Intercept Pharmaceuticals, Inc. ICPT announced that the FDA has granted orphan drug designation for the fixed-dose combination of obeticholic acid (OCA) and bezafibrate, for the potential treatment of primary biliary cholangitis (PBC).
Bezafibrate is a peroxisome proliferator-activated receptor agonist. The orphan drug designation will grant Intercept market exclusivity for a predefined time period for the above indication, along with exemption of FDA application fees, and tax credits for qualified clinical studies, all subject to approval.
The FDA’s orphan drug designations are granted to support the development of medicines for rare disorders that affect fewer than 200,000 people in the United States.
In the past year, shares of Intercept lost 9.3%, compared to the industry’s 2.6% fall.
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OCA is a farnesoid X receptor agonist, which Intercept markets as Ocaliva in the United States for the treatment of PBC. Bezafibrate, however, is not approved in the United States for any indication. The company is currently studying the OCA/bezafibrate combo in two ongoing phase II studies, 747-213 & 747-214, which are designed to explore a range of therapeutic doses for the combination drug.
Intercept looks forward to completing planned interim analyses from both ongoing phase II studies in 2023, with the first data readouts to be presented at a medical conference in June 2023. The company plans to meet with the FDA to discuss further steps regarding the combination drug, post-completion of the phase II studies. Per the company, planned interim analysis data from these phase II studies, along with phase I and pre-clinical data, will provide the basis for a potential meeting with the FDA.
PBC in the United States, affects approximately 1 in every 10000 women, mostly over the age of 40. It is a progressive and chronic autoimmune disease that affects the bile ducts in the liver.
Management believes that the OCA/bezafibrate combo has the potential to establish best-in-class clinical benefits and further improve the treatment of PBC.
Intercept Pharmaceuticals, Inc. Price and Consensus
Intercept Pharmaceuticals, Inc. price-consensus-chart | Intercept Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Intercept currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Allogene Therapeutics ALLO, Anixa Biosciences ANIX and ADMA Biologics, Inc. ADMA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.83 to $2.32. In the past year, shares of Allogene Therapeutics have fallen by 15.7%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Anixa Therapeutics’ 2023 loss per share has narrowed from 62 cents to 43 cents. In the past year, shares of Anixa Therapeutics have increased by 1.8%.
ANIX beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 24.04%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. In the past year, shares of ADMA Biologics have increased by 102.9%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
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