Melkoista taaperrusta. Trainwreck, sanottaisiin rapakon toisella puolella.Taas kerran joudutaan toimittamaan lisätietoja FDA:lle ja BLA on vedetty pois. Odotettavissa arviolta 6-12 kk lisäviive JA tarvitaan mahdollisesti vieläkin lisää pääomaa.
Koostin huvikseni pienen aikajanan lehdistötiedotteista (päivämäärät ovat linkkejä k.o. lehdistötiedotteeseen, alla lyhennelmät). Tänä aikana ennen viimeisintä antia mukaan tulleet sijoittajat ovat käytännössä menettäneet kaiken. Xbrane toimii monellakin tavalla case-esimerkkinä riskeistä, joita biotech-sijoittamiseen liittyy.
Xbrane announces ambition to generate positive operating cash flow monthly by late 2023/early 2024
2022 alussa jätettiiin XIMLUCI (LUCENTIS) BLA FDA:lle. Tätä ei julkaistu erikseen tiedotteena.
Xbrane Biopharma AB has withdrawn the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® after receiving feedback from the FDA
Based on the time required to complete the BLA as per FDAs comments and recommendations, Xbrane plans to resubmit the BLA during 2022.
The delivery of a critical report required for the re-submission has been delayed and therefore the re-submission of the BLA has been postponed to first quarter of 2023.
Xbrane has submitted the BLA for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to the FDA. Within 60 days, FDA is expected to validate and decide to initiate the review of the BLA. Thereafter, Xbrane expects a 10 month review process and hence an approval could take place during the first half of 2024.
XBRANE UPDATES AMBITION TO GENERATE POSITIVE OPERATING CASH FLOW ON AN MONTHLY BASIS BEFORE END OF FIRST QUARTER 2025
Xbrane provides regulatory update on FDA review of its ranibizumab biosimilar candidate. Xbrane will work closely with the agency to submit as quickly as possible responses to the issues raised, which relate primarily to the reference standard and pre-approval inspections of manufacturing partners’ sites. Xbrane will request a meeting with FDA, expected to be held within 30 days from request, to clarify further requirements related to above issues and will after that announce a planned date for resubmission of the BLA.
A reasonable base case estimate would be that the new BsUFA could span anywhere from 6-12 months from today, which to us implies a potential H1 2025 launch in the US.
Regarding financing, numerous factors contribute to a range of potential outcomes where Xbrane could require more capital or not.