It has been a roller coaster ride for Intercept Pharmaceuticals ICPT so far in 2023.
Last month, Intercept reported a wider loss in the first quarter of 2023 and revenues also missed estimates. Shares declined on the same.
While the miss was disappointing, investors seem warier about the upcoming advisory meeting by the Gastrointestinal Drugs Advisory Committee of the FDA to review its new drug application (NDA) seeking approval of obeticholic acid (OCA) in pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis (NASH). The meeting is scheduled for May 19, 2023.
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Earlier in the year, Intercept announced the resubmission of its NDA to the FDA for OCA for treating patients with pre-cirrhotic liver fibrosis due to NASH.
In June 2020, Intercept received a complete response letter (“CRL”) from the FDA stating that its new drug application (NDA) for OCA for the treatment of liver fibrosis due to NASH could not be approved in its present form. The CRL indicated that the FDA has determined that the predicted benefit of OCA, based on a surrogate histopathologic endpoint, remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH.
This analysis was based on the data reviewed by the agency. The FDA then recommended that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the trial should continue.
The target action date for the NDA review is set for June 2023.
The successful development of OCA for NASH will give a significant boost to Intercept.
Nevertheless, shares have gained 26.2% in the year so far against the industry’s 5.3% decline.
OCA is already approved under the brand name Ocaliva for treating primary biliary cholangitis (PBC) (in combination with ursodeoxycholic acid [UDCA]) in adults with an inadequate response to UDCA alone or as a monotherapy for adults intolerant to UDCA.
While the NASH market promises potential with no approved therapies yet, it is challenging.
Quite a few players are trying their hand at successfully developing a treatment for the same condition.
Madrigal Pharmaceuticals, Inc. MDGL announced that its pipeline candidate resmetirom has received Breakthrough Therapy designation from the FDA for the treatment of patients with NASH with liver fibrosis. A drug that receives Breakthrough Therapy designation is eligible for more intensive guidance on an efficient drug development program and organizational commitment involving senior managers from the FDA.
Madrigal is currently conducting four phase III clinical studies to demonstrate the safety and efficacy of resmetirom for the treatment of NASH: MAESTRO-NASH, MAESTRO-NAFLD-1, MAESTRO-NAFLD-OLE and MAESTRO-NASH-OUTCOMES.
Zacks Rank & Stocks to Consider
Currently, Intercept has a Zacks Rank #3 (Hold). Some top-ranked stocks in the healthcare sector include Spero Therapeutics SPRO and Ligand Pharmaceuticals LGND, both of which carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Over the past 60 days, loss estimates for SPRO have narrowed to $1.02 from $1.45 for 2023. SPRO topped earnings estimates in all of the last four quarters and, the average surprise being 67.54%.
Over the past 90 days, earnings estimates for LGND in 2023 have increased by 86 cents to $4.16. LGND topped earnings estimates in two of the last four quarters and missed in the other two, the average surprise being 21.50%.
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