Intercept Pharmaceuticals Weighed Down By A Troubling Trifecta
Stephen Simpson, CFA
Stephen Simpson, CFA
NASH Drugs Update: Intercept's Phase 3 Details, Genfit's Diagnostic Tool And Raptor's Failure
Logribel Biostocks • 54 Comments
Logribel Biostocks • 54 Comments
Thu, Jun. 30, 9:16 AM
Wed, Jun. 29, 5:38 PM
Tue, May 31, 7:01 AM
- As expected, the FDA grants accelerated approval for Intercept Pharmaceuticals' (NASDAQ:ICPT) Ocaliva (obeticholic acid) (OCA), in combination with ursodeoxycholic acid (UDCA), for the treatment of primary biliary cholangitis, formerly known as primary biliary cirrhosis, an autoimmune disease in which the bile ducts in the liver are slowly destroyed.
- Ocaliva is approved in combination with UDCA in patients who have not responded adequately to UDCA or as monotherapy in patients who cannot tolerate UDCA.
- In early April, the FDA's Gastrointestinal Drugs Advisory Committee voted 17-0 backing approval.
- OCA is an agonist of the farnesoid X receptor, a nuclear receptor expressed in the liver and intestine that is a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways.
- Intercept is up 14% premarket on light volume.
- Previously: Intercept Pharma up 5% premarket after positive Ad Comm vote (April 8)
Fri, Apr. 8, 8:11 AM
- Intercept Pharmaceuticals (NASDAQ:ICPT) is up 5% premarket on increased volume. Yesterday afternoon, the FDA's Gastrointestinal Drugs Advisory Committee voted 17-0 backing approval of the company's obeticholic acid for the treatment of primary biliary cirrhosis, now called primary biliary cholangitis (PBC). The FDA action date (PDUFA) is May 29.
- Previously: Ad Comm review approaches for Intercept's lead product candidate (April 5)
Thu, Apr. 7, 3:57 PM
- The FDA's Gastrointestinal Drugs Advisory Committee votes 17-0 backing approval of Intercept Pharmaceuticals' (ICPT) obeticholic acid (OCA) for the treatment of primary biliary cirrhosis (PBA), accepting the use of the liver enzyme alkaline phosphatase (ALP) as a surrogate endpoint.
Wed, Apr. 6, 1:45 PM
- Gilead Sciences' (GILD +2%) acquisition of Nimbus Therapeutics for as much as $1.2B appears to have investors in a lather over other developers of therapies to treat nonalcoholic steatohepatitis (NASH), especially Galmed Pharmaceuticals (GLMD +38.3%).
- NASH-related tickers: (MNOV +0.4%)(RGLS +4.8%)(ICPT +4.4%)(CNAT +10.9%)(VBLT +3%)(GALT +2%)(TBRA -0.1%)(OTCPK:ISLT)(SHPG +7.2%)(RPTP +3.6%)(OTCPK:GNFTF -0.9%)(CANF +11.8%)
- Read now NASH Drugs: A Comprehensive Review Of Current Clinical Trials
Tue, Apr. 5, 12:45 PM
Tue, Apr. 5, 9:23 AM
- Intercept Pharmaceuticals (NASDAQ:ICPT) is up 10% premarket on increased volume ahead of Thursday's meeting of the FDA's Gastrointestinal Drugs Advisory Committee to review the company's New Drug Application (NDA) seeking approval of obeticholic acid oral tablets, in combination with ursodeoxycholic acid (UDCA), for the treatment of adults with primary biliary cirrhosis (PBC) who fail to respond adequately to UDCA or as monotherapy in adults unable to tolerate UDCA.
- Draft questions
- FDA briefing doc
- Errata to FDA briefing doc
- Company briefing doc
- Errata to company briefing doc
- Update: The buying appears to be stoked by the clarity around the endpoints in the Phase 3 study, 747-301, which measured OCA's efficacy by the reduction in a liver enzyme called alkaline phosphatase (ALP) or total bilirubin (TB). Eligible participants had to have elevated values in at least one of the biomarkers. Most of the subjects, though, had elevated ALP levels but normal TB. The link between specific reductions in ALP and clinical benefit have not be conclusively established, so the FDA expressed doubt that ALP alone would be sufficient to demonstrate efficacy. Later in the FDA's briefing doc, the author provides the details from an analysis of 5,000-person registry study that supports the use of ALP as an indicator of efficacy (Section 4).
Tue, Apr. 5, 9:16 AM
Wed, Mar. 30, 8:43 AM
- Intercept Pharmaceuticals (NASDAQ:ICPT) has a full slate of abstract presentations on lead product candidate obeticholic acid (OCA) at the upcoming International Liver Congress 2016, the 51st Annual Meeting of the European Association for the Study of the Liver, in Barcelona Spain, April 13 - 17.
- The abstracts focus on the use of OCA in primary biliary cirrhosis (now called primary biliary cholangitis or PBC), and nonalcoholic steatohepatitis (NASH) and include new analyses of the Phase 3 POISE study and Phase 2 FLINT trial in NASH. Results from the Phase 2 CARE study in biliary atresia (bile duct is abnormally closed or absent) will also be presented.
- Shares are up 3% premarket but only on 1,162 shares.
Fri, Feb. 12, 12:48 PM
Fri, Feb. 12, 12:28 PM
- Intercept Pharmaceuticals (ICPT +21.9%) jumps on modest volume in apparent response to yet another rumor of a possible sale. In December, shares spiked on the rumor that Shire plc (SHPG +4.3%) was interested, but it took out Baxalta instead.
- Its lead product candidate is obeticholic acid (OCA), under development for the treatment of primary biliary cirrhosis (PBC), nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis and biliary atresia.
- The supposed allure for potential suitors is NASH, a blockbuster opportunity for the first mover. OCA flunked a Japan-based Phase 2 study in NASH, however. The FDA's action date for its review of the company's NDA for PBC is February 29.
- Previously: Intercept Pharma's NASH candidate flunks mid-stage study; shares off 15% premarket (Oct. 28, 2015)
- Previously: Intercept Pharma's obeticholic acid NDA for PBC gets Priority Review; PDUFA date is February 29 (Aug. 31, 2015)
Dec. 18, 2015, 9:15 AM
Dec. 17, 2015, 6:14 PM
- Intercept Pharma (NASDAQ:ICPT) states the FDA has "has extended the Prescription Drug User Fee Act (PDUFA) date for its Priority Review of obeticholic acid (OCA) in primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC)."
- Additional clinical data has been given to the FDA, as requested. The PDUFA date, which was previously Feb. 29, 2016, is now May 29, 2016. An advisory committee meeting is planned for April 7.
- Shares have fallen to $156.50 after hours.
Dec. 17, 2015, 5:39 PM
Dec. 15, 2015, 12:48 PM
Intercept Pharmaceuticals, Inc. is a development stage biopharmaceutical company. It focuses on the discovering, developing and commercializing of novel therapeutics to treat chronic liver diseases utilizing its proprietary bile acid chemistry. It develops obeticholic acid, a bile acid analog... More
Country: United States