Det gjør vi. Har veldig tro på xbrane fremover. Definitivt min favorittaksje
Sterk avslutning i dag
Helt utrolig at denne aksjen ikke har blitt en «folkeaksje» blant biojunkiene her på TI.
Et enklere og mer solid case enn Xbrane skal man lete lenge etter
Helt enig. Dette har føltes som åpent mål. Lav omsetning har tydet på at denne har gått under radaren for folk flest. Det kommer til å endre seg
Hehe. Har hatt den på watch listen, men den har føltes litt som om den allerede har gått når jeg har vurdert inngang. Kanskje flere som har samme oppfatning?
Står fortsatt på perrongen altså, selv om toget har kjørt for en stund siden
Ja, det er fort for hvis man barer ser på TA, men ikke vurderer det fundamentale
Helt suverent. Må innrømme at jeg tok litt penger av bordet da jeg så vi var på 172. 100 kr i gevinst pr aksje. Men ingen grunn til at den ikke går over 200 ved positiv utlesning av data nå i juni.
Xlucane™ meets the primary endpoint in the pivotal Phase III trial with Xlucane™ – regulatory submission in EU and US planned for second half of 2021
Xbrane Biopharma AB (publ) (“Xbrane” or “the Company”) (Nasdaq Stockholm: XBRANE) today announces top-line results from the 6 months interim read-out in the pivotal Phase III equivalence trial with the Lucentis® biosimilar candidate Xlucane™. Xlucane™ met the primary endpoint demonstrating equivalent efficacy in change of BCVA (Best Corrected Visual Acuity) at week 8 of treatment compared to Lucentis®. Xbrane confirms the plans to submit the Marketing Authorization Application (MAA) to European Medicines Agency (EMA) in Q3 2021 and the Biologics License Application (BLA) to US Food and Drug Administration (FDA) in Q4 2021 on the basis of the interim results. Xbrane and its co-development partner STADA Arzneimittel AG (“STADA”) are committed to bring Xlucane™ to market and contribute to an increased worldwide access to an effective and safe treatment option to millions of patients suffering from serious eye diseases.
Xlucane™ is a biosimilar candidate to Lucentis ® , a VEGF-a inhibitor used in treatment of serious eye diseases, mainly wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Xplore is a randomized, double-blinded, multi-center study evaluating efficacy, safety, pharmacokinetics, and immunogenicity of Xlucane™ compared to Lucentis ® in patients with wAMD. The primary endpoint in the study is the change in BCVA (Best Corrected Visual Acuity) at week 8. wAMD patients were randomized (1:1) to receive monthly injections of Xlucane™ or the reference product, Lucentis ®, for a duration of one year. Approximately 140 clinics in 15 countries contributed to a successful recruitment completion of the 583 patients in November 2020, this despite the challenges due to the COVID-19 pandemic. An interim read-out was performed when the last patient had reached month 6 in the treatment schedule.
Xlucane™ met the primary endpoint in Xplore demonstrating equivalent efficacy measured in improvement in BCVA at week 8 compared to Lucentis ® . Equivalence was determined since the two-sided 95 % confidence interval around the difference in change in BCVA at week 8 between Xlucane™ and Lucentis ® was within the pre-defined equivalence margin as agreed with EMA and FDA. Furthermore, no clinically meaningful differences on secondary endpoints regarding pharmacokinetic, safety and immunogenicity between Xlucane™ and Lucentis ® could be observed. Xbrane will receive data on additional secondary endpoints and analyze these further, along with above mentioned endpoints, during this summer. The complete dataset is planned to be presented in a scientific journal or at a scientific conference during 2022 at the earliest.
Xbrane confirms the plans to proceed towards submission of the MAA and BLA in Q3 2021 and Q4 2021, respectively. As per agreement with both authorities the application will be complemented with the final study report during Q1 2022 including full 12 months treatment data from all patients. The authorities will assess the application on a totality of evidence principle for which the full 12 months clinical data from Xplore as well as the analytical comparability package will be crucial components.
“The positive interim results from the large Xlucane™ phase III study represents yet another significant milestone for Xbrane Biopharma to become a leading global biosimilar developer”, comments Xbrane Chairman of the Board Anders Tullgren.
“ I want to extend a big thank you to all clinics and patients having participated in Xplore for making this possible despite the ongoing COVID-19 pandemic. We are now on track towards filing of Xlucane™ in Europe and the US during second half of 2021”, says Xbrane CEO Martin Åmark
Xplore Webcast
Xbrane will host a webcast for investors, analysts and journalists, in which the company will discuss the interim results and provide an update on the Xlucane™ development program. The webcast is sent tomorrow Monday June 28th, 2021, 14.00-14.45 CET. Please register using the following link:
Weblink
https://tv.streamfabriken.com/press-conference-20210628
Participant dial in number
Sweden: +46 850558374
United Kingdom: +44 3333009261
United States: +1 6467224904
Redeye uttaler seg om resultatene i dag:
"In light of this news, Xbrane reiterates its previous plan to submit MAA and BLA in Q3 and Q4 2021, respectively. Provided approximately 12 months lead-time for the regulatory process, the current outlook aligns with a launch of Xlucane in the second half of 2022.
Redeye undoubtedly has a very positive view of this news. We argue it brings further validation towards Xbrane’s in-house capabilities, providing strength in partner discussions for subsequent biosimilars."
Benchmarket opp mot tyske Formycon så har har Xbrane myyye å gå på i mcap!
Enig. Åpnet på 180 nå. Regner med mye trading og høyt volum de nærmeste dagene.
Tror det skal kjøres emisjon på dette, så forventer ikke at den popper 200 i denne omgangen.
Men utrolig viktig at de leverte på dette, selv om det var forventet
Ja det ligger i kortene at det kjøres en emisjon snart. Er nok ikke vanskelig å få med større investorer nå som caset er derisket ytterligere. Jeg solgte endel da den gikk over 170 for et par uker siden, og ser an emisjonen før jeg kjøper tilbake, gjerne til en høyere kurs.
Jepp!
Godt mulig at STADA tar hele potten. Som for øvrig vil være et godt tegn på at det går opp mot oppkjøp
Da har jeg kjøpt mine første svenske aksjer - syntes det ble attraktivt nok på 140-tallet. Bør komme noen oppjusterte kursmål fra Pareto, RedEye mfl. på at Xlucane nådde primærendepunkt? Hvor høye blir disse? Skal de kjøre emisjon med rabatt på dette nivået? Kjøpte jeg TI sine aksjer? Mange spørsmål
Neineinei, TI sitter med sine aksjer til hele bruket går under hammeren i 2H 2022;)
Ser svenskene jazzer om at det vil/kan kjøres en rettet emisjon på dette. Hva tenker du rabatten i så fall @InVivo? Usikker på om jeg vil være med på den. Om de må ha penger kan det jo være like greit å kjøpe / øke etter den er gjennonført
Tipper STADA tar en god chunck av den emisjonen.
Men ligger vel emi i luften, ellers hadde nok aksjen blastet 200!
Basert på denne kommentaren bør vi vel vente et kursmål fra PAS i området 284 SEK:
. We have a Buy rating on Xbrane and since our valuation suggests a post-positive phase 3 fair value of SEK 284, our target price of SEK 157 is under review.