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Orexo — Investor Relations & Filings

Ticker · ORX ISIN · SE0000736415 LEI · 549300LJ5CCWDPTK9Z08 ST Manufacturing
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Filings indexed 843 across all filing types
Latest filing 2015-01-15 Legal Proceedings Report
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 har mottagit Paragraph IV-meddelande rörande Abstral® i USA
Legal Proceedings Report Classification · 1% confidence The document is titled "Pressmeddelande" (Press Release) and announces that Orexo has received a Paragraph IV notice from Actavis regarding a generic version of Abstral®. This is a specific, time-sensitive legal/regulatory update concerning patent litigation and generic drug applications (ANDA) with the FDA. This type of announcement, detailing a legal challenge or regulatory action involving the company's products, fits best under the 'Legal Proceedings Report' (LTR) category, as it directly relates to a significant legal matter affecting intellectual property rights. It is not a full financial report (10-K, IR), an earnings release (ER), or a general regulatory filing (RNS), but a specific legal development announcement.
2015-01-15 Swedish
Declaration of Voting Results & Voting Rights Announcements 2014
Declaration of Voting Results & Voting Rights Announcements Classification · 1% confidence The document details a change in shareholding percentage for a specific holder (Handelsbanken Fonder AB) in Orexo AB, showing the 'Before the transaction' and 'After the transaction' share counts and resulting percentages. The reason for the notification is explicitly stated as 'Sell'. This type of filing, which reports changes in significant share ownership thresholds (crossing 5% in this case), directly corresponds to the Major Shareholding Notification category. The document structure and content are characteristic of insider/major shareholder transaction reporting, fitting the definition for Major Shareholding Notification (MRQ).
2014-12-18 English
Orexo erhåller delmålsersättning på 5 miljoner GBP för Abstral® i Europa och Zubsolv® fortsätter den positiva försäljningsutvecklingen i USA
Regulatory Filings Classification · 1% confidence The document is titled "Pressmeddelande" (Press Release) and announces specific financial milestones, such as receiving a milestone payment of 5 MGBP for Abstral and updates on Zubsolv sales in the US. It includes financial figures, partnership details, and management commentary. Crucially, the final line states: "Informationen lämnades för offentliggörande den 17 december 2014 kl 08.45" (The information was released for public disclosure on December 17, 2014 at 08:45). This structure strongly indicates an immediate public disclosure of material, non-periodic information. Since it is not a full Annual Report (10-K), a comprehensive Interim Report (IR), or a specific regulatory filing like a Director's Dealing (DIRS) or Proxy Statement (DEF 14A), it fits best as an Earnings Release (ER) if it were quarterly results, or more generally, a Regulatory Filing (RNS) for miscellaneous material announcements. Given the content is a specific, material business update rather than a summary of period results (ER) or a formal report announcement (RPA), RNS is the most appropriate general regulatory disclosure category for this type of press release that doesn't fit a more specific code like DIV or CAP.
2014-12-17 Swedish
Orexo receives million 5£ milestone payment for Abstral® in Europe and Zubsolv® continues strong market share growth in the US
Earnings Release Classification · 1% confidence The document is a press release dated December 17, 2014, announcing a milestone payment received by Orexo AB due to sales performance of Abstral in Europe and providing an update on Zubsolv growth in the US. It details financial achievements, partnership updates, and market share data. This type of announcement, focusing on key financial highlights and business updates outside of a formal quarterly or annual filing, is characteristic of an Earnings Release (ER). It is not a full Annual Report (10-K), an Interim Report (IR), or a transcript (CT). Given its nature as an initial announcement of financial performance milestones, ER is the most appropriate classification. FY 2014
2014-12-17 English
FDA godkänner två högre styrkor av Zubsolv®
Regulatory Filings Classification · 1% confidence The document is titled "Pressmeddelande" (Press Release) and announces that the FDA has approved two higher strengths of the drug Zubsolv®. It includes details about the approval, expected launch dates, quotes from the CEO, and standard company/product information. Crucially, the final line states: "Informationen lämnades för offentliggörande den 12 december 2014, kl 08.30." This structure strongly indicates an immediate public announcement of a significant event (regulatory approval), which aligns best with a general Regulatory Filing (RNS) or potentially an Earnings Release (ER) if it were tied to a specific reporting period, but since it's a specific regulatory event announcement, RNS is the most appropriate general category for non-standard filings. Given the short length (4675 chars) and the nature of announcing a regulatory milestone rather than providing comprehensive financial statements (like 10-K or IR), RNS is the best fit as a general regulatory announcement.
2014-12-12 Swedish
FDA approves two higher dosage strengths of ZUBSOLV®
Regulatory Filings Classification · 1% confidence The document is titled "Press release" and announces that the FDA approved two higher dosage strengths of ZUBSOLV®. It includes a date (December 12, 2014), quotes from the CEO, and standard sections like 'About Orexo AB' and 'Important Safety Information'. This format is characteristic of an initial announcement of significant corporate or product news, often released before or alongside a more detailed regulatory filing. Since it is a press release announcing a regulatory approval (FDA approval), it is not a full Annual Report (10-K), an Interim Report (IR), or a specific financial filing like DEF 14A or DIV. It is a general corporate announcement. Given the options, the most fitting category for a press release announcing a major regulatory event, which is not a transcript (CT), a management change (MANG), or a specific financial report, is the general Regulatory Filings category (RNS), as it serves as a broad announcement mechanism for material, non-standardized news. However, since the content is primarily focused on the *results* of regulatory action (FDA approval) and is presented as a press release, it is often classified as an Earnings Release (ER) if it contains key financial/operational highlights, or RNS if it's purely regulatory/corporate news. Since this is a product approval announcement, it is a significant corporate event announcement. Given the available codes, RNS (Regulatory Filings/General Announcement) is the best fit for a press release detailing a regulatory milestone that isn't a formal financial report or earnings release.
2014-12-12 English

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