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Medivir — Investor Relations & Filings

Ticker · MVIR ISIN · SE0020181014 LEI · 549300VWDGUX0WMJ1T79 ST Manufacturing
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Filings indexed 965 across all filing types
Latest filing 2014-07-28 Regulatory Filings
Country SE Sweden
Listing ST MVIR

About Medivir

https://www.medivir.com/

Medivir is a pharmaceutical company specializing in the discovery and clinical development of innovative drugs for cancer. The company focuses on oncology areas with high unmet medical needs, aiming to provide transformative treatments for patients with limited therapeutic options. Its research and development strategy is based on extensive expertise in drug design, particularly targeting enzymes such as proteases and polymerases, and includes the use of a proprietary prodrug platform. Medivir actively pursues collaborations with academic and industrial partners to advance its pipeline from research through to commercialization.

Recent filings

Filing Released Lang Actions
Fas II-data från COSMOS-studien publicerade i The Lancet i samband med Världshepatitdagen
Regulatory Filings Classification · 92% confidence The document is a press release from Medivir AB announcing that Phase II data from the COSMOS study regarding the drug simeprevir/sofosbuvir combination for Hepatitis C was published in The Lancet. It details the positive results (92% SVR12) and mentions subsequent Phase III trials initiated by their partner Janssen. This type of announcement, focusing on the publication of clinical trial results and key efficacy data, is characteristic of an Earnings Release (ER) or a general Regulatory Filing (RNS). Since it is a specific announcement about clinical data publication rather than a comprehensive financial report (10-K, IR) or a general regulatory notice, and it highlights key performance indicators (SVR12), it aligns best with an Earnings Release (ER) which often includes significant operational/clinical milestones, or potentially a Regulatory Filing (RNS) if it were less focused on immediate results. Given the focus on clinical trial success and publication, ER is a strong candidate, but since it's not a standard quarterly financial summary, RNS (Regulatory Filings - general/miscellaneous) is often used for significant non-financial operational announcements. However, many companies use ER for major clinical trial updates coinciding with reporting periods. Given the context of a major publication in a top journal, it is a significant operational update. Since there is no specific category for 'Clinical Trial Result Announcement', and it is not a full financial report, I will classify it as a Regulatory Filing (RNS) as it is a formal announcement of a material event, or ER if we interpret 'Earnings' broadly to include operational milestones. Given the structure and content (announcing publication of data), RNS is the most appropriate fallback for a material, non-standard filing. I will lean towards RNS as it is a formal announcement of a material event outside of standard financial reporting cycles, though ER is plausible if this coincided with a quarterly report period.
2014-07-28 Swedish
U.S. FDA has granted Priority Review for OLYSIO® in combination with sofosbuvir supplementary New Drug Application
Regulatory Filings Classification · 93% confidence The document is a press release from Medivir AB announcing that the U.S. FDA has granted Priority Review designation to a supplemental New Drug Application (sNDA) for their drug OLYSIO®. This announcement concerns regulatory action and updates regarding a pharmaceutical product's development status. It is not a full Annual Report (10-K), an Earnings Release (ER), a Call Transcript (CT), or a standard Audit Report (AR). Since it details a specific regulatory event (FDA action on an sNDA) and is a general corporate announcement, it fits best under the general 'Regulatory Filings' category (RNS) as a specific regulatory update that isn't covered by other specialized codes like DIRS, DIV, or CAP. Given the nature of the announcement—a specific regulatory milestone—RNS is the most appropriate fallback, although it is closely related to LTR (Legal Proceedings Report) or potentially a specialized part of an IR document, RNS serves as the best general regulatory announcement category here.
2014-07-15 English
FDA har beviljat prioriterad granskning av kompletterande registreringsansökan (sNDA) för behandling med OLYSIO® i kombination med sofosbuvir
Regulatory Filings Classification · 95% confidence The document is a press release from Medivir AB announcing that the FDA has granted Priority Review for a supplemental New Drug Application (sNDA) for Olysio. This announcement concerns regulatory progress and clinical trial data related to a drug application, which falls under the category of general regulatory announcements or updates that do not fit the specific financial report types (like 10-K, ER, IR). Since it is a specific announcement regarding regulatory action (FDA review status) and not a comprehensive financial report, it is best classified as a general Regulatory Filing (RNS), as it is a formal communication to the market about a regulatory event, or potentially LTR if it were about legal proceedings, but here it is about drug approval progress. Given the options, RNS serves as the best general regulatory announcement fallback for non-financial, non-management change news.
2014-07-15 Swedish
OLYSIO™ available soon in all Nordic countries for the treatment of adults with hepatitis C genotype 1 and 4 infection
Regulatory Filings Classification · 92% confidence The document is a press release from Medivir AB announcing the upcoming availability of their drug OLYSIO™ in Nordic countries for treating hepatitis C. It discusses product launch progress, regulatory milestones (European Commission approval), clinical trial data, and provides contact information for Investor Relations (IR). This content strongly aligns with general corporate news and investor communications, but it is not a formal regulatory filing like a 10-K, a specific financial report like an IR or MRQ, or a transcript. Since it is a press release detailing business updates, product commercialization, and regulatory progress, it fits best under the general 'Regulatory Filings' (RNS) category as a broad corporate announcement, or potentially an Investor Presentation (IP) if it were structured as slides, but given the format, RNS is the most appropriate catch-all for non-standard, material corporate news releases that aren't explicitly covered by other codes (like ER, DIV, or CAP). Given the context of providing updates to investors and the market, RNS serves as the best fit among the available options for a general press release.
2014-06-10 English
OLYSIO™ snart tillgänglig i samtliga nordiska länder för behandling av vuxna patienter med hepatit C av genotyp 1 och 4
Earnings Release Classification · 95% confidence The document is a press release from Medivir AB announcing the availability of their drug Olysio (simeprevir) in Nordic countries for treating Hepatitis C. It details the recent EU marketing authorization, clinical trial data (QUEST, PROMISE, COSMOS), and provides contact information for Investor Relations (IR). This type of announcement, focusing on product commercialization, regulatory milestones, and providing updates to investors, is characteristic of an Earnings Release (ER) or a general corporate announcement. Since it is not a full financial report (10-K, IR), a transcript (CT), or a specific regulatory filing like a Director's Dealing (DIRS) or Capital Change (CAP), it best fits the 'Earnings Release' category, which often includes key operational and commercial updates alongside financial highlights, even if explicit quarterly numbers are absent. Given the focus on a major product launch/availability following regulatory approval, ER is the most appropriate fit among the provided options for a significant corporate update. H2 2014
2014-06-10 Swedish
Major Shareholding Notification 2014
Major Shareholding Notification Classification · 99% confidence The document details a change in shareholding for an individual named Staffan Rasjö concerning Medivir Aktiebolag. It explicitly states the 'Reason for major shareholding notification Sell' and provides 'Before the transaction' and 'After the transaction' figures for shares and voting rights, culminating in a new percentage holding (e.g., Directly held voting rights 4.98 %). This structure perfectly matches the definition of a Major Shareholding Notification, which tracks when ownership crosses specific thresholds. The corresponding code is MRQ.
2014-05-21 English

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