Dipharma publishes a peer-reviewed study in Organic Process Research & Development: a novel approach to detect and characterize nitrosamine formation in APIs




Dipharma publishes a peer-reviewed study in Organic Process Research & Development: a novel approach to detect and characterize nitrosamine formation in APIs

The pioneer method combines the nitrosation assay procedure (NAP) with 15N-enriched nitrosating reagents and 15N NMR spectroscopy for a safer Active Pharmaceutical Ingredients manufacturing process

MILAN, Nov. 27, 2025 (GLOBE NEWSWIRE) — Dipharma Francis S.r.l. (Dipharma), a leading Contract Development and Manufacturing Organization (CDMO) and a global manufacturer of Active Pharmaceutical Ingredients (APIs) and advanced intermediates, proudly announces the publication of the open-access article titled: “Hunt for NDSRIs: Unveiling Hidden Threats with the Novel ¹⁵N-Enriched NAP Test” in the scientific journal Organic Process Research & Development (OPR&D).

The work outlines a novel and insightful approach developed by Dipharma to detect nitrosamine impurities, particularly nitrosamine drug-substance-related impurities (NDSRIs). Nitrosamines are small nitrogen-based compounds that may form through unintended nitrosation pathways during synthesis, storage or degradation, and are closely monitored because many nitrosamines are potent mutagens and probable human carcinogens. Their control is therefore essential for patient safety, regulatory compliance and the integrity of the pharmaceutical supply chain.

The publication is freely accessible to scientists and industry stakeholders worldwide at:
https://pubs.acs.org/doi/10.1021/acs.oprd.5c00223
It appears in Organic Process Research & Development (OPR&D), a leading peer-reviewed journal focused on chemical process development and scale-up for industrial applications, issued by the American Chemical Society (ACS).

In the article, authored by Anna Simonetto, R&D Researcher, Gabriele Razzetti, Global Director of R&D, and Simone Mantegazza, Research Laboratory Manager, at Dipharma Francis, together with Prof. Enrico Monzani at the University of Pavia (Italy), the research team presents an innovative method that overcomes the limitations of traditional mass-based techniques. By integrating the nitrosation assay procedure (NAP) with ¹⁵N-enriched nitrosating reagents and ¹⁵N-NMR spectroscopy, the authors provide a selective and sensitive technique to detect and characterize nitrosamines, including challenging NDSRIs, even in complex matrices or when dealing with isomeric or degradation-derived species.

This strategy offers a robust and early-stage tool for assessing nitrosamine formation during API development and manufacturing, supporting impurity profiling, process understanding, and alignment with evolving regulatory expectations.
For both innovator and generic pharmaceutical companies, this research represents a significant step forward in proactively identifying and addressing nitrosamine-related challenges and ensuring long-term product reliability.
Dipharma congratulates the authors for this achievement, which reinforces the Company’s commitment to science-driven solutions and to enabling customers to make informed, sustainable decisions throughout the API development lifecycle.

“This publication strengthens Dipharma’s long-term strategy for nitrosamine control, which is grounded in multidisciplinary scientific investigation and combines advanced analytical solutions, a robust Risk Assessment Protocol, and proactive measures designed to safeguard compliance and product safety,” said Gabriele Razzetti, Global Director of R&D at Dipharma Francis S.r.l. “Thanks to our innovative approach, we can confirm or exclude nitrosamine formation with exceptional clarity, even in the most complex scenarios. For our partners, this means having a reliable foundation for risk assessment, regulatory justification, and mitigation planning. It also gives them the confidence that Dipharma is fully aligned with their objectives for safe, robust and future-proof API manufacturing, supported by continuous collaboration and a strong commitment to supply continuity. This study further demonstrates the excellence of our R&D team, whose scientific rigor and problem-solving capabilities continue to drive our success.”

About the Dipharma Francis group
The Dipharma Group is a global CDMO and a leading manufacturer of APIs and Intermediates, with about 600 skilled and highly committed employees, 4 cGMP plants, located in the U.S.A. and Italy, plus sales offices in Italy, the U.S.A. and China. The fully equipped R&D Centers develop innovative chemical processes and crystalline forms for the most prominent pharmaceutical companies worldwide. As a third-generation family-owned company, Dipharma has a long history of stability, commitment, and financial solidity. Dipharma has the right size and variety of scale-up capabilities to act as a global player and manage processes efficiently, while offering flexibility and agility to promptly solve any challenge. Experience you can trust.

For more information:
Paola Clerici         
Communication Manager         
Dipharma Francis S.r.l.
paola.clerici@dipharma.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/a1724d65-6a65-4938-b0ab-a023fec14ef4

GENFIT Announces Appointment of new Chief Medical Officer




GENFIT Announces Appointment of new Chief Medical Officer

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), November 27, 2025 – GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced the appointment of Dr. Pejvack Motlagh, the new Chief Medical Officer of GENFIT.

Member of the Executive Committee, Dr. Motlagh will oversee the strategy, direction, and execution of GENFIT’s clinical development plans and lead the Clinical (Operations and Strategy), Biometrics and Pharmacovigilance teams.

With over 20 years of experience in the pharmaceutical and biotechnology industry, Dr. Motlagh brings extensive expertise in drug development strategy across multiple therapeutic areas. His leadership will be instrumental in shaping GENFIT’s clinical development programs and advancing its pipeline.

Prior to joining GENFIT, Dr. Motlagh served as CMO at Egle Therapeutics, a company focused on therapies targeting regulatory T cells for oncology and autoimmune diseases. He also held the role of CMO at Mablink Biosciences, a biotechnology company specializing in next-generation antibody-drug conjugates (ADCs). Earlier in his career, Dr. Motlagh contributed to the success of several large pharmaceutical organizations, playing a key role in advancing compounds from early phase clinical development up to commercialization.

Dr. Pejvack Motlagh, Chief Medical Officer of GENFIT, commented: “I am thrilled to join GENFIT at a pivotal moment, as Acute on-Chronic Liver Failure becomes an increasingly important focus among the liver disease community. The company’s commitment to innovation and patient-centric development aligns perfectly with my own values. I look forward to working with the team to drive forward our clinical programs and make a meaningful impact in areas of high unmet medical need.” 

Pascal Prigent, CEO of GENFIT, stated: “We are delighted to welcome Pejvack to GENFIT. His deep expertise in clinical development and proven leadership in both large pharmaceutical and innovative biotech companies will be invaluable as we continue to advance our pipeline and deliver on our mission to bring transformative therapies to patients.”

END

ABOUT GENFIT

GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades.  

Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow.

GENFIT’s expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.¹   

Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis).

GENFIT is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT). In 2021, Ipsen became one of GENFIT’s largest shareholders, acquiring an 8% stake in the Company’s capital. www.genfit.com

FORWARD LOOKING STATEMENTS

This press release contains certain forward-looking statements with respect to GENFIT, including, but not limited to statements about the ability of the new Chief Medical Officer to shape GENFIT’s clinical development programs and advancing its pipeline. The use of certain words, such as “believe”, “potential”, “expect”, “target”, “may”, “will”, “should”, “could”, “if” and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 “Risk Factors and Internal Control” of the Company’s 2024 Universal Registration Document filed on April 29, 2025 (no. 25-0331) with the Autorité des marchés financiers (“AMF”), which is available on GENFIT’s website (www.genfit.fr) and the AMF’s website (www.amf.org), and those discussed in the public documents and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s 2024 Annual Report on Form 20-F filed with the SEC on April 29, 2025 and subsequent filings and reports filed with the AMF or SEC, including the Half-Year Business and Financial Report at June 30, 2025 or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

CONTACTS

GENFIT | Investors

Tel: +33 3 2016 4000 | investors@genfit.com

GENFIT | Media

Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com

GENFIT | 885 Avenue Eugène Avinée, 59120 Loos – FRANCE | +333 2016 4000 | www.genfit.com 

1 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo® 

Attachment

• GENFIT Announces Appointment of new Chief Medical Officer

Freya Pharma Solutions Rebrands as Arletta Pharma Solutions, Marking New Phase in Women’s Healthcare Innovation




Freya Pharma Solutions Rebrands as Arletta Pharma Solutions, Marking New Phase in Women’s Healthcare Innovation

• New name reflects company’s transformation as it advances toward the final phase of Lybrido™’s clinical development
• The Arletta butterfly symbolism underscores commitment to women’s health and lifecycle transitions
• CDU Phase II study ongoing with preliminary data expected near-term; ALETTA pivotal study positioned for launch pending financing completion
• Company leverages fifteen years of research in Female Sexual Disorders

Amsterdam, the Netherlands, 27 November 2025 – Freya Pharma Solutions, Freya Pharma Solutions, a pharmaceutical company specializing in innovative therapies for women diagnosed with Female Sexual Disorders (FSD), today announced it will rebrand as Arletta Pharma Solutions, effective December 1, 2025. The new name, derived from a rare butterfly species, symbolizes the company’s transformation as it progresses toward pivotal clinical milestones and its strategic objectives of securing regulatory approval.

“Like a caterpillar emerging as a butterfly, this name change marks the beginning of our company’s final phase,” said CEO Nicole Hijnen, Chief Executive Officer of Arletta Pharma Solutions. “This rebranding comes at the optimal moment in our evolution—as we advance our clinical programs and prepare to deliver on our founding mission to address a significant unmet medical need affecting millions of women worldwide.”

The Butterfly: A Universal Symbol in Women’s Healthcare
The name Arletta, inspired by a rare butterfly species, carries profound significance for women’s medical care. The butterfly symbolizes transformation, change, beauty, and freedom—concepts that resonate deeply throughout women’s healthcare. Internationally, the term “butterfly” appears frequently in medical contexts related to women’s health, from anatomical structures to diagnostic indicators, reflecting the transformative nature of women’s life stages.

Throughout their lives, women undergo remarkable transformations—puberty, reproductive years, perimenopause, and postmenopause—each representing a metamorphosis that requires specialized medical attention and understanding. Arletta Pharma’s focus on developing innovative therapies for Female Sexual Interest/Arousal Disorder (FSIAD) acknowledges these unique transitions and the need for targeted therapeutic solutions that respect the complexity of female sexual health.

Clinical Programs Advancing
Arletta Pharma’s Clitoral Doppler Duplex Ultrasonography (CDU) Phase II study is currently ongoing at Chaim Sheba Medical Center, evaluating two testosterone-sildenafil dose-combinations in 16 premenopausal women with acquired generalized FSIAD. Led by Prof. Cobi Reisman and Dr. Anna Padoa, the study utilizes clitoral doppler duplex ultrasound imaging to quantify clitoral blood flow parameters, with preliminary data expected in the near term. Additionally, the company is finalizing preparations for the ALETTA pivotal study across 20 European research sites in five countries, with enrollment positioned to commence in the foreseeable future pending completion of financing arrangements—a critical milestone toward regulatory approval in Europe.

Building on Fifteen Years of Scientific Foundation
Arletta Pharma Solutions (formerly Freya Pharma Solutions) is developing Lybrido™, an innovative on-demand dual-action therapy for FSIAD and Hypoactive Sexual Desire Disorder (HSDD), building upon fifteen years of research. Lybrido™ features a novel dual-route, dual-release tablet with a testosterone coating for sublingual administration and a sildenafil (PDE-5 inhibitor) inner core. The delayed-immediate-release matrix synchronizes peak plasma concentration of sildenafil with the testosterone-induced window of increased sexual motivation, enhancing genital arousal through increased responsivity to sexual stimuli. Effects last 3 to 6 hours after intake. To date, Lybrido™ has been investigated in 20 Phase I and Phase IIa trials, plus large-scale Phase IIb trials across 17 US research sites.

About Female Sexual Disorders
Low sexual desire is the most common female sexual disorder (FSD), often causing clinically significant distress, dissatisfaction in intimate relationships, and profoundly impacting emotional well-being. Female Sexual Interest/Arousal Disorder (FSIAD), as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), combines persistent reductions in sexual interest and/or arousal lasting six months while causing clinically significant distress. FSIAD represents the clustering of Hypoactive Sexual Desire Disorder and Female Sexual Arousal Disorder, listed in the World Health Organization’s International Classification of Diseases, 11th Revision (ICD-11) under Code HA00/HA01.0.

About Arletta Pharma Solutions
Arletta Pharma Solutions (formerly Freya Pharma Solutions) is a pharmaceutical company focused on developing effective pharmaceutical therapies for FSIAD/HSDD, building upon fifteen years of solid research. The company’s core asset under development is Lybrido™, designed to address FSIAD/HSDD through an innovative on-demand dual-action mechanism. Based in Amsterdam, The Netherlands, Arletta Pharma Solutions aims to offer patients a convenient, personalized on-demand solution for this recognized unmet medical need.

For further information please contact:

Arletta Pharma Solutions, Amsterdam
Marcel Wijma, Chief Business Officer 
marcel@arlettapharmasolutions.com

For media
LifeSpring Life Sciences Communication, Amsterdam
Leon Melens
T: +31 6 538 16 427
E: lmelens@lifespring.nl

Attachment

• Freya Pharma Press Release Rebranding in Arletta_final

Report finds adoption of barcoding system in Canadian healthcare can save billions annually while supporting patient safety




Report finds adoption of barcoding system in Canadian healthcare can save billions annually while supporting patient safety

TORONTO, Nov. 27, 2025 (GLOBE NEWSWIRE) — A new report prepared by Deloitte Canada and commissioned by GS1 Canada finds that the lack of nationwide adoption of global standards via Global Trade Item Numbers (GTINs) and Global Location Numbers (GLNs) is costing the Canadian healthcare system up to $2.3 billion every year. Without alignment to the GS1 global system used in over 150 countries, these costs are expected to continue growing year-over-year.

“Tariffs and economic pressures are highlighting the importance of an integrated, resilient healthcare supply chain both nationally and globally, just as the pandemic did,” said Tony Di Emanuele, President & CEO, Mohawk Medbuy and GS1 Canada Healthcare Advisory Council member. “We have been using the GS1 standards for accurate product identification for years at Mohawk Medbuy, along with multiple countries across the globe where healthcare products come from. Implementing global data standards is a key component of creating safer, smarter healthcare systems.”

Key Takeaways:

• GTINs and GLNs are barcode and product identifier numbers that enable streamlined supply chain management of products.
• When adopted in healthcare, they help facilitate accurate procurement efforts, support emergency response by foreseeing shortages and enabling fast recall efforts, provide useful data analytics on product usage, and improve patient outcomes. 
• Medical errors and adverse drug events which is estimated to impact up to 150,000 Canadians each year could be reduced by up to 63 percent by adopting GTINs and GLNs. 
• Canada’s healthcare system lags international peers in GTIN and GLN adoption, limiting supply chain and trade diversification opportunities.
• Global standards present a much-needed solution to strengthen supply chain independence and address health system challenges like workforce shortages.

Regulatory change is needed to ensure system-wide adoption and the universal use of GTINs and GLNs across all packaged products and health facilities. Health Canada, provincial health ministries, hospital administrators, and industry stakeholders are urged to collaborate on mandating global standards that drive connected care, supply chain transparency, and a national approach that will ultimately benefits patients. 

“Adopting GTINs and GLNs is a low-cost step that can unlock critical resources for wait times, crisis response, and innovative care,” said Altaf Stationwala, President & CEO of Unity Health Toronto. “Beyond efficiency, these standards can help reduce medical errors, better anticipate shortages, and give hospitals the data they need to make smarter decisions for patients. They would enable a clinically integrated supply chain, tracking products from manufacturer right to the patient record and are a practical example of how working together can strengthen Canada’s health system.”

Collaboration across system partners and government is essential to bring these benefits to Canada’s health system.

The Costs of Inaction: Unlocking Potential in Canadian Healthcare Through GTIN and GLN Adoption 
Download the full report
Download the executive summary

Media Contact 
Laural Adams 
Sr. Manager, Communications 
GS1 Canada 
Phone: 416-873-5841 
Email: Laural.Adams@gs1ca.org
Website: https://gs1ca.org/media/ 

Linkedin Instagram Facebook

About GS1 Canada

GS1 Canada is part of GS1, the global not-for-profit organization behind the first barcode and the world’s most widely used supply chain standards. GS1 Canada supports business success through global barcodes and the development of industry-directed solutions that meet common business needs. Their collaborative approach, powered by GS1 standards, delivers measurable value to Canadian businesses of all sizes. As a leader in product data quality, GS1 Canada ensures the seamless exchange of accurate, trusted data between trading partners, fostering operational excellence and consumer trust. By providing essential tools and insights, they empower industries to work smarter, reduce costs, and create a more sustainable future.

About GS1

GS1 is a neutral, not-for-profit organisation that develops and maintains the most widely used global standards for business communication, including the GS1 DataMatrix barcode used to identify and trace medicines worldwide. Best known for the barcode, named by the BBC as one of the “50 things that made the world economy,” GS1 standards enhance efficiency, safety, and visibility across supply chains and sectors. With Member Organisations in over 120 countries and territories and more than 2 million member companies, GS1’s mission is to enable a world where trusted data improves business and lives everywhere. Learn more at www.gs1.org.

Legend Biotech Awarded 2025 FIBA Foreign Investor of the Year by Flanders Investment & Trade




Legend Biotech Awarded 2025 FIBA Foreign Investor of the Year by Flanders Investment & Trade

Recognizes the company’s continued investment and expansion of cell therapy manufacturing and R&D operations in Ghent, reinforcing Flanders’ position as a global biotech hub

SOMERSET, N.J. and GHENT, Belgium, Nov. 27, 2025 (GLOBE NEWSWIRE) — Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today announced that the Company has been awarded Foreign Investor of the Year at the 2025 Flanders International Business Awards (FIBA) hosted by Flanders Investment & Trade (FIT).

FIT is a Flemish government agency that promotes international investment in Flanders, Belgium. The annual FIBA honors companies that elevate Flanders’ international profile and strengthen their role as a leading innovation hub. Among these awards, the Foreign Investor of the Year award recognizes organizations for their long-term commitment, economic contributions, and job creation in the region. Notably, Legend Biotech received the Startup of the Year award in 2022, highlighting its rapid and significant establishment in Flanders.

“We are proud to be recognized once again by Flanders Investment & Trade for our continued growth and partnership in Belgium,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “This award reaffirms our long-term commitment to advancing cell therapy manufacturing in Flanders and strengthening our global capabilities to deliver transformative treatments to patients worldwide.”

Legend Biotech received this year’s award in recognition of a €165 million joint investment with Johnson & Johnson to expand the state-of-the-art facility at Tech Lane Ghent Science Park. This second phase of investment further reinforces the company’s position in Flanders as one of Europe’s largest CAR-T manufacturing centers. Together with the nearby Obelisc site, the Ghent operations serve as the company’s European hub for the clinical and commercial supply of cell therapies across the EMEA region.

“Three years ago, we started with an empty building and a small, ambitious team,” said Birk Vanderweeën, Senior Vice President, Global Manufacturing & Supply at Legend Biotech. “Today, our Ghent sites are fully operational and play a central role in our global manufacturing network, enabling us to scale our therapies and bring hope to more patients around the world.”

Since commencing operations in Ghent in 2022, the Legend Biotech team in Belgium has grown from just two employees to more than 1,000, representing 66 nationalities. This momentum is expected to continue, with additional hires planned over the coming years.

“Our growth story is closely tied to the strength of the Flemish biotech ecosystem,” added Frederik Buysse, General Manager, Legend Biotech Belgium. “Through our partnerships with FIT and VOKA, and our collaborations with leading research institutions, including VIB and Ghent University, Flanders offers a unique environment where science and industry reinforce one another. This award is a testament to that shared success.”

About Legend Biotech
With over 2,900 employees, Legend Biotech is the largest standalone cell therapy company and a pioneer in treatments that change cancer care forever. The company develops and markets CAR-T cell therapy ciltacabtagene autoleucel (cilta-cel) with collaborator Johnson & Johnson. In the EU, cilta-cel is approved under the brand name CARVYKTI®▼ for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy.

Headquartered in the United States, Legend is building an end-to-end cell therapy company by expanding its leadership to maximize CAR-T cell therapy patient access and therapeutic potential. From this platform, the company plans to drive future innovation across its pipeline of cutting-edge cell therapy modalities.

Learn more at www.legendbiotech.com, and follow us on X (formerly Twitter) and LinkedIn.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives, and the potential benefits of Legend Biotech’s product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; government, industry, and general product pricing and other political pressures; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 11, 2025. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date of this press release. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

INVESTOR CONTACT:
Jessie Yeung
Tel: (732) 956-8271
jessie.yeung@legendbiotech.com

PRESS CONTACT:
Alexandra Ventura
Tel: (732) 850-5598
media@legendbiotech.com

Kane Biotech Announces New Private Placement Offering




Kane Biotech Announces New Private Placement Offering

Not for distribution to U.S. news wire services or dissemination in the United States

WINNIPEG, Manitoba, Nov. 27, 2025 (GLOBE NEWSWIRE) — Kane Biotech Inc. (TSX-V:KNE) (“Kane Biotech”, “Kane” or the “Company”) today announces its intention to undertake a non-brokered private placement offering (the “Offering”) of up to 16 million common shares (“Shares”) at a price of $0.05 per Share for gross proceeds of up to $800,000.

The net proceeds of the Offering will be used for working capital and general corporate purposes. Certain insiders of Kane Biotech may participate in the Offering. Closing of the Offering is expected to take place on or about December 17, 2025.

All Shares issued in connection with the Offering are subject to a hold period of four-months and one day from the date of issuance.

The Offering is subject to receipt of all necessary approvals, including the approval of the TSX Venture Exchange.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall it constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful. These securities have not been, and will not be, registered under the United States Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States or to U.S. persons unless registered or exempt therefrom.

About Kane Biotech Inc. (TSX-V: KNE)

Kane Biotech is developing novel wound care treatments that disrupt biofilms and transform healing outcomes. Biofilms are one of the main contributors to antibiotic resistance in wounds which results in serious clinical outcomes and significant cost. revyve^® addresses both biofilms and wound bacteria. revyve^® Antimicrobial Wound Gel and revyve^® Antimicrobial Wound Gel Spray are US FDA 510(k) cleared. revyve^® Antimicrobial Wound Gel is Health Canada approved. To learn more about revyve, visit revyvegel.com or revyvegel.ca.

Join Kane’s Distribution List & Social Media:

To stay informed on the latest developments, sign-up for the Company’s email distribution list HERE.

Follow Kane

Website: kanebiotech.com

LinkedIn: https://www.linkedin.com/company/kanebiotech/

Presentations: https://kanebiotech.com/publications-posters/

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Caution Regarding Forward-Looking Information
This press release contains certain statements regarding Kane Biotech Inc. that constitute forward-looking information under applicable securities law. These statements reflect management’s current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, risks relating to the Company’s: (a) financial condition, including lack of significant revenues to date and reliance on equity and other financing; (b) business, including its early stage of development, government regulation, market acceptance for its products, rapid technological change and dependence on key personnel; (c) intellectual property including the ability of the Company to protect its intellectual property and dependence on its strategic partners; and (d) capital structure, including its lack of dividends on its common shares, volatility of the market price of its common shares and public company costs. Further information about these and other risks and uncertainties can be found in the disclosure documents filed by the Company with applicable securities regulatory authorities, available at www.sedarplus.ca. The Company cautions that the foregoing list of factors that may affect future results is not exhaustive.

Kane Biotech Announces New Private Placement Offering




Kane Biotech Announces New Private Placement Offering

Not for distribution to U.S. news wire services or dissemination in the United States

WINNIPEG, Manitoba, Nov. 27, 2025 (GLOBE NEWSWIRE) — Kane Biotech Inc. (TSX-V:KNE) (“Kane Biotech”, “Kane” or the “Company”) today announces its intention to undertake a non-brokered private placement offering (the “Offering”) of up to 16 million common shares (“Shares”) at a price of $0.05 per Share for gross proceeds of up to $800,000.

The net proceeds of the Offering will be used for working capital and general corporate purposes. Certain insiders of Kane Biotech may participate in the Offering. Closing of the Offering is expected to take place on or about December 17, 2025.

All Shares issued in connection with the Offering are subject to a hold period of four-months and one day from the date of issuance.

The Offering is subject to receipt of all necessary approvals, including the approval of the TSX Venture Exchange.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall it constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful. These securities have not been, and will not be, registered under the United States Securities Act of 1933, as amended, or any state securities laws, and may not be offered or sold in the United States or to U.S. persons unless registered or exempt therefrom.

About Kane Biotech Inc. (TSX-V: KNE)

Kane Biotech is developing novel wound care treatments that disrupt biofilms and transform healing outcomes. Biofilms are one of the main contributors to antibiotic resistance in wounds which results in serious clinical outcomes and significant cost. revyve^® addresses both biofilms and wound bacteria. revyve^® Antimicrobial Wound Gel and revyve^® Antimicrobial Wound Gel Spray are US FDA 510(k) cleared. revyve^® Antimicrobial Wound Gel is Health Canada approved. To learn more about revyve, visit revyvegel.com or revyvegel.ca.

Join Kane’s Distribution List & Social Media:

To stay informed on the latest developments, sign-up for the Company’s email distribution list HERE.

Follow Kane

Website: kanebiotech.com

LinkedIn: https://www.linkedin.com/company/kanebiotech/

Presentations: https://kanebiotech.com/publications-posters/

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Caution Regarding Forward-Looking Information
This press release contains certain statements regarding Kane Biotech Inc. that constitute forward-looking information under applicable securities law. These statements reflect management’s current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, risks relating to the Company’s: (a) financial condition, including lack of significant revenues to date and reliance on equity and other financing; (b) business, including its early stage of development, government regulation, market acceptance for its products, rapid technological change and dependence on key personnel; (c) intellectual property including the ability of the Company to protect its intellectual property and dependence on its strategic partners; and (d) capital structure, including its lack of dividends on its common shares, volatility of the market price of its common shares and public company costs. Further information about these and other risks and uncertainties can be found in the disclosure documents filed by the Company with applicable securities regulatory authorities, available at www.sedarplus.ca. The Company cautions that the foregoing list of factors that may affect future results is not exhaustive.

Change of management at NTG Nordic Transport Group A/S




Change of management at NTG Nordic Transport Group A/S

Company announcement no. 11 – 25
27 November 2025

Change of management at NTG Nordic Transport Group A/S

Appointment of new Group CFO

NTG announces the appointment of Tinneke Torpe as the new Group Chief Financial Officer (“CFO”), effective no later than 1 April 2026. Tinneke brings extensive experience in financial leadership roles, most recently serving as CFO at TP Aerospace Group, where she was responsible for Business Finance, Accounting, IT & Digitalisation, and Legal. Prior to her tenure at TP Aerospace Group, Tinneke held various positions within the A.P. Moller – Maersk Group and FLSmidth. She has demonstrated strong capabilities in managing complex organisations, with a proven track record that includes leading successful ERP implementations, finance standardisation and transformation initiatives, and the offshoring of finance operations. Tinneke will join NTG’s Group Management and Executive Leadership Team.

NTG’s current CFO, Christian Jakobsen, will be departing the organisation to pursue new opportunities. Over the course of his more than seven-year tenure, Christian has played an instrumental role in enhancing NTG’s controlling and reporting infrastructure. He was pivotal in guiding the company through its 2019 initial public offering and subsequent investor relations activities, as well as in leading major integrations of acquired targets that have contributed significantly to NTG’s growth strategy.

“I would like to express my sincere appreciation to Christian Jakobsen for his dedication and contributions as Group CFO of NTG since 2018. With Christian’s support, NTG has experienced significant and sustained growth, more than doubling its size during his tenure, and his invaluable contributions have been integral to the company’s success“, says Mathias Jensen-Vinstrup, Group CEO of NTG.

Departure from Group Management team

Peter Grubert will transition out of the Group Management team of NTG as he moves into a part-time Corporate Development and Special Projects role. In this capacity, Peter will continue his valued affiliation with NTG, providing the organisation with ongoing access to his extensive knowledge, experience, and understanding of the business, thus ensuring continuity while allowing Peter to contribute in a focused manner where his expertise is most needed.

“I would like to acknowledge and thank Peter Grubert for his distinguished service and contributions to NTG across his roles as advisor, board member, and Group Management team member since inception of the company. His dedication and expertise have been exceptional, and I look forward to our continued collaboration“, says Mathias Jensen-Vinstrup, Group CEO of NTG.

Following the organisational changes, the Group Management team of NTG will consist of:

• Mathias Jensen-Vinstrup, Group CEO
• Tinneke Torpe, Group CFO
• Daniel Leegaard Heede, Group CIO
• Jesper E. Petersen, CEO Road & Logistics
• Diederick de Vroet, CEO Air & Ocean

Additional information

For additional information, please contact:

Attachment

• Company announcement no. 11_2025

Change of management at NTG Nordic Transport Group A/S




Change of management at NTG Nordic Transport Group A/S

Company announcement no. 11 – 25
27 November 2025

Change of management at NTG Nordic Transport Group A/S

Appointment of new Group CFO

NTG announces the appointment of Tinneke Torpe as the new Group Chief Financial Officer (“CFO”), effective no later than 1 April 2026. Tinneke brings extensive experience in financial leadership roles, most recently serving as CFO at TP Aerospace Group, where she was responsible for Business Finance, Accounting, IT & Digitalisation, and Legal. Prior to her tenure at TP Aerospace Group, Tinneke held various positions within the A.P. Moller – Maersk Group and FLSmidth. She has demonstrated strong capabilities in managing complex organisations, with a proven track record that includes leading successful ERP implementations, finance standardisation and transformation initiatives, and the offshoring of finance operations. Tinneke will join NTG’s Group Management and Executive Leadership Team.

NTG’s current CFO, Christian Jakobsen, will be departing the organisation to pursue new opportunities. Over the course of his more than seven-year tenure, Christian has played an instrumental role in enhancing NTG’s controlling and reporting infrastructure. He was pivotal in guiding the company through its 2019 initial public offering and subsequent investor relations activities, as well as in leading major integrations of acquired targets that have contributed significantly to NTG’s growth strategy.

“I would like to express my sincere appreciation to Christian Jakobsen for his dedication and contributions as Group CFO of NTG since 2018. With Christian’s support, NTG has experienced significant and sustained growth, more than doubling its size during his tenure, and his invaluable contributions have been integral to the company’s success“, says Mathias Jensen-Vinstrup, Group CEO of NTG.

Departure from Group Management team

Peter Grubert will transition out of the Group Management team of NTG as he moves into a part-time Corporate Development and Special Projects role. In this capacity, Peter will continue his valued affiliation with NTG, providing the organisation with ongoing access to his extensive knowledge, experience, and understanding of the business, thus ensuring continuity while allowing Peter to contribute in a focused manner where his expertise is most needed.

“I would like to acknowledge and thank Peter Grubert for his distinguished service and contributions to NTG across his roles as advisor, board member, and Group Management team member since inception of the company. His dedication and expertise have been exceptional, and I look forward to our continued collaboration“, says Mathias Jensen-Vinstrup, Group CEO of NTG.

Following the organisational changes, the Group Management team of NTG will consist of:

• Mathias Jensen-Vinstrup, Group CEO
• Tinneke Torpe, Group CFO
• Daniel Leegaard Heede, Group CIO
• Jesper E. Petersen, CEO Road & Logistics
• Diederick de Vroet, CEO Air & Ocean

Additional information

For additional information, please contact:

Attachment

• Company announcement no. 11_2025

Happy Go Leafy Launches Its Biggest Black Friday Kratom Event: 30% Off Orders Over $100




Happy Go Leafy Launches Its Biggest Black Friday Kratom Event: 30% Off Orders Over $100

Happy Go Leafy confirms a sitewide Black Friday discount of 30% off on qualifying orders of $100 or more. Sale runs Nov 28–30 with code BLACKOUT30.

Glendale, CA, Nov. 27, 2025 (GLOBE NEWSWIRE) — Black Friday shopping wave is here yet again, and Kratom buyers are about to see one of the most aggressive price drops of the season. Happy Go Leafy has opened its annual Black Friday event with a 30% sitewide discount on orders over $100, giving customers rare access to premium, lab-tested Kratom at significantly reduced prices.

Unlike routine promotional weeks, this three-day sale runs only from November 28 to November 30 and includes every major strain category, including powders, capsules, and liquid extracts. With demand for high-quality Kratom increasing ahead of the holiday season, the brand’s once-a-year markdown gives both new and returning buyers a high-value chance to restock before inventory tightens.

Deal Highlights at a Glance: What You Need to Know?

Here’s a quick breakdown of the Black Friday offer to help shoppers navigate the event easily and make the most of the limited three-day window.

• Flat 30% Savings on the Entire Store

Every Kratom item qualifies for the discount, including powders, capsules, extracts, and mixed strains.

• Cart Minimum: $100 Before Discount

Buyers can pair any strains or formats they prefer to reach the qualifying amount.

• Offer Active November 28–30 Only

The deal opens on Black Friday morning and closes at midnight on November 30.

• Use Code: BLACKOUT30

Enter the code during checkout to see the discount deducted automatically.

• Designed for Maximum Flexibility

With no product restrictions or hidden conditions, you get a straightforward, high-value holiday markdown.

Why This Black Friday Sale Is a Must-Shop Event for Kratom Buyers?

Kratom shoppers often face obstacles throughout the year, making a high-value sale like this especially meaningful. Happy Go Leafy’s Black Friday event directly addresses the issues most buyers deal with.

• Industry-Wide Price Increases

With Kratom prices rising across many vendors, a 30% markdown provides rare relief for routine users.

• Need for Verified, Clean Products

Many shoppers struggle to find brands that consistently publish authentic lab results; Happy Go Leafy offers batch-level testing year-round.

• Uneven Alkaloid Strength Between Sellers

Potency variations make it hard for users to rely on specific strains; the brand’s controlled sourcing helps keep strength more predictable.

• Demand for Holiday Bulk Value

Seasonal restocks are common in November, and this sale gives customers access to premium-quality Kratom at a much lower cost.

Kratom Favorites You Should Stock Up On This Black Friday Weekend 

Black Friday is the ideal time for Kratom buyers to secure the strains they rely on most, especially the ones known for consistent quality and strong customer demand. Happy Go Leafy’s catalog includes several standout options that regularly sell out during major sale periods, making early shopping essential.

• Red Maeng Da

Recognized for its naturally high alkaloid content, this strain has a long-standing reputation for consistent batch results. It remains one of the top picks for customers who value depth and consistency.

• Green Borneo

A balanced, steady-profile strain that daytime users trust for a reliable experience. Its popularity stems from its smoothness and how it fits into everyday routine use.

• White Malay

Known for its lighter, cleaner character, White Malay is often preferred by morning users who want a smoother start to their day. Its subtlety makes it a favorite among shoppers exploring white vein strains.

• Red Thai

A go-to option among evening buyers, appreciated for its mellow, easygoing profile. It’s frequently added to bulk carts during seasonal restocks.

• Trainwreck Kratom

A well-rounded, full-spectrum blend created for users who want a broader alkaloid range in a single product. This blend tends to gain traction during high-value promotions.

• Kratom Liquid Shots

Convenient, fast-absorbing, and ideal for users who prefer quick servings without measuring. These are especially popular during limited-time sales.

Who Can Avail This Offer? 

This limited-time Black Friday offer is open to a wide range of eligible buyers who meet the basic requirements for Kratom purchases.

• Adults 21+ in Permitted Regions

The discount can be used by customers aged 21 and older in areas where Kratom sales and delivery are legally allowed.

• New Shoppers Exploring Kratom

First-time buyers can take advantage of the offer to try premium, lab-tested products at a lower entry cost.

• Returning Happy Go Leafy Customers

Existing users can restock their preferred strains, capsule bundles, or bulk packs while securing substantial Black Friday savings.

• Any Cart That Reaches $100 Before Discount

The offer activates for all qualifying orders, regardless of strain selection or product mix.

How to Claim the Deal: A Quick 5-Step Redemption Guide 

Redeeming the Black Friday offer is simple and takes only a few moments at checkout.

1. Visit HappyGoLeafy.com and browse the full selection of powders, capsules, blends, and liquid shots.
2. Add items totaling $100 or more to your cart. Any strain or format qualifies.
3. Enter BLACKOUT30 in the coupon field during checkout.
4. Confirm that the 30% discount has been applied before completing payment.
5. Place your order before November 30, as the offer expires at midnight.

Note: The code can be used once per customer and cannot be combined with other promotions.

Frequently Asked Questions 

1. Is the 30% discount valid on all Kratom products?

Yes, the offer applies to every product on the website, including powders, capsules, blends, bulk packs, and liquid shots. There are no exclusions on strains or formats during the Black Friday window.

2. Will top strains sell out quickly?

Popular varieties such as Red Maeng Da, Green Borneo, and Trainwreck typically see faster movement during major sales. Shoppers who want specific sizes or bulk options are encouraged to order early.

3. Where do I enter the coupon code at checkout?

The BLACKOUT30 code can be entered in the promo field before completing payment. Once applied, the discount will reflect immediately in the order summary.

4. Are all Happy Go Leafy products lab-tested?

Yes, every batch undergoes third-party testing to confirm purity, cleanliness, and alkaloid profile. Customers can rely on transparent quality standards across all strains.

5. Can I combine this coupon with loyalty rewards or other deals?

No, the Black Friday discount must be used on its own and cannot be stacked with points, rewards, or additional promotions. This ensures the full 30% savings apply cleanly.

About Happy Go Leafy: A Brand Built on Trust & Transparency

Happy Go Leafy has built a strong reputation in the Kratom community by prioritizing transparent sourcing, rigorous quality checks, and consistent product standards. The brand works directly with experienced Southeast Asian farmers who use traditional harvesting methods to preserve the plant’s natural profile. 

Every batch undergoes third-party lab testing to verify purity, cleanliness, and alkaloid makeup, ensuring customers receive reliable products without additives or fillers. With a broad catalog that includes powders, capsules, and liquid shots, the company caters to diverse preferences while maintaining strict 21+ age-restricted access for responsible, informed purchasing.

CONTACT: Company Name: Happy Go Leafy
Website: https://behappygoleafy.com/
Email: hello@behappygoleafy.com
Headquarters: Miami, Florida