Tag Archives: icpt

Intercept Pharma Gets Dueling Initiation Reports As FDA Panel Nears

Shares of biotech Intercept Pharmaceuticals ( ICPT ) were up in twice-average volume Wednesday, after two analysts launched coverage ahead of a crucial FDA panel vote. Credit Suisse’s Alethia Young initiated with a buy rating, while Salveen Richter at Goldman Sachs initiated with a neutral rating, though they agreed on the general outlines of the investment thesis. Intercept’s lead drug candidate, obeticholic acid (OCA), is up for an FDA advisory committee discussion on April 7 as a treatment for primary biliary cholangitis (PBC), a rare, chronic liver disease. If approved by the FDA’s May 29 deadline, it would be Intercept’s first commercial product. Young estimates that annual sales for obeticholic acid could hit $259 million in 2018, though Richter forecasts it at only $170 million at peak. Both analysts, however, agree that the really big potential market for OCA is in nonalcoholic steatohepatitis (NASH), a much more common liver disease without a current treatment. That could draw $3.5 billion a year, Richter estimates, but that’s a ways in the future: The next batch of data from the NASH clinical trial isn’t expected until 2018. Between the panel meeting and the NASH data, Richter sees “a dearth of catalysts” to drive Intercept’s stock, leading him to set his price target at 114. Young, however, says approval and launch for treatment of PBC, both in the U.S. and Europe, could provide more upside for the stock. Her peak sales estimate in NASH is almost twice Richter’s at $6.5 billion. She set her price target at 200. Intercept stock rose 5% in early trading on the stock market today , but by early afternoon it was up 1%, near 125.50. Shares hit a 19-month high above 314 last May.

Intercept Pharma Spikes On Report That It’s Exploring A Sale

Shares of biotech Intercept Pharmaceuticals ( ICPT ) spiked 30% in early-afternoon trading Friday on a report that the company is exploring a sale. Reuters cited anonymous sources in its report that Intercept has been working with investment bankers this week after it received interest from other companies. Reuters did not name any of the suitors, but Intercept has been a perpetual source of buyout speculation. Gilead Sciences ( GILD ) is a popular choice of buyer due to its overlapping work in liver diseases, and so are big pharmas working in that space such as Bristol-Myers Squibb ( BMY ), Johnson & Johnson ( JNJ ) and Merck ( MRK ). Intercept shares were up about 31% on the stock market today , near 123. An imminent deal would be oddly timed, however, given that Intercept’s lead drug is tied up in a long and uncertain FDA review. Initially the agency set a deadline of Feb. 29 to decide whether to approve Intercept’s obeticholic acid (OCA) for primary biliary cirrhosis (PBC). In December, however, the FDA pushed the deadline out to May 29 to provide time for an advisory committee, or adcom, to review and vote on the application on April 7. The FDA generally calls such committees when it has unresolved issues with the data. Intercept is also studying OCA for the potentially much bigger market in nonalcoholic steatohepatitis (NASH), but safety issues have arisen in its trials. “We doubt that Intercept could or would be acquired before at least an adcom panel to discuss the risk/benefit of the drug for PBC approval, and any indications of interest by an acquirer would be more to just do due diligence and explore scenarios and valuations first,” wrote RBC Capital Markets analyst Michael Yee in a research note. Yee added that an acquirer would likely have to pay up to $5 billion for Intercept but wouldn’t be able to make money off the deal for years since the drug is expected to ramp slowly. This uncertainty over the last few months has helped tamp down Intercept’s stock even more than other biotechs’, as it’s trading at only about a third of its May high of 314.88. Image provided by Shutterstock .

BioMarin, Intercept Pharma Drugs Face FDA Delays

BioMarin Pharmaceutical (BMRN) and Intercept Pharmaceuticals (ICPT) stocks were heading in opposite directions after both of their closely-watched drugs received delays in their FDA approval decisions. BioMarin’s Duchenne muscular dystrophy (DMD) treatment Kyndrisa (drisapersen) had a decision deadline, or PDUFA date, of Dec. 27, which meant that the news was widely expected to come by Christmas Eve. However, BioMarin said in a brief statement