albireo pharma press release
Albireo Pharma (NASDAQ:ALBO): Q3 GAAP EPS of -$1.96 misses by $0.45.Revenue of $2.13M (+53.2% Y/Y) beats by $0.5M.Press Release About Biliary Atresia. Albireo Initiates Global Phase 3 Clinical Trial of Odevixibat in Alagille Syndrome Read the full press release Click here to find out why we have been named a Best Place to Work in Boston for 2 … The resulting bile build-up in liver cells causes liver disease and symptoms. Albireo Announces Two Financing Transactions to Extend Cash Runway Into the B.. Albireo to Present at 2020 Jefferies Virtual Healthcare Conference, Albireo Reports Q1 2020 Financial Results and Provides Business Update, Albireo to Report First Quarter 2020 Financial Results on May 7, Albireo to Present at 19th Annual Needham Healthcare Conference, Albireo Completes Enrollment in Phase 2 Study of Elobixibat in NASH/NAFLD. A high-level overview of Albireo Pharma, Inc. (ALBO) stock. Albireo’s lead product candidate, odevixibat, is being developed to treat rare pediatric cholestatic liver diseases and is in Phase 3 development in progressive familial intrahepatic cholestasis (PFIC) and biliary atresia, and the first site initiation for the Phase 3 trial in Alagille syndrome is planned for this month. Products described on this Website, with the exception of elobixibat for chronic constipation in Japan, are investigational new drugs, and are not approved for use or commercially available. Looking back to 2 days ago, Albireo Pharma Inc (ALBO) priced a 4,000,000 share secondary stock offering at $40.00 per share. Albireo Pharma is located in Boston, Massachusetts, and its key operating subsidiary is located in Gothenburg, Sweden. About AlbireoAlbireo Pharma is a clinical-stage biopharmaceutical company focused on the development of novel bile acid modulators to treat rare pediatric and adult liver diseases, and other adult liver diseases and disorders. About Biliary AtresiaBiliary atresia is a rare pediatric liver disease with symptoms typically developing about two to eight weeks after birth. Albireo Pharma, Inc. (Nasdaq:ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced that … Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to: negative impacts of the COVID-19 pandemic, including on manufacturing, supply, conduct or initiation of clinical trials, or other aspects of our business; whether favorable findings from clinical trials of odevixibat to date, including findings in indications other than PFIC, will be predictive of results from other clinical trials of odevixibat; whether either or both of the FDA and EMA will determine that the primary endpoint for their respective evaluations and treatment duration of the double-blind Phase 3 trial in patients with PFIC are sufficient to support approval of odevixibat in the United States or the European Union, to treat PFIC, a symptom of PFIC, a specific PFIC subtype(s) or otherwise; the outcome and interpretation by regulatory authorities of the ongoing third-party study pooling and analyzing of long-term PFIC patient data; the timing for initiation or completion of, or for availability of data from, clinical trials of odevixibat, including the pivotal program in biliary atresia or the planned pivotal program in Alagille syndrome, and the outcomes of such trials; Albireo’s ability to obtain coverage, pricing or reimbursement for approved products in the United States or European Union; delays or other challenges in the recruitment of patients for, or the conduct of, company’s clinical trials; and Albireo’s critical accounting policies. Albireo cautions you not to place undue reliance on any forward-looking statement. With FDA and EMA regulatory submissions complete, odevixibat has the potential to become the first approved drug treatment for patients with PFIC in the U.S and Europe. - Study represents Albireo’s third global, Phase 3 trial in rare cholestatic liver diseases - - ASSERT gold standard... | December 17, 2020 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. Equal Opportunity Employer. BOSTON , Oct. 02, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced the grant of inducement stock options exercisable for an aggregate of 23,000 shares of Albireo’s common. 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 or in subsequent filings that it makes with the Securities and Exchange Commission. Stay up to date on the latest stock price, chart, news, analysis, fundamentals, trading and investment tools. Positive results from the trial were announced on September 8, 2020: News Release – Albireo Phase 3 Trial Meets Both Primary Endpoints for Odevixibat in PFIC. Upcoming event on ALBIREO PHARMA, INC. 11/17/20: Q3 2020 Earnings Release (Projected) Company calendar Odevixibat does not require refrigeration and can be taken as a capsule for older children, or opened and sprinkled onto food, which are factors of key importance for adherence in a pediatric patient population. In many cases, PFIC leads to cirrhosis and liver failure within the first 10 years of life, and nearly all people with PFIC require treatment before age 30. BOSTON, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of odevixibat for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC). Odevixibat is currently being evaluated in the ongoing PEDFIC 2 open-label trial (NCT03659916) and the BOLD Phase 3 trial in patients with biliary atresia (NCT04336722). The Boston Business Journal named Albireo one of the 2020 Best Places to Work in Massachusetts for the second consecutive year. The Company also provides an Expanded Access Program for eligible patients with PFIC in the U.S., Canada, Australia and Europe. Detailed price information for Albireo Pharma Inc (ALBO-Q) from The Globe and Mail including charting and trades. Additionally, long-term data from PEDFIC 2, an open-label Phase 3 extension study, demonstrate continued and durable reductions in sBAs, improvements in pruritus assessments and encouraging markers of liver and growth function in patients treated up to 48 weeks. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. An Albireo Pharma news release notes that the company saw positive results from its recent Phase 3 clinical trial of odevixibat. Children have clay-colored or no color in their stools, jaundice among other things and a few patients are pruritic. BOSTON, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel … Odevixibat is also currently being evaluated in the ongoing PEDFIC 2 Phase 3 open-label trial in patients with PFIC, and the BOLD Phase 3 trial in patients with biliary atresia. Currently, there are no approved drug treatments. Albireo to Report Fourth Quarter and Year-End 2019 Financial Results on March.. Albireo Announces Closing of $46 Million Public Offering Including Exercise i.. Albireo Announces Proposed Public Offering of Common Stock. Other symptoms include jaundice, poor weight gain and slowed growth. Odevixibat is a potent, once-daily, non-systemic ileal bile acid transport inhibitor (IBATi) being developed to treat rare pediatric cholestatic liver diseases, including PFIC, biliary atresia and Alagille syndrome. Biliary atresia is the most common pediatric cholestatic liver disease and is the leading cause of liver transplants among children as there are no approved drug treatments. The Company expects to complete IND-enabling studies for new preclinical candidate A3907 this year and plans to advance development in adult liver disease. As a result of risks and uncertainties that Albireo faces, the results or events indicated by any forward-looking statement may not occur. Liver damage is caused by a paucity of bile ducts preventing bile flow from the liver to the small intestine. Patients have impaired bile flow, or cholestasis, caused by genetic mutations. Media Contact:Colleen Alabiso, 857-356-3905, firstname.lastname@example.orgLisa Rivero, 617-947-0899, email@example.com, Investor Contact: Hans Vitzthum, LifeSci Advisors, LLC., 857-272-6177. With U.S. and EU regulatory submissions for odevixibat in PFIC completed, the Company anticipates potential regulatory approvals, issuance of a rare pediatric disease priority review voucher and launch in the second half of 2021. The most prominent and problematic ongoing manifestation of the disease is pruritus, or intense itching, which often results in a severely diminished quality of life. Collectively, these studies reaffirm odevixibat’s potential to be the first drug treatment approved for patients living with PFIC, a devastating disease which is currently treated with surgical options including liver transplantation. Albireo Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) BOSTON, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, today announced the grant of inducement stock options exercisable for an aggregate of 18,500 shares of Albireo’s common stock. Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage orphan pediatric liver disease company developing novel bile acid modulators, announced today that … Initiation of a pivotal Phase 3 trial of odevixibat for Alagille syndrome is also anticipated by the end of 2020. About OdevixibatOdevixibat is an investigational product candidate being developed to treat rare pediatric cholestatic liver diseases, including progressive familial intrahepatic cholestasis (PFIC), biliary atresia and Alagille syndrome. Albireo Reports Fourth Quarter and Year-End 2019 Financial Results, and Provi.. Albireo Recognizes Rare Disease Day and Supports Global Effort to “Refr.. Albireo to Present at Cowen and Company 40th Annual Health Care Conference. Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixiba.. New Phase 3 Data at AASLD Show Durable Response to Odevixibat in a Rare Pedia.. Albireo to Participate in Jefferies and Piper Sandler Virtual Investor Confer.. Albireo Reports Q3 2020 Financial Results and Provides Business Update, Albireo's Odevixibat PFIC Phase 3 Results Accepted for AASLD Late-Breakers, Albireo Announces Presentations at NASPGHAN 2020 Annual Meeting, Albireo Recognizes PFIC Awareness Day 2020, Albireo Prices Public Offering of 4,000,000 Shares of Common Stock. Forward-looking statements include statements, other than statements of historical fact, regarding, among other things: the plans for, or progress, scope, cost, initiation, duration, enrollment, results or timing for availability of results of, development of odevixibat or any other Albireo product candidate or program, including regarding expectations regarding the impact of COVID-19 on our business and our ability to adapt our approach as appropriate; the Phase 3 clinical program for odevixibat in patients with PFIC, the pivotal trial for odevixibat in biliary atresia (BOLD), and the planned pivotal trial for odevixibat in Alagille syndrome; the target indication(s) for development or approval, the size, design, population, location, conduct, cost, objective, enrollment, duration or endpoints of any clinical trial, or the timing for initiation or completion of or availability or reporting of results from any clinical trial, including the long-term open-label extension study for odevixibat in PFIC, the pivotal trial for odevixibat in biliary atresia, the planned pivotal trial for odevixibat in Alagille syndrome; the potential approval and commercialization of odevixibat; discussions with the FDA or EMA regarding our programs; the potential benefits or competitive position of odevixibat or any other Albireo product candidate or program or the commercial opportunity in any target indication; the potential effects of odevixibat of the treatment of PFIC patients and its potential to improve the current standard of care; the potential benefits of an orphan drug designation; the potential issuance of a rare pediatric disease priority review voucher; or Albireo’s plans, expectations or future operations, financial position, revenues, costs or expenses.