Skip to main content
Xbrane Biopharma logo

Xbrane Biopharma — Investor Relations & Filings

Ticker · XBRANE ISIN · SE0007789409 LEI · 5493008DKD05APTKQO39 ST Manufacturing
Open in API
Filings indexed 359 across all filing types
Latest filing 2023-08-29 Earnings Release
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 UPPDATERAR SIN AMBITION ATT GENERERA POSITIVT OPERATIVT KASSAFLÖDE PÅ MÅNADSBASIS INNAN SLUTET AV FÖRSTA KVARTALET 2025
Earnings Release Classification · 100% confidence The document is a press release from Xbrane Biopharma updating its guidance regarding achieving positive operating cash flow. It discusses financial targets, development costs, revenue sources (Ximluci®, BIIB801), and mentions an upcoming webcast. Crucially, the text ends with a statement indicating it is information Xbrane is required to disclose under EU Market Abuse Regulation and provides links to attached files (PDFs). Since the document itself is an announcement about business/financial updates and does not appear to be a full quarterly report (IR), an earnings release (ER), or a formal regulatory filing like a 10-K, it fits best as a general regulatory announcement or update. Given the content focuses on financial outlook and operational milestones, it is most closely aligned with an Earnings Release (ER) if it were the primary results, but since it's an *update* to guidance and is presented as a short announcement with attached files, it functions as a general regulatory disclosure. However, because it details financial performance expectations and operational progress, it is more specific than a generic RNS. Since it is not a full financial report (IR) or a preliminary earnings highlight (ER), and it is an announcement of information, the closest fit among the options that cover general corporate updates, especially those related to financial outlook, is often RNS if no better fit exists. Given the content is a specific update on financial targets and operational progress, and it is presented as a regulatory disclosure ('EU:s marknadsmissbruksförordning'), it is a regulatory announcement. Since it is not a formal financial statement, 'RNS' (Regulatory Filings/General Regulatory Announcements) is the most appropriate fallback for this type of market-sensitive, non-standard report announcement. FY 2023
2023-08-29 Swedish
STADA and Xbrane weigh options for ranibizumab biosimilar candidate
Regulatory Filings Classification · 100% confidence The document is a press release dated July 25, 2023, announcing that STADA and Xbrane are considering options, including out-licensing, for their ranibizumab biosimilar candidate in North America, following the discontinuation of a license agreement with Bausch + Lomb. It discusses regulatory filings (FDA BsUFA action date) and market strategy. The final section includes a statement: "This information is information that Xbrane Biopharma is obliged to make public pursuant to the EU Market Abuse Regulation." This strongly suggests a mandatory regulatory disclosure, but it is not a standard SEC form (like 10-K, ER, or DEF 14A). Since it is a general, material announcement required by market regulations that doesn't fit the specific categories like M&A (TAR), Capital Change (CAP/SHA), or Director Dealing (DIRS), the most appropriate fallback category is Regulatory Filings (RNS). The document length (5751 chars) is substantial enough that it is the report itself, not just an announcement of a report (RPA).
2023-07-25 English
STADA och Xbrane överväger alternativ, inklusive utlicensiering av sin ranibizumab biosimilarkandidat
Regulatory Filings Classification · 95% confidence The document is a press release dated July 24, 2023, announcing that STADA and Xbrane are terminating a commercial license agreement with Bausch + Lomb regarding their ranibizumab biosimilar candidate for North America and are exploring alternatives, including out-licensing. It discusses regulatory progress (FDA application validation, BsUFA date) and market strategy. The final line states: "Denna information är sådan information som Xbrane Biopharma är skyldigt att offentliggöra enligt EU: s marknadsmissbruksförordning." (This information is information that Xbrane Biopharma is obliged to disclose pursuant to the EU's Market Abuse Regulation.) This strongly indicates a mandatory regulatory disclosure. Since it is an announcement about business/strategic changes and not a specific financial report (10-K, IR, ER) or a proxy/governance document, and it is a general regulatory announcement required under EU rules, the most appropriate classification is Regulatory Filings (RNS), which serves as the general regulatory announcement fallback category.
2023-07-25 Swedish
Xbrane meddelar idag att bolagets ansökan till FDA avseende en biosimilarkandidat till Lucentis® (ranibizumab) validerats av myndigheten
Regulatory Filings Classification · 100% confidence The document is a press release from Xbrane Biopharma announcing that the FDA has accepted their Biologics License Application (BLA) for a biosimilar candidate. It details the regulatory step taken ('ansökan... validerats'), mentions collaboration partners (STADA, Bausch + Lomb), and provides clinical trial context. Crucially, the document ends with a section titled 'Bifogade filer' (Attached files) which links to the full PDF announcement. Since the text itself is an announcement about a regulatory event and points to an attached file, it fits the definition of a Report Publication Announcement (RPA) or a general Regulatory Filing (RNS). Given that this is a specific announcement regarding a regulatory milestone (FDA application acceptance), and it is presented as a news release with an attachment, RPA is a strong candidate if it's announcing the publication of a more formal document, or RNS as a general regulatory announcement. Since the content is a specific, time-sensitive regulatory update that doesn't fit the comprehensive financial reports (10-K, IR) or specific management/governance reports, RNS (Regulatory Filings - general regulatory announcements) is the most appropriate fallback, although RPA is also plausible if this text is merely the cover note for the attached PDF. Given the content is a direct update on a regulatory process, RNS is selected as the best fit for a non-standard, specific regulatory news item.
2023-06-21 Swedish
Xbrane announce U.S. FDA filing acceptance for a Lucentis® (ranibizumab) biosimilar candidate
Regulatory Filings Classification · 95% confidence The document is a press release titled "Xbrane announce U.S. FDA filing acceptance for a Lucentis® (ranibizumab) biosimilar candidate." It details a specific regulatory event (sBLA acceptance by the FDA) and provides context on the drug, agreements, and clinical data. It is not a full financial report (10-K or IR), an earnings release (ER), or a transcript (CT). It is an announcement regarding a regulatory/development milestone. Since it is a specific announcement about a regulatory process milestone, it fits best under the general 'Regulatory Filings' (RNS) category, as it is a formal communication to the market about regulatory progress, rather than a specific financial report or management change. Given the content is a news announcement about a regulatory step, RNS is the most appropriate general regulatory category available, although it is not a standard SEC filing.
2023-06-21 English
Major Shareholding Notification 2023
Major Shareholding Notification Classification · 99% confidence The document details a change in shareholding for 'Futur Pension Holding AB' in 'Xbrane Biopharma AB'. It explicitly lists the 'Resulting distribution of total holdings', the 'Number of underlying shares', and the 'Percentage of voting rights' crossing a threshold (implied by the structure, even if the exact threshold notification text is brief: 'Reason for major shareholding notification Corporate action'). This structure is characteristic of a notification regarding a significant change in ownership, which aligns with the definition of Major Shareholding Notification (MRQ). The document is short and appears to be the official filing itself, not an announcement of a filing.
2023-06-02 English

Browse filings by year

8 years

Report missing filing

Can't find a specific document? Let us know and we'll add it within 24 hours.

We will notify you once the filing is added.
Report sent
Thank you. We will check the data and update it shortly.