Author: Ravi Shankar

Approval of BRAVNETSA expands radioligand treatment options for adult patients with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

BEDFORD, Mass., Sept. 22, 2026 (GLOBE NEWSWIRE) — Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that the U.S. Food and Drug Administration (FDA) has granted final approval for BRAVNETSA™ (lutetium Lu 177 dotatate), a bioequivalent and therapeutically equivalent radiopharmaceutical to LUTATHERA^® (lutetium Lu 177 dotatate). BRAVNETSA is indicated for the treatment of adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

“As the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to LUTATHERA approved in the United States, BRAVNETSA’s approval marks an important milestone for Lantheus as we continue to expand our radiopharmaceutical portfolio, bringing additional treatment options to people living with GEP-NETs,” said Mary Anne Heino, Executive Chairperson and CEO, Lantheus. “We are focused on a thoughtful launch and ensuring the right commercial and operational capabilities are in place to support reliable supply and broad patient access.”

BRAVNETSA was approved through the FDA’s Abbreviated New Drug Application (ANDA) pathway. As part of this review, BRAVNETSA is the only radiopharmaceutical the FDA has determined to be bioequivalent and therapeutically equivalent to the reference product, LUTATHERA.

“For more than 70 years, Lantheus has helped define what’s possible in radiopharmaceuticals. As the first radioligand therapy approved through the ANDA pathway, BRAVNETSA represents a breakthrough for our industry and opens a new regulatory pathway for innovation,” said Ludger Dinkelborg, PhD, Head of Research and Development, Lantheus. “Innovation comes in many forms, and this approval reflects Lantheus’ ability to apply our deep radiopharmaceutical expertise in navigating the ANDA process and gives clinicians another FDA-approved option to support treatment decisions based on each patient’s needs.”

Visit www.BRAVNETSAhcp.com for more information on when the product will be available.

About GEP-NETs

Neuroendocrine tumors (NETs) are rare, often slow-growing cancers that can develop throughout the body. A subset known as gastroenteropancreatic NETs (GEP-NETs) affects the digestive system and pancreas and may be functional or non-functional depending on hormone activity.¹ Over the last few decades, the incidence of GEP-NETs has increased significantly, with the prevalence in the U.S. estimated to be approximately 200,000 patients.² Because GEP-NETs often grow slowly and cause non-specific symptoms, up to 50% are initially misdiagnosed, with patients waiting an average of 4.3 years from symptom onset to diagnosis.^3,4  

About BRAVNETSA

BRAVNETSA (lutetium Lu 177 dotatate), previously referred to as PNT2003, is bioequivalent and therapeutically equivalent to LUTATHERA.

INDICATION

BRAVNETSA is indicated for the treatment of adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

Pediatric use information is approved for Advanced Accelerator Applications USA INC’s LUTATHERA (lutetium Lu 177 dotatate) injection for intravenous use. However, due to Advanced Accelerator Applications USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

IMPORTANT SAFETY INFORMATION IN ADULTS

WARNINGS AND PRECAUTIONS

Risk From Radiation Exposure

BRAVNETSA contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer.

Radioactivity may be detected in the urine for up to 30 days following BRAVNETSA administration. Minimize radiation exposure in patients, medical personnel, and household contacts during and after treatment with BRAVNETSA consistent with institutional good radiation safety practices, patient management procedures, Nuclear Regulatory Commission patient release guidance, and provide instructions to the patient for follow-up radiation protection at home.

Myelosuppression        

In NETTER-1, myelosuppression occurred more frequently in patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared with patients receiving high-dose, long-acting octreotide (all Grades/Grade 3 or 4): anemia (81%/0% vs 54%/1%), thrombocytopenia (53%/1% vs17%/0%), and neutropenia (26%/3% vs11%/0%). In NETTER-1, platelet nadir occurred at a median of 5.1 months following the first dose. Of the 59 patients who developed thrombocytopenia, 68% had platelet recovery to baseline or normal levels. The median time to platelet recovery was 2 months. Fifteen of the 19 patients in whom platelet recovery was not documented had post-nadir platelet counts. Among these 15 patients, 5 improved to Grade 1, 9 to Grade 2, and 1 to Grade 3. Monitor blood cell counts. Withhold dose, reduce dose, or permanently discontinue BRAVNETSA based on the severity of myelosuppression.

Secondary Myelodysplastic Syndrome and Leukemia

In NETTER-1, with a median follow-up time of 76 months in the main study, myelodysplastic syndrome (sMDS) was reported in 2.3% of patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared with no patients receiving high-dose, long-acting octreotide. In ERASMUS, 16 patients (2%) developed sMDS and 4 (0.5%) developed acute leukemia. The median time to onset was 29 months (9 to 45 months) for sMDS and 55 months (32 to 125 months) for acute leukemia.

Renal Toxicity

In ERASMUS, 8 patients (<1%) developed renal failure 3 to 36 months following lutetium Lu 177 dotatate injection. Two of these patients had underlying renal impairment or risk factors for renal failure (eg, diabetes or hypertension) and required dialysis. Administer the recommended amino acid solution before, during, and after BRAVNETSA to decrease the reabsorption of lutetium Lu 177 dotatate through the proximal tubules and decrease the radiation dose to the kidneys. Advise patients to hydrate and to urinate frequently before, on the day of, and the day after administration of BRAVNETSA. Monitor serum creatinine and calculated creatinine clearance. Withhold dose, reduce dose, or permanently discontinue BRAVNETSA based on the severity of renal toxicity. Patients with baseline renal impairment may be at increased risk of toxicity due to increased radiation exposure.

Hepatotoxicity

In ERASMUS, 2 patients (<1%) were reported to have hepatic tumor hemorrhage, edema, or necrosis, with 1 patient experiencing intrahepatic congestion and cholestasis. Patients with hepatic metastasis may be at increased risk of hepatotoxicity due to radiation exposure. Monitor transaminases, bilirubin, serum albumin, and the international normalized ratio during treatment. Withhold dose, reduce dose, or permanently discontinue BRAVNETSA based on the severity of hepatotoxicity.

Hypersensitivity Reactions

Hypersensitivity reactions, including angioedema, occurred in patients treated with lutetium Lu 177 dotatate injection. Monitor patients closely for signs and symptoms of hypersensitivity reactions, including anaphylaxis, during and following BRAVNETSA administration for a minimum of 2 hours in a setting where cardiopulmonary resuscitation medication and equipment are available. Discontinue the infusion upon the first observation of any signs or symptoms consistent with a severe hypersensitivity reaction and initiate appropriate therapy. Premedicate patients with a history of Grade 1 or 2 hypersensitivity reactions to BRAVNETSA before subsequent doses. Permanently discontinue BRAVNETSA in patients who experience Grade 3 or 4 hypersensitivity reactions.

Neuroendocrine Hormonal Crisis

Neuroendocrine hormonal crises, manifesting with flushing, diarrhea, bronchospasm, and hypotension, occurred in <1% of patients in ERASMUS and typically occurred during or within 24 hours following the initial lutetium Lu 177 dotatate injection dose. Two patients (<1%) were reported to have hypercalcemia. Monitor patients for flushing, diarrhea, hypotension, bronchoconstriction, or other signs and symptoms of tumor-related hormonal release. Administer intravenous somatostatin analogs, fluids, corticosteroids, and electrolytes as indicated.

Embryo-Fetal Toxicity

BRAVNETSA can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to initiating BRAVNETSA. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BRAVNETSA and for 7 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BRAVNETSA and for 4 months after the last dose.

Risk of Infertility

BRAVNETSA may cause infertility in males and females. The recommended cumulative dose of 29.6 GBq of BRAVNETSA results in a radiation absorbed dose to the testes and ovaries within the range where temporary or permanent infertility can be expected following external beam radiotherapy.

ADVERSE REACTIONS

The most common Grades 3-4 adverse reactions (≥4% with a higher incidence in the BRAVNETSA arm) are lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia, and hypokalemia.

DRUG INTERACTIONS

Somatostatin Analogs

Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each BRAVNETSA dose. Administer short-and long-acting octreotide during BRAVNETSA treatment as recommended.

Glucocorticoids

Avoid repeated administration of high doses of glucocorticoids during treatment with BRAVNETSA.

USE IN SPECIFIC POPULATIONS

Advise patients not to breastfeed during BRAVNETSA treatment.

To report SUSPECTED ADVERSE REACTIONS, contact Lantheus at 1-800-362-2668 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for BRAVNETSA.

About Lantheus

Lantheus is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and the United Kingdom, Lantheus has been providing radiopharmaceutical solutions for more than 70 years. For more information, visit www.lantheus.com.

Safe Harbor for Forward-Looking and Cautionary Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “expected,” “only,” “positioned,” “look forward,” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include: (i) our ability to successfully commercialize BRAVNETSA and achieve market adoption; (ii) the ability of our supply and distribution network to manufacture and deliver BRAVNETSA reliably; (iii) the existence, availability and profile of competing products; (iv) the outcome of pending or future litigation; and (v) the risks and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our most recently filed Annual Report on Form 10-K and Quarterly Reports on Form 10-Q).

References:

¹Neuroendocrine Tumors. Cleveland Clinic. Published June 26, 2024. Accessed May 22, 2025. https://my.clevelandclinic.org/health/diseases/22006-neuroendocrine-tumors-net

²Dasari A, Shen C, Halperin D, Zhao B, Zhou S, Xu Y, Shih T, Yao JC. Trends in the Incidence, Prevalence, and Survival Outcomes in Patients With Neuroendocrine Tumors in the United States. JAMA Oncol. 2017 Oct 1;3(10):1335-1342. doi: 10.1001/jamaoncol.2017.0589. PMID: 28448665; PMCID: PMC5824320.

³Kolarova T, et.al. P-136 Survey of challenges in access to diagnostics and treatment for neuroendocrine tumor patients (SCAN): Early diagnosis and treatment availability. Annals of Oncology, Volume 31, S134.

⁴Raphael MJ, Chan DL, Law C, Singh S. Principles of diagnosis and management of neuroendocrine tumours. CMAJ. 2017 Mar 13;189(10):E398-E404. doi: 10.1503/cmaj.160771. PMID: 28385820; PMCID: PMC5359105.

LUTATHERA^® is a registered trademark of Novartis AG and/or its affiliates.

Contacts:

Lantheus
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com

Melissa Downs
Executive Director, External Communications
646-975-2533
media@lantheus.com

SHENZHEN, CHINA, Sept. 22, 2026 (GLOBE NEWSWIRE) — Lianhe Sowell International Group Ltd (Nasdaq: LHSW) (the “Company”), a provider of industrial machine vision products and solutions in China, today announced that it has entered into a strategic cooperation agreement (the “Agreement”) with Kumquat Technology Co., Ltd. (“Kumquat Technology”), a subsidiary of Chery Group and the operating entity for its nationwide network of 1,000 4S stores, to promote intelligent equipment solutions across China’s automotive aftermarket.

Under the Agreement, the two companies will collaborate on intelligent equipment solutions covering 24 automotive aftermarket processes. Lianhe Sowell will provide complete sets of intelligent operating equipment, while Kumquat Technology will provide supporting automotive parts. The parties will also leverage their respective resources and capabilities to promote the solutions in the domestic market.

Kumquat Technology serves as the operating entity for Chery Group’s nationwide network of 1,000 4S stores, providing automotive aftermarket products and services through its extensive distribution and service network. Under the Agreement, Kumquat Technology will leverage this network to promote Lianhe Sowell’s intelligent equipment products to partner stores and downstream customers.

As part of the cooperation, demonstration sites for Lianhe Sowell’s intelligent equipment will be established at selected locations provided by Kumquat Technology, offering Kumquat Technology’s partner customers opportunities to experience the equipment and supporting product promotion.

Beyond the domestic market, the parties intend to explore overseas opportunities, with Kumquat Technology leading market development and operations and Lianhe Sowell providing products and technical support. The cooperation will also include cross-channel promotion of Kumquat Technology’s automotive aftermarket parts to Lianhe Sowell’s industry customers.

“We are pleased to establish this strategic cooperation with Kumquat Technology and expand the application of our intelligent equipment solutions across the automotive aftermarket,” said Mr. Yue Zhu, Chief Executive Officer and Director of the Company. “By combining Kumquat Technology’s automotive industry resources, channel network and aftermarket capabilities with our capabilities in intelligent equipment and industrial automation, we believe this cooperation can support the adoption of intelligent solutions across automotive aftermarket operations. We look forward to working together to develop a scalable model for intelligent upgrades in China and explore additional opportunities in international markets.”

About Lianhe Sowell International Group Ltd

Lianhe Sowell International Group Ltd (Nasdaq: LHSW) provides industrial vision and industrial robotics solutions. With expertise in the field of machine vision and intelligent equipment, the Company specializes in smart transportation, industrial automation, artificial intelligence, and machine vision. Committed to offering comprehensive intelligent solutions to customers worldwide, the Company continuously advances the intelligent transformation of various industries through technological innovation. For more information, please visit: https://sowellai.com/.

Forward-Looking Statement

This press release contains forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as “may, “will, “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate,” “plan” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the uncertainties related to market conditions and other risk factors discussed in the Company’s filings with the SEC, which are available for review at www.sec.gov. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

For more information, please contact:

Lianhe Sowell International Group Ltd
Email: ir@cnsoftweIl.com
WFS Investor Relations Inc.
Email: services@wfsir.com 
Phone: +1 628 283 9214

DOE-funded study findings could help Nuclear Lifecycle Innovation Campuses evaluate integrated recycling and disposition strategies

BERKELEY, Calif., Sept. 22, 2026 (GLOBE NEWSWIRE) — Deep Isolation Nuclear, Inc. (OTCQB: DBHL) (“Deep Isolation” or the “Company”), a leading innovator in nuclear waste disposal technology, today announced results from a three-year U.S. Department of Energy-funded project showing that deep borehole disposal could provide a safe and cost-effective pathway for permanent disposal of waste generated by recycling used nuclear fuel.

Deep Isolation’s analysis performed as part of the project found that all disposal scenarios studied were projected to cost less than the program’s target of 0.1 cent per kilowatt-hour of electricity generated. Long-term safety analyses also found that all scenarios under expected conditions met the study’s safety performance criteria, with projected public radiation doses in most scenarios analyzed orders of magnitude below the 10 millirem-per-year regulatory benchmark used in the analysis. The results of the study could help address an important challenge facing the nuclear industry: how to safely and economically manage waste from future nuclear fuel recycling.

The research was conducted as part of the Department of Energy’s ARPA-E CURIE program in collaboration with Argonne National Laboratory, Oklo Inc. (NYSE: OKLO) and Case Western Reserve University. Deep Isolation developed the waste disposal component of the project, evaluating how waste from recycled nuclear fuel could be packaged and permanently isolated in deep boreholes.

“This project shows the value of designing recycling and disposal systems together rather than treating waste management as a downstream consideration,” said Jesse Sloane, Executive Vice President of Engineering at Deep Isolation. “Working alongside Argonne National Lab and Oklo, we developed a technically grounded disposal pathway that could support the economics of future fuel recycling while safely isolating the resulting waste. These findings give us another important building block toward an integrated and sustainable nuclear fuel cycle.”

Deep Isolation’s work focused on the full disposal pathway for waste produced through fuel recycling, from understanding the waste and how it would be packaged to designing a repository and evaluating its long-term safety and economics. The analysis considered Deep Isolation’s Universal Canister System (UCS) in both horizontal and vertical deep borehole configurations.

Oklo is developing an integrated fuel strategy for used fuel recycling, fuel fabrication, and power generation. It plans to recover usable fuel materials through pyroprocessing, fabricate that material into fuel, and use that fuel in its advanced fast reactors.

“Closing the fuel cycle is about unlocking the full value of used nuclear fuel — recovering its energy potential and extracting isotopes, while safely and permanently managing what remains,” said Ed Petit de Mange, Vice President of Fuel Recycling at Oklo. “This three-year study shows what’s possible when we design recycling and disposal together: an integrated approach that can meet rigorous safety standards while keeping disposal costs low. That’s the model we should work toward as we build the infrastructure for a more complete nuclear fuel cycle.”

Hosts of Nuclear Lifecycle Innovation Campuses, a new Department of Energy effort to strengthen and modernize the nation’s full nuclear fuel cycle, are exploring fuel recycling as a previously untapped energy resource. Within each Innovation Campus, permanent disposal will remain an essential part of managing the resulting waste. The CURIE findings could help Deep Isolation, fuel-cycle companies and advanced reactor developers plan recycling and disposal together from the outset to meet a campus’ needs, supporting a more integrated approach to the future nuclear fuel cycle. 

“CURIE was structured to address several of the technical and economic challenges that need to be considered together as fuel recycling technologies advance,” said Krista Hawthorne, Section Manager, Pyroprocess Engineering, at Argonne National Laboratory. “By bringing together expertise in oxide reduction, process monitoring, fuel-cycle planning and waste disposal, this team has developed a more integrated understanding of how these systems could work together. Deep Isolation’s disposal work provides an important component of that broader fuel-cycle strategy.”

The CURIE project builds on Deep Isolation’s broader ARPA-E-funded work advancing integrated nuclear waste solutions, including the development of the UCS through Project UPWARDS under ARPA-E’s ONWARDS program. The triple-purpose UCS is designed to support storage, transportation and disposal of a range of advanced reactor and fuel-cycle waste streams.

About Deep Isolation

Deep Isolation (OTCQB: DBHL) is the first company to undertake development of technologies for nuclear waste disposal in deep boreholes. When commercialized, Deep Isolation’s solution will offer a unique approach to help countries identify, plan for and complete the necessary steps to dispose of their nuclear waste inventories. With over 100 patents issued to date, Deep Isolation’s technology is being designed to leverage proven drilling practices to allow safe isolation of waste deep underground in horizontal, vertical, or slanted borehole repositories. Deep Isolation’s Universal Canister System was developed through a three-year project funded by the U.S. Department of Energy’s Advanced Research Projects Agency–Energy and is engineered to support integrated management of spent fuel and high-level radioactive waste from legacy and advanced reactors across storage, transportation, and eventual disposal. In January 2026, Deep Isolation launched a full-scale, at-depth deep borehole Commercialization Pilot for its solution at Cameron, Texas, in collaboration with the Deep Borehole Demonstration Center, Halliburton (NYSE: HAL), Amentum (NYSE: AMTM), NAC International (TYO: 7004), and Occlusion Nuclear Solutions.

For more information, visit: https://www.deepisolation.com

Media Contact
Sophie McCallum
media@deepisolation.com

Investor Contact
Caldwell Bailey
InvestorRelations@deepisolation.com

Forward-Looking Statements

Statements contained in this news release that are not historical facts are “forward-looking information” or “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, but are not limited to, statements regarding our plans, objectives and expectations for our business, the future growth of our business and the nuclear energy and nuclear waste disposal industries as a whole, and future benefits expected to arise from our strategic partnerships. In certain cases, forward-looking statements can be identified by the use of words and phrases or variations of words and phrases or statements such as “may,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “will,” “could,” “project,” “target,” “potential,” “continue” and similar expressions. Forward-looking statements are based on management’s belief and assumptions, including current expectations and projections about future events and trends, and on information currently available to management.

Forward-looking statements in this or any other news release are subject to a number of risks, uncertainties, and assumptions that could cause actual results to be materially different from those expressed or implied by such forward-looking statements. Such risks, uncertainties, and assumptions are subject to a number of factors, including, among others: the failure of a market to develop for our deep borehole disposal solutions as quickly as we expect or at all; a failure of demand for our solution to develop sufficiently; regulatory and legal developments, including issues relating to obtaining regulatory approvals or permissions on the timelines we expect or at all; our lack of profitability; delays or failure in our initiative to complete a full-scale, at-depth demonstration of our Universal Canister System and our deep borehole solution; our failure to enter into contracts with customers or, once we do enter into contracts, to continue such contractual relationships or to receive new contract awards; our dependency on governmental contracts and awards and our ability to finalize negotiations on same; our failure to manage our growth effectively or to execute our business plan; our failure to sustain and expand relationships with governmental entities and strategic partners; a failure in the assumptions or analyses we have used in supporting forecasts or plans; our inability to commercialize our products at scale; the development or deployment of other technologies or solutions supplanting or competing with our technologies; challenges to our intellectual property; failures to protect, maintain, enforce, and enhance our intellectual property, and claims by others of intellectual property infringement; political and public perceptions of nuclear energy, including perceptions as to accidents or other high-profile events involving nuclear power facilities or radioactive materials; our liquidity and ability to raise capital; any inability to control operating and project costs and project delays or other project-related problems; security (including cybersecurity) breaches or disruptions; geopolitical, macroeconomic, domestic events or crises, including supply chain disruptions and other risks and uncertainties outside of our control; weather and effects of climate change; and litigation or legal proceedings that may be brought against us.

The foregoing is not an exhaustive list of all the factors that may cause any forward-looking statements to prove inaccurate or our actual results to differ materially from our expectations and forecasts. Moreover, we operate in a highly regulated environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties, and assumptions, the future events and trends discussed in this release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements, and we cannot guarantee future results, performance, or achievements. Accordingly, readers should not place undue reliance on forward-looking statements. We undertake no obligation to update any forward-looking statements for any reason after the date of this release or to conform these statements to actual results or revised expectations, except as required by law.

Additional information concerning the factors above and other factors will be found in the Company’s public filings with the Securities and Exchange Commission (the “SEC”), including the sections titled “Forward-Looking Statements” and “Risk Factors” in the Company’s Reports on Form 10-K and 10-Q for the fiscal year ended December 31, 2025 and the quarter ending March 31, 2026, respectively, as filed with the SEC on March 30, 2026, our Form S-1, originally filed August 18, 2025 and subsequently amended, our Proxy Statement for our 2026 Annual Meeting as filed on April 29, 2026, and in filings with the SEC that will be made in the future. The Company’s SEC filings are available free of charge at www.sec.gov or upon written request to Deep Isolation at InvestorRelations@deepisolation.com or CorpSec@deepisolation.com.

Naples, Italy and Hamilton, Bermuda, Sept. 22, 2026 (GLOBE NEWSWIRE) — The RoyaLand Company Ltd. (the “Company” or “RoyaLand”) (OTCQB: RLNDF), a Bermuda holding company focused on creating immersive, fantasy-based royalty-themed games as well as ownership and growth of its Italian professional football club Savoia 1908 FC (“Savoia” or the “Club”), today announced Savoia’s plans to secure an operating concession for Stadio Alfredo Giraud (“Stadio Giraud”), the home ground of the Club, and develop it into a strategic asset for long-term growth.

A Three-Phase Process

The Municipality of Torre Annunziata has structured the path to the Stadio Giraud concession in three phases. The first was an expression of interest, in which participants were asked to submit a detailed program for the stadium’s use and development. Two parties took part, and Savoia’s proposal was judged the most responsive to the municipality’s requirements and objectives.

The second phase concerned the assignment of the stadium’s use, either temporary or continuous. Savoia applied for continuous use and has already been notified of a positive outcome. In the coming days, the Club expects to sign a formal agreement with the municipality granting exclusive use of Stadio Giraud, from 8:00 a.m. to 10:00 p.m., for its teams’ activities. This agreement is independent of the outcome of the concession tender and will cover the entire 2026/2027 football season, expiring on June 30, 2027.

The Path Ahead: The Concession Tender

The next step will be the tender for the stadium’s concession itself, expected to be published by the end of October, initially for a five-year term. Based on that timeline, Savoia anticipates roughly one month for the publication period and a further month for the submission of documentation and offers, with the award expected in January 2027. Savoia considers its position solid: under the municipality’s rules, the tender awards points based on specific criteria, and two of them favor Savoia directly: being the highest-ranked football club based in the city and having the deepest historical ties to local football. Savoia currently competes in Serie C and has long been the city’s leading team, meeting both criteria. The Club expects this to translate into a high score and limited competition from other bidders. Even so, the final terms, including the required investment, obligations and overall economic conditions of the concession, will only be known once the tender is officially published, and the Club will evaluate them carefully before proceeding. The final assignment, in any case, remains subject to the outcome of the public tender process.

Beyond a Matchday Venue: A Strategic Asset

In the Club’s vision, Stadio Giraud is not simply the ground on which the first team plays its matches. Direct management of the stadium would allow Savoia progressively to transform it into a genuine strategic asset capable of generating revenue, strengthening the Club’s relationship with the local community, and contributing to the growth of the Club’s overall value.

A Strategic Location

Stadio Giraud benefits from a particularly favorable location, being close to the Torre Annunziata motorway exit and along the Naples–Salerno corridor which is one of the principal transportation routes in Campania, Pompei, the Amalfi Coast, and Southern Italy. That location, combined with the potential of the surrounding area, underpins much of the Club’s interest in the concession.

New Commercial, Sponsorship and Hospitality Opportunities

The stadium’s location and the possibility of direct management could, over time, enable Savoia to develop activities that extend beyond the purely sporting use of the venue, creating new commercial, sponsorship, hospitality, events and service opportunities. As part of the Club’s broader sustainability model, Stadio Giraud could become not merely a sporting facility, but an asset that strengthens the Club’s finances over time and deepens its ties to the local community.

Stadio Alfredo Giraud in Torre Annunziata

A Long-Term View

“Stadio Giraud is a strategic asset in Savoia Calcio’s long-term growth plan. Our ambition is to progressively transform it into a modern, sustainable venue that is active throughout the week and can become a benchmark for sports infrastructure in Southern Italy. Its strategic location, in the heart of the Vesuvian area and along the Naples–Salerno corridor, combined with the space available within the stadium complex, provides significant potential to develop hospitality, food and beverage, commercial activities and additional services, subject to the terms of the future concession and the relevant approvals. We want Stadio Giraud to be more than just the home of Savoia. Our goal is to create an infrastructure capable of generating long-term sporting, social and economic value for the Club, for Torre Annunziata and for the wider region.”

–  General Manager and Chief Operating Officer of Savoia, Nazario Matachione.

About The RoyaLand Company Ltd.

The RoyaLand Company Ltd. is a Bermuda holding company focused on creating an online and offline immersive, fantasy-based royalty-themed game called TheRoyal.Land as well as mobile and other games, and ownership and growth of its Italian professional football club Savoia 1908 FC. The Company is actively focused on developing what it believes to be a novel, interactive and immersive game based on a player-empowered design. This game is expected to feature proprietary digital avatars and provide opportunities to players to earn in-game reward currency, build virtual land, and own their online assets while enhancing all of these features with premium incremental in-game content. Bridging the virtual video game world and terrestrial soccer, Savoia 1908 FC has also completed a tournament season for its eSports team competing in EA Sports FC™ online matches.

TheRoyal.Land and the management and development of Savoia 1908 FC are being conducted in collaboration with the Company’s founder and CEO Prince Emanuele Filiberto di Savoia — the grandson of the last King of Italy — as well as seven other royal families and families with legal, hereditary or historically based claims to royal positions in Russia, Albania, France, Bulgaria, Yugoslavia, Lesotho (Africa), and Mecklenburg (Germany). TheRoyal.Land is intended to integrate these families’ first-hand historical perspectives to deliver an authentic and unique past-meets-future entertainment experience.

CONTACT:
investors@theroyal.land
www.TheRoyal.Land

Attachment

• Stadio Alfredo Giraud in Torre Annunziata

Summit to be hosted at site of Genius City in Nuanu, Bali, Indonesia, with speakers including Futurists Dr Michio Kaku and Peter Diamandis.

SINGAPORE, Sept. 22, 2026 (GLOBE NEWSWIRE) — Genius Group Limited (NYSE American: GNS) (“Genius Group”, “GNS” or the “Company”), a leading AI-powered education group, today announced details for the second year of the Genius Future Summit, taking place on November 5-6, 2026.

Billed as Asia’s No.1 Event for Entrepreneur, Changemakers and Visioneers, the Summit will take place at the site of Genius City in Nuanu, Bali.

The Annual Genius Future Summit brings together the world’s brightest leaders, innovators, and thinkers to explore the top trends shaping our future. Over two immersive days, attendees gain insights, connections, and strategies to thrive in the decade ahead.

This year’s headline speakers include:

Dr Michio Kaku: Theoretical physicist, bestselling author, acclaimed public speaker, futurist, and popularizer of science, he co-founded “String Field Theory” and continues Einstein’s quest to unite the fundamental forces of nature into a single grand unified “Theory of Everything.”

Dr. Kaku held the Henry Semat Chair in Theoretical Physics at City University New York, graduating summa cum laude from Harvard with a Ph.D. from UC Berkeley, and is a recipient of the Arthur C. Clarke Lifetime Achievement Award. He has written numerous New York Times bestselling books including The Future of Humanity, The Future of the Mind, Physics of the Future, Physics of the Impossible and The God Equation: The Quest for a Theory of Everything.

Peter Diamandis: A pioneer in innovation, longevity, and exponential technologies, and named by Fortune as one of the World’s 50 Greatest Leaders.

Mr. Diamandis is the Founder and Executive Chairman of XPRIZE Foundation, which has launched over $600 million in competitions, driving more than $10 billion in research and development across space, health, robotics, climate, quantum, and AI. He also co-founded Singularity University, Link-Exponential Ventures, BOLD Capital Partners, and multiple companies focused on extending human healthspan and accelerating technological progress.

Summit speakers also include:

• Roger James Hamilton, Founder & CEO of Genius Group Ltd
• Lev Kroll, CEO of Nuanu Creative City
• Merry Riana, Entrepreneur and Founder of Merry Riana Learning Centre
• Iwan Sugata, Founder and Catalyst, MANOUV
• Eva Mantziou, Chief People Officer & Chief Legal Officer of Genius Group
• Charlie Hearn, Founder of Inspiral Architecture and Design Studios
• Jacek Kaczynski, Education Innovator, Discover Lab Indonesia
• Ni Komang Sri Junisabtika, Venue Manager of Magic Garden

Highlights of the summit include:

• The top 10 trends in the ABC’s of the Future: AI, Blockchain, and Community
• Forums on Entrepreneurship, Education and Environment
• Launch of the inaugural Genius Awards, highlighting AI powered, impact driven projects.
• Tour of the rapidly growing Genius School campus and Future School model
• Launch of the Genius City showcase and launch roadmap.

Genius Group’s CEO, Roger James Hamilton, said “Following the success of the first Genius Future Summit in 2025, we are looking forward to welcoming back entrepreneurs, investors and changemakers from across Asia for our second annual summit. The accelerating rate of change across all exponential technologies makes the topic of our summit more relevant than ever this year. We also look forward to welcoming students of Genius School as well as our first cohort of humanoid robots, who will be joining our attendees for the first time this November.”

To find out more about the Genius Future Summit, visit:
https://geniusbali.ai/genius-future-summit-2026

About Genius Group

Genius Group (NYSE: GNS) is a global education group delivering AI powered, education and acceleration solutions for the future of work. Genius Group serves 6 million users in over 100 countries through its Genius City model and online digital marketplace of AI training, AI tools and AI talent. It provides personalized, entrepreneurial AI pathways combining human talent with AI skills and AI solutions at the individual, enterprise and government level. To learn more, please visit geniusgroup.ai

Forward-Looking Statements 

Statements made in this press release include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by the use of words such as “may,” “will”, “plan,” “should,” “expect,” “anticipate,” “estimate,” “continue,” or comparable terminology. Such forward-looking statements are inherently subject to certain risks, trends and uncertainties, many of which the Company cannot predict with accuracy and some of which the Company might not even anticipate and involve factors that may cause actual results to differ materially from those projected or suggested. Readers are cautioned not to place undue reliance on these forward-looking statements and are advised to consider the factors listed above together with the additional factors under the heading “Risk Factors” in the Company’s Annual Reports on Form 20-F, as may be supplemented or amended by the Company’s Reports of a Foreign Private Issuer on Form 6-K. The Company assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise. No information in this press release should be construed as any indication whatsoever of the Company’s future revenues, results of operations, or stock price.

Contacts
For enquiries, contact investor@geniusgroup.ai

• SemiCab Initiatives Focused on Near-Term Break-Even Operations and Strategic Partnerships
• Newly Acquired Azure Energy Has More Than $10 Million in Active Contracted Revenue Through 2027
• Management Focused on Expanding Revenue and EBITDA Through Azure Existing Customers and Strategic Partnerships
• Company Targets Lower Cost of Capital and Reduced Reliance on Dilutive Financing

FORT LAUDERDALE, FL., Sept. 22, 2026 (GLOBE NEWSWIRE) — Algorhythm Holdings, Inc. (the “Company”) (NASDAQ: RIME), a diversified holding company and owner of SemiCab, an AI-enabled logistics technology business, and Azure Energy, a renewable power infrastructure developer, today outlined its near-term operational, strategic and capital allocation priorities for the remainder of 2026 and 2027.

The update coincides with the Company’s filing of a new corporate presentation with the Securities and Exchange Commission pursuant to Regulation FD.

Driving Profitable Growth Across the Portfolio

Management’s immediate priority is to build a stronger base of recurring and profitable revenue across Algorhythm’s operating business segments.

At SemiCab, management’s immediate priority is to substantially reduce operating losses through a reduction in G&A spending, particularly at the Company’s SemiCab India division, and prioritizing SemiCab’s SaaS model which provides an opportunity to pursue a more capital-efficient business model.

The Company has taken steps to reduce SemiCab’s operating cost structure and intends to focus its investment on activities with the clearest path to near-term, high-margin returns. For longer-term opportunities, management intends to explore strategic partnerships and other capital-efficient structures designed to monetize SemiCab’s technology while limiting additional investment requirements.

At Azure Energy, the Company currently has three customers providing significant revenue visibility under existing contracts, representing more than $10 million of contracted high-margin fee revenue through the end of 2027. The Company is also negotiating additional opportunities that, if successfully contracted, are expected to contribute incremental revenue during 2027. Two of these opportunities involve existing customers of Azure and its affiliates, providing the potential to expand established commercial relationships.

Expanding Through Capital-Efficient Strategic Partnerships

Strategic partnerships represent an important component of the Company’s growth strategy across both SemiCab and Azure.

At Azure, the Company intends to pursue project-specific relationships with established construction and infrastructure firms to expand its participation in large-scale power generation projects. Under this model, Azure would contribute its engineering, project development and technical expertise while its partners provide complementary construction capabilities and commercial bonding capacity.

Management currently believes these relationships could enable Azure to expand into the procurement phase of Engineering, Procurement and Construction (“EPC”) engagements without independently assuming the full capital and bonding requirements associated with those projects. One such opportunity could expand Azure’s existing relationship with a Fortune 500 food and beverage company.

Strengthening Algorhythm’s Balance Sheet and Capital Structure

Management’s third priority is to strengthen Algorhythm’s balance sheet, reduce its cost of capital and decrease reliance on potentially dilutive financing.

As the Company seeks to expand its base of contracted revenue and operating cash flow, management intends to evaluate opportunities to selectively use cash on hand and future cash flows to repay, restructure or refinance higher-cost financing instruments currently outstanding.

Management also intends to pursue lower-cost financing alternatives that may become available as the Company’s revenue base and operating cash flow grow. The objective is to reduce reliance on equity-linked financing while preserving sufficient liquidity to support attractive growth opportunities across the Company’s businesses.

Focused on Execution

“Our priorities for Algorhythm are clear,” said Andrew Thompson, Chief Executive Officer of Algorhythm Holdings. “First, we are focused on driving sustained, profitable revenue growth. Azure brings to the Company more than $10 million of existing contracted revenue, established customer relationships and a growing pipeline of opportunities in power generation infrastructure. Our immediate objective is to execute against that foundation and expand it.”

“Second, we are taking a disciplined approach to how we deploy capital across the Company. With SemiCab, our priority is to substantially reduce operating losses while pursuing partnership structures that can preserve the value of its technology and customer relationships. With Azure, believe strategic partnerships can allow us to participate in larger power generation projects without independently assuming all of the customary capital and bonding requirements.”

“Finally, we are focused on strengthening Algorhythm’s capital structure,” Thompson concluded. “As we grow revenue and operating cash flow, we intend to pursue opportunities to reduce higher-cost financing and our reliance on dilutive sources of capital. Our objective is straightforward: grow profitable revenue, allocate capital where we see the strongest returns, and build a stronger financial foundation for Algorhythm and its shareholders.”

About Algorhythm Holdings

Algorhythm Holdings, Inc. is a holding Company, with two primary assets, SemiCab and Azure Energy.

SemiCab is an AI-enabled logistics software provider. Since 2020, SemiCab has enabled major retailers, brands and transportation providers to address common supply-chain problems globally. Its AI-enabled, cloud-based Collaborative Transportation Platform achieves the scalability required to predict and optimize millions of loads and hundreds of thousands of trucks. SemiCab uses real-time data from API-based load tendering and pre-built integrations with TMS and ELD partners to orchestrate collaboration across manufacturers, retailers, distributors, and their carriers. SemiCab uses AI/ML predictions and advanced predictive optimization models to enable fully loaded round trips. With SemiCab’s AI platform, shippers pay less and carriers make more without having to change a thing. For additional information, please go to: http://www.semicab.com.

Azure Energy is a leading developer of renewable biomass power generation infrastructure. Their team consists of some of the most experienced biomass power plant experts in the US today. Collectively this team has designed and built 72 facilities generating 17.5GW of renewable power to date. As Azure, this team launched in 2025 and has already secured equity participation valued at over $220 million in net present value through multiple power plants under construction in the US today. The Company has significant fee-income consulting revenues under multi-year contracts, and is generating scaling, positive EBITDA. For additional information, please go to: http://www.azure-energy.co.

Investor Relations Contact

Brendan Hopkins
407-645-5295
investors@algoholdings.com
www.algoholdings.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “expects,” “anticipates,” “believes,” “plans,” “potential,” “seeks,” “should,” “strategy,” “targets,” “will” and similar references to future periods. Examples of forward-looking statements in this press release include, among others, statements regarding the Company’s expectations for revenue growth and contracted revenue at Azure Energy, anticipated reductions in SemiCab’s operating losses and general and administrative spending, plans to pursue strategic partnerships in power generation infrastructure, expectations regarding Azure Energy’s ability to expand into EPC engagements, management’s plans to strengthen the Company’s balance sheet and reduce its cost of capital, the Company’s strategy to reduce reliance on dilutive financing, and the anticipated benefits of the Company’s capital allocation priorities. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described from time to time in Algorhythm’s reports to the SEC, including, without limitation Algorhythm’s Annual Report on Form 10-K for the year ended December 31, 2025. You should not place undue reliance on any forward-looking statement, each of which applies only as of the date of this press release. Except as required by law, we undertake no obligation to update or revise publicly any of the forward-looking statements after the date of this press release to conform our statements to actual results or changed expectations, or as a result of new information, future events or otherwise.

Allen facility delivers eBee VISION ISR systems to the U.S. Army and begins shipping the new MicaSense RedEdge-MX sensor to commercial customers

ALLEN, Texas, Sept. 22, 2026 (GLOBE NEWSWIRE) — AgEagle Aerial Systems Inc. (dba, EagleNXT) (the “Company” or “EagleNXT”) (NYSE: UAVS), a leading provider of full-stack drone, counter-UAS, and specialty sensor system solutions for defense, government, and commercial applications worldwide, today announced that its U.S. headquarters and production facility in Allen, Texas is now shipping product across multiple lines, including eBee VISION Intelligence, Surveillance, and Reconnaissance (ISR) unmanned systems and the newly released MicaSense RedEdge-MX multispectral sensor.

Most recently, nine Allen-built eBee VISION UAS kits were delivered to the U.S. Army’s National Training Center (NTC) at Fort Irwin, California, fulfilling the order announced in April 2026. The delivery follows the first VISION units produced on the Allen line, which shipped to Fort Rucker, Alabama earlier this year.

The NTC is the Army’s premier maneuver training venue, preparing rotational units for high-intensity operations that now routinely include adversary unmanned systems and the requirement for friendly ISR at the tactical edge. The kits will support opposing force (OPFOR) realism, rotational-unit training, and counter-UAS instruction.

“Domestic production was a stated objective when we established our headquarters in Allen. It is now an operating reality,” said Bill Irby, Chief Executive Officer. “U.S.-built VISION systems are supporting training at the Army’s National Training Center, and the same facility is shipping our newest MicaSense sensor to commercial customers. Customers across defense and commercial markets are prioritizing American-made unmanned systems and sensors, and EagleNXT is maturing its domestic supply chain to meet that demand. We believe that positioning is a durable foundation for long-term shareholder value.”

The eBee VISION is a backpack-portable, hand-launched fixed-wing ISR drone that deploys in minutes and delivers long-range zoom, optional thermal imaging, and a high-definition video feed. The Group 1 UAS provides up to 90 minutes of flight endurance and a real-time video link range of up to 12 miles (20 km). It is NDAA-compliant, Blue UAS Cleared, and built to operate in GNSS-denied and contested environments.

EagleNXT is also now shipping the updated MicaSense RedEdge-MX multispectral sensor, released in July 2026, from a dedicated assembly and test cell at the Allen facility. The RedEdge-MX features a new metallic enclosure for durability in harsh field environments and is available through EagleNXT’s global network of authorized dealers and partners. The Allen site is EagleNXT’s North American hub for eBee VISION production, MicaSense sensor manufacturing, and ThirdEye USA counter-UAS assembly. Consolidating drone and sensor production in Texas also frees capacity on the Company’s Swiss manufacturing lines to serve international demand.

“U.S. leadership has made American drone production a defense priority,” continued Irby. “Shipping both drones and sensors from Allen shows EagleNXT is already operating on that footing, with U.S.-made, procurement-eligible systems moving from our floor to the field.”

The Fort Irwin delivery builds on broader U.S. Army adoption of the eBee VISION across training centers and operational units in the United States and Europe.

For more information about the full suite of EagleNXT UAS and sensor solutions, visit eaglenxt.com or contact the EagleNXT Media Relations team.

About EagleNXT

EagleNXT is a leading developer of high-performance drones, advanced sensors, and intelligent software solutions that deliver critical aerial intelligence to customers around the world. With more than one million flights conducted globally, EagleNXT’s platforms are trusted across defense, public safety, agriculture, infrastructure, and environmental monitoring applications. The Company’s drone systems have achieved multiple industry firsts, including FAA approvals for Operations Over People (OOP) and Beyond Visual Line of Sight (BVLOS), as well as EASA C2 certification in Europe and inclusion on the U.S. Department of Defense’s Blue UAS list. EagleNXT’s sensors are integrated on more than 150 different drone models and are used in over 100 research publications worldwide, reinforcing its leadership in precision agriculture, surveying, and environmental sustainability initiatives.

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “suggest,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on AgEagle’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the timing and fulfilment of current and future purchase orders relating to AgEagle’s products, the success of new programs and software updates, the ability to implement a new strategic plan and the success of a new strategic plan. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of AgEagle in general, see the risk disclosures in the most recently filed Annual Report on Form 10-K and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by AgEagle. All such forward-looking statements speak only as of the date they are made, and AgEagle undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise.

Media Contact
Andy Woodward
+1 (469) 451-2344
Andy.woodward@EagleNXT.com

LinkedIn Facebook X YouTube

Investor Relations
Email: UAVS@EagleNXT.com

— First targeted therapy approved in Canada for patients four years and older living with acquired hypothalamic obesity (HO) —

BOSTON, Sept. 22, 2026 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that Health Canada has approved IMCIVREE^® (setmelanotide) for the additional indication of weight management in adult and pediatric patients 4 years of age and older with acquired hypothalamic obesity (HO). IMCIVREE was first approved by Health Canada in 2023 for weight management in adult and pediatric patients 6 years of age and older with obesity due to Bardet-Biedl syndrome (BBS), or genetically confirmed biallelic pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency due to variants interpreted as pathogenic, likely pathogenic, or of uncertain significance. Please consult the IMCIVREE product monograph available at www.rhythmtx.ca.

“Acquired hypothalamic obesity is a rare, complex MC4R pathway disease that develops following injury to the hypothalamus, resulting in accelerated and sustained weight gain, hyperphagia and significant impacts on quality of life,” said Jennifer Lee, Executive Vice President, Head of North America for Rhythm. “The approval of this additional indication for IMCIVREE provides healthcare professionals with an important new treatment option for eligible patients in Canada. We are grateful to the Canadian patient and healthcare community and look forward to working to make IMCIVREE available to patients living with acquired hypothalamic obesity.”

IMCIVREE, a melanocortin-4 receptor (MC4R) agonist, is the first targeted therapy approved in Canada to treat acquired HO. The Health Canada approval is based on the positive pivotal Phase 3 TRANSCEND trial of setmelanotide in 142 patients with acquired HO. The global study met its primary endpoint, demonstrating a statistically significant 18.8% placebo-adjusted reduction in body mass index (BMI). Results from the Phase 3 TRANSCEND trial were recently published in The New England Journal of Medicine.

“Patients living with acquired hypothalamic obesity face significant medical and quality-of-life challenges, and treatment options have been extremely limited,” said Jill Hamilton, M.D., Paediatric Endocrinologist at The Hospital for Sick Children. “This approval provides a treatment option that addresses the underlying MC4R pathway dysfunction associated with acquired hypothalamic obesity.”

Following this approval, Rhythm will continue with supporting access to IMCIVREE for patients with acquired HO across Canada.

Disclosure footnote: Dr. Jill Hamilton has received institutional support for industry sponsored studies, including setmelanotide trials from Rhythm Pharmaceuticals.

About Acquired Hypothalamic Obesity

Acquired HO is a rare disease characterized by accelerated and sustained weight gain caused by an injury to the hypothalamus. Hypothalamic injury may lead to decreased alpha-melanocyte-stimulating hormone (α-MSH) production and impairment of MC4R pathway signaling. The MC4R pathway is responsible for regulating energy balance and body weight. Acquired HO most frequently follows the growth or treatment of craniopharyngioma, astrocytoma, or other hypothalamic-pituitary tumors. Additional causes of injury may include traumatic brain injury, stroke, infection, or inflammation. Due to impairment of the MC4R pathway, patients experience accelerated and sustained weight gain, often accompanied by hyperphagia and/or decreased energy expenditure. Acquired hypothalamic obesity can occur as early as six months following hypothalamic injury. Acquired HO is a rare disease with limited epidemiologic data specific to Canada.

About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE^® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 4 years and older with acquired hypothalamic obesity, adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and control of hunger in patients 4 years of age and above with acquired hypothalamic obesity due to hypothalamic injury or impairment; and for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.

Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Please see the Product Monograph at https://rhythmtx.ca/wp-content/uploads/2023/05/IMCIVREE-Product-Monograph-EN.pdf for complete safety information.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the safety, efficacy, potential benefits of, and clinical design or progress of any of our products or product candidates at any dosage or in any indication, including, setmelanotide, bivamelagon, and RM-718; the use of setmelanotide in patients with acquired HO and the success of our commercial launch; our expectations surrounding potential regulatory submissions, progress, or approvals and timing thereof for any of our product candidates; the commercial growth of IMCIVREE; the estimated market size and addressable population for our drug products, including setmelanotide for the treatment of acquired HO; and the timing of any of the foregoing. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, risks associated with the laws and regulations governing our international operations and the costs of any related compliance programs, our ability to successfully commercialize setmelanotide, our liquidity and expenses, our ability to retain our key employees and consultants, and to attract, retain and motivate qualified personnel, and general economic conditions, and the other important factors, including those discussed under the caption “Risk Factors” in Rhythm’s Quarterly Report on Form 10-Q for the three months ended June 30, 2026, and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Corporate Contacts:
David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
dconnolly@rhythmtx.com 

Kate Walsh
Director, Corporate Communications
Rhythm Pharmaceuticals, Inc.
(857) 264-4280
kwalsh@rhythmtx.com 

NORWALK, Conn., Sept. 22, 2026 (GLOBE NEWSWIRE) — FactSet, a leading global intelligence and AI solutions provider to the financial markets, today announced the acquisition of BCC Group International GmbH (bccg), a financial software development firm specializing in cloud-native and hybrid market data distribution platforms. The acquisition marks a milestone in the expansion of FactSet’s Real-Time Solution Suite, strengthening its market data management capabilities. Combined with its premium Real-Time Consolidated Data Feeds, it helps firms meet the demands of a rapidly evolving capital markets landscape.

For decades, market data infrastructure operated on the same premise: build or buy a platform, plug in data feeds, and let it operate. Trading is now moving toward 24-hour operations, AI is rewriting rules for workflows, and regulators are raising the bar on cross-vendor governance. Today, firms are building expensive workarounds for systems never designed to be open, modular, or cloud-ready. The hidden costs are becoming impossible to ignore: innovation timelines stretch, talent is redirected to maintenance, and compliance burdens continue to grow.

FactSet’s acquisition of bccg is a direct response to that challenge. Through the acquisition, FactSet brings bccg’s ONE Platform solution into its Real-Time Solution Suite, giving clients deployment flexibility without the overhead of monolithic systems. The acquisition strengthens FactSet’s real-time portfolio and represents a fundamental shift in how enterprise market data infrastructure can be designed and operated. Together, FactSet and bccg deliver:

• Open Ecosystem with Governed Access: The ability to combine exchange feeds, third-party content, and proprietary data in a single governed environment. Entitlements management, compliance reporting, and cost controls are now centralized rather than siloed.
• API-First Integration: Interoperable components designed to connect seamlessly to existing workflows. Built for the infrastructure clients have today and workflows they are building for tomorrow.
• Flexible Deployment: Choose cloud, on-premises, or hybrid models to match your existing infrastructure and evolving requirements. The ONE Platform modular architecture means clients can select and deploy the components they need.
• Managed Solution: Full-service operations with high availability, key performance indicators (KPIs), and market data management optimization.

FactSet and bccg have worked in collaboration together since 2021, solving real client problems and building technical alignment earned through delivery. The acquisition unites FactSet’s 25 years of real-time data investment with bccg’s modern distribution architecture. Clients gain a single, accountable partner for both content and infrastructure: one with a proven delivery record and the depth to support what comes next.

“Clients have told us they don’t just want another data vendor. They want a deeply invested open technology partner they already trust to manage their data. This acquisition is our response: FactSet’s content expertise, open architecture platform principles, and premier white-glove service, coupled with bccg’s modular, API driven, frictionless data management solution. Combined, our solutions are uniquely positioned to offer clients an alternative to the traditional monolithic offerings of yesterday.”– said Brian Herte, Global Head of Market Data & Trading at FactSet.

“We are excited to join forces with a truly global partner with the scale and ambition to drive a paradigm shift in financial market data. By combining bccg’s leading cloud-native market data distribution technology with FactSet’s comprehensive data and managed services, we can give financial institutions a genuinely source-neutral alternative to today’s lock-in. Openness and choice across the data ecosystem sit at the heart of that vision.” – said Mauricio Gonzalez Evans, CEO of BCC Group International GmbH.

This is not expected to have a material impact on FactSet’s financial results.

About FactSet

FactSet (NYSE:FDS | NASDAQ:FDS) supercharges financial intelligence, offering enterprise data and information solutions that help our clients maximize their potential. Our digital platform seamlessly integrates proprietary data, third-party sources, and flexible technology to deliver tailored solutions across the buy side, sell side, wealth, and corporate sectors. With over 47 years of expertise, we leverage advanced data connectivity, AI, and next-generation tools to streamline workflows and enable smarter decision-making. As an S&P 500 company serving more than 9,100 global clients and over 247,000 individual users, we are dedicated to innovation and long-term client success. Learn more at www.factset.com and follow us on X and LinkedIn.

About BCC Group International

BCC Group (bccgi.com) is a Germany-based financial technology provider specializing in cloud infrastructure and management solutions for real-time, historical, reference, and all other types of market data.

Founded over 20 years ago, the company delivers vendor-neutral platforms—such as its flagship ONE Platform—that enable banks, trading firms, and financial institutions to ingest, entitle, and distribute financial market data across hybrid, private, and public cloud environments (including AWS, Azure, and Google Cloud). By focusing on open integration, usage-based licensing controls, and cloud data governance, BCC Group helps financial organizations streamline data delivery, reduce data provider lock-in, and control market data infrastructure costs.

FactSet Investor Relations:
Kevin Toomey
+1.212.209.5259
Kevin.toomey@factset.com

FactSet Media Relations:
Alexandra Shevchenko
Oleksandra.shevchenko@factset.com

NEW YORK, Sept. 22, 2026 (GLOBE NEWSWIRE) — XFLH Capital Corporation, a publicly traded special purpose acquisition company (the “Company”), today announced the signing of a non-binding letter-of-intent (“Letter of Intent”) for a business combination with Renogen Biolab Inc., a Canadian corporation and a health service provider that offers and provides several core molecular capabilities including DNA services, vector engineering, and protein expression.

Pursuant to the Letter of Intent, the parties have agreed to use their reasonable best efforts to act in good faith to negotiate the definitive agreements embodying the Proposed Business Combination as soon as possible (“Definitive Agreements”), with the intent that the execution of such Definitive Agreements as soon as practicable hereafter. Both parties would also proceed with providing the other party and its representatives with reasonable access to information for the purpose of conducting a due diligence inquiry.

XFLH Capital Corporation

XFLH Capital Corporation is a blank check company formed under the laws of the Cayman Islands for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or similar business combination with one or more businesses.

Forward Looking Statements

This press release includes forward-looking statements that involve risks and uncertainties. Forward looking statements are statements that are not historical facts. Such forward-looking statements, including those with respect to the Company’s search for an initial business combination, are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements, including those set forth in the Risk Factors section of the Company’s registration statement and final prospectus for the Company’s initial public offering filed with the SEC. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based, except as required by law.

For further information, please contact:

Yanzhe Yang | Chief Executive Officer
Phone: (551) 358-2652
Email: yanzheyang@xflh.online