Arctic Therapeutics closes oversubscribed US$21.5 million financing

- The financing round, led by investment firm Pekron, Investcorp-backed Sanos Group, Icelandic investment company Kaldbakur and Landvættir, an Icelandic venture capital fund managed by AxUM Securities, was increased to US$21.5 million following strong investor demand

- The proceeds will advance AT-002 and AT-003 towards clinical development, broadening the company's pipeline and building on key Phase II milestones achieved by its lead programs, AT-001 in rare and common forms of dementia and AT-004 in inflammatory skin diseases.

- The funding round follows the company's participation in the acquisition of the lead clinical-stage asset of US-based Nobias Therapeutics and the subsequent launch of Synaptiq Therapeutics

REYKJAVIK, Iceland AND PHILADELPHIA, October 21, 2026 /PRNewswire/ -- Arctic Therapeutics (ATx), a clinical-stage biopharmaceutical company translating genetic discoveries into new treatments for diseases with significant unmet medical need, today announced the closing of an oversubscribed US$21.5 million financing round, which was increased following strong investor demand.

The financing round was led by investment firm Pekron, Investcorp-backed Sanos Group, Icelandic investment company Kaldbakur and Landvættir, an Icelandic venture capital fund managed by AxUM Securities.

The proceeds will primarily be used to advance ATx's pipeline assets, AT-002 and AT-003, towards clinical development, expanding the company's clinical pipeline beyond its lead programs, AT-001 and AT-004, in rare and common forms of dementia and inflammatory skin diseases, respectively.

The new financing follows the company's oversubscribed approximately US$31 million Series A round, which was allocated towards advancing the company's lead assets, AT-001 and AT-004. ATx has since achieved the clinical development milestones targeted with the Series A financing, with both programs reaching key Phase II clinical milestones.

"The support from both new and existing investors allows us to build on the substantial progress made across Arctic Therapeutics over the past two years," said Ivar Hakonarson, co-founder and chief executive officer. "Our Series A enabled us to move our lead programs forward and achieve the clinical milestones we set out to reach. This new financing gives us the opportunity to unlock additional value within the broader pipeline by advancing AT-002 and AT-003 towards the clinic, while advancing partnering and out-licensing activities for AT-001 and AT-004," he added.

AT-002 is a peptide mimetic of the kinase inhibitory region (KIR) domain of suppressor of cytokine signaling 1 (SOCS1), a potent inhibitor of the JAK-STAT signaling pathway. The program is initially being developed for autoimmune uveitis, with potential applications across other autoimmune and inflammatory diseases including lupus, psoriasis, and juvenile dermatomyositis.

AT-003 is a small-molecule mitophagy and autophagy modulator designed to counteract the consequences of aberrant activity of CLEC16A. Genetic variation involving CLEC16A has been strongly associated with 16 autoimmune diseases, including lupus, rheumatoid arthritis, multiple sclerosis, and type 1 diabetes, as well as Parkinson's disease. The program is intended to address cellular dysfunction associated with impaired mitochondrial function and autophagy dysregulation.

"AT-002 and AT-003 reflect the same genomics-driven approach on which Arctic Therapeutics was founded, identifying disease biology through human genetics and translating those discoveries into therapeutic interventions," ATx founder Dr. Hakon Hakonarson said. "Both programs target biological pathways implicated across multiple serious diseases both common and rare. Bringing them closer to clinical development significantly expands the potential reach of our pipeline beyond our current clinical-stage programs," he added.

The company's lead dementia program, AT-001, is an oral investigational treatment designed to prevent and disrupt the aggregation of amyloid, tau and related toxic aggregation proteins. The company has completed the 12-month core treatment period of its pivotal Phase IIb/III study in Hereditary Cystatin C Amyloid Angiopathy (HCCAA), a rare familial form of dementia, with an approved extension continuing to evaluate longer-term treatment.

AT-001 is also being evaluated in an ongoing fully recruited randomized, double-blind, placebo-controlled Phase IIa biomarker study in patients with mild cognitive impairment and mild Alzheimer's disease, investigating its effects using blood-based biomarkers and brain imaging. The program is intended to evaluate whether findings from ATx's work in genetically defined amyloid disease can translate into the much larger Alzheimer's disease population.

AT-004, the company's second lead clinical program, is an acetylcholinesterase inhibitor targeting the non-neuronal cholinergic anti-inflammatory pathway, a biological system present in human skin involved in regulating inflammation and pro-inflammatory cytokines such as TNF-α. A Phase IIa signal finding proof-of-concept study in acne vulgaris has been completed, demonstrating favorable safety, tolerability and generating encouraging efficacy signals supporting further clinical development. The program is initially focused on acne but has potential applications across other inflammatory skin diseases, including atopic dermatitis, rosacea, psoriasis as well as wound healing.

Earlier this year, ATx participated in the acquisition of NB-001, a clinical-stage program previously owned by US-based Nobias Therapeutics. The asset, now known as SYN-001, forms the foundation of newly established Synaptiq Therapeutics, which was launched in July 2026 by a consortium including ATx, Sanos Group, an Icelandic investment fund managed by AxUM Securities, and investors in Nobias Therapeutics, including US-based Medical Excellence Capital.

SYN-001 is being developed for the treatment of neuropsychiatric symptoms associated with 22q11.2 deletion syndrome (22q11DS). The program has received FDA Rare Pediatric Disease Designation and Orphan Drug Designation and, following positive Phase II clinical results, is being prepared for a Phase IIb clinical trial in North America and Europe. ATx provides Synaptiq with clinical development infrastructure, scientific expertise, and operational capabilities.

Arctic Therapeutics was advised by Arctica Finance as financial advisor and BBA//Fjeldco as legal advisor in connection with the financing.

About Arctic Therapeutics

Arctic Therapeutics (ATx) is a clinical-stage biopharmaceutical company established in 2015 as a spin-off from the US-based Center for Applied Genomics (CAG), a research center at the Children's Hospital of Philadelphia. The company's diversified pipeline reflects its commitment to addressing diseases with significant unmet medical need by translating human genetic discoveries into safe and effective treatments. ATx is advancing clinical and preclinical programs across neurology, autoimmune diseases and inflammatory skin conditions and has operations in Iceland and the United States, alongside research and clinical collaborations across Europe. For more information, please visit www.arctictherapeutics.com and follow Arctic Therapeutics on LinkedIn.

About Pekron

Pekron is a private investment firm and family office headquartered in Reykjavík, Iceland. The firm invests and manages capital across private and public securities, real estate and other investment opportunities, with a long-term approach to capital allocation. For more information, please visit www.pekron.is.

About Sanos Group

Sanos Group is a leading specialist provider of clinical study services to the global pharmaceutical and biotechnology industries. Headquartered in Denmark, the group operates across Europe, the United States and Asia and provides clinical development capabilities through specialist CROs, research clinics, technology platforms and clinical supply services. Its specialist areas include dermatology, central nervous system disorders and osteoarthritis. For more information, please visit www.sanos.com.

About AxUM Securities and Landvættir

AxUM Securities Ltd. (AxUM Verðbréf hf.) is an Icelandic licensed alternative investment fund management company headquartered in Akureyri, Iceland. AxUM manages investment funds for professional private investors, including venture capital fund Landvættir. For more information, please visit www.axum.is.

About Kaldbakur:

Kaldbakur is an international investment company focused on creating long-term value through active ownership and strategic investments. The company manages a diversified portfolio spanning the seafood industry, tourism, food production, healthcare and a range of smaller businesses, reflecting its commitment to diversification, sustainable growth, and long-term value creation. For more information, please visit www.kaldbakur.net

For media inquiries

Gulli Arnason, Chief Strategy Officer

[email protected]

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- Global cure observed in 83.3% of LMN-201 recipients versus 36.4% randomized to placebo

- LMN-201 treatment plus standard-of-care antibiotics demonstrated a six-fold reduction in C. difficile infection recurrence compared to standard-of-care antibiotics and placebo (9.1% versus 55.6%)

- Results to be featured in a late-breaking oral presentation at IDWeek 2026

SEATTLE, Oct. 21, 2026 /PRNewswire/ -- Lumen Bioscience today announced positive results from the RePreve Clinical Trial of oral LMN-201, an investigational biologic cocktail drug, that demonstrate a statistically significant global cure and recurrence reduction versus placebo in patients with C. difficile infection (CDI).

LMN-201 is an oral biologic cocktail, delivered in capsules, intended for use with and following antibiotics to improve clinical outcomes for CDI. LMN-201 is made with Lumen's proprietary spirulina-based GMP manufacturing system. In the Phase 2 RePreve Trial (NCT05330182), participants diagnosed with CDI (total n=45 (Part B 23; Part A 22)) were given LMN-201 or placebo during and after standard-of-care antibiotic treatment, with the goal of both improving primary treatment outcomes and preventing CDI recurrence (together, "global cure").

Global cure was observed in 83.3% of LMN-201 Part B recipients (10 of 12) versus 36.4% receiving placebo (4 of 11). The 47-percentage-point risk difference (odds ratio, 8.75) is statistically significant in accordance with the prespecified Bayesian statistical analysis plan. Part B was placebo-randomized (1:1) and double-blinded, with participants stratified by standard-of-care antibiotic and age.

In addition, LMN-201 reduced primary cure failure by more than 50% relative to standard-of-care alone in Part B (odds ratio, 0.425), a directionally favorable trend on a secondary endpoint that did not reach statistical significance. LMN-201 was well tolerated, with a favorable safety profile and adverse event rates similar to placebo and consistent with the underlying infection and initial antibiotic treatment. There were no drug-related serious adverse events or deaths.

"These data support LMN-201's potential as a first-in-class oral biologic for C. difficile infection, one that could both improve primary treatment outcomes and prevent recurrence," said Carl Mason, MD, Lumen's VP, Clinical. "We are incredibly grateful to the participating patients and their families for generously agreeing to participate in the RePreve Trial, to the clinical research teams who facilitated the study, and to the Department of War's CDMRP program for supporting this important work."

"Every recurrence we prevent is an opportunity to spare a patient a second, third, or subsequent C. difficile episode," said Kole Krieger, Lumen's SVP, Business Development. "LMN-201 could expand hospital and primary care access, potentially becoming a routine part of C. difficile care and improving outcomes for millions of patients."

Additional details of the RePreve Trial results will be featured in a late-breaking oral presentation at the IDWeek 2026 conference in Washington, DC. Dr. Carl Mason, Lumen's head of clinical research, will present on October 24 at 1:30 p.m. ET. IDWeek is the annual joint meeting of leading infectious disease organizations designed to highlight the latest advances in infectious disease prevention, diagnosis, and treatment.

About LMN-201

LMN-201 combines three toxin-binding proteins and an antibacterial enzyme, all produced in engineered spirulina, together in conveniently administered oral capsules. LMN-201 is orally delivered and highly scalable, allowing for much broader potential use in routine CDI management. It is among the most advanced cocktail biologic drugs in development, and the first that implements the principle of rationally designed synthetic avidity to be tested in a clinical trial. Lumen previously released a preprint with LMN-201's preclinical data. Manuscripts are in preparation for this study and an earlier trial that assessed LMN-201's safety, tolerability, and gastrointestinal pharmacokinetics (NCT04893239).

Background on C. difficile infection

CDI remains a serious and costly problem. Nearly half a million cases occur in the U.S. each year, leading to an estimated 29,000 deaths and ~$5 billion in hospital costs annually. Recurrent CDI drives much of this burden: patients who relapse often require extended hospital care and may suffer multiple recurrences. Antibiotic resistance also remains a significant concern. The U.S. Centers for Disease Control and Prevention lists CDI as an antimicrobial resistance "Urgent Threat," and researchers worry about growing resistance to vancomycin, the main antibiotic used to treat CDI. Until now, efforts to improve CDI outcomes have had limited impact, due in part to high costs and inconvenient administration of other preventive therapeutics (chiefly fecal microbiota transplants and injected monoclonal antibodies).

About Lumen Bioscience

Seattle-based Lumen Bioscience has developed a new spirulina-based drug discovery, manufacturing, and delivery platform for highly prevalent diseases that have been difficult to address with conventional biopharmaceutical tools. The company's unique platform has the potential to transform the biologics industry through faster development, straightforward assembly of cocktail therapeutics, mass-market scale, and exponentially lower costs than legacy approaches. Visit www.lumen.bio.

About the Funding Source: Congressionally Directed Medical Research Program (CDMRP)

The work was supported by the Assistant Secretary of War for Health Affairs endorsed by the Department of War, in the amount of $16,288,194 through the Peer Reviewed Medical Research Program under Award No. HT9425-23-1-0959. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of War for Health Affairs or the Department of War.

SOURCE Lumen Bioscience

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Alerts & What’s Trending

Produce

Produce costs remain a mixed bag: iceberg lettuce is at its highest since late 2022, tomatoes are rising, and potatoes unexpectedly jumped. Hass avocados moved lower again. Keep lettuce-heavy menu items under review, and check whether avocado savings can offset some of the pressure elsewhere.

Outlook: Lettuce and tomatoes likely stay elevated near term, while potatoes should ease after harvest and avocado prices appear close to stabilizing.

Grains

Grain markets moved lower again, with corn holding closer to steady than the rest. Strong export sales have not yet removed the risk of another corn-price drop. For operators, this is a market to monitor rather than a reason to assume immediate savings on grain-based purchases.

Outlook: Corn could slide toward $4.40 if $4.80 fails to hold, though export demand and tight global supplies may provide support.

Dairy

Most spot dairy markets rose, with whey reaching a record, but nonfat dry milk slipped. Cheese blocks hit a one-year high even as cheese supplies remained adequate to ample. Distributor cheddar prices rose in September, but the commentary expects earlier wholesale weakness to bring relief to invoices.

Outlook: Distributor cheddar prices are expected to decline over the next several weeks, although recent spot-market strength warrants watching.

Beef

Beef offered some relief as boxed prices and trim softened, but ribs continued their seasonal climb. Production improved from the prior week, although year-to-date output remains lower. For burger-heavy menus, softer trim is worth watching; rib-focused specials still need a careful food-cost check.

Outlook: Better supplies should help moderate beef prices this fall, while seasonal rib demand and cattle-import uncertainty remain risks.

Pork

Pork is providing welcome menu-cost relief, with the cutout at its lowest level in more than three years. Hams and ribs led the weekly declines, and bellies remained well below year-earlier prices. That makes pork worth comparing against higher-cost proteins when planning specials.

Outlook: An expected seasonal increase in fourth-quarter production and subdued consumption should keep downward pressure on pork prices.

Poultry

Chicken breast, tender and wing prices moved lower, while thighs and leg quarters climbed; eggs also eased. That split gives operators a reason to compare cuts rather than assume all chicken is getting cheaper. Producers are slowing output as margins tighten, even as chicken consumption remains strong.

Outlook: Strong demand and slower production could eventually firm chicken prices, so treat today’s lower breast and wing costs as a buying opportunity to evaluate.

Seafood

Fresh yellowfin tuna posted a sharp August price increase after a prolonged stretch of below-normal pricing. Import volumes have begun easing, and the commentary sees longer-term recovery potential. Keep tuna specials flexible rather than assuming today’s seafood costs will stay on a steady downward path.

Outlook: Yellowfin prices may ease modestly through year-end before rising again in January, with longer-term upside risk into 2027.

THE 50 BEST RESTAURANTS ANNOUNCES THE 51-100 LIST FOR 2026

LONDON, Oct. 21, 2026 /PRNewswire/ -- The 50 Best Restaurants 2026, sponsored by S.Pellegrino & Acqua Panna, today reveals the list of restaurants ranked No.51 to No.100, ahead of this year's awards ceremony, taking place in Lima, Peru on 4 November. The extended 51-100 list spans six continents and is compiled from the votes of over 1,100 restaurant experts, including chefs, food writers and culinary specialists.

- The 51-100 list includes restaurants in 36 cities across six continents

- 17 entries from Asia, 20 from Europe, six from North America, three from South America, two from Africa and two from the Middle East

- Nine new entries from nine different cities including Dubai, Giza, São Paulo and Seoul

Restaurants in Europe lead the list with 20 entries, including The Jane (No.63) in Antwerp and Eliane (No.86) in Brussels. Berlin features Nobelhart & Schmutzig (No.76), Coda (No.82) and Tim Raue (No.85). Paris boasts Arpège (No.67) and Septime (No.81) and Le Doyenné (No.84) in Saint-Vrain. Cocina Hermanos Torres (No.69) in Barcelona; Txispa (No.80) in Atxondo and Aponiente (No.100) in El Puerto de Santa María secure places.

Asia welcomes five new entries: Ling Long (No.53) in Shanghai; Seroja (No.64) in Singapore; Eatanic Garden (No.72) in Seoul; Baan Tepa (No.90) in Bangkok and Lamdre (No.92) in Beijing. The Middle East claims two new entries with FZN (No.88) in Dubai and Khufu's (No.97) in Giza.

North America spotlights five restaurants in Mexico: Alcalde (No.55) in Guadalajara; Huniik (No.79) in Mérida; Arca (No.87) in Tulum; Rosetta (No.96) in Mexico City and Fauna (No.99) in Valle de Guadalupe re-entering the list. The USA is represented by SingleThread (No.93) in Healdsburg.

South America's sole new entry is Nelita (No.54) in São Paulo, alongside returning names from São Paulo and Cusco. South Africa's Fyn (No.65) and Salsify at the Roundhouse (No.71) also feature.

For the full 51-100 list, click here.

Rikki Tidball, Managing Director of Events for The 50, comments: "This year's extended list reflects the breadth and brilliance of global gastronomy. The extended list is an opportunity to celebrate the excellence we've seen this year, while also looking ahead to what's next with more innovation and a new generation of chefs bringing fresh ideas to the table."

The 50 Best Restaurants 2026 will be livestreamed on The 50 YouTube channel here at 20:00 Lima time.

Media centre:

https://mediacentre.The50.com/

SOURCE The 50

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The Illinois General Assembly recently enacted HB 3392, which amends several provisions of the Illinois Assisted Living and Shared Housing Act (“Act”). The legislation imposes new assessment requirements, modifies qualifications for assisted living directors, updates medication administration provisions, revises dementia care requirements and strengthens enforcement authority for repeated compliance deficiencies. The law took effect immediately upon becoming law on July 24, 2026. HB 3392 continues Illinois’ recent efforts to modernize the Act, following 2025 reforms addressing resident rights, dementia care and reporting obligations, as well as 2026 legislation expanding the role of physician assistants and advanced practice registered nurses (“APRNs”) in resident assessments and dementia care oversight.

New Admission Assessment Requirements

HB 3392 eases pre-admission screening requirements, adding physician assistants and APRNs with experience in geriatric dementia care to complete the required pre-admission assessments for individuals seeking admission to assisted living and shared housing establishments. Existing law also requires annual reassessments and reassessments whenever there is a significant change in a resident’s condition, including a diagnosis of Alzheimer’s disease or a related dementia. Physician assistants and APRNs are also now permitted to perform these ongoing assessments. Previously, these pre-admission and ongoing assessments could only be completed by the resident’s physician.

Changes to Director Qualifications

The law expands the qualifications for assisted living directors. In addition to existing experience-based paths, a facility may now satisfy the licensure requirement if its full-time director holds a college degree in health administration or completes an approved program within six months of hire. The legislation also continues to require directors to participate in at least 20 hours of training every two years.

Medication Administration Clarifications

HB 3392 updates the Act’s medication administration provisions. The amendments recognize licensed health care professionals employed by an establishment as being authorized to administer certain medications, including insulin, vitamin B12 injections, oral medications, topical treatments, eye and ear drops, nitroglycerin patches and intramuscular injections.

Enhanced Dementia Care Requirements

HB 3392 makes significant revisions to dementia care programs. The Illinois Department of Public Health is directed to identify a validated dementia-specific assessment standard with inter-rater reliability for evaluating residents. Dementia assessments must be approved by a physician, a physician assistant with experience in geriatric dementia care or an APRN with experience in geriatric dementia care. The assessments must occur before admission, annually and whenever a change in condition is identified by specified individuals. Annual assessments and assessments completed due to a change in condition must be signed by a physician.

Increased Enforcement Risk for Repeat Deficiencies

While the Act already authorizes civil penalties for violations, HB 3392 adds a new enforcement provision stating that repeated technical infractions within a calendar year may result in a Type 3 violation. Under Illinois regulations, a Type 3 violation is an act or omission that causes a significant negative impact on the delivery of services to residents. A facility cited with a Type 3 violation may be required to participate in a consultative review with the Illinois Department of Public Health unless corrective action is taken within an agreed-upon timeframe. As a result, providers should pay close attention to recurring compliance issues that previously may have been viewed as isolated technical deficiencies.

Illinois Continues to Refine Its Assisted Living Regulatory Framework

HB 3392 is the latest in a series of recent amendments to the Act. In 2025, Illinois enacted several significant assisted living reforms addressing resident rights, dementia care and reporting obligations. Collectively, the 2025 and 2026 legislative changes reflect an ongoing effort by Illinois lawmakers and regulators to modernize the state’s assisted living framework.

- Expanded Resident Rights and Readmission Protections

The 2025 legislation requires facilities to notify residents and resident representatives when a significant change in condition affects the facility’s ability to meet the resident’s needs, requires notice to the Illinois Department of Public Health when a facility initiates an involuntary residency termination and expands appeal rights related to discharge decisions. The law also provides additional protections for residents returning from hospitalization or other medical absences and authorizes penalties when a provider improperly refuses a required readmission. Providers must also furnish residents with enhanced information regarding resident rights.

- Updated Dementia Assessment Standards

Illinois also amended its dementia care requirements in 2025 by moving away from reliance on a specified list of assessment tools. Instead, the legislation requires providers to utilize assessment tools approved or recommended by recognized Alzheimer’s disease and dementia care experts and to ensure those tools are reviewed and updated to reflect current clinical standards and best practices.

- New Incident Reporting Requirements

Another 2025 amendment created new incident and accident reporting requirements for assisted living and shared housing establishments. Providers must report incidents or accidents resulting in significant physical harm or injury to a resident, as well as situations requiring outside emergent medical treatment resulting from an incident or accident. The legislation clarifies that a resident’s health or medical decline alone is not a reportable incident.

Practical Takeaways for Providers

Assisted living and shared housing establishments in Illinois should review and, where necessary, update:

- Admission assessment policies and procedures;

- Dementia care program assessment protocols;

- Director qualification and onboarding standards;

- Medication administration policies; and

- Compliance monitoring programs designed to identify and correct repeat deficiencies.

If you have questions about how these changes may affect your organization, please contact:

- Brian Jent at (317) 977-1402 or bjent@hallrender.com;

- Ellie Tucker at (314) 228-7508 or etucker@hallrender.com;

- Sean Fahey at (317) 977-1472 or sfahey@hallrender.com;

- Robert Markette at (317) 977-1454 or rmarkette@hallrender.com;

- Todd Selby at (317) 977-1440 or tselby@hallrender.com; or

- Your primary Hall Render contact.

Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.

On September 29, 2026, in LifeLink Foundation, Inc. v. Kennedy, the U.S. District Court for the Middle District of Florida (the “Court”) upheld the Centers for Medicare & Medicaid Services (“CMS”) 2020 rule governing Organ Procurement Organization (“OPO”) performance measures and tier classifications (the “Final Rule”). The decision rejects one significant legal challenge to the Final Rule and, for now, leaves the current framework in place for the 2026–2030 recertification cycle, although other lawsuits challenging the framework remain pending and an appeal or future regulatory developments could alter the legal landscape.

The Court did not rule entirely in CMS’s favor. Although it upheld the Final Rule on the merits, it also held that Tier 2 and Tier 3 OPOs may challenge the rule in federal court before completing CMS’s administrative appeal process. The Court further included an extensive discussion questioning whether a court may broadly vacate agency rules under the Administrative Procedure Act (“APA”), although those observations were not necessary to the Court’s ultimate decision upholding the Final Rule.

Background

The National Organ Transplant Act requires CMS to establish standards for certifying OPOs using evidence-based outcome and process measures. OPOs are generally recertified on four-year cycles and must have an opportunity to appeal a decertification.

The Final Rule replaced the prior self-reported eligible-death measure with two outcome measures based on federal death data: the donation rate and the age-adjusted organ transplantation rate. CMS uses those measures, together with applicable process requirements, to place OPOs into three tiers:

- Tier 1: OPOs that meet or exceed the top-quartile threshold on both outcome measures and satisfy applicable process requirements are eligible for recertification.

- Tier 2: OPOs that meet or exceed the median threshold on both measures but do not qualify for Tier 1 must compete to retain their designated service area (“DSA”) during recertification.

- Tier 3: OPOs that fall below the median on either measure, or fail to satisfy the applicable process requirements, receive an initial decertification determination.

Tier 2 and Tier 3 OPOs have materially different appeal rights. A Tier 3 OPO may seek reconsideration and a hearing before a CMS hearing officer. By contrast, a Tier 2 OPO that loses its DSA does not have a comparable administrative appeal because CMS treats the loss as a non-renewal rather than a decertification.

Seven OPOs challenged the Final Rule under the APA, arguing that CMS exceeded its statutory authority, adopted an arbitrary and capricious framework and failed to adequately address significant public comments. The Court rejected those challenges but separately considered whether Tier 2 and Tier 3 OPOs have a meaningful path to judicial review.

What the Court Held

- The Court upheld the Final Rule’s performance framework. The Court rejected challenges to CMS’s use of death-certificate data, the 12-month measurement period, the exclusion of zero-organ donors, the Tier 1 threshold and the confidence-interval methodology. It also concluded that CMS acted within its statutory authority and adequately addressed significant comments during the rulemaking process.

- Tier 2 and Tier 3 OPOs may challenge the rule, but Tier 1 OPOs may not. The Court found that Tier 2 and Tier 3 OPOs face sufficiently concrete consequences, including the costs of competing to retain a DSA and the risk of losing the DSA or being decertified. The Tier 1 plaintiff did not establish a comparable injury.

- Tier 2 OPOs may seek federal court review without completing CMS’s administrative process. The Court found that CMS’s appeal framework does not provide Tier 2 OPOs with a meaningful avenue for review because neither a Tier 2 designation nor the loss of a DSA is treated as a decertification. CMS acknowledged that a Tier 2 OPO whose agreement is not renewed has no administrative appeal.

- Tier 2 OPOs do not have to rely on Tier 3 OPOs to bring a challenge. CMS argued that Tier 3 OPOs could pursue administrative and judicial review that would indirectly protect Tier 2 OPOs. The Court rejected that position, emphasizing that relief obtained by another OPO may not protect a Tier 2 OPO whose DSA has already been reassigned.

- The Court questioned whether it has authority to broadly vacate an agency rule. In the Court’s view, the APA permits a court to decline to apply an unlawful rule in the case before it, but not necessarily to eliminate the rule’s effect for all parties. The Court also observed that setting aside the rule for all parties, vacatur, would not restore a DSA that had already been reassigned. The Court’s skepticism of universal vacatur is in line with questions left open by the U.S. Supreme Court in Trump v. CASA (2025).

Practical Takeaways

- Continue planning under the current framework. The decision leaves CMS’s existing performance measures, tier methodology and process requirements in place for the 2026–2030 recertification cycle unless modified through appeal, future rulemaking or another court decision. While this is the first merits decision addressing the Final Rule, other lawsuits challenging the framework remain pending.

- Use interim rankings to identify risk early. OPOs should review CMS data, monitor interim rankings and assess likely tier status before final rankings are issued. Hospitals should know how their designated OPO has performed in CMS’s interim and final assessments, as this may affect future agreement cycle planning.

- Prepare separately for Tier 2 and Tier 3 outcomes. Different designation levels carry different consequences and review mechanisms, requiring distinct legal and operational planning.

- Review process requirements independently of outcome performance. Compliance efforts should address both the outcome measures and applicable CMS process requirements.

- Develop organization-specific support for potential challenges. OPOs should preserve evidence regarding how alleged data or methodological issues affect their own performance results, tier designation or service area.

- The decision does not immediately alter day-to-day organ procurement operations. Although the ruling is significant for OPO certification and DSA allocation, it does not itself change donor referral obligations, organ recovery practices, transplant center responsibilities or the underlying regulatory requirements governing organ donation and transplantation.

If you have questions regarding the potential impact of this development on your organization or would like assistance evaluating operational, regulatory or compliance considerations, please contact:

- Megan Culp at (317) 429-3644 or mculp@hallrender.com;

- Lori Wink at (414) 721-0456 or lwink@hallrender.com;

- Brian Betner at (303) 802-1298 or bbetner@hallrender.com;

- David Yanda at (414) 721-0928 or dyanda@hallrender.com;

- Hall Render’s Transplant & Organ Procurement service line; or

- Your primary Hall Render contact.

Special thanks to Summer Associate Nick Baker for his assistance in the preparation of this article.

Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.

JIS Fall 2026 Welcomes 11,000 Jewelry Professionals to Miami Beach for Holiday Buying and Connection

MIAMI, Oct. 21, 2026 /PRNewswire/ -- JIS Fall 2026 welcomed over 11,000 jewelry professionals to the Miami Beach Convention Center October 16–19, marking a 12% year-over-year increase in attendance. The show brought together jewelry retailers, manufacturers and industry professionals from across the United States, Latin America, the Caribbean and beyond. The four-day show gave buyers a timely opportunity to source inventory ahead of the holiday season, with options to purchase for immediate delivery or place future orders.

Across the show floor, buyers explored fine and fashion jewelry, gemstones, accessories and more as they prepared their assortments for the months ahead.

"JIS Fall 2026 was one of the strongest shows in the event's history, with record-breaking attendance and incredible energy across the show floor," said Sara McDonough, Event Director of JIS. "It brought the jewelry community together for a few exciting days of sourcing, discovery and connection. The conversations and connections made here will continue well beyond the show."

The show's "Spark Holiday Success" theme came to life through experiences designed to give attendees fresh ideas for their businesses. At the gift-wrapping demonstration, retailers picked up techniques they could bring back to their stores. The Gem Color Forecast invited attendees to predict the color they expect to shine in the coming year, while Puppies and Personalization offered a playful break from the show floor.

Connections continued after show hours at the opening- night Welcome Reception and JIS Unwrapped, a Saturday evening gathering with drinks and a photo opportunity. Together with the show floor activations, these events gave buyers and exhibitors more ways to meet, exchange ideas and celebrate the industry in Miami Beach.

JIS Spring returns to the Miami Beach Convention Center March 7– 9, 2027. For more information, visit jisshow.com.

About Jewelers International Showcase (JIS)

Founded in 1979, JIS produces trade-only jewelry shows in Miami Beach that connect manufacturers and wholesalers with buyers from the United States, Latin America, the Caribbean and beyond. Its events are timed around retailers' seasonal buying needs and offer opportunities for immediate at-show delivery. For more information, visit jisshow.com.

About RX

RX is a global events and exhibitions company that uses industry expertise, data and technology to help people and businesses connect and grow. RX operates in 25 countries and hosts approximately 350 events annually. RX is part of relx, a global provider of information-based analytics and decision tools. For more information, visit rxglobal.com.

SOURCE Jewelers International Showcase (JIS)

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The Indiana Court of Appeals (the “Court”) recently reversed a regular commitment for a schizophrenic patient because the hospital failed to offer any evidence that the patient was dangerous to himself or others and that he was unable to function independently. The Court found the hospital did not present clear and convincing evidence. In re. Matter of Civil Commitment J.A., No. 26A-MH-606 (Ind. Ct. App. Sept. 18, 2026).

Background

J.A. has received care for schizophrenia since at least 2021. In October 2025, J.A. was admitted to the hospital for treatment and was discharged after a week. Three days later, he was readmitted and remained hospitalized until, on November 20, 2025, Marion County Superior Court 8 (the “Trial Court”) ordered temporary commitment because J.A. was mentally ill and gravely disabled.

J.A.’s treating psychiatrist invoked IC § 12-26-6-11 and requested the Trial Court extend J.A.’s temporary commitment to a regular commitment. The psychiatrist testified J.A. met all five of the diagnostic criteria, planned to stop taking medication at the end of the commitment, lacked insight into his condition, did not believe he actually suffered from schizophrenia and missed 11 out of 20 scheduled appointments. The psychiatrist also testified, “schizophrenia is a lifelong illness that we do not have a cure for, and so we expect he will continue to need chronic treatment.” In re. Matter of Civil Commitment J.A., No. 26A-MH-606, at 3.

The Trial Court ordered regular commitment on the basis that J.A. suffered schizophrenia, was dangerous to himself and was gravely disabled. J.A. appealed.

Analysis

An order for commitment must be premised on clear and convincing evidence that an individual is: (1) mentally ill; and (2) either dangerous or gravely disabled. I.C. § 12-26-2-5(e). J.A. appealed, arguing the hospital did not present sufficient evidence on the second prong of the test, which would establish that J.A. was either dangerous or gravely disabled. The Court agreed.

The psychiatrist focused her testimony on J.A.’s diagnosis, missed appointments, lack of medication management and symptoms. However, she did not provide testimony about whether J.A. was dangerous to himself or others. IC § 12-7-2-53. Accordingly, the Court found this testimony did not clearly and convincingly prove J.A. was in danger of coming to harm because he was unable to provide for his needs or function independently. IC § 12-7-2-96. The Court held that J.A.’s denial of illness and refusal of medication, alone, did not establish grave disability by clear and convincing evidence. Thus, the Court reversed J.A.’s regular commitment.

Practical Takeaways

- Must Present Clear and Convincing Evidence: To successfully order a regular commitment, a hospital must present clear and convincing evidence of either dangerousness or grave disability. Failure to present this evidence could result in a reversal on appeal.

- Denial of Illness and Refusal to Medicate Do Not Meet Standard: A patient’s denial of an illness and refusal to medicate do not meet the clear and convincing standard required to establish a grave disability.

If you have questions or would like more information about this topic, please contact:

- Ryan McDonald at (317) 429-3671 or rmcdonald@hallrender.com; or

- Your primary Hall Render contact.

Special thanks to Kelsey Linzell Bauer, Summer Associate, for her assistance with the preparation of this article.

Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot, outside of an attorney-client relationship, answer specific questions that would constitute legal advice.

On October 8, 2026, the Michigan Attorney General, on behalf of the State and in its parens patriae authority on behalf of the people of Michigan, sued Blue Cross Blue Shield of Michigan (“BCBSM”) alleging federal and state antitrust violations and state claims of nuisance and unjust enrichment. The complaint alleges that BCBSM conspired with other insurance companies that make up the Blue Cross Blue Shield Association (the “Association”) to reduce competition and increase prices for insurance sold to national accounts and large group commercial accounts. The complaint also alleges that BCBSM exercised “monopsony” power as a purchaser of health care services to artificially depress prices for health care providers, leading to reduced staffing, closures and a degradation of the quality and availability of health care services throughout Michigan.

This lawsuit represents a frontal assault on the rules that govern the Association. It also directly challenges the most significant aspects of BCBSM’s business, alleging that it has acted unlawfully in selling insurance to national accounts and large group customers in Michigan and used its dominant position to unlawfully negotiate with health care providers.

The Complaint

While BCBSM is the only defendant, the complaint alleges that the Association and the other Blue Cross Blue Shield insurance companies (“Blue insurers”) are co-conspirators with BCBSM. The complaint focuses on the rules imposed by the Association. The Association holds the Blue Cross and Blue Shield trademarks and licenses those trademarks to Blue insurers, including BCBSM, to use in exclusive geographic territories. Under the Association’s rules, each insurance company that licenses the Blue Cross and Blue Shield trademarks agrees that it will have exclusive rights to the Blue brand within a designated geographic area and will not derive revenue from services under the Blue brand outside of its exclusive area.

The insurance companies that own the Association can also offer insurance outside of their designated territory without using the Blue brand, which the complaint terms “green” competition. The rules of the Association, however, limit the extent to which its owners can engage in green competition.

The Alleged Restraints

The complaint focuses on three rules of the Association, which it claims constitute an unlawful agreement:

- Exclusive Service Areas. The Association assigns each Blue insurer an exclusive territory. And for “national accounts,” which are employers with 5,000 or more members spread across two states, with limited exceptions, only the Blue insurer in the territory in which a national account is headquartered can bid to offer insurance to the national account.

- The National Best Efforts Rule. The National Best Efforts Rule requires a Blue insurer to derive at least two-thirds of its net revenue attributable to health care plans and related services from its Blue brand. Although the rule was formally rescinded by the Association after a court found the rule to be anticompetitive in 2021, the complaint alleges that Blue insurers continue to abide by it and it remains in place “de facto.”

- The Local Best Efforts Rule. The Local Best Efforts Rule requires that 80% of the revenue received by a Blue insurer from within its allocated territory come from the sale of services using the Blue brand. The complaint alleges that this rule inhibits BCBSM and other Blue insurers from developing competing brands that might otherwise engage in “green” competition.

The complaint alleges that these rules have allowed Blue insurers to artificially restrict competition for national account customers, leading to higher prices and lower quality services.

BCBSM’s Dominance

The complaint also focuses on BCBSM’s dominance in Michigan. According to the complaint, BCBSM holds a 69% share of the large group market in Michigan. BCBSM also holds a 65% share of all health insurance products in Michigan and a 79% share of the Preferred Provider Organization products in Michigan, making it the dominant commercial purchaser of health care services in Michigan.

In the large group market, the complaint alleges that BCBSM has unlawfully abused its monopoly power under Section 2 of the Sherman Act and analogous Michigan law. The complaint alleges that the unlawful restraints described above have shielded BCBSM from competition and allowed it to maintain its monopoly. The result of its monopoly is inflated premiums and fees for large group accounts.

Similarly, the complaint alleges that BCBSM has abused its position as a dominant purchaser of health care services, in violation of Michigan state antitrust law. The result of this exercise of “monopsony” power—that is, monopoly power as a purchaser—has been to suppress provider reimbursement rates to anticompetitively low levels. According to the complaint, BCBSM can dictate the fee schedules that providers must accept, as providers cannot afford to be out of network with BCBSM. Further, the complaint alleges that BCBSM’s rates act as a benchmark for other commercial insurers, exerting downward pressure on all commercial rates for Michigan health care providers. This has led to reimbursement rates for providers that are among the lowest in the nation and terms that providers must accept which are favorable to BCBSM.

The result of BCBSM’s low provider rates and restrictive terms is a “degraded . . . healthcare infrastructure” for Michigan residents. This includes closures, service reductions and provider departures, which have led to “reduced access to care, increased wait times, and diminished the quality of healthcare services available to Michigan patients.” The results are allegedly particularly acute in rural areas, low-income communities and communities of color.

Practical Takeaways

- The Association is in the crosshairs. The complaint concentrates on the exclusive territories assigned by the Association, which is the model by which Blue insurers have organized themselves. The outcome of the litigation could thus have consequences that extend beyond Michigan.

- High market shares continue to attract antitrust scrutiny. BCBSM’s alleged market shares are significant, and commercial insurance markets in Michigan are allegedly more concentrated than in many other areas. BCBSM has previously attracted the attention of antitrust regulators, and that scrutiny continues with this lawsuit. The monopoly claims against Blue Cross are facially more viable than they would be against insurers in other areas that have lower market shares.

- Low prices can form the basis of antitrust complaints. Generally, low prices are favored by antitrust law. But antitrust law has long acknowledged that the exercise of “monopsony” power can be unlawful. The complaint alleges the ways in which unlawful buyer power can ultimately harm consumers and, in this case, patients. Michigan will likely need to establish those harms to ultimately prevail on its claim that BCBSM has abused its market power to harm providers.

- Providers may become the subject of third-party discovery. Because one of the theories in the complaint focuses on the harm that BCBSM has caused to health care providers in Michigan, these providers are likely to become the subject of third-party discovery once discovery opens. This could include third-party document or deposition subpoenas.

- This is likely the start of a long process. Antitrust cases—and particularly cases focusing on monopolization—can often take years to play out. The complaint likely marks the start of extended litigation.

If you have any questions or would like additional information about this topic, please contact one of the following members of Hall Render’s Antitrust Practice:

- William Berlin at (202) 370-9582 or wberlin@hallrender.com;

- Michael Greer at (317) 977-1493 or mgreer@hallrender.com;

- David Stoltzfus at (202) 780-2991 or dstoltzfus@hallrender.com;

- John Bowen at (317) 429-3629 or jbowen@hallrender.com;

- Hannah Clarke at (317) 429-3615 or hclarke@hallrender.com;

- Liza Sawyer at (303) 557-2120 or lsawyer@hallrender.com; or

- Your primary Hall Render contact.

Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot, outside of an attorney-client relationship, answer specific questions that would constitute legal advice.

Ellevio signs SEK 1 billion loan with the Nordic Investment Bank to strengthen Stockholm's regional grid

STOCKHOLM, Oct. 21, 2026 /PRNewswire/ -- Ellevio AB (publ) has signed a SEK 1 billion loan agreement with the Nordic Investment Bank (NIB) to co-finance the modernisation and expansion of the Beckomberga substation in Stockholm's regional electricity network. The project will significantly strengthen the grid's ability to meet growing electricity demand in the Stockholm region while contributing to a more reliable and resilient electricity system.

The Beckomberga substation, which currently supplies electricity to approximately 120,000 customers, has reached the end of its technical lifespan. It will now be modernised and expanded, including through a strengthened connection to the national transmission grid.

NIB offers long-term financing that strengthens competitiveness, sustainability and resilience of the Nordic-Baltic region. The bank has previously provided financing to Ellevio for the reconstruction of the substations in Skanstull and Värtan, as well as for the refurbishment and replacement of approximately 5,000 kilometres of power lines, primarily with underground cables.

- We are pleased to continue our partnership with NIB through the financing of this strategically important project. Long-term financing is essential for enabling the large-scale investments required to renew and expand the electricity network, supporting both electrification and sustainable growth in the Stockholm region, says Johan Lindehag, CEO of Ellevio.

Eva Nickull, Senior Banker at NIB, commented:

- NIB's financing strengthens the reliability and security of electricity supply in western Stockholm and contributes to meeting growing electricity demand in the region.

About the Beckomberga project

Key project investments

- New and extended gas-insulated switchgear (GIS)

- New 1,000 MVA transmission grid connection node linked to transmission system operator Svenska kraftnät's nearby substation

- New transformers

- Strengthens the connection to Sweden's national transmission grid

- Increases available power capacity

- Enhances the reliability of the regional electricity system

- Improves grid resilience and security of supply

About NIB

Nordic Investment Bank (NIB) is an international financial institution owned by Denmark, Estonia, Finland, Iceland, Latvia, Lithuania, Norway, and Sweden. NIB strengthens the competitiveness, sustainability, and resilience of the Nordic-Baltic region. The Bank is headquartered in Helsinki with a regional hub in Riga. NIB has the highest possible credit rating, AAA/Aaa, with S&P Global Ratings and Moody's.

About Ellevio

Ellevio is one of Sweden's leading energy companies, enabling the transition to a low-carbon economy. We distribute electricity to almost one million customers and provide energy solutions across Sweden. We enable the electrification of industry and transportation through a modern, reliable grid and major investments in the energy system. Ellevio employs more than 800 professionals, and together with our partners we provide jobs for more than 4,000 people. The company is owned by pension fund managers OMERS Infrastructure, the Third Swedish National Pension Fund (AP3), Folksam and AMF. For more information, visit ellevio.se.

For further information, please contact:

Sarah Östberg

Head of Financial and Sustainability Communications

+46 709 71 12 40

[email protected]

This information was brought to you by Cision http://news.cision.com

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