Bifogade filer
Xbrane provides an update on the timeline for resubmission of the market authorization application in the United States
Prenumeration
Kalender
| Est. tid* | ||
| 2026-10-30 | 08:00 | Kvartalsrapport 2026-Q3 |
| 2026-07-17 | 08:00 | Kvartalsrapport 2026-Q2 |
| 2026-05-06 | N/A | X-dag ordinarie utdelning XBRANE 0.00 SEK |
| 2026-05-05 | N/A | Årsstämma |
| 2026-05-05 | 08:00 | 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 |
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Xbrane Biopharma AB (publ) announces today that the company intends to resubmit its Biologics License Application (BLA) for the ranibizumab biosimilar to the U.S. Food and Drug Administration (FDA) during April/May 2026.
The decision follows after Xbrane’s contract manufacturer received further detailed feedback from the FDA related to the Complete Response Letter (CRL) issued in October 2025. The CRL concerned remaining observations at one of the manufacturing sites. No other parts of the BLA application were addressed by the FDA.
According to the FDA’s feedback, the contract manufacturer is required to complete all observations before a resubmission can take place, which results in a minor delay to the original plan. The outstanding actions are related to observations concerning the second product that was inspected at the contract manufacturer at the same time as Ximluci. The outstanding corrective actions are expected to be completed and verified at the relevant facility by the end of April 2026, after which Xbrane will resubmit the BLA, with an expected review time of approximately six months.
Xbrane’s ranibizumab biosimilar has been approved by EMA and MHRA since November 2022 and has been used commercially in the relevant regions since March 2023.
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 2026-03-31 18:00 CEST.