ICPT Stock Recent News
ICPT LATEST HEADLINES
Shares of Intercept Pharmaceuticals Inc. ICPT, -1.95% tumbled 15.2% toward an 11-month low in premarket trading Monday, after the biopharmaceutical company said a U.S. Food and Drug Administration committee voted to “defer approval” for its treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH). The company said 15 of 16 FDA committee members voted to defer approve until clinical outcome data from a trial are submitted and reviewed, and 12 of 16 members voted “no” on the question of whether current efficacy and safety data suggests benefits of the treatment (OCA 25 milligram) outweigh risks in NASH patients.
A panel of advisers to the U.S. Food and Drug Administration on Friday recommended holding off on an accelerated approval of Intercept Pharmaceuticals Inc's oral drug for a type of fatty liver disease until more study data is available.
Intercept (ICPT) falls 14.7% a couple of days before the scheduled GIDAC meeting to review its NASH treatment on concerns of adverse events.
Intercept's (ICPT) fixed-dose combination of obeticholic acid and bezafibrate for the potential treatment of primary biliary cholangitis gets the FDA's Orphan Drug Designation.
Intercept (ICPT) has been having a good run in the year so far, but investors are wary ahead of the upcoming advisory meeting by the FDA's Gastrointestinal Drugs Advisory Committee to review its NDA seeking approval of OCA in steatohepatitis (NASH).
Intercept (ICPT) reports wider-than-expected loss in the first quarter of 2023. Revenues rise year over year.
Intercept Pharmaceuticals reported 2023 Q1 earnings today. The company missed Wall Street's revenue estimate for the three-month period by approximately $4.7 million.
Intercept Pharmaceuticals, Inc. (ICPT) Q1 2023 Earnings Call Transcript.
Intercept Pharmaceuticals (ICPT) came out with a quarterly loss of $0.77 per share versus the Zacks Consensus Estimate of a loss of $0.57. This compares to loss of $0.58 per share a year ago.
Intercept (ICPT) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road.