Intercept Pharmaceuticals Announces Pivotal Phase 3 Clinical Trial of Obeticholic Acid in NASH

Barclays Starts Intercept Pharmaceuticals (ICPT) at Overweight

Barclays initiated coverage on Intercept Pharmaceuticals (NASDAQ: ICPT) with an Overweight rating and a price target of $425.00.

For an analyst ratings summary and ratings history on Intercept Pharmaceuticals click here. For more ratings news on Intercept Pharmaceuticals click here.

Shares of Intercept Pharmaceuticals closed at $269.74 yesterday.

BofA/Merrill Lynch Downgrades Intercept (ICPT) to Neutral on Lack of Catalysts

BofA/Merrill Lynch downgraded Intercept Pharmaceuticals (NASDAQ: ICPT) from Buy to Neutral with a price target of $315. Earlier Intercept announced plans for an international Phase 3 trial of OCA in NASH. Analyst Ying Haung sees the design "as expected" though the trial... More

Intercept (ICPT) NASH Study to be Larger, Riskier and Delayed, Leerink Partners Says

Leerink Partners analyst Joseph Schwartz weighed in on Intercept Pharmaceuticals (NASDAQ: ICPT) after the company announced the design of Ph.3 REGENERATE study to evaluate the impact of obeticholic acid (OCA) treatment on non-alcoholic steatohepatitus (NASH) with fibrosis, after receiving final harmonized guidance from FDA and EMA. Schwartz said the study will be larger, riskier and take longer compared to Street estimates.

Schwartz commented, "As previously guided by ICPT, total trial population of F2/3 and high-risk F1s (with concomitant diabetes, obesity, etc.) does mimic the one that received breakthrough therapy designation; however... More

BMO Capital Says Buy Intercept Pharmaceuticals (ICPT) on Weakness Related to Trial Design

BMO Capital analyst Jim Birchenough reiterated an Outperform rating and $515 price target on Intercept Pharmaceuticals (NASDAQ: ICPT) following review of REGENERATE phase 3 trial design. The firm would be buyers on today's weakness (-11.2%).

Birchenough commented, "Following FLINT... More

Intercept (ICPT) Bearish Concerns Tied to Trial Size; RBC Reiterates Outperform

RBC Capital reiterated an Outperform rating on Intercept Pharmaceuticals (NASDAQ: ICPT) with a price target of $490. Earlier Intercept announced plans for an international Phase 3 trial of OCA in NASH. In the view of analyst Michael J. Yee the trial design and plans look straight-forward.

Yee also commented on bear concerns related to the larger than previously suggested size of the trial -- a key point with shares lower pre-market.

"We reiterate our Outperform and think stock continues to move higher based on positive announcement of ICPT's... More

Intercept's (ICPT) OCA Ph3 Trial Design or Size Not Seen as Surprise - Deutsche Bank

Shares of Intercept Pharmaceuticals (NASDAQ: ICPT) declined pre-market after it announced its plans for an international Phase 3 trial of OCA. Deutsche Bank's Alethia Young is not surprised by the design or size of this trial.

Young added that the File-able surrogate endpoint at 72 weeks was in-line with expectations. Young also said endpoints of the trial are not surprising and are in-line with management commentary.

"Primary endpoint is a co-primary endpoint of 1) fibrosis improvement- proportion of patients getting at least one stage of fibrosis improvement... More

Intercept Pharma (ICPT) Announces Design of OCA Phase 3 in NASH with Liver Fibrosis

Intercept Pharma (NASDAQ: ICPT) announced its plans for an international Phase 3 trial of obeticholic acid (OCA), the company's lead FXR agonist, in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis. OCA has received breakthrough therapy designation in this patient population from the U.S. Food and Drug Administration (FDA). In accordance with harmonized advice from the FDA and European Medicines Authority (EMA), the Randomized Global Phase 3 Trial to Evaluate the Impact on NASH with Fibrosis of Obeticholic Acid Treatment (REGENERATE) has been designed as a double-blind, placebo-controlled pivotal Phase 3 clinical trial expected to... More