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Hyloris Pharmaceuticals SA — Investor Relations & Filings

Ticker · HYL ISIN · BE0974363955 LEI · 875500LZIWS7QEQE0I73 BR Manufacturing
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Filings indexed 259 across all filing types
Latest filing 2025-09-25 Interim / Quarterly Rep…
Country BE Belgium
Listing BR HYL

About Hyloris Pharmaceuticals SA

https://hyloris.com/

Hyloris Pharmaceuticals SA is a specialty biopharma company focused on innovating, reinventing, and optimizing existing medications to address unmet medical needs. The company's strategy centers on reformulating and repurposing established drugs to create value-added medicines for patients, healthcare professionals, and payors. By utilizing established regulatory pathways, such as the FDA's 505(b)(2) process, Hyloris aims to reduce development timelines, costs, and risks. The company has built a broad, patented portfolio of product candidates. Its commercialized products include Sotalol IV for the treatment of atrial fibrillation and Maxigesic® IV, a non-opioid for post-operative pain. In addition to its core focus, Hyloris also develops and commercializes high-barrier generic products.

Recent filings

Filing Released Lang Actions
PR Half Year Results 2025_FR final.pdf
Interim / Quarterly Report Classification · 100% confidence The document is a comprehensive financial report for the first half of 2025 (semestriels consolidés 2025) for Hyloris Pharmaceuticals. It contains detailed financial performance metrics (operating results, net loss, cash position), operational progress, and a breakdown of the product portfolio. It is not a mere announcement (RPA) as it provides substantive financial data and analysis for the interim period. Therefore, it is classified as an Interim/Quarterly Report. H1 2025
2025-09-25 French
2025 06 30 Hyloris HY report_EN final.pdf
Interim / Quarterly Report Classification · 100% confidence The document is titled 'Half Year Report 2025' and contains comprehensive financial statements, including a 'Condensed Consolidated Statement of Financial Position' and 'Condensed Consolidated Statement of Profit or Loss' for the six months ended 30 June 2025. It also includes a message from the CEOs, business highlights, and an auditor's report. This meets the definition of an Interim/Quarterly Report (IR) as it provides substantive financial data and analysis for a period shorter than a full fiscal year. H1 2025
2025-09-25 English
2025 06 30 Hyloris HY report_FR final.pdf
Interim / Quarterly Report Classification · 100% confidence The document is titled 'Rapport semestriel 2025' (Half-year report 2025) and contains comprehensive financial statements, including the 'État consolidé résumé de la situation financière' (Consolidated statement of financial position) as of June 30, 2025. It also includes a message from the CEOs, operational highlights, and a declaration from the Board of Directors regarding the interim financial statements. Since it provides substantive financial data for a period shorter than a full fiscal year (six months), it is classified as an Interim/Quarterly Report. H1 2025
2025-09-25 French
Press Release Hyloris Signs XTRAZA Licensing Agreement with HUONS.pdf
M&A Activity Classification · 100% confidence The document is a press release announcing a new exclusive licensing and supply agreement between Hyloris Pharmaceuticals and Huons Co., Ltd. for the product XTRAZA in South Korea. It details the nature of the partnership, the market opportunity, and provides background information on both companies. As this is a corporate announcement regarding a business development/commercial partnership and does not fit into specific financial reporting categories like 10-K or IR, it is classified as a general regulatory filing/announcement.
2025-08-22 English
PR Hyloris Signs XTRAZA Licensing Agreement with Huons FR.pdf
M&A Activity Classification · 100% confidence The document is a press release issued by Hyloris Pharmaceuticals announcing an exclusive licensing and supply agreement with Huons Co., Ltd. for the product XTRAZA in South Korea. It follows the standard format of a corporate press release, including contact information, company background, and a disclaimer regarding forward-looking statements. As it is a general regulatory announcement regarding business development and partnerships that does not fit into specific categories like M&A (which typically involves corporate takeovers or mergers) or financial reporting, it is classified as a Regulatory Filing (RNS).
2025-08-22 French
Press Release_ Atomoxetine Clinical Trial_EN.pdf
Regulatory Filings Classification · 99% confidence The document is a press release dated July 17, 2025, announcing positive clinical study results for a drug candidate (Atomoxetine Oral Solution) and stating that a New Drug Application (NDA) to the FDA is under preparation. This type of announcement, detailing clinical progress and future regulatory steps, is characteristic of an Earnings Release (ER) or a general Regulatory Filing (RNS). Since it is a specific announcement about clinical trial outcomes and future regulatory filings, and not a comprehensive periodic report (like 10-K or IR), it fits best under the 'Earnings Release' category, which often encompasses significant operational and clinical updates released to the market, or 'Regulatory Filings' as a general announcement. Given the context of a major clinical update and preparation for an NDA, it functions as a significant market-moving announcement, aligning closely with the purpose of an ER, even if it's not strictly quarterly earnings figures. However, since it is a specific announcement about clinical results and regulatory progress rather than financial performance highlights, and it is clearly a formal communication to the market, 'Regulatory Filings' (RNS) is a strong candidate as a general announcement category. Comparing the options, 'ER' is for financial results highlights, 'IR' is for comprehensive interim reports, and 'RNS' is for general regulatory announcements. This is a regulatory/clinical announcement, making RNS the most appropriate general fit if ER is reserved strictly for financial results. Given the structure and content (clinical data, management commentary, forward-looking statements), it is a standard press release announcing a major development. I will classify it as RNS as it is a general regulatory/company update that doesn't fit the specific financial report codes.
2025-07-17 English

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