Panthera Resources PLC on Monday reported a wider interim loss as it continued to incur arbitration and exploration costs, while confirming progress on its $1.58 billion legal claim against India.
The London-based gold explorer and mine developer in West Africa and India posted a net loss of $1.4 million for the six months that ended September 30, widened from $1.1 million a year earlier. Basic and diluted loss per share was $0.01, unchanged from a year prior.
Panthera said the increased loss reflected the cost of arbitration activity related to its Bhukia gold project in India, alongside continued investment in exploration across its West African portfolio.
Arbitration income more than doubled to $2.6 million for the period from $1.2 million a year prior, but was largely offset by arbitration expenses of $2.5 million, up from $1.2 million.
Cash at the end of September stood at $1.9 million, down from $3.1 million at March 31. Since then, however, Panthera raised a further $1.2 million through the exercise of warrants.
Panthera said the arbitral tribunal has now set a phase one hearing date for December 2026 in relation to its claim against the government of India, which seeks damages of $1.58 billion net of Indian taxes.
The company added that its $13.6 million arbitration funding facility remains available, with around 63% drawn to date.
On the operational front, Panthera said it commenced a 1,740-metre reverse circulation drilling programme at the Bido project and initiated a feasibility study at the Cascades project, both in Burkina Faso.
Chief Executive Officer Mark Bolton said: ‘During the half-year, significant progress was made in the arbitration process for the Bhukia gold project.
‘More recently, the company achieved an important milestone with the commencement of cross-trading on the OTCQB Venture Market in the USA.’
Shares in Panthera Resources opened 2.4% lower at 22.44 pence in London on Monday morning.
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The world’s largest accounting body is to stop students being allowed to take exams remotely to crack down on a rise in cheating on tests that underpin professional qualifications.
The Association of Chartered Certified Accountants (ACCA), which has almost 260,000 members, has said that from March it will stop allowing students to take online exams in all but exceptional circumstances.
“We’re seeing the sophistication of [cheating] systems outpacing what can be put in, [in] terms of safeguards,” Helen Brand, the chief executive of the ACCA, said in an interview with the Financial Times.
Remote testing was introduced during the Covid pandemic to allow students to continue to be able to qualify at a time when lockdowns prevented in-person exam assessment.
In 2022, the Financial Reporting Council (FRC), the UK’s accounting and auditing industry regulator, said that cheating in professional exams was a “live” issue at Britain’s biggest companies.
A number of multimillion-dollar fines have been issued to large auditing and accounting companies around the world over cheating scandals in tests.
The FRC’s investigation found that instances of cheating also included some tier-one auditors, a category comprising the “big four” accountants – KPMG, PwC, Deloitte and EY – along with Mazars, Grant Thornton and BDO.
In 2022, EY agreed to pay a record $100m (£74m) to US regulators over claims that dozens of its employees cheated on an ethics exam and that the company then misled investigators.
The ACCA said it has now concluded that online tests have become too difficult to police, given the rise in artificial intelligence (AI) tools available to students.
Brand said the ACCA, which has more than half a million students, had worked “intensively” to combat cheating but “people who want to do bad things are probably working at a quicker pace”.
She added that the rapid rise of technology, led by AI tools, had pushed the issue of cheating to a “tipping point”.
Last year, the Institute of Chartered Accountants in England and Wales (ICAEW), which also trains accountants around the world, said reports of cheating were still increasing.
However, the ICAEW still permits some exams to be sat online.
“There are very few high-stakes examinations now that are allowing [remote invigilation],” Brand said.
The National Cyber Crime Investigation Agency (NCCIA) has issued a New Year alert, warning citizens about a rise in online scams and fraudulent activities ahead of year-end celebrations.
In an official advisory, the NCCIA urged the public to remain cautious as cybercriminals increasingly target users through fake links, messages, and congratulatory offers related to the New Year.
The agency said fraudsters are circulating bogus messages promising gifts and rewards to deceive unsuspecting individuals.
The NCCIA advised citizens not to click on suspicious links or share personal or financial information online. It stressed that increased online activity during New Year celebrations provides scammers with more opportunities to exploit users.
Earlier, the agency also released emergency protocols to help users recover hacked WhatsApp accounts amid a surge in account takeovers.
NCCIA officials said users who suspect unauthorized access should immediately uninstall and reinstall WhatsApp, then re-register using their phone number.
Upon re-registration, WhatsApp sends a six-digit verification code via SMS. Entering this code instantly logs out the hacker, as WhatsApp allows only one active session per account at a time.
If hackers have enabled two-step verification, users may need to wait up to seven days before regaining full access. The NCCIA assured users that during this period, messages remain secure and inaccessible to unauthorized parties.
The agency urged citizens to stay alert, follow cybersecurity guidelines, and report suspicious online activity to prevent financial loss and identity theft.
Top row, from left: Alex Sanchez, Cal State LA; Rylee Jue, Cal State Monterey Bay; Veronica Zaragoza, Cal Poly Humboldt. Bottom row, from left: Eryka Lepper, Stanislaus State; Carlos Garcia Sanchez, Cal State San Marcos; Oliver Sanchez, Stanislaus State.
What did you learn in 2025?
At the year’s end, EdSource posed that deceptively simple question to a group of college students around California. Their answers hinted at some of the technological changes and political disruptions that have defined 2025 on so many university campuses. But they also spoke to the perennial challenges and triumphs of college life: relief at earning a B when a C seemed more likely, gratitude for friends that made a difficult semester feel a little lighter, and the hopeful uncertainty that awaits after graduation.
Somewhere between multivariable calculus and web development classes — somewhere between leading student government or working at an off-campus internship — college students around California learned things that don’t fit neatly into a transcript. They learned timeless techniques for self-care, ample skepticism of artificial intelligence, the need for persistence despite hurdles, and the confidence that they are bolder and more capable than they previously thought. And maybe take a deep breath and some breaks from social media and screens.
An award, a word of support and a third try
After two unsuccessful attempts at a bachelor’s degree, Alex Sanchez thought he might try something completely different: an apprenticeship in construction.
Alex SanchezCourtesy of Alex Sanchez
He was making good money for his age, and he liked working with his hands, but Sanchez was exhausted and bored. “Hey, kid,” he remembers his boss asking him, “what are you doing here?”
Sanchez decided to give college a third shot. This time, he studied mechanical engineering.
And that’s how Sanchez, now 27 and set to graduate from Cal State LA in May this year, won a research competition across all 22 California State University campuses. He also snagged internships at the Jet Propulsion Laboratory research and development center and at a NASA facility in Cleveland, Ohio, that specializes in jet engines and energy storage, among other areas.
Research requires, at times, frustrating trial and error. On his last day at NASA, Sanchez marveled at what other interns had achieved, accomplishments that made him feel “like I did nothing compared to these guys.”
A mentor dispelled his fears. “You’re doing higher fidelity work than some of the engineers here,” he told Sanchez.
Those words have stuck with him — perhaps the most memorable lesson he learned all year. NASA is full of “wicked smart, super-cool people,” he said. To have even one of them say that about him, that’s reason enough to keep pushing.
Between college and parenting, quiet moments of rest
Veronica Zaragoza, 35, is one semester away from earning a bachelor’s degree.
Veronica ZaragozaCredit: CSU San Bernardino
It’s a hard-earned milestone for Zaragoza, a single mother of six children studying social work in a mostly remote program at Cal Poly Humboldt. “It’s hectic here,” she said of her home life. Her children attend three different schools. She lost one of two jobs this year, a financial setback.
But there were reasons to celebrate. Zaragoza won a California State University Trustees’ Award, a recognition for advocating on behalf of low-income students with dependents. She maintained the GPA she hoped to achieve.
She now facilitates a student-parent group as part of an internship toward her social work degree.
In between, she has tried to adopt the same coping strategies she wants to instill in other student parents. “If I don’t take care of myself, I’m not going to be able to take care of my family,” said Zaragoza, who lives in Southern California.
Her self-care routine is simple. Five minutes to herself in the bath. A few moments to meditate or read her Bible in the car. “It’s really helped out a lot,” she said, “and I’ve been teaching my kids that it’s good to always get away from the electronics, the screens and all that stuff and just take care of yourself for a minute.”
Seeing through a new lens
When Carlos Garcia Santos, 26, enrolled in a marketing internship class this year at Cal State San Marcos, he found the work “a little intimidating.”
Carlos Garcia Santos
Garcia Santos had served for four years in the Marines. But now, interning for a small business that sells refurbished designer eyeglass frames with rose-colored lenses, he felt new doubts. “Do I really know as much as I think I know?” he wondered.
He worked for an entrepreneur who was knowledgeable and passionate. At first, Garcia Santos worried about asking questions that would make him look silly.
But then he embraced the reality that he had a lot to learn. He worked to improve the shop’s email and text message marketing campaigns. He fixed website glitches. “I try to take it in like a sponge — take everything in, even if I sound a little dumb,” said Garcia Santos, who will graduate in the spring semester.
And he soon realized that he wasn’t the only person who felt a touch of impostor syndrome. “I have a class, over 30 other students with me, that are like, ‘We’re right there with you, man. We’re doing this together. We’ll figure it out along the way.’”
Navigating ‘a touchy subject’ on campus
Asked an open-ended question about which federal, state or university policy impacted them most in 2025, a few students had a ready answer: California State University’s decision to roll out a ChatGPT subscription across its campuses.
Eryka Lepper
Eryka Lepper, 22, the outgoing student government president of Stanislaus State, said artificial intelligence has become “a touchy subject.” She’s opted not to use ChatGPT in her schoolwork. “I don’t know what that’s going to do to people in the long term,” said Lepper, a senior who finished her last semester of college this fall. “I feel like it’s going to make some of us a little bit lazier.”
But Lepper feels she can’t avoid artificial intelligence entirely. Are other students gaining an advantage, leaving her behind?
Why do some of the asynchronous online classes she took this year feel easier than the first Merced College course she took as a 14-year-old? “I don’t know if that has to do with this new technology,” she said.
“What’s going to happen with universities if students are using AI and if they’re not using it the right way?”
Teaching others — and learning himself
Oliver Sanchez, a 20-year-old math major at Stanislaus State, can chart personal growth this year well beyond learning formulas and multivariable calculus.
Oliver Sanchez
Besides his studies, he also serves as a campus ambassador for the College Corps, a state program that places student fellows at community organizations and, in exchange, helps them pay for school.
Sanchez used to prefer that others ask questions or lead presentations. Gaining new confidence this year, he said, “I’m not the one standing behind people as they talk; I’m the one who steps up and talks.”
That growing assurance is one reason Sanchez is starting to focus on a potential career as a math teacher.
It’s a path that probably wouldn’t surprise the classmates who have joined him for a group study session. “I try teaching someone (else) how to do it,” he said, “so I can learn it myself.”
A D.C. stalemate didn’t stifle her
Rylee Jue, a third-year student at Cal State Monterey Bay, landed in Washington, D.C., this fall, eager to intern for a member of the U.S. Congress.
Rylee Jue
Then came a historic stalemate. The White House began a 43-day government shutdown.
Public policy — and education policy in particular — was a theme of Jue’s year. She participated in a student leadership program with the Campaign for College Opportunity, an organization that works to expand access to higher education. She also helped draft a student government statement in support of immigrant and undocumented students.
It would be easy to feel apathetic after witnessing the shutdown’s record political impasse.
And Jue, 20, knows the chaotic politics of 2025 may leave some feeling angry and demotivated. But she returned home to California’s Central Coast feeling inspired. “Why would we waste our energy being mad when we can be out there advocating?” she said.
Xtera to be acquired by a joint venture between Prysmian (80% stake) and Fincantieri (20% stake)
Prysmian becomes a global player in submarine telecom thanks to the acquisition, building on its leadership in submarine energy solutions
Fincantieri confirms its role as a leader for the development of integrated solutions in the underwater domain, focusing on unmanned and security solutions
Customers will benefit from a one-stop shop for comprehensive submarine telecom solutions, including leadership in cable security
Business positioned for long-term growth thanks to data centers and hyperscalers and from incumbent telecom players
Milan/Trieste, December 29, 2025 – A Prysmian led joint venture with Fincantieri has signed an agreement to acquire Xtera Topco Limited (“Xtera”), a UK and US-based leader in turnkey submarine telecom systems, enabling Prysmian to become a competitive global player in submarine telecom solutions.
The acquisition of Xtera from an affiliate of H.I.G. Capital, LLC (“H.I.G.”), a leading global alternative investment firm with $72 billion of capital under management, will be carried out through the aforementioned joint venture between Prysmian (80% stake) and Fincantieri (20% stake).
Prysmian and Fincantieri have also established a partnership which includes the development of innovative installation and security services to become a one-stop shop for comprehensive submarine telecom solutions. Fincantieri’s position as a leading integrator of advanced subsea systems is strengthened thanks to the partnership and joint venture.
Submarine telecom cables are major strategic assets and have long-term growth prospects as telecom operators look for new solutions as the adoption of AI is fueling the expansion of data centers and hyperscalers that will require regional and long-haul submarine connections.
Security will be central to Prysmian’s offer, as its established assets in monitoring and know-how in installation and cable production will be combined with Fincantieri which confirms its role as a leader for the development of integrated solutions in the underwater domain, focusing on unmanned and security solutions.
Raul Gil, EVP Transmission at Prysmian, said: “Thanks to the acquisition of Xtera we have made a significant leap forward in submarine telecoms, where growth is accelerating driven by the adoption of AI. As the market leader in submarine energy cables, we will now be competitive in delivering regional and long-haul telecom connections globally. Security is a differentiator for our customers, and also thanks to the partnership with Fincantieri, we will offer unique and technologically advanced solutions to the market in a one-stop shop.”
Pierroberto Folgiero, CEO and Managing Director at Fincantieri, commented: “This operation marks a significant step forward in implementing our industrial vision, which positions the underwater sector as one of the Group’s strategic pillars, both now and in the future. By covering every area of this field—including through partnerships with leading companies such as Prysmian—we are strengthening our ability to anticipate global challenges and drive innovation across the entire value chain. In a world where subsea infrastructures are increasingly vital, Fincantieri aims to be a leader and a benchmark for the development of integrated and sustainable solutions.”
Keith Henderson, CEO at Xtera, added: “This investment marks a significant milestone in Xtera’s journey to further strengthen our competitive position in subsea telecom systems. We look forward to partnering with Prysmian and Fincantieri to deliver even greater breadth across the value chain to telecom operators and private subsea system owners.”
Xtera Headquartered in London, UK, Xtera is one of just five companies able to deliver subsea telecom networks on a global scale. Their long-standing management team, focus on innovation and track record of project delivery positions Xtera as one of the fastest growing providers in the growing submarine telecom market. A specialist in regional and long-haul submarine telecom projects thanks to their proprietary technology, Xtera has industry-leading revenues per FTE with approximately €130 million in revenues and around 60 employees. Xtera also has state-of-the-art R&D facilities in the UK and Texas, USA.
The transaction implies an enterprise value of $65 million. The acquisition of Xtera remains subject to regulatory approvals. Completion of the transaction is expected to occur in the first quarter of 2026.
One-stop shop for submarine cable solutions The acquisition of Xtera will complement Prysmian’s leadership in submarine telecom production from its Nordenham (Germany) plant, its in-house acoustic and temperature monitoring solutions, and its world leading fleet of cable installation vessels and know-how. The partnership with Fincantieri will build on the already established relationship in cable installation vessels and will expand to new security-focused underwater services including guard vessels and drones. Prysmian’s one-stop shop for submarine telecom solutions will be deeply embedded in both Europe and the US, benefiting from a shared culture and supply chain across the two continents. Prysmian and Fincantieri are also exploring extending the partnership to submarine energy cables.
Air passengers are being warned to brace for ticket rises as regional airports across the UK face “unprecedented” rises in property tax next year.
Analysis of government data for the Press Association has revealed regional airports are among those facing the steepest increases in business rates of any sector in the UK amid an overhaul of property valuations underpinning the tax.
While London’s Heathrow and Gatwick are also being hit with huge increases in their business rates bills, the figures show that the most extreme cases are focused outside London, with regional airports poised to suffer.
Global tax firm Ryan’s calculation of Valuation Office Agency data found that the rateable values have jumped more than six-fold in some cases in the latest property revaluation, sending tax bills soaring higher.
Even with transitional relief, which limits increases to 30% next year, regional airports will still endure some of the largest cash increases in the country.
And most airports face their bills more than doubling over the next three years.
Manchester airport is among the worst affected, with its business rates bill likely to increase by £4.2m to £18.1m next year, according to Ryan’s data.
Bristol airport will receive a £1.2m increase to £5.2m, while Birmingham International airport faces a £1.8m rise to £7.6m.
Newcastle International airport is in line for a £244,755 rise to £1.1m.
Alex Probyn, the practice leader for Europe and Asia-Pacific property tax at Ryan, told PA: “With an unprecedented 295% sector-wide uplift, regional airports simply cannot absorb a cost shock of this magnitude.
“These increases will inevitably flow through the system: first into airport charges, then into airline costs, and ultimately into ticket prices.”
Airport operators have said the tax blow may also hold back investment in the sector.
A Manchester Airports Group spokesperson said: “Airports were already some of the highest rates-payers in the country and were prepared to pay significantly more.
“But increases of more than 100% mean we have to look again at our plans to invest more than £2bn in our airports across the UK over the next five years.
“It is inevitable air travel will become more expensive as the industry absorbs these costs. That impacts hard-working people throughout the country and makes global trade harder for businesses.”
AirportsUK – the trade group representing the sector – is working on a response to the Treasury’s consultation on the business rates plan, which closes in February.
It said the plans are “shortsighted” and will “have a knock-on effect for the businesses that depend on airport connectivity in all areas of England”.
This risks “negatively impacting local economies that depend on the supply chains, tourists and connections their airports provide”, according to the group.
“That is why the long-term review into how airport business rates are calculated, also announced by government, is so important and we will engage with Treasury to ensure this delivers the positive outcome airports need to drive investment and economic growth.”
Other regional airports heading for large bill increases include Liverpool airport with a £233,100 rise to £1m, East Midlands International airport with a £437,895 increase to £1.9m, and Bournemouth airport with a £102,398 increase to £443,723.
This abbreviated commentary is reprinted without references from the Cleveland Clinic Journal of Medicine (September 2025, 92[9] 550-554; doi: 10.3949/ccjm.92a.25014). The open-access and fully referenced original article is available atccjm.org/content/92/9/550.
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BySamuel M. Schut, DC
For patients with acute or chronic musculoskeletal conditions, guidelines recommend a variety of noninvasive pharmacologic and nonpharmacologic treatments as first-line management. However, many patients receive suboptimal care, including unneeded imaging, too many prescriptions for opioids, not enough evidence-based advice, and premature referrals for interventional or surgical procedures, without first exhausting conservative measures.
These practices are associated with worse financial and clinical outcomes, including higher total healthcare costs and greater risk of developing chronic, disabling pain. Notably, many of the recommended frontline treatments outlined in clinical practice guidelines align with approaches central to the chiropractic profession. And some US healthcare systems now include chiropractors on interdisciplinary pain management teams.
Integrating chiropractors into multidisciplinary care settings can help support high-value, guideline-concordant musculoskeletal care and may free up internists to see more patients with other problems. Here, we outline for internists and other medical specialists the following aspects of chiropractic care.
Extensive training
Doctors of chiropractic (DCs) are licensed healthcare professionals trained to operate as point-of-contact practitioners for musculoskeletal complaints. To become licensed, DCs must successfully complete a 3- to 4-year accredited doctoral degree program and obtain satisfactory scores on a four-part examination administered by the National Board of Chiropractic Examiners. These examinations involve both computer-based and structured practicums and assess knowledge in the areas of basic and clinical science, diagnostic imaging, and case management.
Matriculates into doctoral programs must hold a bachelor’s degree or have obtained a cumulative grade-point average of 3.0 (2.75 in select circumstances) or higher on a 4.0 scale for 90 semester credits at an accredited institution before admission. Didactic and clinical training consists of a minimum of 4,200 hours of basic and clinical science instruction correlated with analytical and practical skill development. A minimum of 1,000 contact hours is spent in a patient-care setting.
After completing the doctoral program, some DCs pursue advanced postgraduate training in integrated residency or fellowship programs. Such training is optional and not currently required for licensure in any state. Requirements to obtain and maintain active licensure are set forth by each state individually. States stipulate regular continuing education in topics such as documentation, ethics, law, and clinical practice to retain a license to practice.
What do chiropractors do?
Chiropractic is a healthcare profession and not a singular treatment approach. Chiropractors possess diagnostic autonomy and use nonpharmacologic, noninvasive therapies to treat musculoskeletal disorders and improve quality of life using an integrative, whole-person approach. The chiropractic profession is not categorically opposed to pharmacologic or invasive therapies; rather, chiropractors simply do not provide these types of treatment, and patients should not expect to receive them from chiropractors.
An initial trial of chiropractic care typically includes a cluster of treatment sessions within a short time (eg, 4–6 visits over 1–2 months), followed by a reevaluation to assess treatment effectiveness and determine the need for continued or escalated care.
For chronic or more complex conditions, patients may benefit from supportive treatment beyond the initial trial of care. However, empowering patients to self-manage symptoms and minimize practitioner dependency remains a top priority.
Evidence-based care
Spinal manipulative therapy as an isolated intervention has been shown to be as effective as other guideline-recommended treatments and more effective than non-recommended treatments in terms of relieving pain and improving function and quality of life in patients with acute and chronic back pain. Additionally, spinal manipulative therapy may allow patients to minimize their reliance on pain medications, with their attendant risks.
While the degree of benefit varies, the combination of spinal manipulative therapy and other goal-oriented interventions such as rehabilitative exercise or neuromuscular reeducation is a well-rounded and patient-centered approach as recommended by clinical practice guidelines.
When considering the evidence supporting chiropractic care, it is most pragmatic to evaluate the benefits of multimodal integrative care rather than the efficacy of isolated interventions and single outcomes. Clinical practice guidelines recommend treatments such as joint manipulation and mobilization, myofascial therapies, and exercise as part of a multimodal care plan for managing back and neck pain — all of which are central to the chiropractic scope of practice.
Chiropractic care is also cost-effective. In a recent retrospective analysis, patients who started care with a chiropractor for acute low back pain incurred total medical costs that were $8,848 lower than those who started care with primary care clinicians and $12,267 lower than those who started care in the emergency department.
Practical considerations
Who should — or should not — see a chiropractor? Conditions commonly managed by chiropractors include mechanical low back and neck pain, with or without associated extremity symptoms, cervicogenic and tension-type headaches, and musculoskeletal extremity complaints such as knee osteoarthritis, rotator cuff tendinopathy, and carpal tunnel syndrome.
Contraindications to certain chiropractic treatments can be broadly categorized as absolute or relative, depending on the resultant impact on treatment decisions. Absolute contraindications to spinal manipulative therapy include but are not limited to acute fractures or dynamic spinal instability, severe or progressive neurologic deficits related to the area of concern, and pain caused by cancer or infection; relative contraindications include diseases that cause bone softening, prior spinal surgery, bleeding disorders, and inflammatory diseases in the nonactive phase.
The best available evidence suggests that if patients obtain pain relief from chiropractic therapy, they get it quickly, whereas factors that predict lack of relief include poor psychological status (eg, depression, anxiety, kinesiophobia), adverse sleep and fatigue patterns, chronic pain, and high baseline pain intensity.
In most instances, it is not necessary to obtain imaging, laboratory work, or other specialty testing before referring patients for chiropractic care unless there is suspicion for sinister disease or treatment contraindications.
Chiropractors vs. physical therapists
Internists and other medical specialists are likely familiar with indications for physical therapy and, at this point, may observe substantial overlap between it and chiropractic. So, what differentiates chiropractors from physical therapists? While there are similarities between the two professions, including training in rehabilitative and manual therapies, chiropractors receive approximately twice as much academic and clinical training, and this is reflected by their broader scope of practice.
Since DCs can establish a diagnosis and order or perform imaging or other diagnostic studies (eg, electrodiagnostics, musculoskeletal ultrasonography, laboratory studies), this authority eliminates the need for the referring physician or the patient’s primary care clinician to coordinate clinical decisions on the chiropractor’s behalf, leaving chiropractors to independently evaluate, diagnose, and manage patient care.
A practical solution
Integrating chiropractors into multidisciplinary healthcare teams offers a practical solution to the challenges faced by internists when managing painful musculoskeletal conditions. Their specialized training, evidence-based approaches and ability to act as point-of-contact case managers offer a unique solution to provide guideline-concordant, cost-effective care without excessive administrative demands. By collaborating more with chiropractors, healthcare systems can improve patient outcomes, reduce costs, and alleviate burdens on primary care clinicians.
STOCKHOLM, Dec. 29, 2025 /PRNewswire/ — Diamyd Medical has reached alignment with the U.S. Food and Drug Administration (FDA) to accelerate the primary efficacy readout in its ongoing pivotal, registrational Phase 3 DIAGNODE-3 trial in type 1 diabetes from 24 to 15 months, per FDA guidance, enabling the full primary efficacy readout of the trial to occur nine months earlier than previously planned and communicated. The previously announced interim efficacy readout, involving approximately 170 participants with 15-month data, remains on track for the end of March 2026 and may support an accelerated BLA pathway, consistent with FDA guidance.
“We are very pleased with the FDA’s feedback as it provides a clear way forward,” says Ulf Hannelius, CEO of Diamyd Medical. “The proposed change meaningfully shortens the timeline to the full primary efficacy readout in our registrational Phase 3 trial, while maintaining a robust assessment of long-term efficacy. We remain focused on the upcoming interim efficacy readout in March 2026, which is on track as the next key catalyst in our efforts to bring this therapy to patients with type 1 diabetes.”
The trial’s co-primary efficacy endpoints, C-peptide area under the curve (AUC), a marker of endogenous insulin production, and HbA1c, a measure of blood sugar control, were originally defined at 24 months. Following a recent Type C meeting, and consistent with FDA guidance, the FDA agreed with the Company’s proposal to change the timepoint for the primary efficacy readout to 15 months, with a formal protocol amendment to be submitted for FDA review. The originally planned 24-month assessment will be retained as a secondary endpoint to assess durability of the treatment effect of Diamyd®.
DIAGNODE-3 is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating Diamyd® in approximately 300 genetically defined individuals with Stage 3 type 1 diabetes. Diamyd® is a precision-medicine, antigen-specific immunotherapy designed to preserve endogenous insulin production.
The FDA has granted Fast Track Designation for Diamyd® across Stages 1-3 of type 1 diabetes, Orphan Drug Designation for Stage 3 type 1 diabetes, and has confirmed C-peptide as an acceptable surrogate endpoint that may support an accelerated approval pathway in the United States.
About Diamyd Medical
Diamyd Medical develops precision medicine therapies to prevent and treat type 1 diabetes. Diamyd® is an investigational antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production specifically for individuals carrying an HLA DR3-DQ2 gene. Diamyd® has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes. DIAGNODE-3, a confirmatory Phase 3 trial with potential for an accelerated approval pathway in the US is actively recruiting patients with recent-onset (Stage 3) type 1 diabetes at 57 clinics in eight European countries and in the US. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group – both in a large-scale meta-analysis as well as in the Company’s prospective European Phase 2b trial. The DIAGNODE-3 trial is recruiting only this patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with type 1 diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd®. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.
Diamyd Medical’s B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser.
For further information, please contact: Ulf Hannelius, President and CEO Phone: +46 736 35 42 41 E-mail: [email protected]
Diamyd Medical AB (publ) Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68 E-mail: [email protected] Reg. no.: 556242-3797 Website: https://www.diamyd.com
This information was brought to you by Cision http://news.cision.com.
STOCKHOLM, Dec. 29, 2025 /PRNewswire/ — Diamyd Medical has reached alignment with the U.S. Food and Drug Administration (FDA) to accelerate the primary efficacy readout in its ongoing pivotal, registrational Phase 3 DIAGNODE-3 trial in type 1 diabetes from 24 to 15 months, per FDA guidance, enabling the full primary efficacy readout of the trial to occur nine months earlier than previously planned and communicated. The previously announced interim efficacy readout, involving approximately 170 participants with 15-month data, remains on track for the end of March 2026 and may support an accelerated BLA pathway, consistent with FDA guidance.
“We are very pleased with the FDA’s feedback as it provides a clear way forward,” says Ulf Hannelius, CEO of Diamyd Medical. “The proposed change meaningfully shortens the timeline to the full primary efficacy readout in our registrational Phase 3 trial, while maintaining a robust assessment of long-term efficacy. We remain focused on the upcoming interim efficacy readout in March 2026, which is on track as the next key catalyst in our efforts to bring this therapy to patients with type 1 diabetes.”
The trial’s co-primary efficacy endpoints, C-peptide area under the curve (AUC), a marker of endogenous insulin production, and HbA1c, a measure of blood sugar control, were originally defined at 24 months. Following a recent Type C meeting, and consistent with FDA guidance, the FDA agreed with the Company’s proposal to change the timepoint for the primary efficacy readout to 15 months, with a formal protocol amendment to be submitted for FDA review. The originally planned 24-month assessment will be retained as a secondary endpoint to assess durability of the treatment effect of Diamyd®.
DIAGNODE-3 is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating Diamyd® in approximately 300 genetically defined individuals with Stage 3 type 1 diabetes. Diamyd® is a precision-medicine, antigen-specific immunotherapy designed to preserve endogenous insulin production.
The FDA has granted Fast Track Designation for Diamyd® across Stages 1-3 of type 1 diabetes, Orphan Drug Designation for Stage 3 type 1 diabetes, and has confirmed C-peptide as an acceptable surrogate endpoint that may support an accelerated approval pathway in the United States.
About Diamyd Medical
Diamyd Medical develops precision medicine therapies to prevent and treat type 1 diabetes. Diamyd® is an investigational antigen-specific immunomodulatory therapeutic for the preservation of endogenous insulin production specifically for individuals carrying an HLA DR3-DQ2 gene. Diamyd® has been granted Orphan Drug Designation in the U.S. as well as Fast Track Designation by the U.S. FDA for the treatment of Stage 3 (clinically diagnosed symptomatic) type 1 diabetes. Diamyd® has also been granted Fast Track Designation for the treatment of Stage 1 and 2 (pre-symptomatic) type 1 diabetes. DIAGNODE-3, a confirmatory Phase 3 trial with potential for an accelerated approval pathway in the US is actively recruiting patients with recent-onset (Stage 3) type 1 diabetes at 57 clinics in eight European countries and in the US. Significant results in preserving endogenous insulin production have previously been shown in a large genetically predefined patient group – both in a large-scale meta-analysis as well as in the Company’s prospective European Phase 2b trial. The DIAGNODE-3 trial is recruiting only this patient group that carries the common genotype known as HLA DR3-DQ2, which constitutes approximately 40 % of patients with type 1 diabetes in Europe and the US. A biomanufacturing facility is under development in Umeå, Sweden, for the manufacture of recombinant GAD65 protein, the active ingredient in the antigen-specific immunotherapy Diamyd®. Diamyd Medical is a major shareholder in the stem cell company NextCell Pharma AB and in the artificial intelligence company MainlyAI AB.
Diamyd Medical’s B share is traded on Nasdaq First North Growth Market under the ticker DMYD B. FNCA Sweden AB is the Company’s Certified Adviser.
For further information, please contact: Ulf Hannelius, President and CEO Phone: +46 736 35 42 41 E-mail: [email protected]
Diamyd Medical AB (publ) Box 7349, SE-103 90 Stockholm, Sweden. Phone: +46 8 661 00 26, Fax: +46 8 661 63 68 E-mail: [email protected] Reg. no.: 556242-3797 Website: https://www.diamyd.com
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Concessional co-financing to be provided by the HIPCA
The European Bank for Reconstruction and Development (EBRD) is helping micro, small and medium-sized enterprises (MSMEs) in Uzbekistan to improve their access to green finance and promote green innovation by providing fresh funds under its Uzbekistan Green Economy Financing Facility II (GEFF II Uzbekistan).
An EBRD loan of up to US$30 million (€25.7 million) under GEFF II Uzbekistan will allow Hamkorbank to expand its energy-efficiency lending to companies and households across the country, who can use the funds to modernise production, increase their energy efficiency and improve their climate resilience. The loan will be supported by concessional co-financing provided by the government of Canada under the High-Impact Partnership on Climate Action (HIPCA).
HIPCA donors include: Austria, Canada, Finland, Germany, the Netherlands, Norway, South Korea, Spain, Switzerland, the TaiwanICDF (International Cooperation and Development Fund), the United Kingdom and the United States of America.
The EBRD has invested over US$6.6 billion in Uzbekistan to date through 196 projects, with the majority of those funds supporting private entrepreneurship, contributing to the country’s economic development.
