OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review

OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review




OraSure Submits CT/NG Molecular Self-Test and Colli-Pee™ Urine Collection Device for FDA Review

BETHLEHEM, Pa., Jan. 05, 2026 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR) (“OraSure” and “OTI”), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced that it submitted two separate applications at the end of 2025 to the U.S. Food and Drug Administration (FDA) for clearance of its rapid molecular self-test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) as well as its Colli-Pee™ at-home urine collection device for sexually transmitted infections (STIs).

“These submission milestones reflect meaningful progress on our innovation roadmap and bring us closer to realizing our vision of decentralizing diagnostics and connecting people to care that is more accessible, convenient, private, and personalized,” said Carrie Eglinton Manner, President and CEO of OTI. “As we look ahead to 2026, we are continuing to execute on our strategy with purpose and momentum to create value for all our stakeholders.”

OTI’s rapid self-test for CT/NG is built on the Sherlock molecular diagnostics platform and is designed to provide results in approximately 30 minutes in a disposable, over-the-counter format. The test uses a self-collected swab, and results can be read directly on the hand-held testing device without the need for an electrical connection, enhancing flexibility and convenience. OTI estimates that testing for CT/NG represents a total addressable market of more than $1.5 billion. Today, the vast majority of CT/NG tests in the U.S. are processed in centralized laboratories, creating an opportunity for meaningful market expansion through the introduction of an affordable rapid self-test.

OTI also submitted the Colli-Pee™ device, which is designed for at-home urine collection and is aligned with patient preferences for private and convenient diagnostic testing. The submission covers multiple STI indications and is being pursued in collaboration with a leading diagnostics platform provider. Receipt of clearance for the Colli-Pee™ device for these indications would be in addition to the existing Research-use Only (RUO) product and is expected to expand access to testing and further strengthen OTI’s leadership position in novel collection devices and chemistries.

About OraSure Technologies, Inc. 
OraSure Technologies, Inc. (“OraSure” and “OTI”) transforms health through actionable insight and decentralizes diagnostics to connect people to healthcare wherever they are. OTI improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. Together with its wholly-owned subsidiaries, DNA Genotek Inc., Sherlock Biosciences, Inc., and BioMedomics, Inc., OTI is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OTI’s portfolio of products is sold globally to clinical laboratories, hospitals, physicians’ offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers.  For more information, please visit www.orasure.com.

Forward Looking Statements
This press release contains certain “forward-looking statements,” including with respect to products, product candidate development, regulatory submissions and authorizations and other matters. Forward-looking statements are based on current expectations of future events and are not guarantees of future performance or results. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from expectations and projections. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: uncertainty of commercial success; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; uncertainty and timing of regulatory clearances or approvals; ability to comply with applicable regulatory requirements; uncertainty relating to patent protection and potential patent infringement claims; impact of competitors, competing products and technology changes and patents obtained by competitors; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; impact of negative economic conditions; changes in behavior and spending patterns of purchasers; and changes to applicable laws and regulations. These and other factors that could affect our results are discussed more fully in our SEC filings, including our registration statements, Annual Report on Form 10-K for the year ended December 31, 2024, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and OraSure undertakes no duty to update these statements.

Investor Contact:
Jason Plagman
VP, Investor Relations
investorinfo@orasure.com
Media Contact:
Amy Koch
Director, Corporate Communications
media@orasure.com

Krystal Biotech to Present at 44th Annual J.P. Morgan Healthcare Conference

Krystal Biotech to Present at 44th Annual J.P. Morgan Healthcare Conference




Krystal Biotech to Present at 44th Annual J.P. Morgan Healthcare Conference

PITTSBURGH, Jan. 05, 2026 (GLOBE NEWSWIRE) — Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that the Company will participate in the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026, in San Francisco. Krish S. Krishnan, Chairman and Chief Executive Officer, is scheduled to give a presentation at 10:30 am ET / 7:30 am PT and host investor meetings throughout the day.

A webcast of the presentation will be available here beginning at 10:30 am ET / 7:30 am PT on Monday, January 12, 2026 and will be posted on the Investors section of the Company’s website.

About Krystal Biotech, Inc.

Krystal Biotech, Inc. (NASDAQ: KRYS) is a fully integrated, commercial-stage, global biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK®, the Company’s first commercial product, is the first-ever redosable gene therapy and the first genetic medicine approved in the United States, Europe, and Japan for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. For more information, please visit http://www.krystalbio.com, and follow @KrystalBiotech on LinkedIn and X (formerly Twitter).

CONTACT
Investors and Media:                                                                                        
Stéphane Paquette
Krystal Biotech
spaquette@krystalbio.com                                                                                   

Hyperion DeFi Appoints Hyunsu Jung as Chief Executive Officer

Hyperion DeFi Appoints Hyunsu Jung as Chief Executive Officer




Hyperion DeFi Appoints Hyunsu Jung as Chief Executive Officer

Board Confirms Leadership Team to Execute 2026 Strategic Priorities

Company Also Appoints Robert Rubenstein as General Counsel

LAGUNA HILLS, Calif., Jan. 05, 2026 (GLOBE NEWSWIRE) — Hyperion DeFi, Inc. (NASDAQ: HYPD) (“Hyperion DeFi” or the “Company”) today announced that its Board of Directors has appointed Hyunsu Jung as Chief Executive Officer, effective immediately.

Mr. Jung’s appointment marks an important milestone in the Company’s leadership evolution as it advances its strategic priorities for 2026. Mr. Jung joined Hyperion DeFi as Chief Investment Officer in June 2025, where he has focused on developing on-chain business lines, strengthening operational discipline, and expanding institutional relationships.

Prior to joining the Company, Mr. Jung designed and deployed differentiated digital asset strategies at DARMA Capital, a $1B+ asset manager registered with the CFTC and NFA. His work included optimizing on-chain utility across leading digital assets such as Ethereum and Filecoin, with a focus on scalable, revenue-generating strategies.

The Company also previously announced the appointment of David Knox, CFA, as Chief Financial Officer on September 29, 2025. Mr. Knox brings deep experience in capital markets and financial services, having held leadership roles at PayPal, SoFi, and Cantor Fitzgerald. As CFO, he is focused on strengthening Hyperion DeFi’s financial infrastructure and positioning the Company as a trusted bridge between traditional capital markets and decentralized finance.

“I am honored to step into the CEO role at Hyperion DeFi during this important phase for the digital asset industry,” said Mr. Jung. “Our focus is on building a leading Hyperliquid-native DeFi company that supports global adoption, monetizes growth through disciplined on-chain strategies, and provides shareholders with meaningful exposure to the expansion of the Hyperliquid ecosystem. As the market continues to prioritize fundamentals and sustainable revenue models, we believe Hyperion DeFi is well positioned to differentiate itself in 2026 and beyond.”

Rachel Jacobson, Independent Director, added:

“On behalf of the Board, we are very pleased to appoint Hyunsu Jung as CEO. He brings the right combination of leadership, strategic focus, and operational discipline to build a strong foundation for the company. The Board is fully supportive of this appointment, and together with the recent strengthening of the leadership team, we believe Hyperion DeFi is well positioned for its next phase of growth to execute its strategy and drive long-term shareholder value.”

In addition to the CEO and CFO appointments, Robert Rubenstein will be joining as General Counsel, effective January 12, 2026. Mr. Rubenstein is a seasoned legal executive with nearly three decades of experience leading legal, compliance, and business development functions for multinational public and private companies. Over his career, he has managed more than $20 billion in complex corporate transactions, overseen global regulatory compliance programs, and directed significant litigation matters in both U.S. and international jurisdictions.

About the Hyperliquid Platform and the HYPE Token

Hyperliquid is a next-generation layer one blockchain optimized for high frequency, transparent trading. The blockchain includes fully on-chain perpetual futures and spot order books, with every order, cancel, trade, and liquidation occurring within 70 millisecond block times. It also hosts the HyperEVM, a general-purpose smart contract platform that supports permissionless decentralized financial applications akin to Ethereum.

HYPE is the native token of Hyperliquid. Staked HYPE provides utility for users via reduced trading fees and increased referral bonuses. As of January 2026, more than 37 million HYPE have been autonomously purchased and sequestered by the blockchain with the trading fees generated on the network’s central limit order books.

About Hyperion DeFi, Inc.

Hyperion DeFi, Inc. is the first U.S. publicly listed company building a long-term strategic treasury of HYPE. The Company provides investors with streamlined access to the Hyperliquid ecosystem, one of the fastest growing, highest revenue-generating blockchains in the world. Shareholders benefit from compounding exposure to HYPE, both from its native staking yield and additional revenues generated from its unique on-chain utility.

Hyperion DeFi is also developing its proprietary Optejet User Filled Device that is designed to work with a variety of topical ophthalmic liquids, including artificial tears and lens rewetting products. The Optejet is especially useful in chronic front-of-the-eye diseases due to its ease of use, enhanced safety and tolerability, and potential for superior compliance versus standard eye drops. Together, these benefits may result in higher treatment compliance and better outcomes for patients and providers.

For more information, please visit Hyperiondefi.com or follow @hyperiondefi on X.

Forward Looking Statements

Except for historical information, all the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements, our future activities or other future events or conditions, including the viability of, and risks associated with, our cryptocurrency treasury strategy, the growth and revenue potential of the Hyperliquid ecosystem and the growth prospects of the Company. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission.

Any forward-looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Hyperion DeFi does not undertake any obligation to update any forward-looking statements.

Certain information contained in this press release relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Hyperion DeFi’s own internal estimates and research. While Hyperion DeFi believes these third-party studies, publications, surveys and other data to be reliable as of the date of this press release, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, no independent source has evaluated the reasonableness or accuracy of Hyperion DeFi’s internal estimates or research and no reliance should be made on any information or statements made in this press release relating to or based on such internal estimates and research. You should conduct your own investigation and analysis of Hyperion DeFi, its business, prospects, results of operations and financial condition. In furnishing this information, Hyperion DeFi does not undertake any obligation to provide you with access to any additional information (including forward-looking information and any projections contained herein) or to update or correct the information.

Hyperion DeFi, Inc. Investor Contact:
Jason Assad
Hyperion DeFi, Inc.
IR@hyperiondefi.com
(678) 570-6791

TME Pharma provides update on its activities

TME Pharma provides update on its activities




TME Pharma provides update on its activities

TME Pharma provides update on its activities

Berlin, Germany, January 5, 2025, 08.00 CETTME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases, announced today updates on its research and development activities and its potential investment strategies.

NOX-E36 developments
TME Pharma announces the initiation of a subsequent study for NOX-E36 and the simultaneous termination of its collaboration with the Singapore Eye Research Institute (SERI) for the development of NOX-E36 for glaucoma filtration surgery, as previously announced on June 18, 2025. The end of this partnership is unrelated to the quality and potential of NOX-E36. TME Pharma is pleased to confirm its commitment to this program with the launch in January 2026 of studies to validate detection of NOX-E36 in a toxicologically relevant animal, which are the first of the studies necessary to enable local administration of NOX-E36 to patients undergoing glaucoma filtration surgery to continue advancing this promising program.

The costs of this initial study are limited, and by starting the study as planned, no further delays are necessary for follow-up studies. TME Pharma believes strongly in the potential of NOX-E36 and by starting this new program it will become easier to find a new partner to help further the research and development of this program either in collaboration with TME Pharma or through a carveout, sale, or joint venture for NOX-E36.

Fibrosis is a major contributor to glaucoma filtration surgery treatment failure and increased severity in several clinically important eye diseases with significant unmet needs, such as proliferative diabetic retinopathy and age-related macular degeneration. Collectively, these conditions affect approximately 30 million people in the US alone, with millions at risk of vision-threatening complications. This underscores the substantial market potential for innovative anti-fibrotic therapies like NOX-E36 and the interest in a future partnership for this program.

NOX-A12
TME Pharma continues its active discussions with potential partners for the NOX-A12 program. TME Pharma has kept the clinical trial for glioblastoma open so that it can be resumed as soon as a suitable partner is found. TME Pharma expects to be able to present a clear update and strategy to the market in the coming weeks.

Investment in Cryptocurrencies
On June 30, 2025, TME Pharma announced a new treasury policy to allow investment in higher-risk assets such as crypto-currency related investments. To date, no attractive opportunity has presented itself, and the Company has not invested in the crypto markets. TME Pharma has closed the year with approximately €2.0 million in cash-on-hand (as compared to €2.06 million as at June 30, 2025), reflecting a responsible treasury policy and strict cost control.

Investment in ‘GRDC’
On November 5, 2025, TME Pharma announced it had signed a non-binding LOI with a ‘German Resource Development Company’ (‘GRDC’). Discussions with this partner are still ongoing, and due diligence is underway. Only in the event that the discussions and due diligence are positive and the Company believes the transaction will create significant value, TME Pharma will submit it to the shareholders for approval.

“We have high expectations for NOX-36 and NOX-E12 and are currently considering all options. We would have liked to continue the collaboration with SERI, but we also see opportunities to develop the program with other partners. TME is pursuing alternatives and will inform the market as soon as there is concrete news about ongoing discussions about NOX-E36 and NOX-E12.” said Diede van den Ouden, CEO. “Moreover, as previously announced, I’m enthusiastic about the additional activities we are considering. Our status of being a listed company, which is structured as an holding company, is still opening up new interesting opportunities. I emphasize again that we will only present potential partnerships to shareholders that we believe could create significant shareholder value. We will act responsibly and proposals will be presented to our shareholders for approval when necessary.”

For more information, please contact:

TME Pharma N.V.
Diede van den Ouden, CEO
ir@tmepharma.com

About TME Pharma

TME Pharma is a clinical-stage biotechnology company specializing in the development of novel therapies for cancer and eye diseases. The Company’s lead compounds have been designed to act on the tumor microenvironment (TME) and the cancer immunity cycle by breaking tumor protection barriers against the immune system and blocking tumor repair. The Company’s two lead assets are:

  • NOX-A12 (olaptesed pegol, an anti-CXCL12 L-RNA aptamer), which is being studied (GLORIA Phase 1/2 clinical trial) in newly-diagnosed brain cancer patients who will not benefit clinically from standard chemotherapy. The US FDA and the German BfArM have approved the design of a randomized Phase 2 trial in glioblastoma, and TME Pharma was awarded Fast Track Designation by the FDA for NOX-A12 in combination with radiotherapy and bevacizumab for use in the treatment of the aggressive adult brain cancer, glioblastoma. NOX-A12 in combination with radiotherapy had also previously received orphan drug designation (ODD) for glioblastoma in the United States and glioma in Europe.
  • NOX-E36 (emapticap pegol, L-RNA aptamer inhibiting CCL2 and related chemokines), which is being evaluated in ophthalmic diseases with a high need for well-tolerated therapies with anti-fibrotic effect.

The Company, under the leadership of its new CEO, Diede van den Ouden, who joined in the June 2025, is currently undertaking a strategic restructuring with the goal of providing the financial resources to unlock the value of NOX-A12 and NOX-E36. These steps include:

  • Raising funds from alternative sources (€1.7 million raised in May 2025, including €500,000 from the new CEO)
  • Pursuing stable, cash-generating business opportunities to achieve positive operational cash flow for the Company
  • Leveraging tax loss carry forwards
  • Potential to gain exposure to digital assets via newly established crypto brokerage account

Further information can be found at: www.tmepharma.com.

About the GLORIA Study

GLORIA (NCT04121455) is TME Pharma’s multi-part dose-escalation, Phase 1/2 and Phase 2 study of NOX-A12 in combination with radiotherapy +/- bevacizumab (anti-VEGF) in first-line partially resected or unresected glioblastoma (brain cancer) patients with unmethylated MGMT promoter (resistant to standard chemotherapy).

About the OPTIMUS Study

OPTIMUS (NCT04901741) is TME Pharma’s envisaged open-label two-arm Phase 2 study of NOX-A12 combined with pembrolizumab and nanoliposomal irinotecan/5-FU/leucovorin or gemcitabine/nab-paclitaxel in microsatellite-stable metastatic pancreatic cancer patients.

Disclaimer

Translations of any press release into languages other than English are intended solely as a convenience to the non-English-reading audience. The Company has attempted to provide an accurate translation of the original text in English, but due to the nuances in translating into another language, slight differences may exist. This press release includes certain disclosures that contain “forward-looking statements.” Forward-looking statements are based on TME Pharma’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Factors that could cause actual results to differ include, but are not limited to, the risks inherent in oncology drug development, including clinical trials and the timing of and TME Pharma’s ability to obtain regulatory approvals for NOX-A12 as well as any other drug candidates. Forward-looking statements contained in this announcement are made as of this date, and TME Pharma undertakes no duty to update such information except as required under applicable law.

In parallel to its core biotechnology activities, the Company is exploring potential acquisitions and partnerships in stable, profitable businesses. These efforts are aimed at creating a fundamentally profitable corporate structure in which revenues from non-core activities will support and strengthen the further development of its patented drug candidates, which remain the company’s flagship products, NOX-A12 and NOX-E36.

Attachment

Nicox Announces Complete Repayment of Kreos Capital Debt and Extends Cash Runway Beyond 2027 with New Additional Financing

Nicox Announces Complete Repayment of Kreos Capital Debt and Extends Cash Runway Beyond 2027 with New Additional Financing




Nicox Announces Complete Repayment of Kreos Capital Debt and Extends Cash Runway Beyond 2027 with New Additional Financing

Press Release

Nicox Announces Complete Repayment of Kreos Capital Debt and Extends Cash Runway Beyond 2027 with New Additional Financing

  • Company’s position strengthened, enabling flexibility in strategic discussions
  • All Kreos Capital secured debt repaid using cash on hand
  • Unsecured bond financing of up to €4 million concluded with partner and shareholder, Vester Finance
  • Cash runway extended beyond 2027

January 5, 2026 – release at 7:30 am CET
Sophia Antipolis, France

Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced repayment of all secured debt and extension of its cash runway beyond 2027 with an additional unsecured financing.

“The full repayment of our debt to funds and accounts managed by Kreos Capital announced today removes a number of obligations on the Company as a result of the security interests granted over Nicox’s assets. In the last 24 months, we have demonstrated our ability to meet our timelines and fulfil our obligations, and we appreciate the support that our long-term debtholders have given us,” said Gavin Spencer, Chief Executive Officer of Nicox. “To reinforce our cash position and better manage our resources, we have taken the opportunity to continue our successful collaboration with our financing partner and shareholder, Vester Finance. Based on our current cash on hand and the current timelines, this additional financing of up to €4 million extends our cash runway beyond the end of 2027. We are now in a healthier and significantly stronger position to navigate the future, including in our strategic discussions.”

Nicox has fully repaid all outstanding debt with funds and accounts managed by Kreos Capital1 using existing cash at 31 December 2025, thereby releasing all security guarantees over Nicox assets and terminating the right for Kreos Capital to appoint an Observer to the Board of Directors. This transaction coincides with raising new financing through the issuance of bonds to European investors, including Vester Finance, a current financing partner and established institutional investor. This financing consists of an issue of €3 million of convertible bonds and €1 million of ordinary bonds (subject to certain conditions precedent) and extends the Company’s cash runway beyond the end of 2027. This financing does not have any guarantee or security interest associated with it.

Nicox is continuing to evaluate future strategic growth opportunities, including collaborations or business combinations.

Key Future Milestones

  • NCX 470 NDA submission in the United States: expected in summer 2026, based on a pre-NDA meeting, which is scheduled in Q1 2026
  • NCX 470 NDA submission in China: expected shortly after submission in the U.S.
  • NCX 470 Phase 3 clinical program in Japan: initiated in summer 2025. Managed and financed by Kowa.

Cash Runway

Based on the expected upcoming milestones, including the submission of an NCX 470 New Drug Application in the U.S. and a standard review period of 12 months, the financing announced today and the repayment of the Kreos Capital debt, the Company believes that its current activities are financed to beyond the end of 2027. The Company remains committed to cost control and optimizing resource allocation while maintaining the capabilities required to support our strategic objectives. If any of the assumptions around estimated income or costs change, this may impact the cash runway.

Potential proceeds from existing warrants and the €1 million additional bond financing, subject to certain conditions precedent, are not included in the above cash runway calculation.

Full Repayment of the Kreos Capital Debt

Nicox originally subscribed to a secured long-term debt with funds and accounts managed by Kreos Capital totalling €20 million in 2019. Today’s payment reimburses the remaining outstanding balance of that debt in totality. In accordance with the amendment announced on 14 October 2024, Kreos Capital retains 17 warrants giving the right to acquire 400,000 shares per warrant in Nicox at €0.25, which can be exercised until 14 October 2036.

As of 31 December 2025, Nicox’s remaining debt amounted to €0.3 million, consisting entirely of the outstanding balance of a COVID loan, which will be repaid from cash in hand by the end of August 2026.

New Bond Financing from Institutional Investors

The issuance of the convertible bonds was carried out based on the delegation granted by the Company’s shareholders during the General Meeting held on June 27, 2025, under the 13th resolution2.

The convertible bonds, with a nominal unit value of €10, were subscribed at 92% of their nominal value for a total subscription price of €3,000,028.00, paid in full on the day of subscription. The bonds bear no interest and are unsecured. The bonds are convertible at any time, at a conversion price determined based on the stock market price3 at the time, in accordance with pricing rules and the ceiling set by the shareholders’ meeting.

The ordinary bonds with a nominal unit value of €9.20, have been subscribed by the same investors at 100% of their nominal value, for a total subscription price of €1,000,003.20. They do not bear any interest nor guarantees and have the same term as the convertible bonds. Their subscription price will be made as one payment, at the moment when certain conditions have been met, at the latest at the start of September 2026.

At a term of 24 months following the issuance of the debt, the bonds will be redeemed at maturity at 100% of their nominal value if they have not been converted at that date.

This transaction was advised by Vester Finance, which is also a subscriber to these bonds.

For illustrative purposes, if all convertible bonds were converted based on the Nicox share closing price on December 31, 2025, a shareholder holding 1% of the capital (calculated on the basis of the number of outstanding shares as of December 31, 2025) prior to the issuance and conversion would hold 0.876% of the capital on a non-diluted basis and 0.650% on a fully diluted basis. The new shares issued from conversion will be subject to all the provisions of the Company’s bylaws. They will be fully fungible with existing ordinary shares and will carry the same rights.

Risk Factors

Risk factors affecting the Company are detailed in section 3 of the “Rapport Annuel 2024” and in section 4 of the “Rapport semestriel 2025” which are available on Nicox’s website (www.nicox.com).

Since the conversion price of the bonds set out above is linked to the Company’s share price, the exact number of shares to be issued upon conversion cannot be determined at the time of issuance, and such conversion may significantly dilute existing shareholders.

Impact on the shareholder’s situation and on the distribution of share capital

The following table, provided for illustrative purposes only, outlines various scenarios regarding the impact of the issuance of new shares resulting from the conversion of convertible bonds on the shareholder’s situation, depending on the evolution of the share price.

Convertible bonds conversion price -10% Current* +10%
Number of shares issued upon conversion of the convertible bonds 13,935,470 12,541,920 11,401,750
Number of outstanding shares after the issuance 102,377,243 100,983,693 99,843,523
Dilution of existing capital** 15.76% 14.18% 12.89%
Stake of shareholder holding 1% of the share capital before conversion 0.864% 0.876% 0.886%

*Closing price at 31 December 2025, i.e. €0.2980
**Calculated on the basis of 88,441,773 Nicox shares as of December 31, 2025

The table below presents the Company’s share capital structure before and after the conversion of the convertible bonds, based on information available to the Company, and on the assumption that all the bonds are converted at a conversion price corresponding to the closing share price as at 31 December 2025:

Shareholders Before conversion of the convertible bonds

After conversion of the convertible bonds
  Number of shares % of equity Number of shares % of equity
Ocumension 3,059,046 3.46 3,059,046 3.03
HBM Healthcare Investments 1,801,421 2.04 1,801,421 1.79
Vester Finance 175,000 0.20 10,033,580 9.95
Other bond holders 2,508,360 2.49
Treasury shares 311,067 0.35 311,067 0.31
Public 83,095,239 93.95 83,095,239 82.43
Total 88,441,773 100.00 100,808,713 100.00

Prospectus – Admission to trading

The bonds will not be subject to any application for admission to trading on Euronext Growth. This issue does not give rise to the preparation of a prospectus subject to the approval of the Autorité des marchés financiers (AMF).

Termination of the PACEO4 Equity Financing Line

The PACEO Equity Line with Vester Finance announced on 6 March 2025 and extended on 8 August 2025 is now finished. It has permitted Nicox to raise €3.9 million, through the issuance of 15,000,000 new shares.  

About Nicox

Nicox SA is an international ophthalmology company developing innovative solutions to help maintain vision and improve ocular health.  Nicox’s lead late-stage development program is NCX 470 (bimatoprost grenod), a novel nitric oxide-donating bimatoprost eye drop, for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, licensed to Ocumension Therapeutics for the Chinese, Korean and Southeast Asian markets and to Kowa in the rest of the world.  Nicox also has a preclinical research program on NCX 1728, a nitric oxide-donating phosphodiesterase-5 inhibitor, with Glaukos.  Nicox’s first product, VYZULTA® in glaucoma, licensed exclusively worldwide to Bausch + Lomb, is available commercially in the U.S. and over 15 other territories.  Nicox generates revenue from ZERVIATE® in allergic conjunctivitis, licensed in multiple geographies, including to Harrow, Inc. in the U.S., and Ocumension Therapeutics in the Chinese and in the majority of Southeast Asian markets.

Nicox, headquartered in Sophia Antipolis, France, is listed on Euronext Growth Paris (Ticker symbol: ALCOX).

For more information www.nicox.com

Analyst coverage

H.C. Wainwright & Co Yi Chen New York, U.S.

The views expressed by analysts in their coverage of Nicox are those of the author and do not reflect the views of Nicox. Additionally, the information contained in their reports may not be correct or current. Nicox disavows any obligation to correct or to update the information contained in analyst reports.
Contacts

Nicox
Gavin Spencer
Chief Executive Officer
T +33 (0)4 97 24 53 00
communications@nicox.com

Disclaimer

The information contained in this document may be modified without prior notice. This information includes forward-looking statements. Such forward-looking statements are not guarantees of future performance. These statements are based on current expectations or beliefs of the management of Nicox S.A. and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Nicox S.A. and its affiliates, directors, officers, employees, advisers or agents, do not undertake, nor do they have any obligation, to provide updates or to revise any forward-looking statements.

Risk factors which are likely to have a material effect on Nicox’s business are presented in section 3 of the “Rapport Annuel 2024” and in section 4 of the “Rapport semestriel 2025” which are available on Nicox’s website (www.nicox.com).

Finally, this press release may be drafted in the French and English languages. If both versions are interpreted differently, the French language version shall prevail.

Nicox S.A.
Sundesk Sophia Antipolis, Bâtiment C, Emerald Square, Rue Evariste Galois, 06410 Biot, France
T +33 (0)4 97 24 53 00


1 BlackRock Inc. announced the completion of its acquisition of Kreos Capital, a leading provider of growth and venture debt financing to companies in the technology and healthcare industries, on 2 August 2023.
2 Delegation of competence to the Board of Directors to increase the share capital for the benefit of a category of investors (physical or moral persons, trusts, investment funds or other financial placement vehicles; strategic partners of the Company; or all other creditors) without preferential right of subscription of the shareholders
3 At least equal to the lower of (i) €0.35 and (ii) 93.5% of the lowest of the volume-weighted average daily prices over a 2-day period preceding each conversion request
4 Capital increase program through exercise of warrants (Programme d’Augmentation de Capital par Exercice d’Options)

Attachment

Burning Rock Announces Founder’s Purchase of Its ADSs

Burning Rock Announces Founder’s Purchase of Its ADSs




Burning Rock Announces Founder’s Purchase of Its ADSs

GUANGZHOU, China, Jan. 05, 2026 (GLOBE NEWSWIRE) — Burning Rock Biotech Limited (NASDAQ: BNR, the “Company” or “Burning Rock”), a company focusing on the application of next generation sequencing (NGS) technology in the field of precision oncology, today announced that as of the date of this press release, its founder, chairman of the board of directors and chief executive officer, Mr. Yusheng Han, has purchased US$811,721.28 of the Company’s ADSs from the open market, which was conducted in compliance with the applicable rules and regulations and the Company’s insider trading policy. Mr. Han’s purchase of the Company’s ADSs indicates his confidence in the Company’s business and prospect.

Mr. Han may continue to purchase the Company’s ADSs through open-market transactions, privately negotiated transactions or block trades, or other legally permissible means, depending on market conditions and in accordance with the applicable rules and regulations. The timing and conditions of Mr. Han’s purchase will be subject to various factors, including the requirements under Rule 10b-18 and Rule 10b5-1 of the Securities Exchange Act of 1934, as well as the Company’s insider trading policy.

About Burning Rock

Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to guard life via science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, and ii) cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.

For more information about Burning Rock, please visit: ir.brbiotech.com.

Contact: IR@brbiotech.com

Idorsia’s JERAYGO (aprocitentan) approved in Canada for the treatment of resistant hypertension

Idorsia’s JERAYGO (aprocitentan) approved in Canada for the treatment of resistant hypertension




Idorsia’s JERAYGO (aprocitentan) approved in Canada for the treatment of resistant hypertension

  • Idorsia receives approval from Health Canada for JERAYGO (aprocitentan) as the first and only endothelin receptor antagonist (ERA) for the treatment of resistant hypertension.
  • JERAYGO is a new oral antihypertensive therapy – the first systemic hypertension treatment to target a new pathway in over 30 years.

Allschwil, Switzerland – January 5, 2026
Idorsia Ltd (SIX: IDIA) announces that Health Canada has granted marketing authorization for JERAYGO (aprocitentan) for the treatment of resistant hypertension in adult patients in combination with at least three antihypertensive medicinal products.1 The recommended dose is 12.5 mg orally once daily. The dose can be increased to 25 mg once daily for patients tolerating the 12.5 mg dose and in need of tighter blood pressure (BP) control.1

Hypertension remains a leading global health challenge and the number one modifiable risk factor for early morbidity and mortality. Despite advances in treatment, many patients still struggle with uncontrolled blood pressure, leaving them at significantly higher risk of heart attack, stroke, kidney failure, and premature death.

Approximately 10% of hypertensive patients have resistant hypertension3,4 – defined by uncontrolled blood pressure despite receiving at least three antihypertensive medications from different classes, at optimal doses – underscoring the urgent need for more effective therapies.

Srishti Gupta, MD, Chief Executive Officer of Idorsia, commented:
“JERAYGO is the first and only hypertension treatment to target the endothelin pathway, a fundamental yet previously unaddressed driver of disease onset, progression, and complications. The results of PRECISION show that targeting the endothelin pathway is crucial to adequately manage uncontrolled blood pressure. JERAYGO has demonstrated rapid, durable, and clinically significant double-digit blood pressure reduction across a broad spectrum of challenging patient populations, including those with obesity, chronic kidney disease, or type 2 diabetes. I am very proud of our team for achieving this milestone.”

Idorsia is engaged in discussions to maximize the ability to make JERAYGO available to patients.

For more information on the marketing authorization of JERAYGO in Canada and important safety information, please review the Product Monograph.

Notes to the editor

About the Phase 3 PRECISION study1,5
The efficacy of aprocitentan was evaluated in one randomized, double-blind (DB), placebo-controlled Phase 3 multicenter study. Patients with uncontrolled blood pressure (systolic blood pressure [SBP] ≥140 mmHg) despite the use of at least three antihypertensive medicinal products and following exclusion of pseudo-resistant hypertension (e.g., white coat effect, inappropriate blood pressure measurement, secondary causes of hypertension) were considered to have resistant hypertension. The patients were switched to standardized background antihypertensive therapy consisting of an angiotensin receptor blocker (valsartan 160 mg), a calcium channel blocker (amlodipine 5 or 10 mg), and a diuretic (hydrochlorothiazide 25 mg) throughout the study. Patients with concomitant use of beta-blockers continued this treatment throughout the study, in addition to the standardized background antihypertensive therapy and study treatment. A total of 730 patients received either aprocitentan 12.5 mg, aprocitentan 25 mg, or placebo once daily during the initial 4-week DB treatment (part 1). Thereafter, patients received aprocitentan 25 mg once daily during the 32-week single-blind treatment (part 2). At the end of the 32 weeks, patients were re-randomized to receive either aprocitentan 25 mg or placebo, once daily, during the 12-week double-blind withdrawal (DB-WD) treatment (part 3).

The primary efficacy endpoint was the change in sitting SBP (SiSBP) from baseline to Week 4 during DB treatment (part 1), measured at trough by unattended automated office blood pressure (uAOBP). The key secondary endpoint was the change in SiSBP measured at trough by uAOBP from DB-WD baseline (Week 36) to Week 40 (part 3).

Patients had a mean age of 61.7 years (range 24 to 84 years; 34.1% were ≥ 65 and < 75 years; 9.9% were ≥ 75 years) and 59.5% were male. Patients were White (82.9%), African American (11.2%) or Asian (5.2%). The mean body weight was 97.6 kg (range 46 to 196 kg) and mean BMI was 33.7 kg/m2 (range 18 to 64 kg/m2). Patients had a medical history of type 2 diabetes mellitus (54.1%), ischemic heart disease (30.8%), central nervous system vascular disorders (23.0%), chronic kidney disease stages 3 and 4 (22.2%; 19.3% of patients had eGFR 30–59 mL/min/1.73 m2 and 2.9% had eGFR 15–29 mL/min/1.73 m2), congestive heart failure (19.6%), and sleep apnea syndrome (14.1%). 63.0% of patients had four or more antihypertensive medicinal products.

Key PRECISION findings1,5
Doses of aprocitentan 12.5 and 25 mg showed a statistically significant reduction vs placebo on SiSBP at Week 4. The treatment effect was consistent for sitting diastolic blood pressure (SiDBP). The persistence of the BP-lowering effect of aprocitentan was shown in DB-WD treatment (part 3). In patients re-randomized to placebo, the mean SiSBP increased, whereas in patients re-randomized to aprocitentan 25 mg the mean effect on SiSBP was stable, resulting in a statistically significant difference. The treatment effect was consistent for SiDBP. The effect was also consistent across SBP and DBP measured by ambulatory BP monitoring (ABPM) and assessed as daytime, night-time, and 24h periods at Week 4 and Week 40. A substantial proportion (i.e., at least 90%) of the BP-lowering effect was observed within the first two weeks of treatment with aprocitentan. The effect of aprocitentan was consistent across subgroups of age (including patients ≥ 75 years), sex, race (including patients with Black or African American origin), BMI, baseline urine albumin-to-creatinine ratio (UACR), baseline eGFR and medical history of diabetes.

The most frequently reported adverse reactions with aprocitentan were edema/fluid retention (mostly peripheral edema) (9.1%, 12.5 mg; 18.4%, 25 mg) and hemoglobin decreased (3.7%, 12.5 mg; 1.2%, 25 mg).

JERAYGO is contraindicated for use in women who are pregnant, breast-feeding, in women of childbearing potential who are not using reliable contraception, patients with severe hepatic impairment, and in patients with hypersensitivity to the active substance or to any of the excipients.

About aprocitentan
Aprocitentan is Idorsia’s once-daily, orally active, dual endothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors. Aprocitentan is approved as TRYVIO™ in the US for the treatment of systemic hypertension in combination with other antihypertensives and has been commercially available since October 2024. Aprocitentan is approved as JERAYGO™ for the treatment of resistant hypertension in combination with at least three antihypertensives in the European Union, the UK, and Switzerland, and now in Canada.

Idorsia Pharmaceuticals Ltd has transferred its rights for aprocitentan (including JERAYGO™) to Idorsia Investments SARL to allow the repayment of notes issued in connection with the repurchase offer completed in August 2025. More details on the transfer can be found in the press release issued on May 21, 2025 and on the exchange offer in the press release issued on August 27, 2025.

References

  1. JERAYGO Product Monograph
  2. NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in hypertension prevalence and progress in treatment and control from 1990 to 2019: a pooled analysis of 1201 population-representative studies with 104 million participants. Lancet 2021; 398:957-80.
  3. Noubiap JJ, et al. Global prevalence of resistant hypertension: a meta-analysis of data from 3·2 million patients. Heart 2019; 105: 98–105.
  4. Williams B, et al. 2018 ESC/ESH guidelines for the management of arterial hypertension. Eur Heart J 2018; 39: 3021–104.
  5. Schlaich MP, et al. A randomized controlled trial of the dual endothelin antagonist aprocitentan for resistant hypertension. The Lancet, 2022; Dec 3;400(10367):1927-1937.

About Idorsia
The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core.

Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA).

For further information, please contact:
Investor & Media Relations
Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil
+41 58 844 10 10
investor.relations@idorsia.com – media.relations@idorsia.com – www.idorsia.com

The above information contains certain “forward-looking statements”, relating to the company’s business, which can be identified by the use of forward-looking terminology such as “intend”, “estimates”, “believes”, “expects”, “may”, “are expected to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and development programs, business development activities and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company’s existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

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argenx Announces Leadership Transition Marking Next Evolution of Growth

argenx Announces Leadership Transition Marking Next Evolution of Growth




argenx Announces Leadership Transition Marking Next Evolution of Growth

Tim Van Hauwermeiren to transition from CEO to Non-Executive Director and Chairman of Board of Directors and Karen Massey to transition from COO to CEO and Executive Director

January 5, 2026 7:00 a.m. CET

Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that Karen Massey, current Chief Operating Officer, will transition to Chief Executive Officer and Executive Director and Tim Van Hauwermeiren, current Chief Executive Officer, will transition to non-Executive Director and Chairman of the Board of Directors. Tim will succeed Peter Verhaeghe, who is retiring from the Board of Directors after dedicated service to the company since 2008. These changes are subject to shareholder approval at the Annual General Meeting on May 6, 2026, which allows for a comprehensive transition period.

“This leadership evolution comes at the right time and represents a natural step as we prepare for the next phase of growth at argenx – a long-term future that remains bold, patient-focused, and built to last,” said Peter Verhaeghe, Chairman of the Board of Directors. “I am proud to have been part of this journey in building a leading biotech company from the start. The Board and I move forward with strong confidence in Tim as our incoming Chairman, Karen as our trusted COO and incoming CEO, and the entire leadership team, to guide the organization towards Vision 2030 and beyond.”

“My ambition has always been to build a strong, independent biotech company for the long-term. This transition is the next step in that evolution and Karen is the right person to lead our company forward. Karen has delivered exceptional impact since joining argenx three years ago – accelerating VYVGART’s launch, building a future-proof commercial engine, being a leading ambassador of our culture, and connecting to and inspiring our teams,” said Tim Van Hauwermeiren, co-founder and current Chief Executive Officer. “As Chairman, I will be a sounding board to Karen and the team on long-term strategy, stay close to the innovation mission by engaging with the external ecosystem and lead the Board’s evolution to facilitate our next phase of growth. I am deeply grateful to the Board of Directors for this opportunity, and especially to Peter, for his leadership and partnership as we’ve built this company.”

“This is a special company with a bright future that is founded on the strength of our science, our entrepreneurial culture, and the deep accountability of our talented teams to transform the lives of our patients,” said Karen Massey, current Chief Operating Officer. “My commitment is to elevate the unique argenx DNA as we execute on Vision 2030 and beyond and to ensure we are making the most of this bold opportunity to build the biotech company of the future. I’m humbled to lead argenx, alongside our network of exceptional teams, partners and the Board, into this next chapter of growth.”

Biographies of Karen, Tim and Peter can be accessed on the argenx website.

About argenx
argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedInInstagramFacebook, and YouTube.

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014).

Contacts

Media:

Ben Petok

bpetok@argenx.com

Investors:

Alexandra Roy
aroy@argenx.com

Forward-looking Statements

The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “aim,” “are,” “can,” “continue,” “may,” and “will” and include statements argenx makes concerning argenx’s proposed leadership and board transition as well as the company’s ability to execute on Vision 2020 and its other objectives and initiatives. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, whether shareholders approve the proposed leadership and board transition proposal, the results of argenx’s clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements; the acceptance of its products and product candidates by its patients as safe, effective and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; its reliance on third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

HUTCHMED Initiates Phase III Stage of the Ongoing Trial of the Combination of Surufatinib and Camrelizumab for Treatment-Naïve Pancreatic Ductal Adenocarcinoma

HUTCHMED Initiates Phase III Stage of the Ongoing Trial of the Combination of Surufatinib and Camrelizumab for Treatment-Naïve Pancreatic Ductal Adenocarcinoma




HUTCHMED Initiates Phase III Stage of the Ongoing Trial of the Combination of Surufatinib and Camrelizumab for Treatment-Naïve Pancreatic Ductal Adenocarcinoma

HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Jan. 05, 2026 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that it has initiated the Phase III part of the Phase II/III trial to evaluate the efficacy of the combination of surufatinib, camrelizumab, nab-paclitaxel and gemcitabine as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (“PDAC”) in China. The first patient received the first dose on December 30, 2025.

PDAC is a highly aggressive form of cancer, representing over 90% of pancreatic cancer cases. Globally, an estimated 511,000 people were diagnosed with pancreatic cancer, leading to approximately 467,000 deaths in 2022, with an average five-year survival rate of less than 10%. In China, an estimated 119,000 people were diagnosed with pancreatic cancer, causing approximately 106,000 deaths in 2022.1 Treatments such as chemotherapy, surgery and radiation are commonly employed, but have not shown significant improvement in patient outcomes. Under 20% of metastatic pancreatic cancer patients survive for more than a year. 2

The trial is a multicenter, randomized, open-label, active-controlled Phase II/III study to evaluate the efficacy and safety of surufatinib combined with camrelizumab, nab-paclitaxel and gemcitabine (“S+C+AG”) versus nab-paclitaxel plus gemcitabine (“AG”) in adults with metastatic pancreatic cancer who have not previously received systemic anti-tumor therapy. A total of 62 patients were enrolled in the Phase II part, with plans to enroll approximately 400 additional patients in the Phase III part. The primary endpoint for the Phase III part is overall survival (OS). Secondary endpoints include progression-free survival (“PFS”), objective response rate (“ORR”), duration of response (DoR), disease control rate (“DCR”), quality of life and safety. Professor Shukui Qin of China Pharmaceutical University Nanjing Tianyinshan Hospital and Professor Jihui Hao of Tianjin Medical University Cancer Institute and Hospital are the leading principal investigators of this study. Additional details may be found at clinicaltrials.gov, using identifier NCT06361888.

Results from the Phase II part were recently presented at the 2025 European Society for Medical Oncology (ESMO) Asia Congress.3 As of the data cut-off of July 24, 2025, the median PFS follow-up duration was 8.15 months. The S+C+AG regimen demonstrated a median PFS of 7.20 months compared to 5.52 months for the AG arm (stratified hazard ratio [HR] 0.499, log-rank p=0.0407), representing a 50.1% reduction in the risk of progression or death. Consistent benefits were observed across other key efficacy endpoints, including ORR (67.7% vs 41.9%, p=0.0430) and DCR (93.5% vs 71.0%, p=0.0149). Although overall survival data were immature at the time of analysis, a favorable trend was observed (not reached vs 8.48 months, unstratified HR 0.555), with 9 events in the S+C+AG arm (N=31) and 15 events in the AG arm (N=31). The safety profile was manageable. Treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in 80.6% of patients in the S+C+AG arm compared to 61.3% in the AG arm.

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFRs) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA®. HUTCHMED currently retains all rights to surufatinib worldwide.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Camrelizumab has been approved in China for multiple indications in areas such as lung cancer, liver cancer, esophageal cancer, nasopharyngeal cancer and cervical cancer. Camrelizumab is marketed in China by Hengrui Pharma under the brand name AiRuiKa®.

About HUTCHMED

HUTCHMED (Nasdaq/AIM:​HCM; HKEX:​13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of surufatinib for the treatment of PDAC and the further development of surufatinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the timing and outcome of clinical studies and the sufficiency of clinical data to support a new drug application submission of surufatinib for the treatment of PDAC or other indications in China or other jurisdictions, its potential to gain approvals from regulatory authorities on an expedited basis or at all, the efficacy and safety profile of surufatinib, HUTCHMED’s ability to fund, implement and complete its further clinical development and commercialization plans for surufatinib and the timing of these events. In addition, as certain studies rely on the use of other drug products such as camrelizumab, nab-paclitaxel and gemcitabine as combination therapeutics with surufatinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Medical Information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

CONTACTS

Investor Enquiries +852 2121 8200 / ir@hutch-med.com
   
Media Enquiries  
FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com
Ben Atwell / Tim Stamper +44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile)
Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
   
Panmure Liberum Nominated Advisor and Joint Broker
Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500
   
Cavendish Joint Broker
Geoff Nash / Nigel Birks +44 20 7220 0500
   
Deutsche Numis Joint Broker
Freddie Barnfield / Jeffrey Wong / Duncan Monteith +44 20 7260 1000

______________________________

REFERENCES
The Global Cancer Observatory, China fact sheet. https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed December 3, 2025
2 Sarantis P et al. Pancreatic ductal adenocarcinoma: Treatment hurdles, tumor microenvironment and immunotherapy. World J Gastrointest Oncol. 2020;12(2):173-181. DOI:10.4251/wjgo.v12.i2.173
3 Qin S et al. 375P – Surufatinib (S) in combination with camrelizumab (C), nab-paclitaxel and gemcitabine (AG) as the first-line treatment in metastatic pancreatic cancer: Results from phase II part of a randomized, open-label, active-controlled, phase II/III study. Annals of Oncology (2025) 36 (suppl_4): S1859-S1939. 10.1016/annonc/annonc1989


CystoSmart™, an AI Software Tool for Bladder Cancer Detection, Developed with Cutting-Edge Technology Receives Clearance from Health Sciences Authority Singapore

CystoSmart™, an AI Software Tool for Bladder Cancer Detection, Developed with Cutting-Edge Technology Receives Clearance from Health Sciences Authority Singapore




CystoSmart™, an AI Software Tool for Bladder Cancer Detection, Developed with Cutting-Edge Technology Receives Clearance from Health Sciences Authority Singapore

SINGAPORE and LONDON and NEW YORK, Jan. 04, 2026 (GLOBE NEWSWIRE) — Intelligent Scopes Corp (“ISC”), specializing in state-of-the-art image enhancement and precision AI software solutions for urology and gastroenterology, is pleased to announce that CystoSmart™ has received regulatory clearance from Health Sciences Authority (HSA), the National Regulatory Agency for medical products and devices in Singapore.

CystoSmart™, an AI software tool for bladder tumor detection in patients undergoing screening and surveillance endoscopic examination of the bladder is brand agnostic and compatible with flexible and rigid scopes, including single-use scopes. The device is intended to be used with white light cystoscopy to aid clinicians in improving detection accuracy of bladder tumors in real-time and post processing conditions.

The HSA clearance for CystoSmart™, which comes eleven months after it was approved by ANVISA, the Brazilian medical devices regulator, marks a significant milestone. Not only does it clear CystoSmart™ for use in Singapore, but, through the ‘Access Consortium’ collaboration, it paves the way for accelerated regulatory clearances in Australia, Canada, Switzerland and United Kingdom, countries that are part of the Access Consortium group.

Bladder cancer is the tenth most common cancer worldwide, and the sixth most common malignancy in men. With increasing incidence globally, bladder cancer has a high rate of progression and recurrence (up to 80%) requiring repeated follow up examinations. White light cystoscopy is the standard and most widely used method for bladder tumor detection and surveillance, however, as per published studies, between 10% and 20% of bladder tumors are regularly missed by standard white light cystoscopy.

Dr Rajesh Nair, Chief Surgical Officer of ISC, commented, “Early identification of cancer translates to improved clinical outcomes, impacting positively on the patient journey and overall health economy.  Accurate exclusion reduces inappropriate investigations which carry a physical and psychological burden for patients. Early detection or exclusion of bladder cancer allows for more effective resource utilisation.” He added, “CystoSmart™ can be used as an aid for urologists to improve detection accuracy: to reduce missed tumors and reduce unnecessary invasive biopsies and interventions.

As per clinical and technical evaluations conducted, CystoSmart has a sensitivity (true positive rate) of over 95% and a specificity (true negative rate) of over 98% in bladder tumor detection thereby aiding clinicians to improve accuracy.

About Intelligent Scopes Corp

Intelligent Scopes Corp, subsidiary of Claritas HealthTech, leads global deployment of endoscopic solutions. The company provides state-of-the-art image processing and enhancement software medical devices and AI diagnostic tools for the fields of urology and gastroenterology. The company focuses on image processing, image enhancement, AI diagnostic tools, and robotic guidance systems for endoscopy procedures to improve detection rates, reduce unnecessary biopsies and enhance patient outcomes.

For more information, please visit: www.intelligentscopes.com.

For Enquiries, please contact:
Devika Dutt
COO
Intelligent Scopes Corp
d.dutt@intelligentscopes.com