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Xbrane Biopharma — Investor Relations & Filings

Ticker · XBRANE ISIN · SE0007789409 LEI · 5493008DKD05APTKQO39 ST Manufacturing
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Filings indexed 359 across all filing types
Latest filing 2024-08-01 Regulatory Filings
Country SE Sweden
Listing ST XBRANE

About Xbrane Biopharma

https://xbrane.com/en/

Xbrane Biopharma is a biotechnology company that specializes in the development of biosimilars—follow-on versions of approved biological drugs. The company's mission is to enhance the accessibility of biological treatments for serious diseases by creating more affordable alternatives. Xbrane utilizes a patented platform technology and efficient manufacturing systems, employing both bacterial and mammalian cells, to achieve lower production costs. Its development pipeline includes several biosimilar candidates, with a key product being a ranibizumab biosimilar.

Recent filings

Filing Released Lang Actions
Xbrane återfår fullständiga rättigheter till BIIB801, en föreslagen biosimilar till CIMZIA®
Regulatory Filings Classification · 95% confidence The document is a press release from Xbrane Biopharma AB announcing that Biogen Inc. terminated the commercialization and license agreement for the product BIIB801, causing all rights to revert to Xbrane. It details the product, the financial implications (delaying positive cash flow target), and the initiation of a new out-licensing process. The text concludes with a timestamp and a statement indicating the information is required to be made public under EU Market Abuse Regulation, followed by a link to an attached PDF file. Since the document itself is an announcement about a corporate event/update and explicitly mentions that the full details are in an attached file (indicated by the link and the structure), it fits the criteria for a Report Publication Announcement (RPA) or a general Regulatory Filing (RNS). Given that this is a specific corporate update about a licensing agreement termination and subsequent strategic shift, it is more specific than a general RNS. However, it is not a full financial report (10-K, IR), a management discussion (MDA), or an earnings release (ER). It is an announcement of a significant corporate event. Since there is no specific category for 'Corporate Event Announcement' other than the general 'RNS' or 'RPA' (if it were announcing the publication of a formal report), I must choose the best fit. This document is a formal announcement of a material event, often disseminated via regulatory news services. It is not a proxy statement (PSI), director dealing (DIRS), or capital change (CAP). It is closest to a general regulatory announcement, but since it is a formal press release announcing a material change, and the document itself is short and points to an attachment, RPA is a strong candidate if it were announcing a report. Since it is announcing a corporate action/decision, RNS (Regulatory Filings - fallback) is appropriate, but let's re-evaluate against the definitions. It is not a DVA (voting results), LTR (legal), or MANG (board change). It is a significant business update. In many contexts, such press releases are classified as RNS. Given the options, RNS is the most appropriate fallback for a material, non-standard announcement.
2024-08-01 Swedish
Xbrane Provides update on timing of re-submission of BLA for ranibizumab biosimilar candidate
Report Publication Announcement Classification · 98% confidence The document is a short press release (2518 characters) providing an update on the timing of a Biologics License Application (BLA) resubmission to the FDA following a Complete Response Letter (CRL). It details regulatory interactions and future timelines. Crucially, the document ends with an 'Attachments' section linking to the full text/PDF of the announcement. According to Rule 2 (The 'MENU VS MEAL' Rule), a short document announcing the publication of information, rather than being the full report itself, should be classified as a Report Publication Announcement (RPA) or Regulatory Filing (RNS). Since this is a specific regulatory/business update announcement, RPA is the most appropriate fit, as it announces the publication of this specific update.
2024-07-08 English
Xbrane uppdaterar om tidpunkt för återinskick av BLA för ranibizumab biosimilar kandidat
Regulatory Filings Classification · 100% confidence The document is a short press release (2511 characters) written in Swedish. The title and content discuss an update regarding the resubmission timeline for a Biologics License Application (BLA) following a Complete Response Letter (CRL) from the FDA. It provides an update on regulatory progress and future plans (resubmission in Q4 2024). Crucially, the end of the document contains a link to an attached PDF file: "Bifogade filer [Xbrane uppdaterar om tidpunkt för återinskick av BLA...].pdf". According to Rule 2 (The 'MENU VS MEAL' Rule), a short document announcing the publication of a report or filing, often with an attached file link, should be classified as a Report Publication Announcement (RPA) rather than the underlying report itself. Since this is an announcement about a regulatory/development update, RPA is the most appropriate classification.
2024-07-08 Swedish
Interim / Quarterly Report 2024
Interim / Quarterly Report Classification · 100% confidence The document is a 'Delårsrapport' (Interim Report) for the period January–March 2024 for Xbrane Biopharma. It contains comprehensive financial statements, including income statements, balance sheet summaries, cash flow data, and detailed management commentary on business performance, product portfolio, and market outlook. It is not an announcement of a report, but the report itself, and it contains substantive financial data, fitting the definition of an Interim/Quarterly Report. Q1 2024
2024-05-16 Swedish
Interim / Quarterly Report 2024
Interim / Quarterly Report Classification · 100% confidence The document is titled 'Interim report January – March 2024' and contains comprehensive financial statements, including a financial summary table, income statement data, and a CEO's letter discussing quarterly performance. It provides substantive financial data and analysis for a period shorter than a full fiscal year, fitting the definition of an Interim/Quarterly Report (IR). Q1 2024
2024-05-16 English
Major Shareholding Notification 2024
Major Shareholding Notification Classification · 99% confidence The document details a change in shareholding ('Major shareholding notification') by Avanza Bank Holding AB for its pension subsidiary, specifically noting the 'Reason for major shareholding notification Sell' and providing detailed figures for shares held, voting rights, and the resulting percentage, which crossed a threshold ('Flaggning sker för passerat tröskelvärde'). This structure perfectly matches the definition of a Major Shareholding Notification, which corresponds to the code MRQ.
2024-05-10 English

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