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Orexo — Investor Relations & Filings

Ticker · ORX ISIN · SE0000736415 LEI · 549300LJ5CCWDPTK9Z08 ST Manufacturing
Open in API
Filings indexed 843 across all filing types
Latest filing 2014-06-30 Regulatory Filings
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
Orexo ingår nu i Russell Global Index
Regulatory Filings Classification · 1% confidence The document is a 'Pressmeddelande' (Press Release) dated June 30, 2014, announcing that Orexo's stock has been included in the Russell Global Index following the annual index review. This type of announcement, which concerns the company's stock listing status and market visibility rather than core financial results (10-K, ER, IR) or management changes (MANG), fits best under general regulatory announcements or market-related news. Since there is no specific category for 'Index Inclusion Announcement', and it is a formal, market-moving announcement, it falls under the general 'Regulatory Filings' (RNS) category, which serves as a fallback for miscellaneous official announcements not covered by more specific codes like DIV, CAP, or DIRS. The document length is short (2563 chars), but it is the primary content, not an announcement *about* another report, so RPA is not appropriate.
2014-06-30 Swedish
Orexo stämmer Actavis för patentintrång
Legal Proceedings Report Classification · 1% confidence The document is titled "Pressmeddelande" (Press Release) and announces that Orexo has filed a lawsuit against Actavis for patent infringement regarding their drug ZUBSOLV®. This concerns a legal dispute and regulatory action related to intellectual property and market entry (ANDA application). Among the provided categories, 'Legal Proceedings Report' (LTR) is the most appropriate fit for updates on significant lawsuits or regulatory actions involving the company. The document is a direct announcement of the legal action, not a general regulatory filing (RNS) or a comprehensive financial report.
2014-06-27 Swedish
Orexo commences patent infringement litigation against Actavis
Legal Proceedings Report Classification · 1% confidence The document is a press release dated June 27, 2014, announcing that Orexo AB has filed a patent infringement lawsuit against Actavis regarding its ZUBSOLV® product. This content directly relates to significant legal action and regulatory matters (patent disputes, FDA Orange Book listings, ANDA filing). Among the provided categories, 'Legal Proceedings Report' (LTR) is the most appropriate fit for updates on significant lawsuits or regulatory actions involving the company. It is not an earnings release, annual report, or management discussion.
2014-06-27 English
Top-line data from a Phase 3 clinical trial demonstrates that Zubsolv® is as effective as Suboxone® film in the treatment of opioid dependence
Earnings Release Classification · 1% confidence The document is explicitly labeled as a "Press release" announcing "Top-line data from a Phase 3 clinical trial" regarding the drug Zubsolv®. It details the results of the ISTART study, including primary and secondary endpoints, and includes quotes from the CEO and investigator. This format—a news announcement summarizing key findings, often related to clinical trials or financial performance—is characteristic of an Earnings Release (ER) or a general announcement. Since it is a press release announcing clinical trial results rather than a comprehensive financial report (10-K, IR) or a transcript (CT), the most fitting category among the provided options is Earnings Release (ER), as clinical trial updates are frequently bundled with or released around earnings periods to provide operational highlights. It is not a formal regulatory filing like 10-K or a dedicated report like AR or SR. Given the context of a major clinical data announcement, ER is the best fit for a high-impact operational update released via press release. FY 2014
2014-06-25 English
Klinisk studie visar att Zubsolv® (buprenorfin/naloxon sublingual tablett) är lika effektiv som Suboxone® film för behandling av opiatberoende
Regulatory Filings Classification · 1% confidence The document is titled "Pressmeddelande" (Press Release) and announces the results of a clinical study (ISTART) for the drug Zubsolv®. It details efficacy data, compares it to Suboxone®, and includes quotes from the CEO and study lead. The text concludes with a standard disclaimer about information disclosure according to financial instrument laws, dated June 25, 2014. This format—a formal announcement of significant operational/clinical news intended for immediate public dissemination—is characteristic of an Earnings Release (ER) or a general Regulatory Filing (RNS). Since it is a specific announcement of clinical trial results rather than a comprehensive periodic financial report (like 10-K or IR), and it is not a transcript (CT) or a presentation (IP), it fits best as an Earnings Release (ER) if it were tied to a reporting period, or more generally, a Regulatory Filing (RNS) as it is a material announcement. Given the context of financial reporting databases, press releases announcing key operational milestones or clinical data often fall under ER if they contain performance metrics, or RNS if they are purely regulatory/operational updates. Since this is a major clinical data release, it functions similarly to an earnings announcement in terms of market impact. However, it is not explicitly an 'Earnings Release' covering revenue/profit. It is a material announcement. Since it doesn't fit perfectly into ER (no P&L), and it's a specific, non-standard announcement, RNS (Regulatory Filings / General Announcement) is the most appropriate fallback, although ER is plausible if the database treats major operational news as such. Given the structure, it is a formal announcement of a material event, which aligns well with the broad scope of RNS, or potentially ER if the company uses ER for all major news releases. I will classify it as RNS as it is a general regulatory/material announcement not covered by other specific codes.
2014-06-25 Swedish
Positive Top-line Results from Two Phase 3 Clinical Trials that Assessed Zubsolv® for Induction of Buprenorphine Maintenance Therapy
Regulatory Filings Classification · 1% confidence The document is explicitly titled "Press release" and announces positive top-line results from clinical trials assessing a drug (Zubsolv). It details study names (ISTART, OX219-007), efficacy data, and states the intention to 'pursue a regulatory submission of an expanded label'. This format—a news announcement summarizing key findings and future regulatory steps—is characteristic of an Earnings Release (ER) or a general corporate announcement. Since it is not a full financial report (10-K, IR) or a transcript (CT), and it is a direct release of performance information, ER is the most appropriate fit, even though the content is clinical trial data rather than quarterly financials. It is a primary announcement of results.
2014-06-23 English

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