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Independent advisers to the U.S. Food and Drug Administration voted on Friday against confirmatory trial data for Intercept Pharmaceuticals' liver disease drug, putting into question the treatment's future in the U.S. market.
The U.S. Food and Drug Administration's staff on Wednesday raised concerns over the efficacy of Intercept Pharmaceuticals' liver disease drug, which is awaiting the regulator's traditional approval.
Intercept (ICPT) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.
Intercept (ICPT) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.
The stock is exploding following an announcement that it's on track to be acquired. Alfasigma is poised to buy Intercept at a price of $19 per share.
Amid a rough day on Wall Street, Intercept Pharmaceuticals (NASDAQ: ICPT ) represented a bright spot, with shares swinging up 75% before slightly adding to those gains. Catapulting the biopharmaceutical specialist was the announcement that Italy-based Alfasigma will acquire Intercept, seeking to leverage its lead therapeutic Ocaliva.
Intercept Pharmaceuticals (NASDAQ:ICPT) Inc shares surged 79% to $18.64 in late-morning trading on Tuesday after the biopharmaceutical company specializing in rare and serious liver diseases announced that it has agreed to be acquired by Alfasigma SpA, one of Italy's largest pharma companies, for $19 per share in cash, or an 82% premium to Intercept's closing price on September 25, 2023. Intercept's lead medicine is Ocaliva, the only US Food and Drug Administration (FDA) approved second-line treatment for primary biliary cholangitis (PBC), a progressive autoimmune disease affecting the liver, which generated revenue of $152 million during the first half of 2023.
Shares of Intercept Pharmaceuticals Inc. ICPT, -0.38% were set to soar Tuesday, after the biopharmaceutical company announced an agreement to be acquired by Italy's Alfasigma S.p.A in a deal that values Intercept shares at an 82% premium. Intercept's stock has been halted for news until 8:30 a.m.
Intercept (ICPT) reports a lower net loss and beats on revenues in the second quarter. The company also updates its guidance for its lead drug, Ocaliva.
Intercept Pharmaceuticals, Inc. (NASDAQ:ICPT ) Q2 2023 Earnings Conference Call August 2, 2023 8:30 AM ET Company Participants Nareg Sagherian - Executive Director, Investor Relations Jerry Durso - President and CEO Andrew Saik - Chief Financial Officer Linda Richardson - Chief Commercial Officer Michelle Berrey - President, Research & Development and Chief Medical Officer Conference Call Participants Yasmeen Rahimi - Piper Sandler Mayank Mamtani - B. Riley Securities Ed Arce - H.C.