On 18 September 2026 AB Artea Bankas received permission from the European Central Bank (ECB) to buy back up to 13 000 000 of its own shares (ISIN LT0000102253). Shares to be acquired in the market in the one-year period starting from the date of the permission.
Additional information:
Arnas Šukys
Head of Investor Relations
arnas.sukys@artea.lt, +370 610 44447
Coop Pank AS (the Bank) announces that during the period 14.09.2026 – 20.09.2026, it has acquired the company’s own shares on the Nasdaq Tallinn Stock Exchange as follows:
| Date | Aggregated volume (pcs) | Weighted average price per day (EUR) |
| 14.09.2026 | 9,264 | 2.37000000 |
| 15.09.2026 | 9,264 | 2.35500000 |
| 16.09.2026 | 9,264 | 2.36500000 |
| 17.09.2026 | 946 | 2.35000000 |
| 18.09.2026 | 9,264 | 2.35000000 |
Bank is acquiring its own shares based on the resolution of the company’s general meeting of shareholders held on 8 April 2026, and under the conditions decided by the Supervisory Board and Management Board. Summary data of the acquisitions will be disclosed no later than on the seventh trading day after the transaction and will be made available to the Financial Supervision and Resolution Authority, via the Nasdaq Tallinn system, and on Coop Bank´s investor website.
Additional information:
Paavo Truu
CFO
Phone: 5160 231
E-mail: paavo.truu@cooppank.ee
Coop Pank, based on Estonian capital, is one of the five universal banks operating in Estonia. The bank has 239,100 clients who use everyday banking services. Coop Pank uses the synergy created between retail trade and banking and brings everyday banking solutions closer to people. The majority shareholder of the Bank is a domestic retail chain Coop Eesti, the sales network of which comprises over 330 stores.
On 2 January 2026, Schouw & Co. initiated a share buy-back programme as outlined in Company Announcement no. 59 of 18 December 2025. Under the programme, Schouw & Co. will acquire shares for up to DKK 240 million during the period 2 January to 31 December 2026. As outlined in Company Announcement no. 48 of 14 August 2026, the programme was extended with up to DKK 170 million, increasing the total amount of which Schouw & Co. will acquire shares to up to DKK 410 million.
The buy-back will be structured in accordance with Regulation (EU) No. 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (MAR) and the Commission’s delegated regulation (EU) 2016/1052 of 8 March 2016 (“Safe Harbour” rules).
| Trading day | No. of shares |
Average price |
Amount DKK |
||
| Accumulated until 11 September 2026 | 409,083 | 690.78 | 282,586,228 | ||
| Monday, 14 September 2026 | 4,000 | 795.43 | 3,181,720 | ||
| Tuesday, 15 September 2026 | 9,000 | 787.71 | 7,089,387 | ||
| Wednesday, 16 September 2026 | 5,458 | 794.63 | 4,337,091 | ||
| Thursday, 17 September 2026 | 6,000 | 807.58 | 4,845,496 | ||
| Friday, 18 September 2026 | 5,000 | 802.90 | 4,014,509 | ||
| In the period 14 September 2026 – 18 September 2026 | 29,458 | 796.67 | 23,468,204 | ||
| Accumulated until 18 September 2026 | 438,541 | 697.89 | 306,054,432 | ||
| Following the above transactions, Schouw & Co. holds a total of 2,736,334 treasury shares corresponding to 10.95% of the total share capital of 25,000,000 shares. | |||||
Aktieselskabet Schouw & Co.
Jørgen Dencker Wisborg, Chairman
Jens Bjerg Sørensen, President, telephone number +45 86 11 22 22
Attachments
– Amendments align trigger event of existing warrants with anticipated FDA approval of CGuard Prime 80 cm, which the Company continues to anticipate in Q4 2026 –
– The amended warrants, if exercised in full, together with existing cash balances, expected to provide additional resources to fund launch of CGuard Prime 80 cm following FDA approval –
– No additional warrants issued in connection with the amendments –
MIAMI, Sept. 21, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced that it has entered into amendments with certain of the existing holders of its outstanding Series J and Series K warrants originally issued as part of the Company’s May 2023 private placement financing. The amendments are intended to align the potential exercise of these warrants with the anticipated FDA approval of CGuard Prime 80 cm for transcarotid artery revascularization (“TCAR”) procedures, which the Company continues to anticipate to take place during the fourth quarter of 2026, potentially providing additional capital to support the Company’s commercial plans and ongoing pipeline initiatives.
The amendments apply to approximately 4.8 million shares underlying the Series J warrants and 9.5 million shares underlying the Series K warrants held by participating holders. Pursuant to the amendments, the Company agreed to amend the Series J Warrants with respect to 50% of the shares underlying the participating holders’ Series J Warrants and all of the shares underlying the participating holders’ Series K Warrants to modify (i) the exercise price to $0.7674 per share, representing the Nasdaq Official Closing Price of the Company’s common stock on September 18, 2026, and (ii) the termination date to 5:00 p.m. Eastern time on the earlier of (a) May 15, 2028 and (b) 20 trading days following the Company’s announcement of receipt of FDA approval for the CGuard Prime 80 cm.
The exercise price and termination date with respect to the other 50% of the shares underlying the participating holders’ Series J Warrants remained unchanged, including the original exercise price of $1.3827 per share and the termination trigger events which include the Company’s announcement of FDA approval of the SwitchGuard transcarotid system, which is currently in a Phase III clinical study. All terms and conditions of the Series J Warrants and Series K Warrants held by existing holders that did not elect to enter into the amendments remain unchanged. The amendments do not include the issuance of any additional warrants or any additional shares underlying the existing warrants.
“These amendments align a meaningful portion of our outstanding warrants with a significant near-term regulatory milestone with important commercial implications: the anticipated FDA approval of CGuard Prime 80 cm for TCAR expected later this year,” said Marvin Slosman, Chief Executive Officer of InspireMD. “The expected proceeds, combined with our existing cash resources, will enable us to launch the CGuard Prime 80 into the TCAR market and support other strategic priorities. We appreciate the continued confidence and financial support of many of our major equity holders, as we work to expand the CGuard Prime platform across both the carotid artery stenting (“CAS”) and TCAR markets.”
CGuard Prime 80 cm is designed for use in TCAR procedures, expanding the CGuard Prime platform beyond CAS to both major carotid stenting techniques. The Company estimates that over 35,000 TCAR procedures are performed annually in the United States, representing a doubling of the U.S. addressable market for CGuard Prime. In the CGUARDIANS II pivotal study, CGuard Prime 80 cm demonstrated 100% acute device success and zero major adverse events at 30 days in the first 36 patients evaluated.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.
Additional information regarding the warrant amendments will be included in a Current Report on Form 8-K to be filed by the Company with the Securities and Exchange Commission (“SEC”).
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™ mesh technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on the Company’s website. For more information, please visit www.inspiremd.com.
Forward-looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” “scheduled” or similar words. In particular, forward-looking statements in this press release include the Company’s expectations regarding potential FDA approval for CGuard Prime 80 cm; ; anticipated gross proceeds from the potential exercise of the Series J Warrants and Series K Warrants and expectations regarding the cash runway of the Company; the Company’s ability to compete effectively in the carotid stenting market and increase adoption of its products; expectations regarding market penetration, commercialization, revenue growth and future operating performance; the anticipated benefits of recent organizational and cost-saving initiatives, including expected annualized savings and improved operational efficiency; and the Company’s strategic priorities, growth plans and future business prospects. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with the voluntary U.S. recall of the CGuard Prime 135 cm delivery system, including current and future costs associated with the recall, including refunds or inventory write-off costs and other remediation costs, loss of sales and customers due to the recall or otherwise, our ability to effectively implement enhancements to CGuard Prime 135 cm delivery system, potential actions by regulators or other governmental entities associated with the recall, potential claims and lawsuits by customers and patients, including class action product liability lawsuits, other operational impacts and consequences of the recall, such as business disruption and distraction of management and other key employees; the Company’s history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of its liquidity to pursue its complete business objectives, and substantial doubt regarding its ability to continue as a going concern; the Company’s need to raise additional capital to meet its business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; the clinical development, commercialization and market acceptance of the Company’s products; whether the clinical trial results for the Company’s products will be predictive of real-world results; an inability to secure and maintain regulatory approvals for the sale of the Company’s products; negative clinical trial results or lengthy product delays in key markets; the Company’s ability to maintain compliance with the Nasdaq listing standards; the Company’s ability to generate significant revenues from its products; estimates of the Company’s expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the ongoing commercial launch of its products; the Company’s dependence on a single manufacturing facility and its ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from the Company’s current and planned clinical trials may not be sufficient to demonstrate that its technology is an attractive alternative to other procedures and products; intense competition in the Company’s industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than it does; entry of new competitors and products and potential technological obsolescence of the Company’s products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with the Company’s research and products and potential product liability claims; product malfunctions; price increases for supplies and components; whether access to the Company’s products is achieved in a commercially viable manner and whether its products receive adequate reimbursement by governmental and other third-party payers; the Company’s efforts to successfully obtain and maintain intellectual property protection covering its products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that the Company conducts business in multiple foreign jurisdictions, exposing it to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; security, political and economic instability in the Middle East that could harm the Company’s business, including due to the current security situation in Israel; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; and changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements and the impact of such policies on the Company, its customers and suppliers, and the global economic environment. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Investor Contacts:
Jeff Warren
LifeSci Advisors
jwarren@lifesciadvisors.com
investor-relations@inspiremd.com
FORESIGHT VENTURES VCT PLC
LEI: 213800R88MRC4Y3OIW86
Results of Annual General Meeting
21 September 2026
The Board of Foresight Ventures VCT plc is pleased to announce that at the Annual General Meeting of the Company held on 21 September 2026 all of the resolutions were duly passed on a show of hands.
Based on an Issued Share Capital of 105,707,817 Ordinary Shares at the voting record date, 3.01% of the shares in issue lodged valid proxies in relation to this meeting. The proxy voting was as follows:
| Resolution | Votes For | (%) | Votes at Discretion | (%) | Total Votes For | (%) | Votes Against | (%) | Votes Withheld* |
| 1 | 2,938,358 | 93.28 | 205,947 | 6.54 | 3,144,305 | 99.82 | 5,816 | 0.18 | 57,704 |
| 2 | 2,639,571 | 84.16 | 212,825 | 6.79 | 2,852,396 | 90.95 | 283,960 | 9.05 | 71,469 |
| 3 | 2,650,044 | 84.48 | 214,056 | 6.82 | 2,864,100 | 91.30 | 272,966 | 8.70 | 70,759 |
| 4 | 2,758,050 | 87.67 | 236,603 | 7.52 | 2,994,653 | 95.19 | 151,190 | 4.81 | 61,982 |
| 5 | 2,719,137 | 88.72 | 239,829 | 7.83 | 2,958,966 | 96.55 | 105,805 | 3.45 | 143,054 |
| 6 | 2,652,846 | 86.66 | 239,829 | 7.83 | 2,892,675 | 94.49 | 168,533 | 5.51 | 146,617 |
| 7 | 2,651,138 | 86.53 | 249,106 | 8.13 | 2,900,244 | 94.66 | 163,611 | 5.34 | 143,970 |
| 8 | 2,666,939 | 87.04 | 239,829 | 7.83 | 2,906,768 | 94.87 | 157,173 | 5.13 | 143,884 |
| 9 | 2,982,471 | 93.62 | 197,947 | 6.21 | 3,180,418 | 99.83 | 5,434 | 0.17 | 21,973 |
| 10 | 2,837,701 | 89.98 | 224,480 | 7.12 | 3,062,181 | 97.09 | 91,638 | 2.91 | 54,006 |
| 11 | 2,676,457 | 85.36 | 294,048 | 9.38 | 2,970,505 | 94.74 | 164,988 | 5.26 | 72,332 |
| 12 | 2,869,697 | 90.87 | 224,405 | 7.11 | 3,094,102 | 97.97 | 64,017 | 2.03 | 49,706 |
* A vote withheld is not a vote in law and is not counted in the calculation of the votes for or against a resolution.
A copy of the resolutions passed at the AGM will be submitted to the National Storage Mechanism at: https://data.fca.org.uk/#/nsm/nationalstoragemechanism in accordance with UK Listing Rules 6.4.2R and 6.4.3R.
For further information, please contact:
Company Secretary:
Foresight Group LLP
Contact: Stephen Thayer Tel: 0203 667 8100
Investor Relations:
Foresight Group LLP
Contact: Andrew James Tel: 0203 667 8181
Company plans to phase in AI-assisted health management and smart devices across its community network
YANTAI, China, Sept. 21, 2026 (GLOBE NEWSWIRE) — Decent Holding Inc. (NASDAQ: DXST) (“Decent” or the “Company”), a technology-driven provider of wastewater treatment and community-based senior health and elderly care services in China, today announced the next phase of development of its Suncare senior health and elderly care platform. As previously announced, management estimated that this platform comprised approximately 623 community service locations and approximately 200,000 paid members as of August 2026. These figures are management estimates that have not been independently verified and remain subject to reconciliation of location records, member rosters, payment records and usage data. The Company plans to introduce a standardized, tiered subscription service model across this community network and to phase in AI-assisted health management and smart devices.
Building on this network and membership base, the Company is now shifting its focus from primarily expanding network scale toward deepening service offerings, enhancing member engagement and creating recurring service opportunities.
The initial subscription model under development is focused on community-based services, AI-assisted health and wellness management, smart wearable devices, home monitoring sensors and home-based elderly care support. These elements are intended to be introduced gradually, subject to operational readiness, service-provider availability and applicable regulatory requirements.
Management believes this approach may enable Decent to transform its growing community network from a primarily service-access infrastructure into an integrated, technology-enabled service platform capable of supporting recurring member relationships across both community and home settings.
Planned Tiered Membership Structure
The Company is currently developing a multi-tier service architecture designed to address different levels of member needs. The Company’s role under the proposed structure is to coordinate services through Suncare’s existing community-service operations and its community locations and member relationships. Healthcare, elderly care and device-related services under the framework would be provided by qualified third-party healthcare, elderly care and device providers, as applicable, and not by the Company. The Company does not have, and does not intend to obtain, licenses to provide regulated medical diagnosis or treatment.
The initial framework under consideration includes:
Essential Health Management — approximately RMB 500 per month
Designed for members seeking ongoing preventive health and wellness management, this tier may include personal health profiles, authorized data collection through wearable and home monitoring devices, AI-assisted health information analysis, wellness reminders, abnormal-condition alerts, access to designated community services and family notifications.
Enhanced Home Health and Care Services — approximately RMB 1,990 per month
In addition to the Essential services, this tier is expected to provide more frequent health and wellness monitoring, home-based support services, enhanced family communication tools, personalized service coordination and access to participating healthcare and elderly care service providers.
Advanced Assisted Care — approximately RMB 2,990 per month
Designed for elderly members requiring higher-frequency daily support, this tier is expected to incorporate enhanced home monitoring, fall and abnormal-condition alerts, priority home-service coordination, intelligent robotic and assistive technologies where available, family and caregiver information interfaces, and coordination with qualified healthcare and elderly care service providers.
The subscription tiers described above are under development and have not been launched, therefore, remain subject to revision and change. The final scope, if introduced, may vary by market, community location, member requirements, service-provider availability and applicable regulatory requirements, and may differ materially from the framework described above. The Company expects to introduce the program gradually through selected community service locations before expanding it across a broader portion of its network, and can give no assurance whether or when it will do so.
From Network Expansion to Service Monetization
Decent believes that the combination of its physical community network and growing paid membership base creates an opportunity to develop a more scalable recurring-revenue model. Rather than relying solely on individual service transactions, the planned subscription architecture is intended to establish an ongoing service relationship connecting each member with Decent’s community operation centers, digital platform, home-based monitoring technologies and third-party service resources.
While the Company currently has no fixed commercial launch date at this time, it anticipates that its current implementation sequence is to begin with selected community service locations, evaluate operating performance and member feedback, and consider broader deployment only after service-provider readiness, technology integration and applicable regulatory requirements have been assessed. Over time, the Company intends for participating community service locations to function as local service and technology hubs capable of supporting members both within the community location and in their homes. This model is expected to include the gradual deployment of smart health-monitoring equipment at community service locations, while making selected wearable devices, home sensors and intelligent assistance solutions available directly to participating members.
The Company also intends to integrate AI-assisted service coordination into the platform, enabling authorized member information from different devices and service interactions to support more continuous health and elderly care management.
Building a Connected Community-to-Home Ecosystem
Decent’s longer-term objective is to establish an integrated service loop connecting community service locations, members, home monitoring devices and wearables, AI-assisted service coordination, robotics and home-based support, and families and qualified service providers.
Management believes this structure can increase member engagement, broaden the range of services delivered through each operational center and create additional opportunities for recurring service revenue. The model also provides a potential distribution and real-world application channel for intelligent healthcare devices, wearable technologies and household robotics.
Decent previously announced a strategic cooperation with Taihao Robotics to develop real-world training and validation infrastructure for healthcare robotics and physical AI applications. The planned membership service architecture may provide an additional pathway for progressively introducing robotics and intelligent devices into community and home-based elderly care environments if and when such technologies become available. The Company has generated no revenue from robotics activities and has not commenced commercial operations in this area.
Management Commentary
“Our first stage was about building the network and establishing meaningful community access. We believe that work has created an important foundation,” said Haicheng Xu, Chief Executive Officer of Decent Holding Inc.
“Our next stage is about increasing the value delivered through that network. We intend to connect community centers, individual members, families, intelligent devices, home monitoring and robotics through a standardized subscription-based service model. Instead of viewing each service as an isolated transaction, our goal is to build a long-term service relationship around each member.”
Mr. Xu continued, “We believe the future of elderly care will increasingly move from episodic services toward continuous, technology-enabled support delivered across both community and home environments. Decent’s growing network gives us an opportunity to build that infrastructure at meaningful scale.”
Next Steps
The Company plans to refine the service packages through phased implementation, member feedback and operating data before broader deployment. Decent will continue to evaluate additional partnerships in robotics, smart devices, digital health, home-based services and elderly care to expand the capabilities available through the Suncare platform. There can be no assurance that any of the initiatives described in this release will be implemented on the timeline described or at all.
The platform and the services described above are not intended to independently provide medical diagnosis or medical treatment. Any regulated medical services will be provided or coordinated through appropriately licensed healthcare professionals or service providers, as required by applicable laws and regulations.
About Decent Holding Inc.
Decent Holding Inc. (NASDAQ: DXST) specializes in the provision of wastewater treatment by cleansing industrial wastewater, ecological river restoration and river ecosystem management by enhancing water quality, as well as microbial products primarily used for pollutant removal and water quality enhancement, through the Company’s operating subsidiary, Shandong Dingxin Ecology Environmental Co., Ltd. In addition, through its operating subsidiary Suncare (Shanghai) Health Technology Co., Ltd., the Company operates an AI-powered, community-based senior health and elderly care platform serving China’s aging population. For more information, please visit: https://ir.dxshengtai.com.
Forward-Looking Statements
This press release contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “could,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “intends,” “views,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to complete the reconciliation of our reported operating metrics; our ability to keep pace with new technology and changing market needs; the competitive environment of our business; our ability to open and operate new community service locations on our anticipated timeline; our ability to attract and retain paid members; the development and deployment of AI-enabled technologies and related services; the regulatory environment applicable to healthcare and elderly care services in China; and the evolving PRC legal and regulatory framework governing data privacy, data security, and cross-border data transfers. For a more detailed discussion of these and other risks, you should review the risk factors and other disclosures contained in our filings with the U.S. Securities and Exchange Commission, including our most recent annual report on Form 20-F. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by applicable law.
Investor Relations Contact:
WFS Investor Relations Inc.
Connie Kang, Partner
Email: ckang@wealthfsllc.com
Tel: +86 1381 185 7742 (CN)
Results validate Avalyn’s approach of delivering established antifibrotic medicines directly to the lungs to maximize local exposure while limiting systemic exposure and improving tolerability
Findings support continued advancement of AP02 for idiopathic pulmonary fibrosis (IPF); enrollment is on track in AURA Phase 2 trial with topline data expected late 2027
BOSTON, Sept. 21, 2026 (GLOBE NEWSWIRE) — Avalyn Pharma Inc., (“Avalyn” or the “Company”), a clinical-stage biopharmaceutical company pioneering inhaled therapies to transform the treatment paradigm of serious, rare respiratory diseases, today announced that Respiratory Research has published detailed results from two Phase 1 clinical trials of AP02 (nebulized nintedanib) in healthy volunteers and patients with IPF. Topline data from the trials were previously presented at the American Thoracic Society (ATS) International Conference in May 2025.
“The publication of these Phase 1 data marks an important milestone for the AP02 program and reinforces the scientific rationale behind Avalyn’s inhaled approach to treating IPF,” said Melissa Rhodes, PhD, Chief Operative Officer of Avalyn Pharma. “Our goal has always been to address what many consider the central challenge of antifibrotic therapy: delivering more drug to the lungs, where it is needed, while reducing exposure throughout the rest of the body and improving tolerability. The data published today demonstrate substantially higher predicted lung exposure alongside significantly lower systemic exposure than oral nintedanib, supporting AP02’s potential to improve the therapeutic profile of this important medicine. We believe this lung-targeted approach may ultimately help patients derive greater benefits from treatment, with fewer side effects that can limit adherence to long-term therapy and impact quality of life.”
Dr. Rhodes continued, “We are encouraged by the continued progress of our AURA Phase 2 trial and the strong interest we have seen from investigators and patients across participating sites. We look forward to Phase 2 clinical data from AURA further evaluating AP02’s potential to deliver meaningful benefit for people living with IPF.”
Highlights from the Respiratory Research Publication
Data were generated in two randomized Phase 1 clinical studies. The first study evaluated AP02 in single ascending doses up to 2.0 mg in healthy volunteers (n=32) and patients with IPF (n=6) and included a healthy volunteer cohort receiving the approved 150mg oral dose of nintedanib (n=4). The second study evaluated AP02 in single (n=36) and multiple (n=24) ascending doses up to 8.0 mg twice daily for seven days in healthy volunteers. Safety, tolerability, and nintedanib plasma pharmacokinetics were evaluated, and AP02 and oral nintedanib bronchoalveolar lavage pharmacokinetics were assessed to evaluate lung exposure.
Published results show:
Together, these findings demonstrate AP02’s potential to achieve substantially higher lung exposure and markedly lower systemic exposure, supporting its potential to deliver both enhanced efficacy and reduced side effects compared to oral nintedanib.
Based on these data, Avalyn advanced AP02 into the AURA clinical trial. AURA is a Phase 2 randomized, double-blind, placebo-controlled trial evaluating two doses of AP02 administered twice daily in patients with IPF. The 12-week study is designed to enroll 160 patients to assess safety and efficacy; topline data are anticipated in late 2027.
The paper, titled, “Nebulized nintedanib (AP02) for idiopathic pulmonary fibrosis demonstrates favorable safety and lung lining fluid exposures: Results from two Phase 1 safety, tolerability, and pharmacokinetics studies,” was published in Respiratory Research on September 21, 2026, and can be found here.
About Avalyn Pharma
Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has indicated encouraging safety and clinical activity across Phase 1b and multi-year open-label extension trials, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.
Investor Contact:
Cassie Saitow, Avalyn Pharma Inc.
Sr. Director, IR and Corporate Communications
ir@avalynpharma.com
Media Contact:
Precision AQ
avalyn@precisionaq.com
A new Gartner market report takes shape as enterprises work to secure the new AI stack
MIAMI, Sept. 21, 2026 (GLOBE NEWSWIRE) — Varonis Systems, Inc. (Nasdaq: VRNS), the data and AI security leader, today announced it has been recognized as a Pace Setter in the Gartner® Emerging Market Quadrant for AI Application Security – Established Vendors as of September 2026. The report evaluates vendors on their potential to execute and potential for Market Disruption.
Gartner defines the AI application security market as technologies that protect enterprise-developed AI applications and agents by combining security testing, exposure management, and runtime defense to detect, alert on, or block threats. Delivered via SaaS or on-premises technologies, these tools enable cybersecurity and risk teams to manage posture, conduct adversarial testing, and enforce real-time protection of AI applications.
“The more data an AI system can reach, the more valuable and riskier it becomes,” said Rob Sobers, CMO at Varonis. “At Varonis, we’ve built the trust layer that helps organizations to securely connect any AI system to any data source.”
As companies deploy AI applications at scale, these systems are no longer limited to analyzing data: they read, write, modify, and act on it at machine speed. This shift introduces a new class of risk.
Without knowing which systems exist, what they’re doing, or what data they can reach, organizations can’t safely use AI at scale. By integrating AI application visibility and enforcement with the leading Data Security Platform, Varonis gives organizations a way to adopt AI while working to keep risk under control.
Gartner, Emerging Market Quadrant for AI Application Security — Established Vendors, By Meghan Hollis, Dionisio Zumerle, Dennis Xu, Marissa Schmidt 14 September 2026
Gartner Citation and Disclaimer
Gartner does not endorse any company, vendor, product or service depicted in its publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner publications consist of the opinions of Gartner’s business and technology insights organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this publication, including any warranties of merchantability or fitness for a particular purpose.
GARTNER is a trademark of Gartner, Inc. and/or its affiliates.
Additional Resources:
About Varonis
Varonis (Nasdaq: VRNS) secures AI and the data that powers it. The Varonis platform gives organizations automated visibility and control over their critical data wherever it lives and helps ensure safe and trustworthy AI from code to runtime. Backed by 24x7x365 managed detection and response, Varonis gives thousands of organizations worldwide the confidence to adopt AI, reduce data exposure, and stop AI-powered threats.
Investor Relations Contact:
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– First-in-Class approval supported by Phase 3 BROADWAY, BROOKLYN, and TANDEM trials demonstrating significant LDL-C reductions with favorable tolerability profile-
– First global regulatory approval of obicetrapib marks a defining milestone for NewAmsterdam and Menarini, expanding treatment options for patients with elevated LDL-C –
NAARDEN, The Netherlands and MIAMI and FLORENCE, Italy, Sept. 21, 2026 (GLOBE NEWSWIRE) — NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, along with partner Menarini Group (“Menarini”), today announced that the European Commission (EC) has granted marketing authorization for Ubeslo® (obicetrapib 10 mg monotherapy) and Evlarco® (10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination for patients with primary hypercholesterolaemia, both heterozygous familial (“HeFH”) and non-familial or mixed dyslipidaemia, marking the first regulatory approval of obicetrapib worldwide.
“The European Commission approval of Ubeslo and Evlarco marks a major milestone for NewAmsterdam as the first regulatory approval of obicetrapib globally, a novel oral therapy, and validates years of work focused on delivering a potential new treatment option for patients who continue to struggle to achieve recommended LDL-C levels despite previously available therapies,” said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam Pharma. “This first-in-class approval reflects the strength of the clinical evidence supporting obicetrapib, the dedication of our team and partners, and our commitment to addressing one of the largest unmet needs in cardiovascular medicine. Together with Menarini, we look forward to bringing Ubeslo and Evlarco to patients across Europe and building on this important milestone as we advance our vision of making obicetrapib available to patients around the world.”
The European Commission approval follows the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and is supported by data from NewAmsterdam’s comprehensive clinical development program evaluating obicetrapib, including the Phase 3 BROADWAY, BROOKLYN and TANDEM trials, which demonstrated statistically significant LDL-C reductions of up to 40% with obicetrapib monotherapy versus placebo and approximately 50% with obicetrapib combined with ezetimibe versus placebo, with a tolerability profile comparable to placebo. NewAmsterdam and Menarini continue to advance the clinical development of obicetrapib through multiple ongoing Phase 3 trials, including PREVAIL, a cardiovascular outcomes trial, as well as REMBRANDT and RUBENS.
“This approval represents an important advancement for patients across Europe who require additional LDL-C lowering despite available therapies,” said Elcin Barker Ergun, Chief Executive Officer of Menarini Group. “We are proud to reach this significant achievement alongside NewAmsterdam and look forward to leveraging our well-established commercial capabilities and deep cardiovascular expertise to bring Ubeslo and Evlarco to healthcare providers and eligible patients throughout Europe.”
Under the parties’ licensing agreement, Menarini holds exclusive commercialization rights for obicetrapib in Europe and is responsible for regulatory interactions and commercialization activities throughout the region. NewAmsterdam is entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the Menarini Territory and up to an additional €833 million upon the achievement of various clinical, regulatory and commercial milestones.
For full details on the approved indications, contraindications, warnings, and precautions please refer to the Summary of Product Characteristics (SmPC) which will be made available on the European Medicines Agency websites at:
https://www.ema.europa.eu/en/medicines/human/EPAR/ubeslo
https://www.ema.europa.eu/en/medicines/human/EPAR/evlarco
About Obicetrapib
Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. In each of the Company’s Phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, as well as the Company’s Phase 3 BROOKLYN, BROADWAY and TANDEM trials, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. The Company commenced the Phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of Major Adverse Cardiovascular Events (“MACE”). The Company completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients. Commercialization rights of obicetrapib in Europe, either as a monotherapy or as part of a fixed-dose combination with ezetimibe, have been exclusively granted to the Menarini Group, an Italy-based, leading international pharmaceutical and diagnostics company.
About Cardiovascular Disease
Cardiovascular disease remains the leading cause of death globally, despite the availability of lipid-lowering therapies (“LLTs”). By 2050 more than 184 million U.S. adults are expected to be affected by CVD and hypertension, including 27 million with coronary heart disease and 19 million with stroke. In the United States from 2019 through 2022, CVD age-adjusted mortality rates increased by 9%, reversing the trend observed since 2010 and undoing nearly a decade of progress. Despite the availability of high-intensity statins and non-statin LLTs, LDL-C target level attainment remains low, contributing to residual cardiovascular risk, and underscoring a significant clinical need for improved therapeutic regimens. Even with 269 million LLT prescriptions written over the last 12 months, 30 million under-treated US adults are not at their risk-based LDL-C goal, of which 13 million have ASCVD. Less than 1 in 4 patients with ASCVD achieve an LDL-C goal of less than 70 mg/dL and only 10% of very high risk ASCVD patients achieve the goal below 55 mg/dL. In addition to the 30 million under-treated U.S. adults, there are 10 million patients diagnosed with elevated LDL-C who are not taking any LLTs including statins. Beyond LDL-C, additional factors are at play, such as lifestyle choices, tobacco use, and obesity, as well as inflammation, thrombosis, triglyceride levels, elevated Lp(a) levels, and type 2 diabetes.
About NewAmsterdam
NewAmsterdam Pharma (Nasdaq: NAMS) is a late-stage biopharmaceutical company dedicated to build a new standard of care for people living with cardiometabolic disease. The Company is advancing therapies designed to address a significant unmet need for safe, well-tolerated, and convenient treatment options that lower LDL-C while advancing innovation beyond a single marker to better address cardiovascular risk. In multiple Phase 3 trials, NewAmsterdam is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, alone and as a fixed-dose combination with ezetimibe, in patients at risk of cardiovascular disease with elevated LDL-C. Guided by its mission, the Company challenges convention with courage, translates deep biological insight into meaningful patient impact, and delivers with rigor, precision, and purpose.
About Menarini Group
The Menarini Group, with headquarters in Florence, is present in 140 countries worldwide to date, with $5.5 billion in consolidated turnover and more than 17,000 employees. Menarini’s products are present in the most important treatment areas, including those of cardiometabolic, oncology, gastroenterology, diabetology, pneumology, and anti-inflammatory/analgesic products. Through its commitment to R&D and high-quality manufacturing activities, Menarini continuously contributes to patients’ health worldwide, maintaining the highest quality standards.
Forward-Looking Statements
This press release contains “forward-looking” statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and are subject to the “safe harbor” provisions created thereunder. All statements that are not historical facts are hereby identified as forwarding-looking statements for this purposes and include, among others, statements relating to: the therapeutic potential of obicetrapib; expected availability of Ubeslo and Evlarco across Europe; the Company’s licensing agreement with Menarini and entitlement to potential future payments thereunder; the continued advancement of clinical development of obicetrapib through multiple ongoing Phase 3 trials; and other statements regarding the Company’s future operations, prospects, objectives, strategies and other future events. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon management’s current expectations and assumptions. Actual results or events could differ materially and adversely from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various risks, uncertainties and other factors, including, among others: whether projections regarding clinical outcomes will reflect actual results in clinical use of Ubeslo and Evlarco; risks related to the Company’s ability to achieve its business plans, objectives and milestones, including those related to its licensing agreement with Menarini; challenges inherent to the clinical development and launch of new drug products; risks related to the Company’s reliance on third parties; and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, that are described in greater detail in the sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on February 18, 2026 and in its Quarterly Report on Form 10-Q filed with the SEC on August 5, 2026, as well as in other filings the Company may make with the SEC in the future, which are available at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date of this press release, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of new information, future events, changed circumstances or otherwise, except as otherwise required by law.
BROADWAY (NCT05142722)
BROOKLYN (NCT05425745)
OCEAN: NCT04770389
PREVAIL (NCT05202509)
REMBRANDT (NCT06305559)
ROSE: NCT04753606
ROSE2: NCT05266586
RUBENS (NCT07219602)
TANDEM (NCT06005597)
TULIP: NCT01970215
Company Contact
Matthew Philippe
P: 1-917-882-7512
matthew.philippe@newamsterdampharma.com
Media Contact
Real Chemistry on behalf of NewAmsterdam
Christian Edgington
P: 1-513-310-6410
cedgington@realchemistry.com
Investor Contact
Precision AQ on behalf of NewAmsterdam
Austin Murtagh
P: 1-212-698-8696
austin.murtagh@precisionaq.com
Menarini Group Media Contact
Valeria Speroni Cardi
pressoffice@menarini.com
LAS VEGAS, Sept. 21, 2026 (GLOBE NEWSWIRE) — Galaxy Gaming, Inc.® (OTC: GLXZ), the world’s leading independent developer and distributor of casino table games and technology, will showcase an exciting lineup of new products, progressive innovations, and iGaming content at Global Gaming Expo (G2E) 2026, booth #4452.
Hasbro’s Iconic Brands Take Over the Table Game Pit
Through its exclusive licensing agreement with Hasbro®, Galaxy Gaming continues to bring some of the world’s most recognizable brands to casino table games. MONOPOLY® and YAHTZEE® have been transformed into engaging pit experiences that combine familiar gameplay elements with innovative mechanics, linked progressives, and premium presentation.
Leading the portfolio is MONOPOLY Table Games Progressive, which has quickly become one of the industry’s most talked-about new products and was recently shortlisted for the Global Gaming Awards Americas 2026 Product Innovation of the Year category.
Building on the proven success of MONOPOLY Table Games Progressive, now installed across North America and EMEA, Galaxy Gaming will unveil its newest MONOPOLY-branded innovation at G2E: MONOPOLY Building Riches™. Designed for floor-wide excitement, MONOPOLY Building Riches links different table games together through a thrilling bonus round experience. Featuring the iconic MONOPOLY game board, a single-seed meter, and rapidly growing jackpots, the game turns every bonus round into a memorable player moment.
“Players want more ways to win, and MONOPOLY Building Riches delivers exactly that,” said Matt Reback, President and CEO of Galaxy Gaming. “The combination of the dynamic bonus round, the power of the MONOPOLY brand, and the flexibility to connect multiple table game types creates a compelling new experience for players and operators alike.”
Visitors to the Galaxy Gaming booth will also have the opportunity to experience 3-Dice YAHTZEE®. Easy to learn and highly entertaining, 3-Dice YAHTZEE continues to generate strong interest from operators seeking distinctive branded table game experiences.
“We’re just getting started with what we can bring to the casino floor through our partnership with Hasbro,” added Reback. “G2E attendees will get an early look at what’s next and see firsthand how these beloved brands are creating new excitement for table game players.”
Introducing Spotlight Spin Progressive and Galaxy Link
Galaxy Gaming will also debut Spotlight Spin Progressive™, a striking new progressive solution that can be linked with MONOPOLY Building Riches or deployed as a standalone experience. Inspired by the glamour of Hollywood’s golden age, Spotlight Spin features luxurious Art Deco styling, dazzling graphics, individual prize outcomes through a shared bonus game experience, and high-incrementing progressive jackpots designed to keep players engaged and the pit energized.
At the heart of MONOPOLY Building Riches and Spotlight Spin Progressive is Galaxy Link™, Galaxy Gaming’s newest innovation and the connective technology that makes these linked experiences possible. Every linked table draws from a single seed, so jackpots climb faster and hit bigger. That same single-seed design gives operators a real edge, too: bigger, faster-growing jackpots without the cost or complexity of funding separate seed pools for every table. Powered by GOS™ Sapphire, Galaxy Link connects progressives across games, tables, pits, and even properties, giving operators the ability to link MONOPOLY Building Riches with Spotlight Spin Progressive, and with future Galaxy Gaming progressives still to come.
Delivering Excitement with GOS Sapphire and World-Class Games
Behind all of Galaxy Gaming’s newest progressive products is the award-winning GOS Sapphire, the company’s next-generation table game operating system. GOS Sapphire powers some of the industry’s most exciting progressive experiences through advanced jackpot configurations, sleek sensor technology, and real-time digital tracking capabilities. Its flexible electronic bonusing platform supports Dynamic Progressive™, an exciting feature that can randomly award multipliers of up to 10x, creating additional anticipation and engagement on every eligible wager.
Operators continue to embrace GOS Sapphire’s flexibility, now extended through Galaxy Link, which creates larger prize opportunities and enhanced player excitement across the floor.
Beyond progressives, Galaxy Gaming maintains the industry’s most comprehensive table game portfolio, featuring proven performers such as 21+3®, Perfect Pairs®, EZ Baccarat®, Lucky Ladies®, and Heads Up Hold’em®, alongside newer innovations including Ride Free™ MONOPOLY® Edition and High Card Flush® Ultra.
Galaxy Gaming Digital Continues Global Expansion
Galaxy Gaming remains the leading licensor of proprietary table game content for both live dealer and RNG platforms worldwide. Popular titles including 21+3, Lucky Ladies, Perfect Pairs, EZ Baccarat, and Buster Blackjack® are available across more than 5,000 iGaming sites globally.
Over the past year alone, players have placed more than 4.5 billion wagers online across Galaxy Gaming content, demonstrating the continued global demand for the company’s portfolio.
“Galaxy Gaming Digital has achieved tremendous growth in recent years, expanding our footprint through new B2B and B2C partnerships and driving billions of wagers across our titles worldwide,” said Jason McCulloch, Vice President of iGaming. “As we look ahead, we remain committed to delivering innovative content that elevates the iGaming experience.”
Experience the Future of Table Games at G2E
From award-nominated branded progressives to next-generation operating systems and industry-leading digital content, Galaxy Gaming continues to redefine what’s possible on the casino floor.
Visit Galaxy Gaming at booth #4452 during G2E 2026 to experience MONOPOLY Building Riches™, Spotlight Spin Progressive™, Galaxy Link™, 3-Dice YAHTZEE®, GOS Sapphire™, and more.
Hasbro, MONOPOLY, and Yahtzee are trademarks of Hasbro Inc. group. All other trademarks are the property of their respective owners.
About Galaxy Gaming
Headquartered in Las Vegas, Nevada, Galaxy Gaming (galaxygaming.com) develops and distributes innovative games, bonusing systems, and technology solutions to physical and online casinos worldwide. Galaxy Gaming offers games proven to perform, developed by gaming experts and backed by the highest level of customer support. Galaxy Gaming Digital is the world’s leading licensor of proprietary table games to the online gaming industry. Galaxy Gaming has over 140 licenses worldwide, including licenses in 28 U.S. states and more than 30 countries around the world.
Contact:
Media:
Phylicia Middleton (702) 938-1753
Investors:
Steve Kopjo (702) 727-8886
