ALBO - アルビレオ・ファ―マ （Albireo Pharma Inc.）

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 AgreementAlbi…

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 (odevixibat) indication for patients with Alagille syndrome (ALGS). As defined by the FDA, the Priority Review timeline is 6 months and the agency will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. With completed submissions for Bylvay in the U.S. and EU for use in patients with ALGS, the Company anticipates approvals in mid-2023.

Albireo, Mirum''s only competitor in a billion-dollar market, is being acquired by Ipsen for up to $1.2 billion. Find out why I''m bullish on MIRM stock.

Albireo Pharma Inc. (NASDAQ:ALBO) price on Friday, January 13, fall -0.09% below its previous day’s close as a downside momentum from buyers pushed the stock’s value to $43.90. A look at the stock’s price movement, the close in the last trading session was $43.94, moving within a range at $43.85 and $44.3998. The beta value … Is Albireo Pharma Inc. (NASDAQ: ALBO) A Top Momentum Pick? Read More »

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 AgreementAlbi…

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 (odevixibat) indication for patients with Alagille syndrome (ALGS). As defined by the FDA, the Priority Review timeline is 6 months and the agency will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. With completed submissions for Bylvay in the U.S. and EU for use in patients with ALGS, the Company anticipates approvals in mid-2023.

Albireo, Mirum''s only competitor in a billion-dollar market, is being acquired by Ipsen for up to $1.2 billion. Find out why I''m bullish on MIRM stock.

Albireo Pharma Inc. (NASDAQ:ALBO) price on Friday, January 13, fall -0.09% below its previous day’s close as a downside momentum from buyers pushed the stock’s value to $43.90. A look at the stock’s price movement, the close in the last trading session was $43.94, moving within a range at $43.85 and $44.3998. The beta value … Is Albireo Pharma Inc. (NASDAQ: ALBO) A Top Momentum Pick? Read More »

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 AgreementAlbi…

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 (odevixibat) indication for patients with Alagille syndrome (ALGS). As defined by the FDA, the Priority Review timeline is 6 months and the agency will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. With completed submissions for Bylvay in the U.S. and EU for use in patients with ALGS, the Company anticipates approvals in mid-2023.

Albireo, Mirum''s only competitor in a billion-dollar market, is being acquired by Ipsen for up to $1.2 billion. Find out why I''m bullish on MIRM stock.

Albireo Pharma Inc. (NASDAQ:ALBO) price on Friday, January 13, fall -0.09% below its previous day’s close as a downside momentum from buyers pushed the stock’s value to $43.90. A look at the stock’s price movement, the close in the last trading session was $43.94, moving within a range at $43.85 and $44.3998. The beta value … Is Albireo Pharma Inc. (NASDAQ: ALBO) A Top Momentum Pick? Read More »