Xbrane Biopharma AB (publ) (“Xbrane” or “the Company”) (Nasdaq Stockholm: XBRANE) receives FDA BsUFA date of October 29, 2026 for its investigational biosimilar candidate to LUCENTIS® (ranibizumab)
Prenumeration
Kalender
| Est. tid* | ||
| 2027-02-19 | 08:00 | Bokslutskommuniké 2026 |
| 2026-10-30 | 08:00 | Kvartalsrapport 2026-Q3 |
| 2026-07-17 | 08:00 | Kvartalsrapport 2026-Q2 |
| 2026-05-06 | - | X-dag ordinarie utdelning XBRANE 0.00 SEK |
| 2026-05-05 | - | Årsstämma |
| 2026-05-05 | - | Kvartalsrapport 2026-Q1 |
| 2026-02-20 | - | Bokslutskommuniké 2025 |
| 2025-10-24 | - | Kvartalsrapport 2025-Q3 |
| 2025-10-17 | - | Split XBRANE 125:1 |
| 2025-10-13 | - | Extra Bolagsstämma 2025 |
| 2025-08-26 | - | Kvartalsrapport 2025-Q2 |
| 2025-05-08 | - | Kvartalsrapport 2025-Q1 |
| 2025-05-06 | - | X-dag ordinarie utdelning XBRANE 0.00 SEK |
| 2025-05-05 | - | Årsstämma |
| 2025-02-21 | - | Bokslutskommuniké 2024 |
| 2024-10-24 | - | Kvartalsrapport 2024-Q3 |
| 2024-08-28 | - | Kvartalsrapport 2024-Q2 |
| 2024-05-16 | - | Kvartalsrapport 2024-Q1 |
| 2024-05-03 | - | X-dag ordinarie utdelning XBRANE 0.00 SEK |
| 2024-05-02 | - | Årsstämma |
| 2024-02-26 | - | Bokslutskommuniké 2023 |
| 2024-02-22 | - | Extra Bolagsstämma 2024 |
| 2023-11-30 | - | Kvartalsrapport 2023-Q3 |
| 2023-08-29 | - | Kvartalsrapport 2023-Q2 |
| 2023-05-31 | - | Kvartalsrapport 2023-Q1 |
| 2023-05-05 | - | X-dag ordinarie utdelning XBRANE 0.00 SEK |
| 2023-05-04 | - | Årsstämma |
| 2023-02-17 | - | Bokslutskommuniké 2022 |
| 2022-10-28 | - | Kvartalsrapport 2022-Q3 |
| 2022-07-22 | - | Kvartalsrapport 2022-Q2 |
| 2022-05-06 | - | X-dag ordinarie utdelning XBRANE 0.00 SEK |
| 2022-05-05 | - | Årsstämma |
| 2022-05-05 | - | Kvartalsrapport 2022-Q1 |
| 2022-02-24 | - | Bokslutskommuniké 2021 |
| 2021-10-29 | - | Kvartalsrapport 2021-Q3 |
| 2021-08-13 | - | Kvartalsrapport 2021-Q2 |
| 2021-05-07 | - | X-dag ordinarie utdelning XBRANE 0.00 SEK |
| 2021-05-06 | - | Årsstämma |
| 2021-05-06 | - | Kvartalsrapport 2021-Q1 |
| 2021-02-26 | - | Bokslutskommuniké 2020 |
| 2020-11-13 | - | Kvartalsrapport 2020-Q3 |
| 2020-09-22 | - | Extra Bolagsstämma 2020 |
| 2020-08-21 | - | Kvartalsrapport 2020-Q2 |
| 2020-06-22 | - | X-dag ordinarie utdelning XBRANE 0.00 SEK |
| 2020-06-18 | - | Årsstämma |
| 2020-05-14 | - | Årsstämma |
| 2020-05-13 | - | Kvartalsrapport 2020-Q1 |
| 2020-02-28 | - | Bokslutskommuniké 2019 |
| 2019-11-15 | - | Kvartalsrapport 2019-Q3 |
| 2019-08-23 | - | Kvartalsrapport 2019-Q2 |
| 2019-06-18 | - | Extra Bolagsstämma 2019 |
| 2019-05-17 | - | X-dag ordinarie utdelning XBRANE 0.00 SEK |
| 2019-05-16 | - | Årsstämma |
| 2019-05-14 | - | Kvartalsrapport 2019-Q1 |
| 2019-02-28 | - | Bokslutskommuniké 2018 |
| 2018-11-16 | - | Kvartalsrapport 2018-Q3 |
| 2018-08-24 | - | Kvartalsrapport 2018-Q2 |
| 2018-05-25 | - | X-dag ordinarie utdelning XBRANE 0.00 SEK |
| 2018-05-14 | - | Kvartalsrapport 2018-Q1 |
| 2018-04-03 | - | Extra Bolagsstämma 2018 |
| 2018-02-28 | - | Bokslutskommuniké 2017 |
| 2017-11-13 | - | Kvartalsrapport 2017-Q3 |
| 2017-08-31 | - | Kvartalsrapport 2017-Q2 |
| 2017-05-19 | - | X-dag ordinarie utdelning XBRANE 0.00 SEK |
| 2017-05-18 | - | Årsstämma |
| 2017-05-18 | - | Kvartalsrapport 2017-Q1 |
| 2017-03-07 | - | Kapitalmarknadsdag 2017 |
| 2017-02-27 | - | Bokslutskommuniké 2016 |
| 2016-11-21 | - | Kvartalsrapport 2016-Q3 |
| 2016-08-22 | - | Kvartalsrapport 2016-Q2 |
| 2016-05-27 | - | X-dag ordinarie utdelning XBRANE 0.00 SEK |
| 2016-05-27 | - | Kvartalsrapport 2016-Q1 |
| 2016-05-26 | - | Årsstämma |
| 2016-02-18 | - | Bokslutskommuniké 2015 |
| 2015-10-23 | - | Kvartalsrapport 2015-Q3 |
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
Intresserad av bolagets nyckeltal?
Analysera bolaget i Börsdata!
Vem äger bolaget?
All ägardata du vill ha finns i Holdings!
Xbrane Biopharma AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmitted Biologics License Application (BLA) for the Company's investigational biosimilar candidate to LUCENTIS® (ranibizumab) and set a BsUFA (Biosimilar User Fee Act) action date of October 29, 2026.
The BsUFA date marks the target date by which the FDA expects to complete its review of the resubmitted application. The acceptance follows Xbrane's resubmission of the BLA to the FDA in April 2026, which addressed the items raised in the Complete Response Letter received in October 2025.
The candidate is intended to be marketed in the United States under the brand name Lucamzi™.
The product is already approved and marketed in Europe under the brand name Ximluci®, where it was launched in 2023 as a biosimilar to LUCENTIS® (ranibizumab), used in the treatment of a range of retinal disorders.
Contacts
Martin Åmark, CEO
E: martin.amark@xbrane.com
Jane Benyamin, CFO/IR
E: jane.benyamin@xbrane.com
About Us
Xbrane Biopharma AB develops biological drugs based on a patented platform technology that provides significantly lower production costs compared to competing systems. Xbrane has a portfolio of biosimilar candidates targeting EUR 23 billion in estimated annual peak sales of the respective reference product. The lead candidate Ximluci® is granted market authorization approval in Europe and was launched during 2023. Xbrane’s head office is in Solna, just outside Stockholm. Xbrane is listed on Nasdaq Stockholm under the ticker XBRANE. For more information, visit www.xbrane.com
This information is information that Xbrane Biopharma is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-06-03 18:00 CEST.