Submission status for ALBIREO PHARMA INC's drug BYLVAY (ORIG-1) with active ingredient ODEVIXIBAT has changed to 'Approval' on 07/20/2021. Application Category: NDA, Application Number: 215498, Application Classification: Type 1 - New Molecular Entity

Transaction focused on Bylvay® (odevixibat), the first-approved treatment in progressive familial intrahepatic cholestasis in U.S. and E.U., with potential in other rare diseases Acquisition aligned with Ipsen's long-term strategy for expanding the scope of its Rare Disease portfolio and pipeline Ipsen to commence cash tender offer to acquire all issued and outstanding shares of Albireo for $42.00 per share plus a contingent value right (CVR) of $10.00 per share related to the U.S. FDA approval of Bylvay in biliary atresia Regulatory News: Ipsen (OTC:IPSEY) and Albireo (NASDAQ:ALBO) today announced that they have entered into a definitive merger agreement under which Ipsen will acqu

Bylvay® (odevixibat) Q3 2022 PFIC net revenue of $7.5 million, September YTD 2022 $18.1 millionNew disease modification and native liver survival data with Bylvay in PFIC patients presented at AASLD Positive Bylvay Phase 3 ASSERT topline data in ALGS presented at AASLD; submissions on track Completed enrollment in BOLD study in biliary atresia, third Bylvay Phase 3 programCompany to host a conference call and webcast today at 4:30 p.m. ET BOSTON, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare disease company developing novel bile acid modulators to treat rare pediatric and adult liver diseases, today provided a business update and reported financial results

BOSTON, Oct. 31, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on November 8, 2022, to provide a business update and review the company's financial results for the quarter ended September 30, 2022. To access the live conference call by phone, dial 1-855-327-6837 (domestic) or 1-631-891-4304 (international), and provide the access code 10020423. A live audio webcast will be accessible from the Investors page at ir.albireopharma.com/. To ensure a timely connection to the webcast, it is recommended that partici

Highly statistically significant improvement in pruritus primary endpoint (p=0.002)Significant reductions in key secondary endpoint of serum bile acid levels (p=0.001)Substantial improvements in multiple sleep parametersWell tolerated with low incidence of drug-related diarrhea, no discontinuationsPlans to immediately file in the U.S. and EU, adding to approved indication for PFIC Conference call to be held today at 8:30am EDT BOSTON, Oct. 11, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced positive topline results from the Phase 3 ASSERT study evaluating

Bylvay®(odevixibat) Q2 2022 net product revenue $5.9 million, June YTD 2022 $10.5 millionAgreed Bylvay reimbursement contract in Italy and Belgium with launches planned for the fallGlobal Phase 3 ASSERT study in Alagille syndrome on track for topline data readout this fallGlobal Phase 3 BOLD study in biliary atresia on track for full enrollment in 2022Company to host a conference call and webcast today at 4:30 p.m. ET BOSTON, Aug. 15, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators to treat rare pediatric and adult liver diseases, today provided a business update and reported financial results for the quarter

BOSTON, Aug. 01, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on August 15, 2022, to provide a business update and review the company's financial results for the quarter ended June 30, 2022. To access the live conference call by phone, dial 1-855-327-6837 (domestic) or 1-631-891-4304 (international), and provide the access code 10019926. A live audio webcast will be accessible from the Investors page at ir.albireopharma.com/. To ensure a timely connection to the webcast, it is recommended that participants re

Positive Bylvay™ (odevixibat) global commercial launch in U.S., Germany and United Kingdom with Q1 2022 product revenue, net $4.7 million Phase 3 ASSERT study in Alagille syndrome fully enrolled, patient numbers above original target and on track for topline data readout in 2022Phase 3 BOLD study in biliary atresia on track for full enrollment in 2022A3907 and A2342 on track for Phase 2 and Phase 1 study starts this yearCompany to host a conference call and webcast today at 4:30 p.m. ET BOSTON, May 16, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today provided a business update and reported financial res

BOSTON, May 09, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced that management will host a conference call and live audio webcast at 4:30 p.m. ET on May 16, 2022, to provide a business update and review the company's financial results for the quarter ended March 31, 2022. To access the live conference call by phone, dial 877-407-0792 (domestic) or 201-689-8263 (international), and provide the access code 13729296. A live audio webcast will be accessible from the Investors page at ir.albireopharma.com/. To ensure a timely connection to the webcast, it is recommended that participants register

Bylvay™ (odevixibat) launched in the U.S. and Europe, 2021 product revenue, net $7 millionNICE endorses clinical and economic benefits of BylvayPhase 3 study in Alagille syndrome on track for readout in 2022Reports $248.1 million of cash and cash equivalents, sufficient to fund operations into 2024Company to host a conference call and webcast today at 10:00 a.m. ET BOSTON, March 01, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today provided a business update and reported financial results for the fourth quarter and year ended December 31, 2021. "The response to Bylvay from healthcare providers, patients

BOSTON, Feb. 22, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced that management will host a conference call and live audio webcast at 10:00 a.m. ET on March 1, 2022, to provide a business update and review the company's financial results for the fourth quarter and year ended December 31, 2021. To access the live conference call by phone, dial 877-407-0792 (domestic) or 201-689-8263 (international), and provide the access code 13727211. A live audio webcast will be accessible from the Media & Investors page of Albireo's website ir.albireopharma.com/. To ensure a timely connection to the webcas

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– Dr. Craig Hopkinson, currently EVP of Research & Development and Chief Medical Officer at Alkermes, brings strong global orphan drug development expertise – Dr. Paul Streck, former Chief Medical Officer at Arena Pharmaceuticals, brings significant global drug development and commercialization expertise – Two appointments strengthen Company's ability to scale up global drug development and grow the portfolio BOSTON, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the appointments of two scientific leaders, Drs. Paul Streck and Craig Hopki

– Habib Dable, Former President and CEO of Acceleron Pharma, and Susan Alesina, Vice President, National Business Development and Alliances at Boston Children's Hospital, bring significant global drug development, financial and commercial operations expertise to Albireo BOSTON, Aug. 10, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the appointments of Habib Dable and Susan Alesina to its Board of Directors — two experienced, strategic leaders with vast pharmaceutical and biotech expertise in business development, operations and commercialization. T

BASEL, Switzerland, Feb. 28, 2022 (GLOBE NEWSWIRE) -- Noema Pharma, a Swiss-based clinical stage company targeting orphan central nervous system (CNS) diseases, today announces the appointment of Michael Gutch, Ph.D., as Chief Financial Officer. Dr. Gutch has extensive experience in the healthcare and pharmaceutical industries and venture capital investment. He served as Executive Director of Corporate Development and Head of Equities at AstraZeneca and was most recently Chief Business Officer and Chief Financial Officer at Entasis Therapeutics, an AstraZeneca spin-off, where he was involved in the company's private financing rounds, its NASDAQ listing in 2018 and in the strategic partneri

BOSTON, Dec. 02, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators, today announced the appointment of Constantine Chinoporos as Chief Business Officer and a member of the Albireo Enterprise Leadership Team. Mr. Chinoporos was most recently at Boston Pharmaceuticals where he was the Chief Business Officer responsible for all business development, new product planning operations and in-licensing of 20 programs over his tenure. He brings 30 years of experience in business development, new product planning operations, corporate development, global licensing and divestitures. In this new role, Mr. Chinoporos will be

– Appointment strengthens leadership team as the Company readies for potential global odevixibat launch and progresses multiple clinical development programs – – Deep experience spanning drug development, manufacturing, quality and supply chain – BOSTON, April 13, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced the appointment of Joan Connolly as Chief Technology Officer and key member of the Albireo Enterprise Team. In this new role, Connolly will be responsible for overseeing drug substance and product development, clinical supply distribution, commercial supply chain and qua

Ipsen extends expiration date of tender offer for Albireo Pharma, Inc. to 1 March 2023 Extension allows for the satisfaction of the HSR Act related condition as outlined in the Merger AgreementAlbireo stockholders are encouraged to tender their shares to the offer today PARIS, FRANCE, 22 February 2023 – Ipsen S.A. ((Euronext: IPN, OTC:IPSEY) today announced that Anemone Acquisition Corp. (Purchaser), its wholly owned indirect subsidiary, has extended the expiration time for the previously announced tender offer to purchase all of the issued and outstanding shares of common stock (the "Shares") of Albireo Pharma, Inc. (NASDAQ:ALBO) (Albireo) at a price of $42.00 per share, net to the holder

Bylvay (odevixibat) granted Priority Review by U.S. FDAASSERT study demonstrated efficacy of Bylvay in pruritus, bile acids and sleep with a low drug-related diarrhea rate in Alagille patientsApproval in second indication would more than double Bylvay market opportunity BOSTON, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's supplemental New Drug Application (sNDA) and issued a Prescription Drug User Fee Act (PDUFA) action date of June 15, 2023 for a second Bylvay (odevixi

Transaction focused on Bylvay® (odevixibat), the first-approved treatment in progressive familial intrahepatic cholestasis in U.S. and E.U., with potential in other rare diseases Acquisition aligned with Ipsen's long-term strategy for expanding the scope of its Rare Disease portfolio and pipeline Ipsen to commence cash tender offer to acquire all issued and outstanding shares of Albireo for $42.00 per share plus a contingent value right (CVR) of $10.00 per share related to the U.S. FDA approval of Bylvay in biliary atresia Regulatory News: Ipsen (OTC:IPSEY) and Albireo (NASDAQ:ALBO) today announced that they have entered into a definitive merger agreement under which Ipsen will acqu

BOSTON, Dec. 20, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the grant to its newly appointed Chief Medical Officer, Paul D. Streck, M.D., of inducement restricted stock units to acquire 63,966 shares of Albireo's common stock. The restricted stock units were granted as an inducement material to Dr. Streck's acceptance of employment with Albireo in accordance with Nasdaq Listing Rule 5635(c)(4). The restricted stock units vest over a four-year period, subject to the employee's continued service with Albireo through the applicable vesting dates. Th

- Gold standard Phase 3 ASSERT study supports supplementary filings in the U.S. and EU - ASSERT study demonstrated efficacy of Bylvay (odevixibat) in pruritus, bile acids and sleep with a low drug-related diarrhea rate - Data submitted to support use across wide age range of patients, including those with JAG1 and NOTCH2 mutations  BOSTON, Dec. 19, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a variation application to the European Medicine

BOSTON, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the grant of inducement restricted stock units to acquire 13,700 shares of Albireo's common stock. The restricted stock units were granted as an inducement material to the employee's acceptance of employment with Albireo in accordance with Nasdaq Listing Rule 5635(c)(4). The restricted stock units vest over a four-year period, subject to the employee's continued service with Albireo through the applicable vesting dates. The vesting schedule for each restricted stock unit is 25 percent on

– Dr. Craig Hopkinson, currently EVP of Research & Development and Chief Medical Officer at Alkermes, brings strong global orphan drug development expertise – Dr. Paul Streck, former Chief Medical Officer at Arena Pharmaceuticals, brings significant global drug development and commercialization expertise – Two appointments strengthen Company's ability to scale up global drug development and grow the portfolio BOSTON, Dec. 06, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare liver disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced the appointments of two scientific leaders, Drs. Paul Streck and Craig Hopki

BOSTON, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, today announced participation in the Jefferies London Healthcare Conference in London, UK, from November 15-17, 2022. Simon Harford, Chief Financial Officer of Albireo, will be presenting on November 15, 2022, at 10:20 AM GMT. A replay of the webcast will be available on-demand on the Albireo Investors page: ir.albireopharma.com. About Albireo   Albireo Pharma is a rare disease company focused on the development of novel bile acid modulators to treat pediatric and adult liver diseases. Albireo's lead produc

Bylvay® (odevixibat) Q3 2022 PFIC net revenue of $7.5 million, September YTD 2022 $18.1 millionNew disease modification and native liver survival data with Bylvay in PFIC patients presented at AASLD Positive Bylvay Phase 3 ASSERT topline data in ALGS presented at AASLD; submissions on track Completed enrollment in BOLD study in biliary atresia, third Bylvay Phase 3 programCompany to host a conference call and webcast today at 4:30 p.m. ET BOSTON, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare disease company developing novel bile acid modulators to treat rare pediatric and adult liver diseases, today provided a business update and reported financial results

Early, rapid, and sustained efficacy across wide range of patients with evidence of disease modificationLong-term preservation of native liver in PFIC, improvements in pruritus, bile acids, and increased growth over timeLate-breaking oral presentation demonstrates restoration of bile acid secretion in PFIC patients receives "Best of Liver Meeting" distinctionLate-breaking oral presentation of new positive Phase 3 ASSERT trial results in Alagille syndrome receives "Best of Liver Meeting" distinction BOSTON, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (NASDAQ:ALBO), a rare disease company developing novel bile acid modulators to treat pediatric and adult liver diseases, presented

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Albireo Pharma (NASDAQ:ALBO) has observed the following analyst ratings within the last quarter: Bullish Somewhat Bullish Indifferent Somewhat Bearish Bearish Total Ratings 0 0 5 0 0 Last 30D 0 0 1 0 0 1M Ago 0 0 0 0 0 2M Ago 0 0 4 0 0 3M Ago 0 0 0 0 0 These 5 analysts have an average price target of $43.2 versus the current price of Albireo Pharma at $44.29, implying downside. Below is a summary of how these 5 analysts rated Albireo Pharma over the past 3 months. The greater the number of bullish ratings, the more positive analysts are on the stock and the greater the number of bearish ratings, the more negative analysts are on the stock This current average represen

HC Wainwright & Co. analyst Ed Arce reiterates Albireo Pharma (NASDAQ:ALBO) with a Neutral and maintains $42 price target.

Cowen & Co. downgraded its rating of Albireo Pharma (NASDAQ:ALBO) to Market Perform with a price target of $48.00, changing its price target from $68.00 to $48.00. Shares of Albireo Pharma are trading up 0.09% over the last 24 hours, at $43.89 per share. A move to $48.00 would account for a 9.36% increase from the current share price. About Albireo Pharma Albireo Pharma Inc is a commercial-stage biopharmaceutical company. It focuses on the development and commercialization of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. The Company's product pipeline includes Bylvay, which is approved in the United States and

Upgrades According to B of A Securities, the prior rating for Toll Brothers Inc (NYSE:TOL) was changed from Neutral to Buy. For the fourth quarter, Toll Brothers had an EPS of $4.70, compared to year-ago quarter EPS of $3.02. The current stock performance of Toll Brothers shows a 52-week-high of $70.05 and a 52-week-low of $39.53. Moreover, at the end of the last trading period, the closing price was at $53.91. Lake Street upgraded the previous rating for Inotiv Inc (NASDAQ:NOTV) from Hold to Buy. Inotiv earned $0.32 in the fourth quarter, compared to $0.06 in the year-ago quarter. At the moment, the stock has a 52-week-high of $42.63 and a 52-week-low of $3.65. Inotiv closed at $5.59 at

Guggenheim analyst Seamus Fernandez downgrades Albireo Pharma (NASDAQ:ALBO) from Buy to Neutral.

Analysts have provided the following ratings for Albireo Pharma (NASDAQ:ALBO) within the last quarter: Bullish Somewhat Bullish Indifferent Somewhat Bearish Bearish Total Ratings 0 0 4 0 0 Last 30D 0 0 2 0 0 1M Ago 0 0 2 0 0 2M Ago 0 0 0 0 0 3M Ago 0 0 0 0 0 In the last 3 months, 4 analysts have offered 12-month price targets for Albireo Pharma. The company has an average price target of $43.5 with a high of $48.00 and a low of $42.00. Below is a summary of how these 4 analysts rated Albireo Pharma over the past 3 months. The greater the number of bullish ratings, the more positive analysts are on the stock and the greater the number of bearish ratings, the more negativ

Cowen & Co. analyst Ritu Baral downgrades Albireo Pharma (NASDAQ:ALBO) from Outperform to Market Perform and lowers the price target from $68 to $48.

Jefferies analyst Eun Yang downgrades Albireo Pharma (NASDAQ:ALBO) from Buy to Hold and lowers the price target from $49 to $42.

Upgrades Morgan Stanley upgraded the previous rating for Stem Inc (NYSE:STEM) from Equal-Weight to Overweight. In the third quarter, Stem showed an EPS of $0.22, compared to $0.15 from the year-ago quarter. The current stock performance of Stem shows a 52-week-high of $18.02 and a 52-week-low of $5.72. Moreover, at the end of the last trading period, the closing price was at $8.14. According to Goldman Sachs, the prior rating for American Tower Corp (NYSE:AMT) was changed from Neutral to Buy. American Tower earned $2.36 in the third quarter, compared to $2.49 in the year-ago quarter. At the moment, the stock has a 52-week-high of $282.47 and a 52-week-low of $178.17. American Tower closed