ALBO Polarstern Vorraus! Für Longies und Fakten!
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BOSTON, Jan. 24, 2018 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced today that it has commenced an underwritten public offering of its common stock. In connection with the offering, Albireo intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares of common stock sold in the offering. All of the shares in the offering will be sold by Albireo. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.
Cowen and William Blair are acting as joint book-running managers and representatives of the underwriters for the offering. Needham & Company, Wedbush PacGrow and Roth Capital Partners are acting as co-managers.
The offering will be made only by means of a written prospectus and related prospectus supplement forming part of a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission (SEC) on October 13, 2017, amended on November 16, 2017 and declared effective by the SEC on December 5, 2017. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available at the SEC’s website located at www.sec.gov, copies of which may be obtained, when available, from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, or by telephone at 631-274-2806, and from William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, or by telephone at 1-800-621-0687 or email at prospectus@williamblair.com.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
About Albireo
Albireo Pharma is a clinical-stage biopharmaceutical company focused through its operating subsidiary on the development of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. Albireo’s clinical pipeline includes a Phase 3 product candidate for the treatment of patients with the orphan pediatric liver disease known as progressive familial intrahepatic cholestasis, as well as a Phase 2 product candidate. In addition, Albireo’s elobixibat, approved in Japan for the treatment of chronic constipation, is the first IBAT inhibitor approved anywhere in the world. Albireo was spun out from AstraZeneca in 2008.
Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden.
Investor Contact:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568
Media Contact:
We currently estimate that we will use the net proceeds from this offering:
∎ to expand the Phase 3 clinical program of A4250 to treat patients with PFIC to support potential future approval in Japan;
∎ to progress clinical development of our pipeline product candidates;
∎ to accelerate our preclinical program in NASH;
∎ to conduct activities in preparation for a potential future commercial launch of A4250 to treat patients with PFIC in the United States and
European Union; and
∎ for general and administrative expenses, capital expenditures, working capital and other general corporate purposes.
Naja, vor kurzem haben wir noch darüber gesprochen, das das Geld bis Break Even reichen könnte. Und prompt kommt die nächste KE.
Die Erweiterung der Studie mit A4250 für eine Asien-Zulassung finde ich gut. Und das sie den Vertrieb in US/EU selber machen wollen, sollte nun auch ein für allemal klar sein.
Ich kann mit der KE leben, solange das Geld dazu genutzt wird das Potential auszubauen. Und das scheint der Fall zu sein.
Was haltet ihr davon?
BK
Ich kann mir gar nicht vorstellen, dass ein Bile Acid Modulator so gute Ergebnisse bei NASH liefert, das es sich lohnt jetzt noch einzusteigen, da so viele Firmen schon in P2 und P3 sind. Und Genfit hat gerade auch grünes Licht für die pädiatrische Entwicklung von Elafibranor und NASH bekommen. Albo hinkt da einfach extrem weit hinterher.
∎ Elobixibat as a treatment for NASH. Based on findings on parameters relevant to NASH in clinical trials of elobixibat that we previously conducted in patients with chronic constipation and in patients with elevated cholesterol and findings on other parameters
relevant to NASH from nonclinical studies that we previously conducted with elobixibat or a different IBAT inhibitor, we believe elobixibat has potential benefit in the treatment of NASH. In particular, in a clinical trial in dyslipidemia patients, elobixibat given for four weeks reduced low-density lipoprotein (LDL) cholesterol, with the occurrence of diarrhea being substantially the same as the placebo group. Also, in other clinical trials in constipated patients, elobixibat given at various doses and for various durations reduced LDL-cholesterol and, in one trial, increased levels of glucagon-like peptide 1 (GLP-1). Moreover, A4250 (an IBAT inhibitor) showed significant improvement (p < 0.05) on the nonalcoholic fatty liver disease activity score in an established model of NASH in mice known as the STAM™ model and improvement in liver inflammation and fibrosis in another preclinical mouse model. If our pending method of use patent for elobixibat in NASH issues in the United States, we may conduct a Phase 2 clinical trial of elobixibat in NASH. If we elect to conduct a Phase 2 clinical trial of elobixibat in NASH, we expect to initiate the trial by the first quarter of 2019.
Elobixibat für NASH. Hmm, interessante neue Wendung. Aber wie gesagt, in NASH tummelt sich aktuell fast alles was,Rang und Namen hat. Deshalb kann ich das nicht ganz nachvollziehen. Aber die werden schon wissen was sie tun.
http://ir.albireopharma.com/node/10971/html
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Also keine Verpartnerungspläne oder eigene Weiterentwicklung von Elo in constipation.
Und nun kommt tatsächlich auch schon die nächste KE. Bravo, wie zum Beweis. Eine KE, bei all den Millionen Cash, die ALBO dem Markt bisher schon abgezapft hat.
Mag sein, dass mehr dahinter steckt - denn wohin mit all dem Geld? Sicher nicht nur in die angegebenen A4250 Aktionen. Das ist unplausibel.
Und so werden viele die KE als Unsicherheit abwerten und damit Verkaufsdruck erzeugen. Dafür habe ich sogar noch etwas Verständnis. Warum keine saubere Kommunikation seitens ALBO, was man wirklich vor hat? Warum in das überbesiedelte Haifischbecken von NASH springen?
Dem ALBO Management muss klar sein, dass sie mehr Fragen als Antworten erzeugen. Deshalb stehe ich zu meinem Ausstieg.
Allen Investierten viel Erfolg, aber eben auch Vorsicht, was hier passiert.
24. Jan. 2018Elobixibat befindet sich in Indonesien, Südkorea, Taiwan, Thailand und Vietnam noch in Phase-II-Studien zur Verstopfung (Albireo-Pipeline, Januar 2018)
24. Januar 2018Kontinuierlich - Phase-II für das Reizdarmsyndrom in den USA und Europa (PO) (Alberio-Pipeline, Januar 2018) 19. Januar 2018Verwiesen für Verstopfung in Japan (PO) - Erste globale Zulassung
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Wertpapier: Albireo Pharma |
Die Übertreibung nach unten in Deutschland ist für mich unverständlicher wie die KE von Albo selbst :D
Die Kurse werden übern Teich gemacht. Also mal abwarten was die Ami´s machen.
Nachbörslich hatte sich da ja der Kurs von 5% minus wieder erholt auf 3,4%
Bin gespannt
Was die KE selbst angeht, ja das ist große schei... was die machen.
Das ist ne Rakete die man auf halber Strecke wieder zum Boden zurück holt.
Aber...... Bei Canadischen Papieren kennt man das im Laufe der Zeit schon.
Die sind immer unberechenbar.
PFIC as the lead indication for A4250 because we believe there is an especially strong scientific rationale for the use of an IBAT inhibitor to prevent progressive liver disease caused by PFIC. Our planned Phase 3 PFIC trial, which we expect to commence by the spring of 2018, is designed to be a randomized, double blind, placebo controlled, multicenter, clinical trial designed to enroll approximately 60 patients with PFIC (type 1 or 2). Patients will be assigned to receive either 40 µg (microgram) per kg per day or 120 µg per kg per day of A4250, or placebo, for 24 weeks. The primary endpoint for U.S. Food and Drug Administration, or FDA, evaluation, and a key secondary endpoint for European Medicines Agency, or EMA, evaluation, will be an assessment of change in pruritus. The primary endpoint for EMA evaluation, and a key secondary endpoint for FDA evaluation, will be serum bile acid responder rate where a responder is a patient who achieves either a reduction in serum bile acid levels of 70% or more from baseline or a reduction of serum bile acid levels at least to an absolute level that is specified in between 50 and 100 micromoles (µmol) per liter. As designed, the trial provides at least 80% power to detect a positive outcome on both the change in pruritus endpoint and the serum bile acid responder rate endpoint, with a positive outcome defined as superiority for either the 40 µg/kg/day A4250 dose group or the 120 µg/kg/day A4250 dose group compared to the placebo dose group at a significance level of p £ 0.025. The trial will also have several additional secondary endpoints. The planned double blind Phase 3 trial, together with available data from the then-ongoing extension study, are expected to form the primary support for drug approval applications for A4250 in both the United States and European Union for the treatment of patients with PFIC.
Patient gilt also als Responder wenn die Reduzierung sBA-Level 70% oder alternativ absolut auf 50-100 micromol pro liter beträgt. Mehr als ich dachte.
Und p<0,025. Das p-Value war zu Beginn noch bei p<0,05.
Machbar scheint es, geschenkt ist ein P3 Erfolg aber sicher auch nicht. PEBD Surgery schafft nach einem Jahr eine absolute durchschnittliche Reduzierung auf ca. 175 micromol, und kommt erst nach 2 Jahren auf unter 100. A4250 muss das in 6 Monaten schaffen.