nerve cells (neurons) to communicate with each other in the brain – orexin A and orexin B. Orexin promotes wakefulness through its receptors OX1R and OX2R. Together, these neuropeptides and receptors make up the orexin system. The orexin system stimulates targeted neurons in the wake system – leading to the release of several chemicals (serotonin, histamine, acetylcholine, norepinephrine) – to promote wakefulness. Orexin regulates wake signaling, which might be overactive at night, preventing people with insomnia from falling asleep or staying asleep. Daridorexant is a dual orexin receptor antagonist (DORA) that equipotently antagonizes orexin receptors 1 and 2, consequently decreasing overactive wake signals throughout the entire night.

About the Phase 3 study
The Phase 3 trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of daridorexant in adult and elderly patients with insomnia. Patients were randomized to receive daridorexant 50 mg or placebo once daily for 28 days.

The study met both its primary and secondary efficacy endpoints. At Day 28, daridorexant significantly improved the primary efficacy endpoint, the change from baseline in subjective total sleep time (sTST), compared with placebo (p<0.0001 for the 50 mg dose). Daridorexant also significantly improved the secondary efficacy endpoints, the change from baseline at Day 28 in subjective latency to sleep onset (sLSO) and subjective wake after sleep onset(sWASO), compared with placebo (both p<0.0001 for the 50 mg dose). The incidence of adverse events was comparable between the daridorexant and placebo treatment groups. The rate of treatment-emergent adverse events (TEAEs) during the double-blind treatment period was comparable between placebo and daridorexant, reported in 13.41% of patients treated with daridorexant 50 mg and 14.81% for placebo.

About Nxera Pharma
Nxera Pharma is a technology powered biopharma company in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. The Company has built an agile, new-generation commercial business in Japan to develop and commercialize innovative medicines, including several launched products, to address this high-value, large and growing market and those in the broader APAC region. In addition, the Company is advancing an extensive pipeline internally and in partnership with leading pharma and biotech companies powered by its unique NxWave™ GPCR structure-based drug discovery platform. Nxera Pharma operates at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565).

For more information, please visit www.nxera.life
LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma

QUVIVIQ® is trademark of Idorsia Ltd.

Enquiries

Media and Investor Relations
Shinya Tsuzuki, VP, Head of Investor Relations
Maya Bennison, Communications Manager
+81 (0)3 5962 5718 | +44 (0)1223 949390 |IR@Nxera.life

MEDiSTRAVA (for International Media)
Mark Swallow, Frazer Hall, Erica Hollingsworth
+44 (0)203 928 6900 | Nxera@medistrava.com

Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

HUTCHMED Initiates Global Trial of PI3K/PIKK-EGFR ATTC Candidate HMPL-A580 in Patients with Solid Tumors

HUTCHMED Initiates Global Trial of PI3K/PIKK-EGFR ATTC Candidate HMPL-A580 in Patients with Solid Tumors




HUTCHMED Initiates Global Trial of PI3K/PIKK-EGFR ATTC Candidate HMPL-A580 in Patients with Solid Tumors

— Second clinical candidate from HUTCHMED’s next-generation ATTC platform —

— Leveraging synergy through simultaneous inhibition of PAM pathway and EGFR signaling —

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 04, 2026 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a Phase I/IIa clinical trial of HMPL-A580, HUTCHMED’s second novel Antibody-Targeted Therapy Conjugate (“ATTC”), in patients with unresectable, advanced or metastatic solid tumors in China and the US. The first patient received the first dose on March 4, 2026.

HMPL-A580 is a first-in-class ATTC comprising a highly selective and potent PI3K/PIKK small-molecule inhibitor payload linked to an anti-EGFR antibody via a cleavable linker, HUTCHMED’s second ATTC based on this highly novel PI3K/PIKK inhibitor payload. EGFR is highly expressed in multiple types of solid tumors and is well recognized as a driving force in tumorigenesis and disease progression. Preclinical data have shown that PAM pathway inhibition synergizes with anti-EGFR therapy to enhance anti-tumor activity, and will be presented at an upcoming scientific conference.

This first-in-human Phase I/IIa, multicenter, open-label study evaluates the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of HMPL-A580. The study consists of two parts. In the Phase I dose escalation part, patients will receive HMPL-A580 intravenously at predefined dose levels to determine the maximum tolerated dose and recommended dose for expansion. The subsequent Phase IIa dose expansion/​optimization part is to further characterize the safety, tolerability and preliminary anti-tumor activity of HMPL-A580 in selected solid tumors, and to determine the recommended dose for the next phase. Additional details may be found at clinicaltrials.gov, using identifier NCT07396584.

About the ATTC Platform

HUTCHMED’s ATTC platform represents a next-generation approach to precision oncology, combining monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. Unlike traditional cytotoxin-based Antibody Drug Conjugates, ATTCs combine targeted therapies to achieve synergistic anti-tumor activity and durable responses in preclinical models, outperforming standalone antibody or small-molecule inhibitor components in efficacy and safety.

Built on over 20 years of targeted therapy expertise, the platform enables development of drug candidates for diverse cancer types. By leveraging antibody-guided delivery and tumor-specific payload release, ATTCs improve the accessibility to tumors and reduce off-tumor toxicity. This overcomes challenges of traditional small-molecule inhibitors, ensures safer long-term use, and supports combinations with chemotherapy and immunotherapy, unlocking potential for early-line treatments.

HUTCHMED has demonstrated how its partnerships leverage the expertise of multinational pharmaceutical companies to accelerate bringing novel medicines to address large unmet needs around the world, and plans to apply this strategy to its ATTC technology this year.

About the PAM Pathway and HMPL-A580

The PI3K/AKT/mTOR (“PAM”) pathway is a critical intracellular network involved in cell growth, survival, and division. Alterations in the PAM pathway are frequently associated with poor prognosis and resistance to treatment across various cancers. However, existing PAM-targeted drugs face significant challenges, including on-target toxicities that restrict dosing, feedback loops that enable pathway reactivation, and insufficient tumor-specific delivery.

By conjugating this highly novel payload to an anti-EGFR antibody, HMPL-A580 is designed to deliver targeted pathway inhibition directly into EGFR-expressing tumor cells, thereby potentially overcoming the systemic toxicity and narrow therapeutic index historically associated with PI3K/PIKK inhibitors. This approach aims to achieve deeper and more durable target inhibition while improving the overall tolerability profile.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of HMPL-A580 and other drug candidates from the ATTC platform and the further development of HMPL-A580 and other drug candidates from the ATTC platform in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support an new drug application submission of HMPL-A580 and other drug candidates from the ATTC platform in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the efficacy and safety profile of HMPL-A580 and other drug candidates from the ATTC platform, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for HMPL-A580 and other drug candidates from the ATTC platform and the timing of these events. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACTS

Investor Enquiries +852 2121 8200 / ir@hutch-med.com
   
Media Enquiries  
FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com
Ben Atwell / Tim Stamper +44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile)
Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
   
Panmure Liberum Nominated Advisor and Joint Broker
Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500
   
Cavendish Joint Broker
Geoff Nash / Nigel Birks +44 20 7220 0500
   
Deutsche Numis Joint Broker
Freddie Barnfield / Jeffrey Wong / Duncan Monteith +44 20 7260 1000

Theolytics Awarded €8 million in Horizon Europe 2025 Grant Funding to Advance Phase 2 Study of THEO-260 in Ovarian Cancer

Theolytics Awarded €8 million in Horizon Europe 2025 Grant Funding to Advance Phase 2 Study of THEO-260 in Ovarian Cancer




Theolytics Awarded €8 million in Horizon Europe 2025 Grant Funding to Advance Phase 2 Study of THEO-260 in Ovarian Cancer

  • Pending final negotiation, grant will fund up to 20 patients in the OCTOPOD-IV Phase 2a expansion study of THEO-260 in platinum-resistant ovarian cancer
  • Competitive funding award highlights Theolytics’ innovative science and strong clinical development plan
  • Application coordinated with several major international clinical centres and world-class partners

Oxford UK, March 4, 2026. Theolytics, a clinical-stage biotechnology company developing next-generation oncolytic immunotherapies, has been awarded, pending final negotiation, €8 million in non-dilutive grant funding from Horizon Europe 2025, the European Union’s flagship research and innovation funding programme. Horizon Europe 2025 is supporting high-impact clinical-stage projects aimed at improving patient outcomes and strengthening Europe’s scientific leadership. The grant to Theolytics will provide significant financial support to advance the company’s Phase 2 OCTOPOD-IV clinical trial evaluating THEO-260, its novel therapeutic candidate designed to address unmet needs in patients with advanced ovarian cancer.

Positioned to tackle the complex, immune-suppressed nature of advanced solid tumours, THEO-260 is an oncolytic immunotherapy designed for effective killing of both cancer cells and cancer-associated fibroblasts (CAFs), while inducing immune activation. Platinum-resistant ovarian cancer represents a prototype of a broader category of stroma-rich solid tumours for which THEO-260 is being developed.

Margaret Duffy, CSO and Co-founder of Theolytics, said, “Our collective success with this grant award reflects the extraordinary work being done by the team at Theolytics, and the calibre of our clinical and translational partner centres. The Horizon Europe award validates both the scientific rationale behind our THEO-260 programme and the huge potential of its novel oncolytic and ‘CAF-lytic’ mechanism to address a significant unmet need in stroma-rich solid cancers. By integrating advanced translational analyses into our clinical trial design, we will clinically demonstrate the differentiated mechanism of action of THEO-260 and provide key data to advance this programme and deliver true impact for cancer patients.”

This highly competitive Horizon Europe 2025 award follows a rigorous grant review process and highlights the company’s innovative science, strong technical area expertise, clear clinical development plan and the opportunity for THEO-260 to address a clear unmet patient need.

The grant application was coordinated with several major partners, expert clinical and translational centres involved in the OCTOPOD-IV study and includes the University of Navarra, Catalan Institute of Oncology in Spain; the Princess Margaret Hospital in Toronto, Canada; and The Institute of Cancer Research (ICR) in London, UK. Two thirds of the funds will be received directly by Theolytics to advance the OCTOPOD-IV Phase 2a expansion trial, and the other third will be deployed directly to the partners in support of their work on the trial.

OCTOPOD-IV (NCT06618235) is a first-in-human, multi-centre trial to assess safety, tolerability and preliminary efficacy of THEO-260 in patients with high-grade serous ovarian or endometrioid cancer. In addition, the trial is designed to determine the recommended Phase 2 dose and demonstrate THEO-260’s differentiated cancer/cancer-associated fibroblast-lytic mechanism of action in patients through comprehensive biomarker analysis.

Prof Alan Melcher, Professor of Translational Immunotherapy at The Institute of Cancer Research, London, said, “The differentiated mechanism of action – targeting the stroma and inducing immune activity in the suppressed tumour microenvironment (TME) – of this oncolytic immunotherapy THEO-260 offers the potential to provide an important new treatment option for patients with advanced solid tumours. We are pleased to support the OCTOPOD-IV study, for which the ICR will provide important translational data to assess this novel and promising approach.”

Dr Antonio González, Director of the Department of Medical Oncology and Cancer Center at the Clínica Universidad de Navarra, and President of the Spanish Cooperative Group for Gynaecological Cancer Research, added, “We see many women with advanced platinum-resistant ovarian cancer, whose life expectancy is typically only a year or less. There remains a serious lack of effective treatment options for these women, and so we are hopeful that THEO-260 may bring an advance in therapy that will improve and extend the lives of our patients.”

Recruitment at UK and Spanish clinical sites for OCTOPOD-IV is ongoing and will now expand into further international centres (including additional sites in Spain and Canada). A second clinical trial (OCTOPOD-IP) in the US, which will investigate intraperitoneal (IP) delivery of THEO-260 to advanced ovarian cancer patients, has also been initiated in collaboration with The University of Texas MD Anderson Cancer Center (NCT07211659).

###

About Theolytics

Theolytics is working to develop best-in-class oncolytic immunotherapies. The company has pioneered a new approach to develop efficacious, targeted adenoviral candidates suitable for direct and systemic intravenous delivery.

The company is focused on the advancement of its lead programme THEO-260 in clinical trials with the ambition of providing better outcomes for patients with stroma-rich solid cancers, for whom current treatment options are limited. Additional pipeline programmes in preclinical development include novel candidates developed for colorectal cancer and haematological malignancies where there remains significant unmet need.

Theolytics was founded in 2017, is headquartered in Oxford UK, and is backed by international life sciences investors Taiho Ventures, M Ventures, Oxford Science Enterprises, Epidarex Capital, Sound Bioventures, BGF and Oxford University Innovation.

For more information, please see our website www.theolytics.com

About Horizon Europe 2025 Programme

The ‘Boosting the translation of biotech research into innovative health therapies’ topic, which forms part of the wider Horizon Europe 2025 Health initiative, is designed to accelerate the translation of promising biotech research into clinical development and aims to deliver the following outcomes:

  • Faster access to innovative therapies for healthcare providers, researchers and patients
  • Increased number of clinical trials evaluating novel biotech therapeutic approaches conducted within the European Union
  • Strengthened competitiveness of small and medium-size enterprises (SMEs) in the EU and Associated Countries within the health biotech sector

More information on the Horizon Europe Health initiative can be found here.

Contact

Theolytics

David Apelian, CEO

enquiries@theolytics.com

MEDiSTRAVA

Frazer Hall, Mark Swallow

Theolytics@medistrava.com

Alvotech to Report Fourth Quarter and Full Year 2025 Financial Results

Alvotech to Report Fourth Quarter and Full Year 2025 Financial Results




Alvotech to Report Fourth Quarter and Full Year 2025 Financial Results

REYKJAVIK, Iceland, March 04, 2026 (GLOBE NEWSWIRE) — Alvotech (NASDAQ: ALVO) (the “Company”), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it will release its fourth quarter and full year 2025 financial and operating results on Wednesday, March 18, 2026, after the U.S. markets close.

The Company will also host a conference call with a live Q&A on Thursday, March 19, 2026 at 08:00 EST (12:00 GMT, 13:00 CET).

Slides and other material will be made available on https://investors.alvotech.com/news-events/events before the call.

For further information, contact:

Media
Benedikt Stefansson
Sarah MacLeod
alvotech.media@alvotech.com

Investors
Dr. Balaji V Prasad (US)
Patrik Ling (SE)
Benedikt Stefansson (IS)
alvotech.ir@alvotech.com

About Alvotech
Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube.

Nxera Pharma Submits Marketing Authorization Application for Daridorexant in South Korea

Nxera Pharma Submits Marketing Authorization Application for Daridorexant in South Korea




Nxera Pharma Submits Marketing Authorization Application for Daridorexant in South Korea

  • Daridorexant is a dual orexin receptor antagonist being developed in South Korea by Nxera for the treatment of adult patients with insomnia and is approved and marketed in Japan as QUVIVIQ®
  • Phase 3 trial of daridorexant in South Korea met both primary and secondary efficacy endpoints of subjective total sleep time (sTST), subjective latency to sleep onset (sLSO) and subjective wake after sleep onset (sWASO)

Tokyo, Japan and Cambridge, UK, 4 March 2026 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TSE 4565) announces that it has submitted a marketing authorisation application (MAA) to the Ministry of Food and Drug Safety (MFDS) in South Korea for daridorexant, a dual orexin receptor antagonist, for the treatment of adult patients with insomnia. This submission follows positive data from the Phase 3 trial of daridorexant in South Korea which met both primary and secondary efficacy endpoints (Link).

Insomnia, characterized by difficulties in sleep onset and/or sleep maintenance, impacts both physical and mental health. The condition is highly prevalent in South Korea, affecting 15-25% of the adult population, or approximately 6.5-11 million people1,2.

Mr. MinBok Lee, President and Representative Director of Nxera Pharma Korea, commented: “This submission represents a key milestone in our efforts to expand access to daridorexant in South Korea. With the medicine already approved and marketed in Japan, we look forward to sharing further progress as it advances through the regulatory review process in South Korea towards anticipated approval in 2027.”

Daridorexant is approved and marketed in Japan as QUVIVIQ® under a commercialization agreement between Nxera and Shionogi. QUVIVIQ®, discovered by Idorsia Pharmaceuticals, is marketed by Idorsia in the US, Canada, and multiple European countries, and marketed by Simcere in China and Hong Kong.

–END–

Notes to Editors

About Insomnia Disorder
Insomnia disorder is defined as difficulty initiating or maintaining sleep, causing clinically significant distress or impairment in important areas of daytime functioning. As defined this impact on sleep quantity or quality should be present for at least three nights per week, lasts for at least three months, and occurs despite an adequate opportunity to sleep.

Insomnia is a condition of overactive wake signaling and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. The disorder is quite different from a brief period of poor sleep, and it can take its toll on both physical and mental health. It is a persistent condition with a negative impact on daytime functioning. Research has shown that poor quality sleep can affect many aspects of daily life, including the ability to concentrate, mood, and energy levels.

The goal of treatments for insomnia is to improve sleep quality and quantity, as well as daytime functioning, while avoiding adverse events and next-morning residual effects. Current recommended treatment of insomnia includes sleep hygiene therapy, cognitive behavioral therapy, and pharmacotherapy.

According to multiple epidemiological studies, insomnia affects around 15% to 25% of the adult population in South Korea, or approximately 6.5-11 million people1,2. The condition is notably more prevalent among women and older adults. Recent data from Korea’s Health Insurance Review and Assessment Service (HIRA) revealed that the number of chronic insomnia patients treated has increased by 21% from 597,529 in 2018 to 722,440 in 2022. Of these patients, 50% are aged 60 or above, and 61% are women.

1Epidemiology of Insomnia in Korean Adults: Prevalence and Associated Factors (Print ISSN 1738-6586 / On-line ISSN 2005-5013)
2The Prevalence and Incidence of Insomnia in Korea during 2005 to 2013 / Print ISSN 1738-3684 / On-line ISSN 1976-3026)

About the Orexin system
Wake and sleep signaling is regulated by intricate neural circuitry in the brain. One key component of this process is the orexin system, which helps promote wakefulness. There are two forms of orexin neuropeptides – small protein-like molecules used by nerve cells (neurons) to communicate with each other in the brain – orexin A and orexin B. Orexin promotes wakefulness through its receptors OX1R and OX2R. Together, these neuropeptides and receptors make up the orexin system. The orexin system stimulates targeted neurons in the wake system – leading to the release of several chemicals (serotonin, histamine, acetylcholine, norepinephrine) – to promote wakefulness. Orexin regulates wake signaling, which might be overactive at night, preventing people with insomnia from falling asleep or staying asleep. Daridorexant is a dual orexin receptor antagonist (DORA) that equipotently antagonizes orexin receptors 1 and 2, consequently decreasing overactive wake signals throughout the entire night.

About the Phase 3 study
The Phase 3 trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of daridorexant in adult and elderly patients with insomnia. Patients were randomized to receive daridorexant 50 mg or placebo once daily for 28 days.

The study met both its primary and secondary efficacy endpoints. At Day 28, daridorexant significantly improved the primary efficacy endpoint, the change from baseline in subjective total sleep time (sTST), compared with placebo (p<0.0001 for the 50 mg dose). Daridorexant also significantly improved the secondary efficacy endpoints, the change from baseline at Day 28 in subjective latency to sleep onset (sLSO) and subjective wake after sleep onset(sWASO), compared with placebo (both p<0.0001 for the 50 mg dose). The incidence of adverse events was comparable between the daridorexant and placebo treatment groups. The rate of treatment-emergent adverse events (TEAEs) during the double-blind treatment period was comparable between placebo and daridorexant, reported in 13.41% of patients treated with daridorexant 50 mg and 14.81% for placebo.

About Nxera Pharma
Nxera Pharma is a technology powered biopharma company in pursuit of new specialty medicines to improve the lives of patients with unmet needs in Japan and globally. The Company has built an agile, new-generation commercial business in Japan to develop and commercialize innovative medicines, including several launched products, to address this high-value, large and growing market and those in the broader APAC region. In addition, the Company is advancing an extensive pipeline internally and in partnership with leading pharma and biotech companies powered by its unique NxWave™ GPCR structure-based drug discovery platform. Nxera Pharma operates at key locations in Tokyo and Osaka (Japan), London and Cambridge (UK), Basel (Switzerland) and Seoul (South Korea) and is listed on the Tokyo Stock Exchange (ticker: 4565).

For more information, please visit www.nxera.life
LinkedIn: @NxeraPharma | X: @NxeraPharma | YouTube: @NxeraPharma

QUVIVIQ® is trademark of Idorsia Ltd.

Enquiries

Media and Investor Relations
Shinya Tsuzuki, VP, Head of Investor Relations
Maya Bennison, Communications Manager
+81 (0)3 5962 5718 | +44 (0)1223 949390 |IR@Nxera.life

MEDiSTRAVA (for International Media)
Mark Swallow, Frazer Hall, Erica Hollingsworth
+44 (0)203 928 6900 | Nxera@medistrava.com

Forward-looking statements
This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Nxera Pharma Group’s actual results to differ materially from those expressed or implied by the forward looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

HUTCHMED Initiates Global Trial of PI3K/PIKK-EGFR ATTC Candidate HMPL-A580 in Patients with Solid Tumors

HUTCHMED Initiates Global Trial of PI3K/PIKK-EGFR ATTC Candidate HMPL-A580 in Patients with Solid Tumors




HUTCHMED Initiates Global Trial of PI3K/PIKK-EGFR ATTC Candidate HMPL-A580 in Patients with Solid Tumors

— Second clinical candidate from HUTCHMED’s next-generation ATTC platform —

— Leveraging synergy through simultaneous inhibition of PAM pathway and EGFR signaling —

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., March 04, 2026 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it has initiated a Phase I/IIa clinical trial of HMPL-A580, HUTCHMED’s second novel Antibody-Targeted Therapy Conjugate (“ATTC”), in patients with unresectable, advanced or metastatic solid tumors in China and the US. The first patient received the first dose on March 4, 2026.

HMPL-A580 is a first-in-class ATTC comprising a highly selective and potent PI3K/PIKK small-molecule inhibitor payload linked to an anti-EGFR antibody via a cleavable linker, HUTCHMED’s second ATTC based on this highly novel PI3K/PIKK inhibitor payload. EGFR is highly expressed in multiple types of solid tumors and is well recognized as a driving force in tumorigenesis and disease progression. Preclinical data have shown that PAM pathway inhibition synergizes with anti-EGFR therapy to enhance anti-tumor activity, and will be presented at an upcoming scientific conference.

This first-in-human Phase I/IIa, multicenter, open-label study evaluates the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of HMPL-A580. The study consists of two parts. In the Phase I dose escalation part, patients will receive HMPL-A580 intravenously at predefined dose levels to determine the maximum tolerated dose and recommended dose for expansion. The subsequent Phase IIa dose expansion/​optimization part is to further characterize the safety, tolerability and preliminary anti-tumor activity of HMPL-A580 in selected solid tumors, and to determine the recommended dose for the next phase. Additional details may be found at clinicaltrials.gov, using identifier NCT07396584.

About the ATTC Platform

HUTCHMED’s ATTC platform represents a next-generation approach to precision oncology, combining monoclonal antibodies with proprietary small-molecule inhibitor payloads to deliver dual mechanisms of action. Unlike traditional cytotoxin-based Antibody Drug Conjugates, ATTCs combine targeted therapies to achieve synergistic anti-tumor activity and durable responses in preclinical models, outperforming standalone antibody or small-molecule inhibitor components in efficacy and safety.

Built on over 20 years of targeted therapy expertise, the platform enables development of drug candidates for diverse cancer types. By leveraging antibody-guided delivery and tumor-specific payload release, ATTCs improve the accessibility to tumors and reduce off-tumor toxicity. This overcomes challenges of traditional small-molecule inhibitors, ensures safer long-term use, and supports combinations with chemotherapy and immunotherapy, unlocking potential for early-line treatments.

HUTCHMED has demonstrated how its partnerships leverage the expertise of multinational pharmaceutical companies to accelerate bringing novel medicines to address large unmet needs around the world, and plans to apply this strategy to its ATTC technology this year.

About the PAM Pathway and HMPL-A580

The PI3K/AKT/mTOR (“PAM”) pathway is a critical intracellular network involved in cell growth, survival, and division. Alterations in the PAM pathway are frequently associated with poor prognosis and resistance to treatment across various cancers. However, existing PAM-targeted drugs face significant challenges, including on-target toxicities that restrict dosing, feedback loops that enable pathway reactivation, and insufficient tumor-specific delivery.

By conjugating this highly novel payload to an anti-EGFR antibody, HMPL-A580 is designed to deliver targeted pathway inhibition directly into EGFR-expressing tumor cells, thereby potentially overcoming the systemic toxicity and narrow therapeutic index historically associated with PI3K/PIKK inhibitors. This approach aims to achieve deeper and more durable target inhibition while improving the overall tolerability profile.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of HMPL-A580 and other drug candidates from the ATTC platform and the further development of HMPL-A580 and other drug candidates from the ATTC platform in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support an new drug application submission of HMPL-A580 and other drug candidates from the ATTC platform in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the efficacy and safety profile of HMPL-A580 and other drug candidates from the ATTC platform, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for HMPL-A580 and other drug candidates from the ATTC platform and the timing of these events. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

CONTACTS

Investor Enquiries +852 2121 8200 / ir@hutch-med.com
   
Media Enquiries  
FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com
Ben Atwell / Tim Stamper +44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile)
Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
   
Panmure Liberum Nominated Advisor and Joint Broker
Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500
   
Cavendish Joint Broker
Geoff Nash / Nigel Birks +44 20 7220 0500
   
Deutsche Numis Joint Broker
Freddie Barnfield / Jeffrey Wong / Duncan Monteith +44 20 7260 1000

Alvotech to Report Fourth Quarter and Full Year 2025 Financial Results

Alvotech to Report Fourth Quarter and Full Year 2025 Financial Results




Alvotech to Report Fourth Quarter and Full Year 2025 Financial Results

REYKJAVIK, ICELAND (March 4, 2026) — Alvotech (NASDAQ: ALVO) (the “Company”), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it will release its fourth quarter and full year 2025 financial and operating results on Wednesday, March 18, 2026, after the U.S. markets close.

The Company will also host a conference call with a live Q&A on Thursday, March 19, 2026 at 08:00 EST (12:00 GMT, 13:00 CET).

Slides and other material will be made available on Events and Presentations before the call.

For further information, contact:

Media
Benedikt Stefansson
Sarah MacLeod
alvotech.media@alvotech.com

Investors
Dr. Balaji V Prasad (US)
Patrik Ling (SE)
Benedikt Stefansson (IS)
alvotech.ir@alvotech.com

About Alvotech
Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release.

For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube.

Viromed Medical AG signs letter of intent to acquire relyon plasma GmbH – Strategic step toward integrated platform for cold plasma technology

Viromed Medical AG

/ Key word(s): Takeover

Viromed Medical AG signs letter of intent to acquire relyon plasma GmbH – Strategic step toward integrated platform for cold plasma technology

04.03.2026 / 07:44 CET/CEST

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


PRESS RELEASE

Viromed Medical AG signs letter of intent to acquire relyon plasma GmbH – Strategic step toward integrated platform for cold plasma technology

Rellingen, March 04, 2026 – Viromed Medical AG (“Viromed“; ISIN: DE000A40ZVN7), a medical technology company and pioneer in cold plasma technology, has signed a letter of intent to acquire relyon plasma GmbH (“relyon”). The Regensburg-based company is a subsidiary of TDK Electronics AG and is one of the leading technology providers in the field of atmospheric plasma technology.

relyon develops modular systems and customized OEM components for industrial and medical applications. The company also has an extensive international patent portfolio in the field of plasma technology. In recent years, relyon has collaborated with Viromed to develop the ViroCAP® and PulmoPlas® cold plasma medical device product families and currently manufactures these systems on behalf of Viromed.

Uwe Perbandt, CEO of Viromed Medical AG, explains: “With the planned integration of relyon, we are strengthening our technological sovereignty and significantly increasing our value creation depth. We are combining an extensive patent portfolio, development expertise, and manufacturing capacity in an integrated structure, thereby laying the foundation for more efficient scaling. Combined with our medical expertise and market penetration, this will result in an integrated plasma platform that is unique internationally in this form. This underscores our ambition to play a leading role in the global market for atmospheric cold plasma technology. Our goal is to further industrialize this technology internationally and position Viromed as an integrated provider with high technological and industrial expertise in the long term.”

Strategic integration along the value chain

The proposed transaction aims to substantially expand Viromed’s technological and industrial base in the field of atmospheric cold plasma technology. Subject to completion, relyon’s research, development, industrial manufacturing, and international patent portfolio would be brought together for the first time in a closely integrated structure. Through this vertical integration, Viromed will increase its control over key stages of the value chain, reduce its dependence on external development and production services, and create the structural conditions for further development of the technology.

Strengthening the technological position

With direct access to relyon’s patent portfolio, Viromed is also expanding its patent base and securing its long-term technological development. The combination of medically validated application expertise, engineering expertise, and industrial vertical integration raises the barriers to market entry. This improves Viromed’s strategic starting position for further growth and strengthens its international competitiveness in a technology-driven market environment.

Positioning in a growth market

Atmospheric cold plasma technology can be deployed across a wide range of applications, including broad use in medicine, in industrial processes, and, looking ahead, in related areas such as agricultural and water technology. Long-term drivers such as increasing regulatory requirements, sustainability goals, and the growing relevance of antimicrobial solutions support the market potential. With the planned transaction, Viromed aims to strategically expand its position in this environment and strengthen the foundation for sustainable, scalable growth.

Details of the transaction

The purchase price is currently under negotiation, but Viromed estimates that it will be in the low to mid double-digit million euro range. The conclusion of the corresponding share purchase agreement and the completion of the transaction are expected in the second quarter of 2026 and will be subject to a successful due diligence review and the fulfillment of customary closing conditions.

 

About Viromed Medical AG

Viromed Medical AG specializes in the development, manufacture and distribution of medical products. The operating business of the company, which has been listed on the stock exchange since October 2022, focuses on the distribution of innovative cold plasma technology for medical applications via its wholly owned subsidiary Viromed Medical GmbH. Viromed can draw on a broad customer base in the DACH region and beyond. Viromed is pursuing the goal of further advancing the use of cold plasma technology in medicine in the coming years and realizing the corresponding growth potential.

www.viromed-medical-ag.de

 

Contact Viromed

E-Mail: kontakt@viromed-medical.de

 

Press contact

E-Mail: viromed@kirchhoff.de


04.03.2026 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: Viromed Medical AG
Hauptstraße 105
25462 Rellingen
Germany
E-mail: kontakt@viromed-medical.de
Internet: https://www.viromed-medical-ag.de/
ISIN: DE000A40ZVN7
WKN: A40ZVN
Listed: Regulated Unofficial Market in Dusseldorf, Frankfurt, Hamburg, Tradegate BSX
EQS News ID: 2285022

 
End of News EQS News Service

2285022  04.03.2026 CET/CEST

BioVersys Announces Publication of BV100 Phase 1 Clinical Data in Journal of Antimicrobial Agents and Chemotherapy

 

Basel, Switzerland. March 04, 2026, 7am CET

 

  • BV100 Phase 1, single- and multiple-ascending dose clinical trial data include pharmacokinetics, safety and tolerability data.
  • BV100 demonstrated a dose-proportional pharmacokinetic profile and was generally safe and well tolerated.
  • BV100 global Phase 3 clinical trial is initiated with read-out expected in H2 2027.
  • Additional Phase 2b to demonstrate clinical differentiation and further de-risk BV100’s registrational path to be initiated in 2026 with interim data read-out expected end of 2026.

 

BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (MDR) bacteria, announced today, the publication of Phase 1, single- and multiple-ascending dose (SAD and MAD) clinical trial data including pharmacokinetics, safety and tolerability of BV100 in healthy volunteers in the Journal of Antimicrobial Agents and Chemotherapy.[1]

BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex. BV100 is being developed for MDR hospital infections caused by Acinetobacter baumannii, including carbapenem-resistant strains.

BV100 demonstrated a dose-proportional PK profile and was generally safe and well tolerated. Based on these positive results, BV100 doses of 200-300 mg administered every 12 hours have been evaluated in a Phase 2 clinical trial in Ventilator Associated Bacterial Pneumonia (VABP) patients, for treating carbapenem-resistant A. baumannii (CRAB) infections. BV100 demonstrated a clear survival benefit, resulting in a 50% relative reduction in all-cause mortality (ACM) in VABP patients suffering from CRAB infections compared with best available therapy (BAT), and was generally safe and well tolerated.

In December 2025, BV100 advanced into a global registration Phase 3 clinical trial (RIV-TARGET), in HABP/VABP patients suffering from CRAB infections, employing a similar  study design to the successful Phase 2 trial. The first patient is expected to be dosed in the coming weeks, and Phase 3 read-out is expected in H2 2027.

A global open-label Phase 2b clinical differentiation trial (RIV-CARE) will be initiated in H1 2026 and will compare BV100 with best available therapy in multiple geographies. Primary efficacy, safety and secondary endpoints will be similar to the Phase 3 trial described above. An interim analysis of the Phase 2b trial is expected towards end 2026.

Dr. Glenn E Dale, Chief Development Officer: “Multi-drug resistant infections, especially those acquired in a hospital setting are a rising medical problem across healthcare systems worldwide. Following the regulatory interactions we have had with the FDA and the CHMP, we continue to make progress with our antibiotic candidate, BV100. We are now advancing BV100 into global registrational study program with our two trials RIV-TARGET and RIV-CARE. As the RIV-CARE trial will be open-label, we are looking forward to first interim data towards end 2026.”

About BV100

BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, the BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including Carbapenem-Resistant ABC (CRAB) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.

 

About Acinetobacter baumannii

Acinetobacter baumannii calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. ABC is considered a significant worldwide threat in the healthcare setting given its ability to survive for prolonged periods on surfaces, combined with its ability to develop or acquire resistance to standard of care antibiotics, e.g. carbapenems. Carbapenem-resistance as well as multi-drug resistance (MDR) rates for ABC are among the highest recorded for any bacteria in current times (The Lancet 2022; 399: 629–55). Incidence and resistance rates for ABC are trending upwards and COVID-19 has exacerbated this significantly. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates.

 

About BioVersys

BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland.

BioVersys contact 
Hernan Levett, CFO, Tel. +41 61 633 22 50; Mail: hernan.levett@bioversys.com
For media: media@bioversys.com Website: www.bioversys.com

 

 

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

 


[1] Single- and Multiple-ascending Dose Study of the Pharmacokinetics, Safety and Tolerability of BV100 (rifabutin for infusion) in Healthy Volunteers; Christian Kemmer et al, 2026. https://journals.asm.org/doi/10.1128/aac.01582-25

DermaFix Nail Fungus Treatment Gel Claims Evaluated in 2026 Market Report Covering Tea Tree Oil Research, Penetration Technology Positioning, and Pricing Transparency

DermaFix Nail Fungus Treatment Gel Claims Evaluated in 2026 Market Report Covering Tea Tree Oil Research, Penetration Technology Positioning, and Pricing Transparency




DermaFix Nail Fungus Treatment Gel Claims Evaluated in 2026 Market Report Covering Tea Tree Oil Research, Penetration Technology Positioning, and Pricing Transparency

An informational industry analysis examining ingredient-level research, marketing positioning trends, regulatory context, and publicly listed pricing structures in the topical nail fungus category

Sheridan, WY, March 03, 2026 (GLOBE NEWSWIRE) — This article contains affiliate links. If a purchase is made through these links, a commission may be earned at no additional cost to the buyer. This article is an informational overview and does not constitute medical, health, or dermatological advice. All product details described below are stated as presented by the company and should be verified directly on the official website before any purchasing decision.

This release provides informational analysis of publicly available product and ingredient data and does not constitute a product review or endorsement.

Consumer interest in topical nail fungus treatment alternatives continues to grow in 2026. Search volume for ingredient-based antifungal formulations has increased as more adults explore options beyond prescription oral antifungals — medications that work systemically but carry well-documented side effect profiles including liver function concerns and required blood monitoring.

If you have been researching topical nail fungus treatments online, you have likely encountered products built around tea tree oil, colloidal silver, and penetration-enhancing carrier oils. DermaFix Nail Fungus Treatment Gel is one example currently marketed in this category. With that visibility come real questions: Are the formula’s core ingredients supported by published research for nail fungus applications? Does the gel’s delivery system address the well-documented challenge of penetrating the nail plate? And how do those claims align with published research and typical transparency standards within the topical antifungal category?

DermaFix Nail Fungus Treatment Gel Claims Evaluated in 2026 Market Report Covering Tea Tree Oil Research, Penetration Technology Positioning, and Pricing Transparency

This report evaluates what the company states, what ingredient-level research supports under controlled study conditions, and where gaps remain between marketing language and product-level clinical evidence.

Current product details, pricing, and terms can be confirmed by viewing the current DermaFix offer (official DermaFix page).

Individual results vary. Topical nail care products are not substitutes for professional dermatological evaluation or prescription antifungal treatment. Consult a qualified healthcare provider before starting any new topical regimen for nail concerns.

2026 Topical Nail Fungus Market Context

Onychomycosis — the clinical term for fungal nail infection — is one of the most common nail disorders worldwide. A 2024 global prevalence review published in the journal Mycoses reported that dermatophyte-caused toenail infections affect approximately 4% of the general population, with prevalence increasing substantially with age, diabetes, and other comorbidities. The condition is recognized in dermatological literature as notoriously difficult to treat, even with FDA-approved therapies.

This difficulty has created sustained consumer demand for alternative and complementary topical approaches. Products positioned around naturally-derived ingredients — particularly tea tree oil, which has a longer research history than most botanical antifungals — have gained increased visibility in direct-to-consumer channels. The category is characterized by several recurring trends worth understanding before evaluating any individual product.

Ingredient transparency varies widely. Some brands disclose exact concentrations per ingredient. Others, including many gel and oil-based formulations, list ingredients without specifying individual amounts — making it difficult for consumers or healthcare providers to compare formulations against published research dosages.

The penetration challenge remains central. The nail plate is composed of densely packed layers of hard keratin that create a formidable barrier to most topical agents. Published dermatology reviews consistently identify nail penetration as one of the primary obstacles in topical onychomycosis treatment. Many products in this category market “deep penetration” claims — the evidence supporting those claims varies significantly from product to product.

Regulatory classification matters. Products marketed as cosmetics or personal care items face different regulatory requirements than products marketed as drugs. The distinction affects what claims a company can legally make and what level of clinical evidence is required to support those claims.

What DermaFix Is and How It Is Positioned

DermaFix Nail Fungus Treatment Gel is a topical gel positioned as a naturally-derived alternative to prescription antifungals and standard topical creams. The product is distributed by Aura Health LLC out of Sheridan, Wyoming, with the website operated by Haur B.V. (Netherlands). The product seller is listed as STR.VERT Consultants Ltd (Cyprus).

The formula combines six ingredients: Tea Tree Oil, Colloidal Silver, Emu Oil, Vitamin E, Bacillus Ferment, and Squalane. Each tube contains 20 ml (0.68 oz). Marketing describes the formula as “nature inspired, clinically tested,” though specific clinical testing documentation — including published study citations, trial registrations, or peer-reviewed publication links — is not provided on the product website.

The website states DermaFix targets the nail bed beneath the nail plate where fungal infections colonize. Individual ingredient concentrations are not disclosed on the label or website, which limits comparison against dosages used in published research.

Tea Tree Oil Research: What Published Evidence Shows

Tea tree oil is the ingredient most prominently associated with DermaFix’s antifungal positioning. It also happens to be the ingredient with the most published research relevant to nail fungus — which makes it the right place to start when evaluating the evidence landscape.

A 1994 randomized controlled trial published in the Journal of Family Practice compared 100% tea tree oil to 1% clotrimazole solution in 117 patients over six months. Both treatments showed comparable clinical improvement, though neither achieved high rates of full mycological cure. A separate 1999 placebo-controlled study tested a cream containing 5% tea tree oil combined with 2% butenafine hydrochloride, achieving an 80% cure rate — though tea tree oil alone did not produce full cures in that trial.

More recent laboratory research has confirmed tea tree oil’s fungistatic effects against the dermatophytes most commonly responsible for nail infections, including Trichophyton rubrum and Trichophyton mentagrophytes — the organisms behind the vast majority of onychomycosis cases.

Here is what that research means in practical terms. Tea tree oil has demonstrated measurable antifungal activity in both clinical and laboratory settings. That is a real finding on a real compound. But the studies tested either pure tea tree oil at 100% concentration or standardized preparations at known dosages. DermaFix lists tea tree oil as one of six ingredients without disclosing its concentration. Whether the amount in DermaFix reaches levels associated with antifungal activity in published research cannot be confirmed from the label alone.

Additionally, antifungal activity demonstrated in a laboratory setting does not automatically translate to clinical effectiveness when applied to an infected nail. The nail plate’s keratin barrier is a fundamentally different challenge than a petri dish — and this penetration gap is exactly why topical nail fungus treatment remains so difficult across the entire category, not just for DermaFix.

Penetration Technology Claims: What the Category Promises vs. What Research Supports

DermaFix markets a “penetrating oil-based formula” as its primary differentiator. The website states that most treatments fail because “they never reach where the fungus actually lives” and that DermaFix “solves the penetration problem” using emu oil and squalane as deep-penetration carriers.

Emu oil has published research supporting its skin penetration-enhancing properties. Some studies suggest it may facilitate transdermal delivery of certain compounds through the skin. However, skin penetration and nail plate penetration involve different biological barriers with different structural properties. Published research specifically examining emu oil’s ability to deliver active compounds through the hard keratin of the nail plate is limited.

The marketing claim that emu oil carries active ingredients “through the nail plate within minutes” represents the company’s promotional positioning rather than a finding documented in published nail-specific penetration research. This distinction is worth understanding — not because the claim is necessarily wrong, but because it has not been independently verified through published study.

Performance Statistics and Marketing Claims on the DermaFix Website

The DermaFix website presents several specific performance statistics, including claims that 93% of users eliminated fungal infection within 8-12 weeks, 95% experienced no reinfection, and 90% noticed improvement within the first two weeks. Elsewhere on the site, slightly different figures appear: 94% said nail fungus was eliminated and 86% experienced less foot odor.

The methodology behind these statistics — including study design, sample size, measurement standards, and whether an independent third party conducted or verified the research — is not disclosed on the website. A quote attributed to “Dr. Emily Rowan, MD, Dermatology & Nail Health Specialist” appears on the product page, but verifiable credentials and institutional affiliation are not provided.

The company’s own footer disclaimer states that “Health Claims on the website have not been proved scientifically or evaluated by doctors.” These disclosures are worth reading carefully before relying on any statistical or testimonial claims to form expectations about the product.

For context, even FDA-approved topical antifungals — which have been evaluated through randomized, placebo-controlled clinical trials — report relatively modest complete cure rates. Published dermatological literature indicates toenail fungus treatment typically requires 12 to 18 months for a complete toenail to grow out, and even prescription topical treatments require 48-week treatment periods in clinical trials. Any topical product claiming visible results in two to four weeks should be evaluated against this well-established clinical timeline.

Colloidal Silver in the Topical Antifungal Category

DermaFix includes colloidal silver as a primary ingredient, described on its website as having antimicrobial properties. Silver compounds have demonstrated antifungal activity in published laboratory research. However, clinical evidence specifically supporting colloidal silver as a topical treatment for nail fungus is limited.

The FDA issued a final rule in 1999 determining that over-the-counter drug products containing colloidal silver ingredients are not generally recognized as safe and effective. DermaFix appears to be marketed as a topical personal care product rather than an FDA-approved drug. The website’s own footer disclaimer acknowledges that health claims have not been scientifically proved. This regulatory context is worth factoring into any product evaluation in this category.

DermaFix Pricing and Purchase Structure

According to pricing published on the official website at the time of this report:

Single Tube: $29.97 per tube.

Buy 1, Get 1 50% Off (2 Tubes): $22.49 per tube.

Buy 2, Get 2 Free (4 Tubes): $14.99 per tube.

The website describes free shipping and a 90-day money-back guarantee across all options. Consumers can confirm current pricing and availability by viewing the current DermaFix offer (official DermaFix page), as pricing may change at any time.

DermaFix Refund Policy

The company’s published Terms and Conditions describe a 90-day money-back guarantee with specific conditions that are worth reviewing carefully. Returned products must be unopened, in original packaging, and in resalable condition to be eligible for a refund. Opened or used tubes are described as non-refundable.

Return shipping is the buyer’s responsibility, and the company does not provide pre-paid return labels. The published processing timeline is seven to fourteen business days for inspection after receipt, followed by five to twenty business days for the refund to appear depending on the payment method and financial institution.

Where DermaFix Fits Within the 2026 Topical Nail Care Category

Based on its positioning and ingredient profile, DermaFix occupies a specific niche within the broader topical nail fungus market: naturally-derived, non-prescription, multi-ingredient formulations that emphasize penetration-enhancing carrier systems over pharmaceutical-grade active ingredients.

This positioning reflects a segment of the market focused on botanical-based topical formulations and non-prescription alternatives. It may be less aligned with consumers who require transparent ingredient concentrations, those dealing with severe infections that may require prescription treatment, or individuals expecting clinical-level cure rates from a single topical product.

As with any product in this category, a dermatologist or podiatrist can confirm whether a nail condition is actually caused by a fungal infection — not all nail discoloration or thickening is fungal in origin — and recommend the most appropriate evidence-based treatment approach for the specific situation.

Transparency Standards Typically Expected in This Category

Ingredient concentration disclosure. Products that list individual concentrations allow consumers and healthcare providers to compare against published research dosages. DermaFix does not disclose individual concentrations.

Clinical evidence documentation. The phrase “clinically tested” carries more weight when accompanied by published study citations, trial registration numbers, or peer-reviewed publication links. These are not provided on the DermaFix website.

Refund policy clarity. The 90-day guarantee applies only to unopened products. This is a meaningful distinction from guarantee language that implies risk-free trial usage.

Corporate structure transparency. Three entities across three countries are involved in the DermaFix transaction. The platform operator states it does not manufacture, test, or store the products.

Professional consultation. Any topical nail care regimen should ideally begin with a confirmed diagnosis from a qualified healthcare provider.

Frequently Asked Questions About Topical Nail Fungus Products and Ingredient Research

Is DermaFix an FDA-approved antifungal drug?

DermaFix does not appear to be marketed as an FDA-approved drug product. A disclaimer on the website states that health claims have not been scientifically proved or evaluated by doctors.

Does DermaFix disclose tea tree oil concentration?

Tea tree oil is listed as one of six primary ingredients, but its concentration is not disclosed. Published clinical research has tested tea tree oil at concentrations ranging from 5% to 100%.

What is the published evidence for colloidal silver in nail fungus treatment?

Silver compounds have demonstrated antimicrobial properties in laboratory settings. Published clinical evidence specifically supporting colloidal silver for nail fungus is limited. The FDA has stated that colloidal silver products marketed for therapeutic purposes are not generally recognized as safe and effective.

Can emu oil penetrate the nail plate?

Emu oil has published research supporting skin penetration enhancement. The nail plate presents a structurally different and more resistant barrier than skin. Published nail-specific penetration data for emu oil is limited.

What does “clinically tested” mean on the DermaFix website?

This phrase appears prominently but is not accompanied by published study citations, trial registration numbers, or links to peer-reviewed journals.

How does the 90-day guarantee work?

Per the published Terms and Conditions, refund eligibility requires products to be returned unopened, in original packaging, and in resalable condition. The buyer is responsible for return shipping costs.

How long does nail fungus treatment typically take?

Published dermatological literature indicates toenail fungus treatment typically requires 12 to 18 months for a complete toenail to grow out. Even FDA-approved topical antifungals require 48-week treatment periods in clinical trials.

Should I see a doctor before using a topical nail fungus product?

Yes. A dermatologist or podiatrist can confirm whether a nail condition is actually fungal in origin, identify the specific organism, and recommend evidence-based treatment. Not all nail discoloration or thickening is caused by fungus.

How do FDA-approved topical antifungals compare to non-prescription alternatives?

FDA-approved topical antifungals have been evaluated through randomized, placebo-controlled clinical trials with published efficacy data. Non-prescription topical products in this category generally have not undergone comparable evaluation as finished formulations.

Additional Independent Research

Independent research across peer-reviewed dermatology journals and clinical resources may provide broader perspective on topical nail fungus treatments, tea tree oil research, and antifungal product evaluation standards. Evaluating multiple sources is recommended before making any purchasing decision. Consumers may also wish to review the FDA’s guidance on cosmetic and drug product classifications and the American Academy of Dermatology’s patient resources on nail fungus treatment.

Summary of Key Findings

DermaFix Nail Fungus Treatment Gel is positioned within the growing category of naturally-derived topical nail care formulations. Tea tree oil, its most prominently marketed ingredient, has published peer-reviewed research demonstrating antifungal activity at the individual compound level. However, individual ingredient concentrations are not disclosed, and no published clinical trial has evaluated the finished product as formulated.

The 90-day refund guarantee requires unopened products for eligibility. Performance statistics and testimonials are presented alongside a disclaimer stating that health claims have not been scientifically proved. The multi-entity corporate structure spanning the Netherlands, Cyprus, and Wyoming is a factor worth considering.

Complete product details, current pricing, and published terms are available by viewing the current DermaFix offer (official DermaFix page).

About the Companies Listed in This Report

Aura Health LLC is a limited liability company organized under the laws of the State of Wyoming, USA, with a registered address at 30 N Gould St, STE R, Sheridan, WY 82801. The company is listed as the U.S. contact entity for the DermaFix product.

Haur B.V. is a private limited company incorporated under the laws of the Netherlands, registered with the Netherlands Chamber of Commerce (RSIN: 867612939), with a company address at John M. Keynesplein 1, 1066EP Amsterdam. Haur B.V. operates the DermaFix website as the platform operator.

STR.VERT Consultants Ltd (company code: HE467408) is registered in Cyprus at Lapithou 11, Flat/Office 101, Egkomi 2410, Lefkosia. STR.VERT is listed as the product seller responsible for product organization and delivery.

Contact Information

Email: hello@trydermafix.com

Phone: +1 (484) 263-5085

Website: https://trydermafix.com

Disclaimers

Content and Information Disclaimer: This article is an independent informational overview and does not constitute medical, health, dermatological, or legal advice. This release provides informational analysis of publicly available product and ingredient data and does not constitute a product review or endorsement. All product details, ingredient information, pricing, and policy terms described in this article are stated as presented by the company on its publicly available website and product labeling. This content has not been independently audited or verified unless specifically noted.

Health and Dermatological Notice: Nail discoloration, thickening, and brittleness can have multiple causes including fungal infection, psoriasis, and trauma. Professional diagnosis is recommended before self-treating any nail condition. The statements made by the manufacturer regarding this product have not been evaluated by the Food and Drug Administration. Individual results vary based on numerous factors. Nail health concerns should be discussed with a qualified dermatologist or podiatrist.

Results, Pricing, and Product Variability: All pricing, shipping terms, and refund policies referenced in this article are based on information published on the official product website at the time of writing and may change without notice. Consumers should verify current terms through the official website before completing any purchase.

FTC Affiliate Disclosure and Publisher Responsibility: This article contains affiliate links. If a product is purchased through these links, a commission may be earned at no additional cost to the buyer. The publisher is not responsible for typographical errors, manufacturer changes after publication, or individual consumer outcomes. The seller’s role does not constitute an endorsement, approval, or review of any claims made in the promotion of this product.

CONTACT: Email: hello@trydermafix.com
Phone: +1 (484) 263-5085