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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 2023-01-17 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
STADA and Xbrane obtain British approval for Ximluci® (ranibizumab) biosimilar referencing Lucentis®
Regulatory Filings Classification · 95% confidence The document is a press release dated January 17, 2023, announcing that STADA and Xbrane obtained marketing authorization from the MHRA (UK regulator) for their biosimilar drug Ximluci®. It details the regulatory process (relying on an EC decision) and the commercial plans. This type of announcement, which communicates a specific regulatory or business event (like drug approval or partnership update) outside of standard periodic financial reports (10-K, IR), typically falls under general Regulatory Filings (RNS) or potentially a specific business update if one existed. Since it is a specific announcement of a regulatory event (drug approval) that doesn't fit the other specific categories (like M&A, Dividend, or Director Dealing), RNS is the most appropriate general regulatory fallback. It is not an Earnings Release (ER), Interim Report (IR), or a formal Audit Report (AR). It is not a Report Publication Announcement (RPA) because it contains the substantive news, not just an announcement that a report is attached.
2023-01-17 English
STADA och Xbrane erhåller godkännande i Storbritannien för Ximluci® (ranibizumab) biosimilar till referensläkemedlet Lucentis®
Regulatory Filings Classification · 95% confidence The document is a press release dated January 16, 2023, announcing that the MHRA (UK regulatory body) granted marketing authorization for the biosimilar drug Ximluci®. It details the partnership between STADA and Xbrane, the drug's indication, and references previous EU approval. The text concludes with boilerplate information about the companies and a section titled 'Bifogade filer' (Attached files) which links to a PDF. Since this is an announcement about a regulatory event (approval) and not a comprehensive periodic report (like 10-K or IR), and it explicitly announces the publication/attachment of the full details (implied by the link), it fits best as a general Regulatory Filing (RNS) or potentially an announcement related to a specific event. Given the content is a news announcement about a regulatory milestone, RNS is the most appropriate general category for non-standard, time-sensitive corporate news that isn't a specific financial report or management change. It is not a formal financial report (10-K, IR, ER, MRQ) nor a specific management/governance filing (MANG, DIRS, DEF 14A).
2023-01-17 Swedish
XBRANE PROVIDES AN UPDATE ON RANIBIZUMAB BIOSIMILAR CANDIDATE FDA FILING
Regulatory Filings Classification · 95% confidence The document is a short announcement from Xbrane Biopharma AB updating the timing for re-submission of a Biologics License Application (BLA) to the FDA. It discusses regulatory feedback, delays, and future updates. It is not a full financial report (like 10-K or IR), nor is it a transcript, management discussion, or director dealing report. Since it is a specific regulatory update concerning a product filing timeline, it fits best under the general 'Regulatory Filings' category (RNS) as a miscellaneous regulatory announcement, as there is no specific code for 'FDA Filing Update'. Given its nature as a formal, non-financial regulatory communication, RNS is the most appropriate fallback.
2022-12-15 English
XBRANE UPPDATERAR OM ANSÖKAN AVSEENDE MARKNADSGODKÄNNANDE TILL FDA FÖR SIN RANIBIZUMAB BIOSIMILARKANDIDAT
Regulatory Filings Classification · 95% confidence The document is a short announcement (3075 characters) from Xbrane Biopharma AB updating the timeline for an application to the FDA regarding a biosimilar candidate. It mentions that the application was previously withdrawn and is now rescheduled for Q1 2023. Crucially, the text ends with a section titled "Bifogade filer" (Attached files) and provides links to a PDF document, indicating this text serves as a notification about the status of a regulatory/business event, rather than being the full report itself. This aligns perfectly with the definition of a Report Publication Announcement (RPA) or, given the regulatory context (FDA update, EU Market Abuse Regulation disclosure), a general Regulatory Filing (RNS). Since it is an update on a specific regulatory process and not a standard financial report (like 10-K or IR), RNS is the most appropriate fallback for a general regulatory disclosure that isn't explicitly covered by other codes like DIRS, DIV, or CAP. The document explicitly states it is information Xbrane is required to publish under the EU Market Abuse Regulation, making RNS the best fit as a general regulatory disclosure.
2022-12-15 Swedish
STADA and Xbrane secure EU approval for Ximluci® (ranibizumab) biosimilar referencing Lucentis®
Regulatory Filings Classification · 95% confidence The document is a press release dated November 2022 announcing that STADA and Xbrane secured European Commission marketing authorization for their biosimilar drug, Ximluci®. It details the approval, partnership terms, and market potential. This type of announcement, which communicates a significant corporate event (regulatory approval) but is not a formal periodic financial report (like 10-K or IR) or a transcript, fits best under the general category for regulatory announcements or corporate news that doesn't fit elsewhere. Since it is a specific corporate announcement about a regulatory milestone, it is classified as a Regulatory Filing (RNS) as the best fit among the provided options, as it is not an Earnings Release (ER), Interim Report (IR), or a specific financing/capital event (CAP). The document length is substantial (7336 chars), so it is not an RPA based on the 'MENU VS MEAL' rule.
2022-11-11 English
STADA och Xbrane erhåller EU-godkännande för Ximluci® (ranibizumab) biosimilar till referensläkemedlet Lucentis®
Regulatory Filings Classification · 95% confidence The document is a press release dated November 11, 2022, announcing that STADA and Xbrane received marketing authorization from the European Commission for their biosimilar drug Ximluci®. It details the partnership, the drug's application (treating retinal diseases), and the next steps (launching in early 2023). The text concludes with boilerplate information about the companies and a final statement indicating the information is required to be disclosed under the EU Market Abuse Regulation, followed by a link to an attached PDF. Since this is an announcement regarding a significant regulatory event (drug approval) and is structured as a press release, it is best classified as a general Regulatory Filing (RNS), as it doesn't fit the specific categories like ER, IR, or CAP, but is a formal public disclosure required by regulation. It is not a full report (10-K, IR) nor a proxy/voting document.
2022-11-11 Swedish

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