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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 2012-09-25 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 provides update on simplified market situation for Zubsolv™ (OX219) in United States
Legal Proceedings Report Classification · 1% confidence The document is explicitly titled "Press release" and announces a major change in the competitive landscape for the drug Zubsolv™ due to a competitor discontinuing supply. It discusses the FDA review process, market dynamics, and future launch projections (Q3, 2013). This content is a direct communication of material, non-public information to the market, typical of an Earnings Release (ER) or a general Regulatory Filing (RNS). Since it is not a full financial report (10-K, IR) or a transcript (CT), and it focuses on business/market updates rather than just dividend/share changes, ER is the closest fit for a significant business/market event announcement. However, given the nature of the announcement (a competitor's action impacting the market for a pending product) and the format being a general press release, it fits well under the broad category of a significant regulatory/market announcement. Since it is not a formal earnings report, but a material business update, and it is short (4610 chars), it could potentially be RNS, but ER often covers major business developments outside of quarterly results. Given the focus on market impact and product status, ER is slightly more specific than RNS, but RNS is the safest fallback for non-standard announcements. Let's re-evaluate the definitions. ER is for 'Initial announcement of quarterly/periodical financial results (key highlights only)'. This is not a financial results announcement. Therefore, it falls best into the general category of a Regulatory Filing (RNS) as it is a material, non-standard announcement required to be made public.
2012-09-25 English
Orexo presents an update on the US opioid dependence market, and the commercial opportunities for Zubsolv™ (OX219)
Regulatory Filings Classification · 1% confidence The document is explicitly titled "Press release" and discusses Orexo's view on the US opioid dependence market and commercial opportunities for Zubsolv, including market projections, clinical programs, and commercialization strategy analysis. It is not a formal regulatory filing like a 10-K, an official earnings release (ER) which usually contains summarized financial tables, or a transcript (CT). It functions as an update and presentation of strategic information to investors, often accompanying a presentation event (as it mentions 'Orexo will at the meeting also present...'). This content aligns best with an Investor Presentation (IP) or a detailed strategic update. Given the context of presenting views, projections, and strategic plans, Investor Presentation (IP) is the most fitting category, as it details strategy and market positioning for investors, even if formatted as a press release.
2012-09-21 English
Orexo ger en uppdatering om den amerikanska marknaden för opiatberoende och möjligheter till kommersialisering av Zubsolv™ (OX219)
Earnings Release Classification · 1% confidence The document is titled "Pressmeddelande" (Press Release) and provides an update on the US market for opioid dependence treatment and commercialization opportunities for Zubsolv™. It discusses market size projections, competitive differentiation (against Suboxone®), planned clinical programs, launch timelines (Q3 2013), and strategic commercialization options. This content is characteristic of an initial announcement of key business and financial updates, rather than a comprehensive periodic report (like 10-K or IR) or a transcript. It fits best under the Earnings Release (ER) category, which covers initial announcements of periodical financial results and key business highlights, even though this specific release focuses heavily on commercial strategy rather than just quarterly numbers. Since it is a press release announcing business updates and market outlook, ER is the most appropriate fit among the defined categories. It is not a formal regulatory filing like 10-K or IR, nor is it a mere announcement of a report (RPA). FY 2012
2012-09-21 Swedish
Orexo invites to a Zubsolv™ (OX219) information meeting on September 21 in Stockholm
Report Publication Announcement Classification · 1% confidence The document is a press release dated September 17, 2012, announcing an 'information meeting' for analysts, investors, and media regarding the product Zubsolv™. It details the date, time, and location of this meeting. Crucially, the last paragraph states: 'The presentation will be posted at Orexos homepage, [www.orexo.com,] following the meeting.' This indicates the document itself is an announcement about an upcoming event where presentation materials will be shared later, rather than the presentation itself (IP) or a formal regulatory filing. Since it is announcing an event where information will be shared, and it is not a standard regulatory filing like 10-K or ER, it most closely aligns with a general announcement or a precursor to an investor presentation. Given the options, and the fact that it is an invitation to an information meeting about a product and company strategy, it is related to investor communication. However, the most specific category for announcing the *publication* of a report or presentation is 'Report Publication Announcement' (RPA). While this is an announcement of a meeting, the final sentence confirms a presentation will be posted afterward. If the document were the presentation itself, it would be 'IP'. As it is a short announcement inviting people to an event where materials will be presented and subsequently posted, it functions as a notice about forthcoming investor information. Given the short length (3377 chars) and the focus on announcing an event where materials will be shared, RPA is a strong candidate, as it signals the release of future investor materials. Alternatively, since it is an invitation to an information meeting, it could be seen as a general investor relations communication. Given the options, and the focus on an upcoming presentation, I will classify it as an Investor Presentation (IP) if the meeting content is the focus, or RPA if it's just the announcement of the meeting. Since the text describes the content of the meeting (market dynamics, development activities) and explicitly states the presentation will be posted afterward, it is highly related to an Investor Presentation (IP). However, following the 'MENU VS MEAL' rule, this is an announcement *about* the meeting, not the presentation itself. Therefore, RPA (Report Publication Announcement) is the most appropriate fit for announcing the upcoming availability of investor materials following an event.
2012-09-17 English
Orexo bjuder in till Informationsträff kring Zubsolv™ (OX219) den 21 september 2012 i Stockholm
Regulatory Filings Classification · 1% confidence The document is a press release dated September 17, 2012, announcing an 'Informationsträff' (Information Meeting) scheduled for September 21, 2012, regarding their product Zubsolv™. This meeting is specifically for analysts, investors, and media to discuss the recent FDA filing and future strategy. Since the document is an announcement about an upcoming event where presentations will be given, and it explicitly states that the presentation material will be made available afterward on the website, it functions as an announcement regarding future investor communication or presentation. This aligns best with the 'Investor Presentation' (IP) category if the meeting itself is the primary focus, or potentially 'Report Publication Announcement' (RPA) if it were announcing the release of a formal report. However, given the context of an invitation to an information meeting focused on strategy and market outlook following a major filing, it is most closely related to investor engagement materials. Since it is an invitation to an event where an investor presentation will occur, and the material will be published later, it is a precursor to a formal presentation. In the context of the provided definitions, 'Investor Presentation' (IP) is the closest fit for materials presented to investors about strategy and financials, even if this specific document is the invitation to the event where the presentation happens. Alternatively, because it is a short announcement detailing an upcoming event where materials will be shared, it could be classified as a 'Report Publication Announcement' (RPA) if interpreted as announcing the upcoming release of the presentation materials. Given the focus on inviting investors to hear about strategy and the filing, 'Investor Presentation' (IP) is a strong candidate, but the 'MENU VS MEAL' rule suggests short announcements about future content lean towards RPA or RNS. Since it is a specific announcement about an investor event, I will classify it as an Investor Presentation (IP) as the core subject matter is the presentation content, despite this being the invitation.
2012-09-17 Swedish
Swedish specialty pharmaceutical company Orexo announced today the submission of a New Drug Application for Zubsolv™ (OX219) to the US FDA
Regulatory Filings Classification · 1% confidence The document is explicitly labeled as a "Press release" dated September 6, 2012, announcing the submission of a New Drug Application (NDA) for Zubsolv™ to the US FDA. This is a significant corporate event announcement related to product development and regulatory milestones, not a comprehensive financial report (like 10-K or IR), a transcript (CT), or a formal shareholder communication (like DEF 14A or AGM-R). Since it is a specific announcement of a major corporate event (drug application submission) that doesn't fit the other specific categories like M&A (TAR) or Capital Change (CAP), it falls best under the general category for regulatory/corporate announcements that aren't financial results or governance updates. Given the options, 'Regulatory Filings' (RNS) is the most appropriate fallback for a press release detailing a regulatory submission, although it could also be argued as a general corporate update. However, RNS is defined as 'General regulatory announcements and fallback category for miscellaneous filings'. Since this is a press release announcing a regulatory action (NDA submission), RNS is the best fit among the provided codes.
2012-09-06 English

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