Albireo neuer big player im Pharma-Milliardenmarkt

Na, "profi", heute mal nicht gesperrt ? Ist ja mal ganz was Neues...lol

SEC Filing Alert

Albireo has filed the following document(s) with the United States Securities and Exchange Commission.
Jun 20, 2017

Form 4 / Scoon, Davey

Form 4 / Chiswell, David

Form 4 / Gutch, Michael

Form 4 / Pollard-Knight, Denise

Form 4 / Brown, Julia R

View all SEC Filings:
ir.albireopharma.com/sec.cfm

sind die schlechten nachrichten die diesen kursverfall rechtfertigen?
hier wird deutlich das fallende kurse können so viel panik auslösen das die verlust-angst
das handeln  bestimt. und der herdentrieb u. passern tut den rest.
wenn ein test gefloppt wäre könnte man den kursverfall verstehen aber.... aber..

Albireo Pharma initiated with an Outperform at Wedbush Wedbush analyst Liana Moussatos started Albireo Pharma with an Outperform rating and $58 price target. The analyst believes the company's lead product A4250, being studied to treat progressive familial intrahepatic cholestasis, can achieve sales of more than $1B in 2024.

Read more at:
thefly.com/landingPageNews.php?id=2573470

Patent No.: US009688720    

link:
pdfpiw.uspto.gov/...N.%2526OS=PN/9,688,720%2526RS=PN/9,688,720

Albireo to Present at Wedbush PacGrow Healthcare Conference


BOSTON, Aug. 08, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, .Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that Ron Cooper, President and Chief Executive Officer, is scheduled to present at the Wedbush PacGrow Healthcare Conference at Le Parker Méridien in New York City on Tuesday, August 15, 2017, at 4:15 ET.

A live audio webcast of the presentation will be accessible from the Investors page of Albireo's website, ir.albireopharma.com/. To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Investors page of Albireo's website for at least two weeks following the event.

For more information about the conference, visit: www.wedbush.com/services/cmg/equities/corporate-access-events.

About Albireo  
Albireo 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, a Phase 2 product candidate, and a product candidate for which an application for regulatory approval has been submitted in Japan. Albireo was spun out from AstraZeneca in 2008.

Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.

Source: Albireo Pharma, Inc.

Investor Contact:

Hans Vitzthum

LifeSci Advisors, LLC.

212-915-2568



Media Contact:

Heather Anderson

6 Degrees

980-938-0260

handerson@6degreespr.com

Recent Highlights and Corporate Update

A4250

Continued to prepare for a planned Phase 3 clinical trial of A4250 in patients with PFIC, which Albireo expects to initiate by the end of 2017.

Completed a successful Phase 2 open label, dose-finding clinical trial of A4250 in children with cholestatic liver disease and pruritus.

Received notification that the abstract for the completed Phase 2 pediatric trial, titled "An Exploratory Phase II Study to demonstrate the Safety and Efficacy of A4250 in Children with Cholestatic Pruritus," has been accepted to The Liver Meeting® 2017, to be held October 20-24, 2017, in Washington, D.C.

Announced the allowance of two new U.S. patents for A4250, including one with claims directed to a method of treatment for A4250 in PFIC and other specified liver cholestatic diseases.  The regular term of this patent, which has since issued, expires in November 2031.
Elobixibat

Albireo's licensee for elobixibat in Japan and other select countries in Asia, EA Pharma Co., Ltd., completed an open-label clinical trial designed primarily to evaluate the long-term safety of elobixibat in Japanese patients with chronic constipation over 52 weeks. [The safety and tolerability profile of elobixibat exhibited in the trial was consistent overall with prior clinical trials of elobixibat in Japan.]
Corporate

Completed an underwritten public offering of shares of common stock, with gross proceeds to Albireo of approximately $51.9 million and net proceeds of approximately $48.5 million, after deducting underwriting discounts and commissions and offering expenses.
Financial Results for the Three and Six Months ended June 30, 2017

Cash Position: Cash and cash equivalents totaled $62.6 million as of June 30, 2017.

Revenue: Revenue totaled $1,000 for the second quarter of 2017 compared with $8.0 million for the second quarter of 2016, a decrease of $8.0 million.  For the six months ended June 30, 2017, revenue totaled $2,000 compared with $8.1 million for the corresponding 2016 period, a decrease of $8.1 million. The decrease for both 2017 periods was primarily due to a nonrefundable one-time payment of $8.0 million received from EA Pharma in April 2016 in connection with a renegotiated payment stream.

R&D Expenses: Research and development expenses totaled $3.0 million for the second quarter of 2017 compared with $2.7 million for the second quarter of 2016, an increase of $249,000.  For the six months ended June 30, 2017, research and development expenses totaled $5.8 million compared with $4.3 million for the corresponding 2016 period, an increase of $1.5 million.  The increase for both 2017 periods was driven primarily by increased costs associated with the development of A4250, partially offset for the three-month period by reductions in other project costs attributable to patent expenses.

G&A Expenses: General and administrative expenses totaled $3.7 million for the second quarter of 2017 compared with $3.0 million for the second quarter of 2016, an increase of $685,000.  For the six months ended June 30, 2017, general and administrative expenses totaled $6.9 million compared with $4.3 million for the corresponding 2016 period, an increase of $2.6 million.  The increase for both 2017 periods was principally attributable to an increase in personnel expense, including stock-based compensation expense, and other costs associated with being a public company.

Interest expense, net: Net interest expense totaled $152,000 for the second quarter of 2017 compared with $512,000 for the second quarter of 2016, a decrease of $360,000.  For the six months ended June 30, 2017, net interest expense totaled $401,000 compared with $1.0 million for the corresponding 2016 period, a decrease of $637,000.  The decrease for both 2017 periods was due to conversion of convertible loan notes issued in 2014 and 2015 into equity in connection with the completion of the share exchange transaction in November 2016 and lower interest paid under an existing loan facility in accordance with the terms of the facility.

Other (income) expense, net: Other (income) expense, net totaled $65,000 of income for the second quarter of 2017 compared with $290,000 of expense for the second quarter of 2016, a difference of $355,000.  For the six months ended June 30, 2017, other (income) expense, net totaled $9,000 of expense compared with $135,000 of expense for the corresponding 2016 period, a decrease of $126,000.  The difference for both 2017 periods resulted from differences in currency exchange rates in the two periods.

Non-operating income, net: Non-operating income, net totaled $585,000 for the second quarter of 2017 compared with $709,000 for the second quarter of 2016, a decrease of $124,000.  For the six months ended June 30, 2017, non-operating income, net totaled $260,000 compared with $620,000 for the corresponding 2016 period, a decrease of $360,000.  The decrease for both 2017 periods primarily reflected a change in mark-to-market adjustments on warrants between the periods.

On August 15, 2017, Albireo filed Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission in respect of its Form 10-Q for the second quarter ended June 30, 2017.  The delayed filing resulted from clerical errors which were discovered late in Albireo's financial closing process for the second quarter of 2017 and which related to the first quarter of 2017. Albireo corrected the errors in the second quarter.  Albireo believes that the errors and corrections do not have a material impact on its financial statements for the three and six months ended June 30, 2017.

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, a second Phase 2 product candidate and a third product candidate for which an application for regulatory approval has been submitted in Japan. 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. For more information on Albireo, please visit www.albireopharma.com.

Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding: the plans for, or progress or scope of, development of A4250, elobixibat or any other Albireo product candidate or program, including regarding the planned Phase 3 clinical program for A4250 in patients with PFIC; the target indication(s) for development, the size, design, population, location, conduct, objective, duration or endpoints of any clinical trial, or the timing for initiation or completion of or reporting of results from any clinical trial, including the timing for initiation of the planned Phase 3 PFIC clinical program for A4250; EA Pharma's plans with regard to the development or commercialization of elobixibat; the competitive position of A4250, elobixibat or any other Albireo product candidate or program or the commercial opportunity in any target indication; any milestone or other payments that EA Pharma may make to Albireo; the period for which Albireo's cash resources will be sufficient to fund its operating requirements (runway); or Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to, risks and uncertainties relating to: whether favorable findings from clinical trials of A4250 to date, including findings in indications other than PFIC, will be predictive of results from future clinical trials of A4250, including the trials comprising the planned Phase 3 PFIC program; whether either or both of the FDA and EMA will determine that the primary endpoint and duration of the planned double blind Phase 3 trial in patients with PFIC is sufficient, even if such primary endpoint is met with statistical significance, to support approval of A4250 in the United States or the European Union, to treat PFIC, a symptom of PFIC or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing long-term PFIC patient data; whether Albireo's cash resources will be sufficient to advance A4250 through completion of the planned Phase 3 PFIC program; the timing for initiation or completion of, or for availability of data from, ongoing or future trials of A4250, including the trials comprising the planned Phase 3 PFIC program, and the outcomes of such trials; delays or other challenges in the initiation of, or recruitment of patients for, the planned double blind Phase 3 trial; whether Albireo receives additional feedback from regulatory authorities on the planned Phase 3 PFIC program for A4250 prior to initiation; the discretion that EA Pharma has in the development and potential commercialization of elobixibat in Japan; and the timing and success of acceptance and approval of the new drug application submitted by EA Pharma with the Japanese Pharmaceuticals and Medical Devices Agency for elobixibat for the treatment of chronic constipation in Japan. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading "Risk Factors" in Albireo's most recent Annual Report on Form 10-K and in other filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.

Source: Albireo Pharma, Inc.


Albireo Pharma, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
(unaudited)§

June 30, 2017 December 31, 2016

    ASSETS§
Current assets:
Cash and cash equivalents $ 62,598 $ 29,931
Trade receivables — 26
Prepaid expenses and other assets 471 560
Other receivables 663 344
Total current assets 63,732 30,861
Property and equipment, net 155 21
Intangible assets 150 150
  Goodwill§ 18,110 18,110
Other noncurrent assets 529 518
Total assets $ 82,676 $ 49,660
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Trade payables $ 1,329 $ 972
Accrued expenses 3,825 7,548
Long-term debt, current portion 1,928 3,075
Warrant liability — 844
Other liabilities 298 269
Total current liabilities 7,380 12,708
Long-term liabilities 43 —
Total liabilities 7,423 12,708
Stockholders' Equity:
Common stock, $0.01 par value per share — 30,000,000 authorized at June  30, 2017 and 200,000,000 authorized at December 31, 2016; 8,859,141 and 6,292,644 issued and outstanding at June 30, 2017 and December 31, 2016 90 63
Additional paid in capital 112,549 61,338
Accumulated other comprehensive income 1,406 1,496
Accumulated deficit (38,792 ) (25,945 )
Total stockholders' equity 75,253 36,952
Total liabilities and stockholders' equity $ 82,676 $ 49,660


Albireo Pharma, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)§

Three Months Ended June 30, Six Months Ended June 30,
2017 2016 2017 2016
   Revenue§ $ 1 $ 7,973 $ 2 $ 8,097
Operating expenses:
Research and development 2,962 2,713 5,774 4,310
General and administrative 3,713 3,028 6,925 4,334
Other (income) expense, net (65 ) 290 9 135
Total operating expenses 6,610 6,031 12,708 8,779
Operating income (loss) (6,609 ) 1,942 (12,706 ) (682 )
Interest expense, net (152 ) (512 ) (401 ) (1,038 )
Non-operating income, net 585 709 260 620
Net income (loss) before income taxes (6,176 ) 2,139 (12,847 ) (1,100 )
Income tax — — — —
Net income (loss) $ (6,176 ) $ 2,139 $ (12,847 ) $ (1,100 )
Net income (loss) per share - basic $ (0.86 ) $ 7.42 $ (1.91 ) $ (3.97 )
Net income (loss) per share - diluted $ (0.86 ) $ 0.69 $ (1.91 ) $ (3.97 )
Weighted average shares outstanding - basic 7,172,265 288,427 6,734,885 277,120
Weighted average shares outstanding - diluted 7,172,265 3,101,115 6,734,885 277,120
Investor Contact:

Hans Vitzthum

LifeSci Advisors, LLC

212-915-2568



Media Contact:

Heather Anderson

6 Degrees

980-938-0260

handerson@6degreespr.com

Albireo to Present at 19th Annual Rodman & Renshaw Global Investment Conference


BOSTON, Sept. 05, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that Paresh Soni, MD, PhD, Chief Medical Officer, is scheduled to present at the 19th Annual Rodman & Renshaw Global Investment Conference at the Lotte New York Palace in New York City on Monday, September 11, 2017, at 9:10 a.m. EDT.

A live audio webcast of the presentation will be accessible from the Investors page of Albireo's website, ir.albireopharma.com/. To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Investors page of Albireo's website for at least two weeks following the event.

For more information about the conference, visit: www.rodmanevents.com.

About Albireo  
Albireo 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, a Phase 2 product candidate and a product candidate for which an application for regulatory approval has been submitted in Japan. Albireo was spun out from AstraZeneca in 2008.

Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.  

Source: Albireo Pharma, Inc.

Investor Contact:

Hans Vitzthum                                    

LifeSci Advisors, LLC.                      

212-915-2568                                    



Media Contact:

Heather Anderson

6 Degrees

980-938-0260

handerson@6degreespr.com  

Albireo to Present at Investor Conferences in September


BOSTON, Sept. 19, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that Ron Cooper, President and Chief Executive Officer, will present at the following investor conferences in September:

Ladenburg Thalmann Healthcare Conference
Location: Sofitel New York in New York City
Presentation date / time: Tuesday, September 26, 2017 at 9:00 a.m. ET

Cantor Fitzgerald Global Healthcare Conference
Location: InterContinental New York Barclay in New York City
Presentation date / time: Wednesday, September 27, 2017 at 3:25 p.m. ET

A live audio webcast of each presentation will be accessible from the Investors page of Albireo's website, ir.albireopharma.com/. To ensure a timely connection to either webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time. An archived version of each webcast will be available for replay on the Events & Presentations section of the Investors page of Albireo's website for at least two weeks following the event.

About Albireo  
Albireo 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, a Phase 2 product candidate and a product candidate for which an application for regulatory approval has been submitted in Japan. Albireo was spun out from AstraZeneca in 2008.

Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.

Source: Albireo Pharma, Inc.

Investor Contact:

Hans Vitzthum

LifeSci Advisors, LLC.

212-915-2568



Media Contact:

Heather Anderson

6 Degrees

980-938-0260

handerson@6degreespr.com
Primary Logo

As part of the regulatory process for the registration of new medicines with the EMA, companies are required to agree with PDCO on a PIP that outlines a development program for the investigational product in the pediatric population. The agreed PIP for A4250 includes Albireo's previously announced double-blind, placebo-controlled, Phase 3 clinical trial in patients with PFIC (type 1 or 2), ages six months to 18 years, as well as Albireo's completed Phase 2 study of A4250 in children with cholestatic liver disease. In addition, the PIP includes a small clinical trial in neonates with PFIC, which will be deferred until after completion of the planned Phase 3 trial, and the development of a liquid formulation.

A4250 has received orphan designation in the European Union (EU) (as well as in the United States) for the treatment of PFIC, which, if maintained at approval, would be expected to provide 10 years of post-approval EU market exclusivity. Completion of the agreed PIP would provide an additional two years of market exclusivity in the EU, making a total of 12 years.

In a recently completed Phase 2 clinical trial in children with cholestatic liver disease, A4250 exhibited a favorable overall tolerability profile, and most patients showed both a reduction in serum bile acid levels and an improvement in pruritus across multiple scales after four weeks of treatment with A4250.

About A4250

A4250 is a first-in-class product candidate in development for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC) and potentially other orphan pediatric cholestatic liver diseases. A4250 is a highly potent and selective inhibitor of the ileal bile acid transporter (IBAT), has minimal systemic exposure and acts locally in the gut.

A4250 has been granted orphan drug designation for PFIC in the United States and the European Union and has been granted support through the PRIority MEdicines (PRIME) program of the European Medicines Agency (EMA) for the treatment of PFIC.

About Albireo

Albireo 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, a Phase 2 product candidate and a product candidate for which an application for regulatory approval has been submitted in Japan. Albireo was spun out from AstraZeneca in 2008.

Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.  

Forward-Looking Statements

This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding: the plans for, or progress or scope of, development of A4250, including regarding the planned Phase 3 clinical program for A4250 in patients with PFIC or the other activities comprising the pediatric investigation plan for A4250; the timing for initiation or completion of or reporting of results from any clinical trial, including the timing for initiation of the planned Phase 3 PFIC clinical program or pediatric investigation plan for A4250; the competitive position of A4250 or the commercial opportunity in PFIC; or Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to, risks and uncertainties relating to: whether favorable findings from clinical trials of A4250 to date, including findings in indications other than PFIC, will be predictive of results from future clinical trials of A4250, including the trials comprising the planned Phase 3 PFIC program; whether either or both of the FDA and EMA will determine that the primary endpoint and duration of the planned double blind Phase 3 trial in patients with PFIC is sufficient, even if such primary endpoint is met with statistical significance, to support approval of A4250 in the United States or the European Union, to treat PFIC, a symptom of PFIC or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing long-term PFIC patient data; whether Albireo's cash resources will be sufficient to advance A4250 through completion of the planned Phase 3 PFIC program; the timing for initiation or completion of, or for availability of data from, ongoing or future trials of A4250, including the trials comprising the planned Phase 3 PFIC program, and the outcomes of such trials; delays or other challenges in the initiation of, or recruitment of patients for, the planned double blind Phase 3 trial; and whether Albireo receives additional feedback from regulatory authorities on the planned Phase 3 PFIC program for A4250 prior to initiation. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading "Risk Factors" in Albireo's most recent Annual Report on Form 10-K, in Albireo's Current Report on Form 8-K filed May 23, 2017 and in other filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.

Source: Albireo Pharma, Inc.

Investor Contact:
Hans Vitzthum                                    
LifeSci Advisors, LLC.                        
212-915-2568                                    

Media Contact:
Heather Anderson
6 Degrees
980-938-0260
handerson@6degreespr.com    

ne prima Nachricht und die Amis verchecken ihre Aktien...die haben doch nicht mehr alle Tulpen auf dem Beet. Verkehrte Welt...

"We're pleased to welcome Roger to the Albireo board of directors. He brings more than 25 years of clinical development and pharmaceutical commercialization experience, including the regulatory approval and launch of six rare disease therapies. His experience advancing drugs for orphan conditions and passion for pediatric medicine will be invaluable as Albireo prepares to advance A4250 into planned Phase 3 development," said David Chiswell, Ph.D., Chairman of Albireo's Board of Directors. "We extend our most sincere gratitude to Denise for her service. As a founding board member, Denise has played a key role in building Albireo."

Dr. Jeffs is the co-founder and co-owner of Bull City Select Investments, an investment firm focused on in-licensing and development of early-stage biotechnology assets. Previously, he served as the worldwide clinical leader of the Infectious Disease Program at Amgen Inc. and as a member of the clinical research team at Burroughs Wellcome & Company. In addition to Albireo, Dr. Jeffs is a member on the boards of directors of the public pharmaceutical companies Axsome Therapeutics, Dova Pharmaceuticals and Sangamo Therapeutics. He holds a B.A. in chemistry from Duke University and a Ph.D. in pharmacology from the University of North Carolina School of Medicine.

About Albireo

Albireo 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, a Phase 2 product candidate and a product candidate for which an application for regulatory approval has been submitted in Japan. Albireo was spun out from AstraZeneca in 2008.

Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.

Forward-Looking Statements

This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding: the plans for, or progress or scope of, planned Phase 3 clinical development of A4250 in patients with PFIC; the timing for initiation of the planned Phase 3 PFIC clinical trial for A4250; the competitive position of A4250 or the commercial opportunity in PFIC; or Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to, risks and uncertainties relating to: whether favorable findings from clinical trials of A4250 to date, including findings in indications other than PFIC, will be predictive of results from future clinical trials of A4250, including the trials comprising the planned Phase 3 PFIC program; whether either or both of the FDA and EMA will determine that the primary endpoint and duration of the planned double blind Phase 3 trial in patients with PFIC is sufficient, even if such primary endpoint is met with statistical significance, to support approval of A4250 in the United States or the European Union, to treat PFIC, a symptom of PFIC or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing long-term PFIC patient data; whether Albireo's cash resources will be sufficient to advance A4250 through completion of the planned Phase 3 PFIC program; the timing for initiation or completion of, or for availability of data from, ongoing or future trials of A4250, including the trials comprising the planned Phase 3 PFIC program, and the outcomes of such trials; delays or other challenges in the initiation of, or recruitment of patients for, the planned double blind Phase 3 trial; and whether Albireo receives additional feedback from regulatory authorities on the planned Phase 3 PFIC program for A4250 prior to initiation. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading "Risk Factors" in Albireo's most recent Annual Report on Form 10-K, in Albireo's Current Report on Form 8-K filed May 23, 2017 and in other filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.

Investor Contact:
Hans Vitzthum                                    
LifeSci Advisors, LLC.                        
212-915-2568                                    

Media Contact:
Heather Anderson
6 Degrees
980-938-0260
handerson@6degreespr.com  

Source: Albireo Pharma, Inc.

link:
ir.albireopharma.com/...ingid=1564590-17-19046&CIK=1322505

Ich kann kein englisch  

Probier mal "www.deepl.com/translator"
Ist ziemlich hilfreich.

hat denn in Stuttgart zu16,608 EUR geschmissen???

Gruß vom
Advamillionär

siehe link:
ir.albireopharma.com/...ingid=1209191-17-54438&CIK=1322505

Final Results of Albireo's Phase 2 Study of A4250 in Children with Cholestatic Liver Disease to be Presented at The Liver Meeting(R) 2017


BOSTON, Oct. 03, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced data from its completed Phase 2 study of lead product candidate A4250 in children with cholestatic liver disease will be presented during a poster session at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2017, being held October 20-24, 2017, at the Walter E. Washington Convention Center in Washington, D.C.

Details of the presentation are as follows:

Title: The ileal bile acid transport inhibitor A4250 reduced pruritus and serum bile acid levels in children with cholestatic liver disease and pruritus: final results from a multiple-dose, open-label, multinational study (Abstract #1200)
Session: Poster Session II
Date/Time: October 21, 2017, from 5:30 to 7:00 p.m. ET
Location: Walter E. Washington Convention Center, Hall D
Presenter: Dr. Ekkehard Sturm, Head of Pediatric Gastroenterology and Hepatology, University Hospital Tuebingen, Germany

Abstracts for the meeting can be viewed in the October issue of HEPATOLOGY.

The Liver Meeting®, the 68th Annual Meeting of the AASLD, brings together more than 9,500 physicians, researchers and health professionals from around the world to discuss and advance the science and practice of hepatology. For more information about the meeting, visit: www.aasld.org/events-professional-development/liver-meeting.

About Albireo  
Albireo 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, a Phase 2 product candidate and a product candidate for which an application for regulatory approval has been submitted in Japan. Albireo was spun out from AstraZeneca in 2008.

Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.

Investor Contact:
Hans Vitzthum                                    
LifeSci Advisors, LLC.                        
212-915-2568                                    

Media Contact:
Heather Anderson
6 Degrees
980-938-0260
handerson@6degreespr.com    

Dr. Sturm serves as the pediatric coordinator of the European Reference Network RARE LIVER. He has authored or co-authored more than 50 original manuscripts, reviews and case reports published in such journals as Journal of Pediatric Surgery, Pediatric Transplantation, European Journal of Pediatrics, The Lancet, Journal of Hepatology and HEPATOLOGY. In addition, he has authored six textbook chapters on topics such as PFIC, disorders of the intrahepatic bile ducts, and living donation for liver transplantation. Dr. Sturm is a member of the American Association for the Study of Liver Diseases, the German Society for Pediatric Gastroenterology and Nutrition, the German Society of Pediatrics and Adolescent Medicine, the Dutch Society for Pediatrics and the European Society for Pediatric Gastroenterology, Hepatology and Nutrition. He holds advanced degrees from Hannover Medical School in Germany and The University Medical Center Groningen in the Netherlands and trained as a post-doctoral research fellow at Yale University.

To register to attend the event, contact LifeSci Advisors, LLC at Mac@LifeSciAdvisors.com.  Advanced registration is required, as space is limited.

A live and archived webcast of the event will be available on the Investors page of Albireo's website at ir.albireopharma.com.  To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time. The archived version of the webcast will be available for replay on the Events & Presentations section of the Investors page of Albireo's website for at least two weeks following the event.

About Albireo
Albireo 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, a Phase 2 product candidate and a product candidate for which an application for regulatory approval has been submitted in Japan. Albireo was spun out from AstraZeneca in 2008.

Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.

Investor Contact:
Hans Vitzthum
LifeSci Advisors, LLC.
212-915-2568

Media Contact:
Heather Anderson
6 Degrees
980-938-0260
handerson@6degreespr.com

Source: Albireo Pharma, Inc.

Rebound....sowas ist einiges Wert, denn anscheinend ist der MArkt "erwachsen" genug, bei Albo das Bekannte richtig zu interpretieren. Wäre prima ,wenn wir sowas noch öfter erleben und den Wacklern der Boden entzogen wird. Sowas brauchen wir in unserer Share nicht.

"The findings from this Phase 2 study of A4250 on various efficacy measures, and the safety and tolerability profile shown, are promising," said Dr. Sturm, head of pediatric gastroenterology-hepatology, liver and intestinal transplantation at Children's Hospital, University of Tuebingen in Germany. "The compelling data in PFIC patients in particular illustrate that A4250 has potential to become a welcomed treatment alternative to the current standards of care, which are bile diversion surgery or transplantation. Further study of A4250 in PFIC is warranted."

A4250 is a highly potent and selective inhibitor of the ileal bile acid transporter (IBAT), which has minimal systemic exposure and acts locally in the gut. The open label, multicenter, dose-finding Phase 2 clinical trial assessed the safety and tolerability of A4250 and explored changes in sBA levels, pruritus and sleep disturbance. Twenty patients aged one to 17 years old with a pediatric cholestatic liver disease, including PFIC (subtype 1, 2 or 3), Alagille syndrome, biliary atresia or intrahepatic cholestasis, were enrolled in the study, with four of the patients reenrolling into a second dose group. A4250 was administered orally once daily for four weeks. Five different doses of A4250 were evaluated, ranging from 10 µg/kg to 200 µg/kg.

A4250 demonstrated a mean reduction in sBA levels in all five dose groups in the study, with substantial sBA reductions (ranging from 43 to 98 percent) in 80 percent of the PFIC patients. In addition, the majority of patients showed improvement in pruritus on three different assessment scales, with a significant correlation between reduction in sBA and improvement in pruritus, as well as improvement in sleep disturbance. The open label study was not powered for formal statistical analyses.

There were no serious adverse events reported in the study that were considered to be drug related.  Most adverse events, including some increased transaminases, were mild, transient and assessed as either unrelated to study drug or the relationship was unclear.

"We are encouraged by the findings from the Phase 2 study in pediatric cholestatic liver disease and look forward to getting underway our planned Phase 3 clinical trial of A4250 in patients with PFIC, a devastating rare liver disease for which there is currently no approved drug treatment," said Paresh Soni, M.D., Ph.D., Albireo's Chief Medical Officer.

In addition to the final results from Albireo's Phase 2 study in children with cholestatic liver disease, data from an investigator-initiated Phase 2 study of A4250 in adults with primary biliary cholangitis (PBC) is scheduled to be presented by the investigator at The Liver Meeting®. Albireo has no plans to develop A4250 to treat PBC.

About A4250
A4250 is a first-in-class product candidate in development for progressive familial intrahepatic cholestasis (PFIC) and potentially other orphan pediatric cholestatic liver diseases. A4250 is a highly potent and selective inhibitor of the ileal bile acid transporter (IBAT), has minimal systemic exposure and acts locally in the gut.

A4250 has been granted orphan drug designation for PFIC in the United States and the European Union. The European Medicines Agency (EMA) has also granted A4250 access to the PRIority MEdicines (PRIME) program for the treatment of PFIC, and its Paediatric Committee has agreed to Albireo's A4250 Pediatric Investigation Plan.

About Albireo  
Albireo 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, a Phase 2 product candidate and a product candidate for which an application for regulatory approval has been submitted in Japan. Albireo was spun out from AstraZeneca in 2008.

Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.

Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements, other than statements of historical fact, regarding: the plans for, or progress or scope of, development of A4250, including regarding the planned Phase 3 clinical program for A4250 in patients with PFIC; the timing for initiation or completion of or reporting of results from any clinical trial; the competitive position of A4250 or the commercial opportunity in PFIC; or Albireo's plans, expectations or future operations, financial position, revenues, costs or expenses. Albireo often uses words such as "anticipates," "believes," "plans," "expects," "projects," "future," "intends," "may," "will," "should," "could," "estimates," "predicts," "potential," "planned," "continue," "guidance," and similar expressions to identify forward-looking statements. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks and uncertainties, including, but not limited to, risks and uncertainties relating to: whether favorable findings from clinical trials of A4250 to date, including findings in indications other than PFIC, will be predictive of results from future clinical trials of A4250, including the trials comprising the planned Phase 3 PFIC program; whether either or both of the FDA and EMA will determine that the primary endpoint and duration of the planned double blind Phase 3 trial in patients with PFIC is sufficient, even if such primary endpoint is met with statistical significance, to support approval of A4250 in the United States or the European Union, to treat PFIC, a symptom of PFIC or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing long-term PFIC patient data; whether Albireo's cash resources will be sufficient to advance A4250 through completion of the planned Phase 3 PFIC program; the timing for initiation or completion of, or for availability of data from, ongoing or future trials of A4250, including the trials comprising the planned Phase 3 PFIC program, and the outcomes of such trials; delays or other challenges in the initiation of, or recruitment of patients for, the planned double blind Phase 3 trial; and whether Albireo receives additional feedback from regulatory authorities on the planned Phase 3 PFIC program for A4250 that results in a delay in its initiation. These and other risks and uncertainties that Albireo faces are described in greater detail under the heading "Risk Factors" in Albireo's most recent Annual Report on Form 10-K, in Albireo's Current Report on Form 8-K filed May 23, 2017 and in other filings that it makes with the Securities and Exchange Commission. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Albireo cautions you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statement in this press release represents Albireo's views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Albireo disclaims any obligation to update any forward-looking statement, except as required by applicable law.

Investor Contact:
Hans Vitzthum                                    
LifeSci Advisors, LLC.                        
212-915-2568                                    

Media Contact:
Heather Anderson
6 Degrees
980-938-0260
handerson@6degreespr.com  

Source: Albireo Pharma, Inc.

Albireo to Present at the Jefferies 2017 London Healthcare Conference



BOSTON, Nov. 09, 2017 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that Ron Cooper, President and Chief Executive Officer, is scheduled to make a corporate presentation and provide a business update at the Jefferies 2017 London Healthcare Conference on Thursday, November 16, 2017, at 10:40 a.m. GMT (5:40 a.m. ET).

A live audio webcast of the presentation will be accessible from the Investors page of Albireo's website, ir.albireopharma.com/. To ensure a timely connection to the webcast, it is recommended that users register at least 15 minutes prior to the scheduled start time. An archived version of the webcast will be available for replay on the Events & Presentations section of the Investors page of Albireo's website for at least two weeks following the event.

For more information about the conference, visit: www.jefferies.com.                  

About Albireo  
Albireo 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, a Phase 2 product candidate and a product candidate for which an application for regulatory approval has been submitted in Japan. Albireo was spun out from AstraZeneca in 2008.

Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary, Albireo AB, is located in Gothenburg, Sweden. For more information on Albireo, please visit www.albireopharma.com.



Investor Contact:
Hans Vitzthum                                    
LifeSci Advisors, LLC.                        
212-915-2568                                    

Media Contact:
Heather Anderson
6 Degrees
980-938-0260
handerson@6degreespr.com  

Source: Albireo Pharma, Inc.

Source: Albireo, Inc.
News Provided by Acquire Media