Passkey:YOU lets employees authenticate with a fingerprint or the door badge they already wear — no phone or hardware token required

HOLMDEL, N.J., Sept. 23, 2026 (GLOBE NEWSWIRE) — BIO-key® International, Inc. (NASDAQ: BKYI), a global provider of workforce and customer Identity and Access Management (IAM) software featuring passwordless, phoneless and tokenless Identity-Bound Biometrics™ (IBB) authentication, today announced that its Passkey:YOU™ authenticator has received Full Certification from the FIDO Alliance, the industry body behind the FIDO2/WebAuthn/Passkey standard now in widespread use to allow phish-resistant sign in without typing a password.

With Passkey:YOU, an employee authenticates to unlock a shared passkey service by touching a shared fingerprint scanner or tapping the door-access badge they already carry — no smartphone or separate hardware token needed. A single enrollment then works everywhere a passkey is accepted, including enterprise identity platforms such as Microsoft Entra ID, Okta, Ping, Duo, BIO-key’s own PortalGuard®, and a growing list of websites, with no separate integration project required for each one. Employees who do carry a phone can authenticate the same way through BIO-key’s MobileAuth app on iOS and Android. Passkey:YOU works at any workstation in the enterprise to provide easy, phish-resistant authentication without phones, or tokens.

Passkey:YOU’s design solves a specific problem: most authentication products assume every user carries a smartphone or can be issued and carry a physical token like a security key, which they use to authenticate. Passkey:YOU is built for the people and places where that assumption breaks down — secure facilities where phones aren’t allowed, air-gapped networks, shared workstations, manufacturing floors, call centers, retail counters, and healthcare settings. Because the Passkey:YOU authentication hardware lives at the workstation rather than in every employee’s pocket, one Passkey:YOU client can serve any number of roving or device-restricted workers.

Full Certification is the FIDO Alliance’s formal confirmation that Passkey:YOU meets the technical and security bar — Security Assurance Level L1, conforming to the FIDO2 CTAP v2.0 specification — to work as a standards-based authenticator with any of those destinations, rather than a proprietary system. It’s secured by BIO-key’s NIST-tested, scanner-interoperable fingerprint platform and its MobileAuth palm and face authentication.

In biometric mode, Passkey:YOU runs on BIO-key’s Identity-Bound Biometrics, meaning each employee’s own fingerprint, palm, or face becomes their credential — something they can’t share, forget, or lose the way they could a password or a token. Biometric data is encrypted to military-grade, quantum-resistant levels, and the platform supports NIST 800-63 and CMMC authentication requirements along with more than 30 interchangeable fingerprint scanners, so organizations aren’t locked into a single hardware vendor. One enrollment carries across devices and locations, and enrollment workflows and user-controlled privacy dashboards are built to comply with GDPR and other privacy laws.

Passkey:YOU Means Better Governance and Control for Enterprises
A traditional hardware security key is, by design, invisible to the organization that issued it: once provisioned to a user, IT typically can’t see which sites or systems it has been registered with, can’t approve new ones, and can’t revoke access to a single third-party account without physically collecting the key back. That’s a reasonable tradeoff for an individual consumer. For a regulated or enterprise workforce, it’s a blind spot.

Because Passkey:YOU is centrally managed, security and compliance teams get the opposite: visibility into which systems employees have authenticated to, the ability to approve new destinations, and the ability to cut off access to any one system instantly — without waiting for someone to physically return a device. It still presents a standard, certified interface to Entra ID, Okta, Ping, Duo, and every other passkey-enabled destination; what changes is what the organization can see and control behind it.

Agentic AI Must Be Controlled by Real People, Not Inanimate Tokens
As AI agents take on the ability to act across applications, data, and payments on a company’s behalf, someone has to be accountable for approving what they do — and that accountability breaks down if approval rests on a credential that isn’t tied to a specific person, such as a password left in a browser session or a hardware key left plugged into a shared machine.

Passkey:YOU ties that approval to a person’s unique physical features instead: a fingerprint on a shared scanner, or a face or palm scan through MobileAuth, is evidence that a specific, named individual — not an unattended device or delegated user  — authorized the action. That decision is then carried to the relevant AI authorization controls using the standardized FIDO-certified, phishing-resistant cryptography behind Passkey:YOU.

Game-Changing Economics
Hardware tokens typically cost $25–$70 each, organizations often issue two or more per employee, and roughly a quarter are lost or replaced each year. Passkey:YOU instead puts the authentication hardware at shared access points rather than in every employee’s pocket, lowering the total cost of a deployment while still meeting the strong-authentication standards cyber insurers increasingly require — now backed by FIDO’s Full Certification.

“FIDO gave the world a trustworthy, interoperable way to kill the password. Full Certification means Passkey:YOU now speaks that language as a certified FIDO authenticator,” said Jim Sullivan, Chief Legal Officer of BIO-key. “A roving user can tap the badge they already carry or touch a shared fingerprint scanner and authenticate to Entra ID, Okta, Ping, Duo, or any website that accepts FIDO passkeys. Mobile users can do the same from MobileAuth on iOS and Android. Security teams can see, approve, and revoke the relying parties behind those passkeys—something they can’t do with an unmoderated hardware security key in the hands of a user.”

“Agentic AI will force a simple question: who approved that action?” Sullivan added. “A security key left in the machine is not an answer. BIO-key Passkey:YOU proves which person was actually present to approve the action.”

Learn more about Passkey:YOU, MobileAuth, and Identity-Bound Biometrics at www.bio-key.com.

About the FIDO Alliance (www.fidoalliance.org)
The FIDO Alliance enables identity technologies that put trust and simplicity at the center of interactions among people, services, and devices. The Alliance publishes open technical specifications, certifies secure and interoperable products, and operates global market enablement programs that have made passkeys the leading standard for phishing-resistant, passwordless authentication. FIDO Certified and the FIDO Certified logo are trademarks of the FIDO Alliance.

About BIO-key International, Inc. (www.BIO-key.com)
BIO-key is revolutionizing authentication and cybersecurity with biometric-centric, multi-factor identity and access management (IAM) software securing access for over forty million users. BIO-key allows customers to choose the right authentication factors for diverse use cases, including phoneless, tokenless, and passwordless biometric options. Its cloud-hosted or on-premise PortalGuard IAM solution provides cost-effective, easy-to-deploy, convenient, and secure access to computers, information, applications, and high-value transactions.

Forward-Looking Statements
All statements contained in this press release other than statements of historical facts are forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Words such as “estimate,” “project,” “intends,” “expects,” “anticipates,” “believes” and similar expressions identify forward-looking statements. Such statements are based on management’s beliefs and assumptions and information currently available to management. They are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially, including those described under “Risk Factors” in BIO-key’s filings with the Securities and Exchange Commission. Readers should not place undue reliance on these statements, which speak only as of the date made. Except as required by law, BIO-key undertakes no obligation to update forward-looking statements.

Engage with BIO-key

Facebook – Corporate: https://www.facebook.com/BIOkeyInternational/
LinkedIn – Corporate: https://www.linkedin.com/company/bio-key-international
X – Corporate: @BIOkeyIntl
X – Investors: @BIO_keyIR
StockTwits: BIO_keyIR


Media and Investor Contacts
William Jones, David Collins
Catalyst IR
BKYI@catalyst-ir.com or 212-924-9800 x3

The covered applications address potential therapeutic uses across a range of indications, including mental health disorders, such as depression and PTSD as well as substance use disorders

Vancouver, Canada, Sept. 23, 2026 (GLOBE NEWSWIRE) — Clearmind Medicine Inc. (Nasdaq: CMND) (the “Company”), a clinical-stage biopharmaceutical company advancing non-hallucinogenic psychedelic-derived neuroplastogen for scalable treatment  of neuropsychiatric, metabolic, and addiction disorders including Alcohol Use Disorder (“AUD”), today announced the publication in the United States of three patent applications covering novel proprietary combinations of lysergic acid diethylamide (“LSD”), ketamine and ibogaine with N-acylethanolamines, such as palmitoylethanolamide (“PEA”). The covered applications address potential therapeutic uses across a range of indications, including mental health disorders, such as depression, post-traumatic stress disorder (“PTSD”), pain and substance use disorders.

The publications expand the intellectual property generated through Clearmind’s ongoing collaboration with NeuroThera Labs Inc. (TSXV: NTLX), under which NeuroThera’s PEA technology is integrated into Clearmind’s psychedelic-derived therapeutic programs. The collaboration has resulted in a growing portfolio of patent applications covering combinations of PEA with psychedelic and psychoactive compounds. Clearmind previously announced U.S. publication of a patent application covering the combination of MDMA and N-acylethanolamines for potential treatment of PTSD, anxiety and eating disorders.

“The publication of these patents come at a significant time as clinical and regulatory interest in LSD, ketamine and ibogaine continues to receive growing recognition and support for their therapeutic potential. Clearmind believes its combination approach may offer the potential for an effective and safer treatment paradigm, aiming to achieve therapeutic benefits at lower doses while preserving efficacy. By reducing the dose required to achieve the intended pharmacological effect, this approach may support improved tolerability while maintaining therapeutic potential.,” said Adi Zuloff‑Shani, Ph.D., Chief Executive Officer of Clearmind.

About Clearmind Medicine Inc.

Clearmind is a clinical-stage neuroplastogens pharmaceutical biotech company focused on the discovery and development of non-hallucinogenic, second generation, neuroplastogen-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods, or supplements.

The Company’s intellectual portfolio currently consists of nineteen patent families, including 32 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on Nasdaq under the symbol “CMND.”

For further information, visit: https://www.clearmindmedicine.com or contact:

Investor Relations
invest@clearmindmedicine.com
www.Clearmindmedicine.com

Forward-Looking Statements:

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, the Company is using forward-looking statements when it discusses the potential therapeutic applications of the combinations covered by the published patent applications; the potential benefits, advantages and characteristics of such combinations, including the possibility of achieving therapeutic benefits at lower doses and supporting tolerability; the Company’s intellectual property strategy and patent portfolio; the expected benefits of its collaboration with NeuroThera Labs Inc.; and the development, advancement and commercial potential of the Company’s product candidates and technologies. The Company cannot assure that any patent will issue as a result of a pending patent application or, if issued, whether it will issue in a form that will be advantageous to the Company. Forward-looking statements are not historical facts, and are based upon management’s current expectations, beliefs and projections, many of which, by their nature, are inherently uncertain. Such expectations, beliefs and projections are expressed in good faith. However, there can be no assurance that management’s expectations, beliefs and projections will be achieved, and actual results may differ materially from what is expressed in or indicated by the forward-looking statements. Forward-looking statements are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in the forward-looking statements. For a more detailed description of the risks and uncertainties affecting the Company, reference is made to the Company’s reports filed from time to time with the Securities and Exchange Commission (“SEC”), including, but not limited to, the risks detailed in the Company’s annual report on Form 20-F for the fiscal year ended October 31, 2025 and subsequent filings with the SEC. Forward-looking statements speak only as of the date the statements are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events or circumstances, changes in assumptions or changes in other factors affecting forward-looking information except to the extent required by applicable securities laws. If the Company does update one or more forward-looking statements, no inference should be drawn that the Company will make additional updates with respect thereto or with respect to other forward-looking statements. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release. Clearmind is not responsible for the contents of third-party websites.


TORONTO and PERTH, Western Australia, Sept. 23, 2026 (GLOBE NEWSWIRE) — Cygnus Metals Limited (ASX:CY5, TSXV:CYG, OTCQB:CYGGF) (“Cygnus” or the “Company”) provides the following update in relation to the proposed transaction under which Central Asia Metals PLC (AIM:CAML) (“CAML”) will acquire 100% of the shares in Cygnus pursuant to a scheme of arrangement under Part 5.1 of the Corporations Act 2001 (Cth) (“Scheme”).

Capitalised terms in this announcement that are not otherwise defined have the meanings given to them in the Scheme Booklet dated 13 August 2026 (“Scheme Booklet”).

Adjournment of Second Court Hearing

Cygnus announces that the Supreme Court of Western Australia (“Court”) has made orders today to adjourn the date of the Second Court Hearing in respect of the Scheme.

The Second Court Hearing has been adjourned from 2:15pm (AWST) on Wednesday, 23 September 2026 and is now scheduled to take place at 2:15pm (AWST) on Wednesday, 14 October 2026. The Second Court Hearing will be held at the David Malcolm Justice Centre, 28 Barrack Street, Perth, Western Australia.

Why has the Second Court Hearing been adjourned?

As at the date of this announcement, the Kazakhstan regulatory approval condition precedent remains outstanding. To allow additional time for the satisfaction (or waiver) of this condition precedent, Cygnus has requested, and received, orders from the Court to adjourn the Second Court Hearing to Wednesday, 14 October 2026.

CAML remains confident that it will receive the required approval and has advised Cygnus that it expects that the approval will be granted on or before 12 October 2026.1

Should the Kazakhstan regulatory approval be received earlier than the date outlined in today’s announcement, Cygnus will announce that to the ASX and ascertain the potential to bring the Second Court Hearing forward.

Updated Indicative Timetable

As a consequence of the Court orders adjourning the Second Court Hearing, the indicative timetable will result in an Effective Date of Thursday 15 October 2026 (being the date that Cygnus Shares are suspended from trading on ASX and TSXV at close of trading), the latest date and time by which the Sale Election Forms and CREST Election Forms must be received or to withdraw a previous election made is extended to 5.00pm (AWST) / 5.00am (EDT), Thursday, 15 October 2026, the Scheme Record Date is 5.00pm (AWST), Monday, 19 October 2026 with the Implementation Date moved to Tuesday, 27 October 2026.2

Appearing at the Second Court Hearing

Cygnus will formally provide details to Cygnus Shareholders by no later than 9 October 2026 of the new date for the Second Court Hearing, the process for appearing at the hearing and opposing the approval of the proposed Scheme, and the name and address for service on Cygnus.

This announcement is authorised for release by the Board of Cygnus Metals Limited.

David Southam Nicholas Kwong Media:
Executive Chair President & CEO Paul Armstrong
T: +61 8 6118 1627 T: +1 418 748 5076 Read Corporate
E: info@cygnusmetals.com E: info@cygnusmetals.com T: +61 8 9388 1474


CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain statements contained in this announcement may constitute “forward-looking information” within the meaning of applicable securities laws. Examples of forward-looking statements in this announcement include, among others, statements regarding the completion of the Scheme and the remaining related steps therefor, including timing thereof. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results or timing to differ materially from those anticipated or implied by such forward-looking information. Information about the risks and assumptions affecting the forward-looking information herein can be found in the “Risk Factors” section in the Scheme Booklet dated 13 August 2026, a copy of which is available under Cygnus’ profile on SEDAR+ at www.sedarplus.ca. All of the forward-looking information in this announcement is qualified by these cautionary statements. Cygnus assumes no obligation to publicly update or revise such information, except as may be required by applicable law and the rules of the ASX and the TSX Venture Exchange.

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

___________________________
1
For further information, Cygnus Shareholders should refer to Cygnus’ ASX announcement dated 21 September 2026 titled “Further update on Scheme of Arrangement” which provides an update on the status of the conditions precedent to the Scheme, including the Kazakhstan regulatory approval condition precedent which has not yet been satisfied.

2 Please note that all of the above times and dates are indicative only. The actual timetable will depend on many factors outside the control of Cygnus and CAML, including the Court approval process and the satisfaction or waiver of the conditions precedent to the completion of the Scheme. Due to the time zone differences between Canada and Australia, certain actions relating to the implementation of the Scheme may occur on Monday, 26 October 2026 during Canadian business hours so as to enable implementation to occur on Tuesday, 27 October 2026 during Australian business hours. Any changes to the above timetable will be announced to ASX and will be available under Cygnus’ profile at www.asx.com.au

HONG KONG, Sept. 23, 2026 (GLOBE NEWSWIRE) — 3 E Network Technology Group Limited (Nasdaq: MASK) (the “Company” or “3 E Network”), a business-to-business (“B2B”) information technology (“IT”) business solutions provider, committed to becoming a next-generation artificial intelligence (“AI”) infrastructure solutions provider, today announced that its Nordic strategic subsidiary and Finnish project entity, Aurora Core Technology Oy, has entered the substantive implementation and execution phase of the project. Building on the Company’s recently established multi-megawatt green energy architecture, this transition advances the data center project from feasibility planning into localized construction preparation and procurement.

Strategic Subsidiary Assumes Execution Mandate for Localized Implementation

Operating as a wholly-owned strategic subsidiary, Aurora Core Technology Oy has formally assumed the localized deployment mandate for the newly established high-capacity green energy architecture. By assigning the Nordic subsidiary responsibility for local implementation, 3 E Network establishes a clear framework for compliance management and capital allocation, creating a foundation for potential regional expansion. The entity is currently managing progress across six operational pillars:

  • Issuing Formal RFPs for Core Supply Chain: Building on preliminary vendor evaluations and the finalized liquid-cooling parameters, Aurora Core Technology Oy has issued formal Requests for Proposals (“RFPs”) for critical hardware designed to support next-generation high-density computing platforms, including the NVIDIA Vera Rubin architecture. Initial procurement focuses on high-capacity Liquid-to-Liquid Cooling Distribution Units, high-efficiency modular Uninterruptible Power Supply systems, and high-ampacity intelligent busways, aimed at securing essential production capacity.
  • Advancing Grid Interconnection Contracts: Acting on behalf of 3 E Network, the Aurora execution team is advancing from initial power capability studies to negotiations toward binding interconnection and capacity allocation with a regional utility provider. Negotiations currently focus on integrating multi-megawatt grid connections, engineering schedules for concurrently maintainable dual-redundant power feeds, and evaluating local power distribution and step-down efficiencies.
  • Progressing EIA Filings: The entity is working alongside regional regulators and environmental consultants to translate baseline studies into formal Environmental Impact Assessment (“EIA”) filings. Key evaluation metrics include liquid-cooling water recycling rates, acoustic management for cooling towers, and lifecycle carbon footprints, aiming to support the facility’s alignment with the Scope 3 emissions standards required by enterprise clients.
  • Structuring Municipal Waste Heat Monetization: Supported by earlier feasibility reviews, the representatives of the subsidiary have commenced commercial discussions with municipal heating providers. The program aims to capture high-grade waste heat from the AI data center’s liquid-cooling loops and route it into the local district heating grid. This structure is intended to reduce the facility’s carbon footprint while evaluating potential revenue-sharing mechanisms.
  • Formalizing Local Engineering and Construction Partnerships: To implement the infrastructure plan, the Company is coordinating with Nordic architectural firms, structural engineers, and Mechanical, Electrical, and Plumbing contractors. Priorities include defining load-bearing structural specifications for fully populated AI racks and establishing construction schedules suited to Finland’s winter climate.
  • Integrating EU Data Sovereignty and Security Standards: The entity is developing its infrastructure and compliance framework to align with the EU’s General Data Protection Regulation, the EUAI Act, and EN 50600 data center standards. Planning has begun for the procurement and installation of biometric mantraps and physical perimeter security topologies.

Deploying Capital for Front-End Engineering and Compliance

Aurora Core Technology Oy’s implementation activities are supported by the Company’s recent capital allocation. 3 E Network confirms that net proceeds from the $1.0 million private placement, subscribed by a CEO-affiliated entity, are funding critical Front-End Engineering Design activities through the local subsidiary. For site preparation, capital is allocated toward comprehensive geotechnical site surveys to verify the ground-bearing capacity required for high-density racks. Concurrently, the funding supports climate modeling teams analyzing a decade of local microclimate meteorological data against the thermodynamic requirements of the liquid-cooling systems, to establish free-cooling operating parameters designed to optimize Power Usage Effectiveness.

Regarding regulatory and permitting processes, this capital funds the preparation of EIA technical documentation, addressing requirements such as acoustic emission modeling and water recycling verification. Furthermore, the Finnish operational group has retained electrical engineering experts to conduct power flow analysis and short-circuit studies in coordination with the utility provider. The Company has systematically established the technical, environmental, and operational expenditure frameworks required for the project prior to full-scale construction.

Management Commentary

“With our infrastructure blueprint for next-generation AI computing now established, Aurora Core Technology Oy is taking responsibility for local project implementation as we move into the next phase of our European deployment,” stated Dr. Tingjun Yang, Chief Executive Officer of 3 E Network. “For cross-border data center projects, using a local subsidiary to manage procurement and contract negotiations directly is a standard and necessary procedure to maintain project timelines. Supported by our recent funding, our Finnish team is actively translating specific engineering parameters into supply chain orders and grid interconnection agreements. We intend to maintain this execution pace as we advance the commercialization of our operations in Europe.”

About 3 E Network Technology Group Limited
3 E Network Technology Group Limited is a business-to-business (“B2B”) information technology (“IT”) business solutions provider committed to becoming a next-generation artificial intelligence (“AI”) infrastructure solutions provider. It upholds the industry consensus of “AI and energy symbiosis” and has a strong vision in the field of energy investment. The Company’s business comprises two main portfolios: the data center operation services portfolio and the software development portfolio. For more information, please visit the Company’s website at https://3emask.com/.

Forward-Looking Statements
Certain statements in this announcement are forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on the Company’s current expectations and projections about future events that the Company believes may affect its financial condition, results of operations, business strategy, and financial needs. Investors can identify these forward-looking statements by words or phrases such as “approximates,” “assesses,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “will,” “would,” “should,” “could,” “may” or similar expressions. The Company undertakes no obligation to update or revise publicly any forward-looking statements to reflect subsequent events or circumstances, or changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that such expectations will turn out to be correct, and the Company cautions investors that actual results may differ materially from the anticipated results and encourages investors to review other factors that may affect the Company’s future results in the Company’s registration statement and other filings with the U.S. Securities and Exchange Commission.

For more information, please contact:

3 E Network Technology Group Limited
Investor Relations Department
Email: ird@3emask.com
Website: https://3emask.com/

– In the first peer-reviewed, real-world, contemporary, comparative effectiveness study of TTR stabilizers in ATTR-CM using U.S. claims data, acoramidis was associated with a statistically and clinically significant 34% reduction in a composite of clinical worsening events (diuretic intensification, heart failure hospitalization, and mortality) versus tafamidis (p=0.046), supporting improved clinical stability of acoramidis over tafamidis

– Acoramidis was also associated with a significant 43% reduction in risk of diuretic intensification versus tafamidis (p=0.021); diuretic intensification is an early marker of worsening heart failure and worse clinical outcomes

– Separation in clinical outcomes emerged within weeks of treatment initiation and increased over time, reinforcing a consistent early treatment effect and durable clinical stabilization

– Findings underscore acoramidis’s differentiated profile, with potential to inform frontline treatment decisions and support switching individuals to acoramidis

– An additional, independent real-world study evaluating the effectiveness of acoramidis versus tafamidis using electronic health records data is expected to be released at an upcoming 2026 medical meeting

PALO ALTO, Calif., Sept. 23, 2026 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a commercial-stage, multi-product biopharmaceutical company focused on developing medicines for genetic conditions, today announced results published in Cardiology and Therapy from the first peer-reviewed, contemporary real-world comparative effectiveness retrospective study of transthyretin (TTR) stabilizers in individuals with transthyretin amyloid cardiomyopathy (ATTR-CM), demonstrating that acoramidis was associated with significantly lower risk of early clinical worsening compared to tafamidis. This represents the first peer-reviewed, real-world evidence differentiating clinical outcomes between approved TTR stabilizers, reinforcing acoramidis’s differentiated clinical profile in present-day practice.

“These findings further position acoramidis as a differentiated TTR stabilizer in contemporary clinical practice,” said Richard Wright, M.D., M.A.C.C. of the Pacific Heart Institute, U.S. “The significant reduction in diuretic intensification, an early indicator of worsening heart failure, points to improved disease control and clinical stability. The progressive nature of ATTR-CM is evident in all Phase 3 trials and is seen again here. This demonstrates the need for clinicians to proactively mitigate disease progression, and these data have the potential to meaningfully inform treatment selection in newly diagnosed patients and in patients currently on other treatments.”

In this analysis of newly treated individuals living with ATTR-CM, acoramidis showed early, consistent, and clinically meaningful advantages compared to tafamidis across key measures of disease progression during a mean follow-up of 4.6 months.

The key findings from the study comparing acoramidis benefit versus tafamidis in individuals with ATTR-CM:

  • 34% statistically and clinically significant reduction in risk of composite clinical worsening (HR 0.66; p=0.046), including diuretic intensification, heart failure hospitalization, and all-cause mortality
  • 43% reduction in risk of diuretic intensification (HR 0.57; p=0.021), an established early marker of worsening heart failure and predictor of hospitalization and mortality; diuretic intensification was rigorously defined as initiation or dose-equivalent escalation of oral loop diuretics, parenteral loop diuretics use, or addition of a thiazide-type diuretic
  • 48% reduction in initiation or dose-equivalent escalation of oral loop diuretics (HR=0.52; p=0.014)
  • Rapid benefit, with separation of Kaplan-Meier curves observed within weeks of treatment initiation and increasing over time
  • Fewer individuals with acoramidis initiated alternative ATTR-CM therapy as compared to those treated with tafamidis (4.6% vs 7.7%, respectively), consistent with findings of improved clinical stability with acoramidis
  • Background heart failure therapies in this study were well balanced across arms and reflect contemporary practice: 43-44% SGLT2i, 36-39% MRA
  • Multiple falsification analyses testing for residual bias were nonsignificant

The study leveraged a retrospective, longitudinal, new-user, active-comparator design using U.S. claims data and incorporated a unique dataset linking Komodo Healthcare Map U.S. claims with Claritas hub and specialty pharmacy data. After weighting, the analysis included 170 individuals with acoramidis and 448 individuals with tafamidis newly initiating treatment between Dec 2024-April 2025 and followed through July 2025, with a mean follow-up of approximately 4.6 months.

Acoramidis is approved as Attruby® by the U.S. FDA and is approved as BEYONTTRA® by the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency, Swissmedic, the Swiss Agency for Therapeutic Products, the UK Medicines and Healthcare Products Regulatory Agency, and the Brazilian Health Regulatory Agency (ANVISA) with all labels specifying near-complete stabilization of TTR.

Additional data on the real-world benefit of acoramidis versus tafamidis in individuals living with ATTR-CM is planned for fall medical meetings and scientific publications, including an independent real-world study evaluating the effectiveness of acoramidis versus tafamidis using electronic health records data, expected to be released at an upcoming 2026 medical meeting.

As with all real-world evidence studies, these findings should be interpreted in the context of inherent limitations of administrative claims data, including limited capture of cardiac biomarkers and other clinical measures of disease severity. Follow-up was limited given the recent approval of acoramidis, and longer-term data are needed to further add to these findings.

About Attruby® (acoramidis)

INDICATION
Attruby is a transthyretin stabilizer indicated for the treatment of the cardiomyopathy of wild-type or variant transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular death and cardiovascular-related hospitalization.

IMPORTANT SAFETY INFORMATION

Adverse Reactions
Diarrhea (11.6% vs 7.6%) and upper abdominal pain (5.5% vs 1.4%) were reported in patients treated with Attruby versus placebo, respectively. The majority of these adverse reactions were mild and resolved without drug discontinuation. Discontinuation rates due to adverse events were similar between patients treated with Attruby versus placebo (9.3% and 8.5%, respectively).

About BridgeBio
BridgeBio exists to develop transformative medicines for genetic conditions. Millions of people worldwide living with genetic conditions lack treatment options, often because drug development for small patient populations can be commercially challenging. We aim to bridge the gap between advancements in genetic science and meaningful medicines for underserved patient populations. Our decentralized, hub-and-spoke model is designed for speed, precision, and scalability. Autonomous and empowered teams focus on individual conditions, while a central hub provides the clinical, regulatory, and commercial capabilities needed to bring innovation to market. For more information, visit bridgebio.com and follow us on LinkedIn, X, Facebook, Instagram, YouTube, and TikTok.

BridgeBio Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (the Exchange Act), which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “projects,” “remains,” “seeks,” “should,” “will,” and variations of such words or similar expressions. BridgeBio intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking statements include statements regarding the potential clinical significance and therapeutic implications of the real-world data regarding acoramidis, including the potential for the findings to inform frontline treatment decisions and treatment selection for newly diagnosed patients and patients currently receiving other treatments, and to support switching individuals to acoramidis; and BridgeBio’s plans and expectations regarding the presentation and publication of additional real-world data regarding acoramidis, including an independent real-world study evaluating the effectiveness of acoramidis versus tafamidis using electronic health records data expected to be released at an upcoming 2026 medical meeting. Although the Company believes that its plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, the Company can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, the risk that results from retrospective, observational, real-world evidence studies, including studies based on administrative claims data, may be subject to confounding, selection bias, residual bias, incomplete or inaccurate data, limited follow-up or other limitations and may not be predictive of future clinical outcomes or treatment effects; that the observed associations and differences between acoramidis and tafamidis may not be replicated in additional analyses, independent studies or longer-term data or may not translate into improved long-term clinical outcomes; that the findings may not meaningfully inform treatment selection or support switching patients to acoramidis; that additional real-world studies, including the independent study evaluating the effectiveness of acoramidis versus tafamidis using electronic health records data, may yield results that differ from or do not confirm the findings described in this press release; that plans or timing for future medical meeting presentations or scientific publications may change; the impacts of current macroeconomic and geopolitical events, including changing conditions from hostilities in Ukraine and in Israel and the Middle East, increasing rates of inflation and changing interest rates, on business operations and expectations, as well as those risks set forth in the Risk Factors section of the Company’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K and the Company’s other filings with the U.S. Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of the Company’s management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, BridgeBio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

BridgeBio Media Contact:
Kaitlyn Reilly, Director, Communications
contact@bridgebio.com  
(650) 789-8220

BridgeBio Investor Contact:
Kristen Kelleher, Director, Investor Relations
ir@bridgebio.com

TORONTO, Sept. 23, 2026 (GLOBE NEWSWIRE) — DPM Metals Inc. (TSX: DPM, ASX: DPM) (ARBN: 689370894) (“DPM” or “the Company”) is pleased to announce the appointment of Peter Brady as Executive Vice President, General Counsel and Corporate Affairs, effective September 28, 2026.

“I am pleased to welcome Peter to DPM’s executive team. He brings a wealth of strategic legal expertise and proven leadership in navigating the complex regulatory and governance challenges facing the mining industry today,” said David Rae, President and CEO of DPM Metals.

“His track record of building high-performing legal teams, combined with his deep experience in managing significant transactions and providing sound counsel to executive teams, will be invaluable as we advance our strategic priorities.”

Mr. Brady has nearly three decades of legal experience in the global mining and metals sector and private practice, with deep expertise in environmental law, regulatory compliance, corporate governance and complex transactions. Prior to joining DPM, he most recently served as Executive Vice President and General Counsel at Lundin Mining, leading the company’s corporate legal, regulatory and governance matters. Prior to that, he was Chief Legal & Governance Officer with Vale Base Metals, responsible for advising their senior leadership team on all legal and business risk, compliance, and corporate governance matters. Previous to Vale Base Metals, he was a Partner at McCarthy Tetrault, co-leading the National Environmental, Regulatory and Aboriginal Practice.

Mr. Brady holds a Bachelor of Laws from Queen’s University and a Master of Arts in environmental law from the University of Windsor, and is called to the Bar in both Ontario and British Columbia.

About DPM Metals Inc.

DPM Metals Inc. is a Canadian-based international gold mining company with operations and projects located in Bulgaria, Bosnia and Herzegovina, Serbia and Ecuador. Our strategic objective is to become a mid-tier precious metals company, which is based on sustainable, responsible and efficient gold production from our portfolio, the development of quality assets, and maintaining a strong financial position to support growth in mineral reserves and production through disciplined strategic transactions. This strategy creates a platform for robust growth to deliver above-average returns for our shareholders. DPM trades on the Toronto Stock Exchange (symbol: DPM) and the Australian Securities Exchange as a Foreign Exempt Issuer (symbol: DPM).

For further information please contact:

Jennifer Cameron
Director, Investor Relations
Tel: (416) 219-6177
jcameron@dpmmetals.com

Privacy Overview

This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.