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Orexo — Investor Relations & Filings

Ticker · ORX ISIN · SE0000736415 LEI · 549300LJ5CCWDPTK9Z08 ST Manufacturing
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Filings indexed 841 across all filing types
Latest filing 2024-07-17 Earnings Release
Country SE Sweden
Listing ST ORX

About Orexo

https://orexo.com/

Orexo is a commercial-stage pharmaceutical company focused on developing improved pharmaceuticals and digital therapies. The company addresses unmet patient needs, particularly within substance use disorders and mental health. It leverages proprietary drug delivery and formulation technologies to create innovative treatment solutions. Orexo's activities span research, development, and commercialization of its products.

Recent filings

Filing Released Lang Actions
Earnings Release 2024
Earnings Release Classification · 1% confidence The document is titled "Delårsrapport kv 2 2024" (Interim Report Q2 2024) and contains detailed financial tables comparing Q2 2024 results with previous periods (Q2 2023, YTD 2024, YTD 2023, FY 2023). It includes key financial highlights (Net sales, EBITDA, Net result), management commentary (VD kommentarer), and a table of contents typical of a comprehensive financial report covering a period shorter than a full year. This strongly indicates an Interim/Quarterly Report. The Swedish term 'Delårsrapport' directly translates to Interim Report. Given the comprehensive nature and the specific period covered (Q2), the appropriate code is IR (Interim / Quarterly Report), not ER (Earnings Release) which is usually just the highlights. H1 2024
2024-07-17 Swedish
Orexo shares new information on OX124, a high-dose naloxone rescue medication in development for opioid overdose
Legal Proceedings Report Classification · 1% confidence The document is a press release dated July 16, 2024, announcing that Orexo AB received a Complete Response Letter (CRL) from the US FDA regarding their New Drug Application (NDA) for OX1224. This announcement details regulatory feedback, required next steps (additional Human Factors study and technical data), and management commentary on the process. This type of communication, which is a formal update on regulatory interactions and product development status, does not fit neatly into the specific financial reporting categories (like 10-K, ER, IR) or corporate governance filings (like DEF 14A, DIRS). It is a general, material announcement concerning the company's operations and product pipeline, making the 'Regulatory Filings' (RNS) category the most appropriate fallback for significant, non-standard regulatory updates that aren't explicitly covered elsewhere.
2024-07-16 English
Orexo delar ny information om OX124, ett högdosläkemedel vid opioidöverdos med naloxon
Legal Proceedings Report Classification · 1% confidence The document is a press release ("Pressmeddelande") dated July 16, 2024, announcing that Orexo AB received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for OX124. This communication details regulatory feedback (requiring an additional Human Factors study and technical data) concerning a drug application process. This type of announcement, which is a specific update on regulatory/legal proceedings related to product development and submission status, fits best under the 'Legal Proceedings Report' (LTR) category, as it concerns official regulatory feedback and potential future legal/submission actions, or potentially 'Regulatory Filings' (RNS) as a general announcement. Given the specific nature of the FDA feedback on an NDA, LTR is a strong candidate, but since it is a direct update on a regulatory submission outcome rather than a lawsuit, 'Regulatory Filings' (RNS) serves as a robust general category for specific, non-financial regulatory news that doesn't fit elsewhere (like M&A or Director's Dealing). However, the content is fundamentally about a legal/regulatory hurdle in product approval. Comparing LTR (Legal Proceedings Report) and RNS (Regulatory Filings - fallback), LTR often covers lawsuits, while RNS covers general regulatory news. Since this is a direct communication about an FDA decision on an NDA, RNS is the most appropriate general regulatory announcement category when LTR is reserved for litigation. Given the document is a press release announcing a specific regulatory outcome, RNS is the best fit as a general regulatory announcement.
2024-07-16 Swedish
Interim / Quarterly Report 2024
Interim / Quarterly Report Classification · 1% confidence The document is a quarterly report ('Delårsrapport kv 1 2024') for Orexo, covering the period of January to March 2024. It contains comprehensive financial statements, key performance indicators (EBITDA, net sales, cash flow), management commentary, and operational updates. It is not a short announcement, but the full report itself, fitting the definition of an Interim/Quarterly Report. Q1 2024
2024-05-08 Swedish
Interim / Quarterly Report 2024
Interim / Quarterly Report Classification · 1% confidence The document is titled 'Interim Report Q1 2024' and contains comprehensive financial statements, including income statements, cash flow data, and detailed management commentary on business performance, R&D, and market outlook. It is a substantive financial report for a period shorter than a full fiscal year, fitting the definition of an Interim/Quarterly Report (IR). Q1 2024
2024-05-08 English
Kommuniké från Orexo AB:s årsstämma den 26 april 2024
AGM Information Classification · 1% confidence The document is explicitly titled "Kommuniké från Orexo AB:s årsstämma den 26 april 2024" (Communication from Orexo AB's Annual General Meeting on April 26, 2024). It details decisions made regarding the election of the board, remuneration, approval of financial statements for 2023, dividend decisions, and authorizations for share issuance and buybacks, all typical outcomes of an AGM. Although it mentions that full proposals and the CEO's presentation are available on the website, the document itself is a summary/communication of the meeting's resolutions, making it directly related to the Annual General Meeting. This aligns perfectly with the AGM Information (AGM-R) category.
2024-04-26 Swedish

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