Intercept (ICPT) Down Ahead of GIDAC Conference on NASH Treatment

shares of intercept drug After the FDA released the explanatory document ahead of a Gastroenterology Drug Advisory Committee (GIDAC) meeting to review information supporting the company’s New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of pre-syndrome, The ICPT fell 14.7%. Cirrhosis fibrosis due to non-alcoholic steatohepatitis (NASH).

The meeting is scheduled for May 19, 2023.

Stock prices probably fell because of concerns about drug-induced liver damage. The document states that during its review, the FDA identified a marginal benefit and a significant risk of his OCA in his NASH treatment. Key issues to consider in the benefit-risk assessment of OCA for NASH with fibrosis include the risk of drug-induced liver injury, gallstones or duct stones/sludge, as well as the theoretical clinical benefit of a one-step improvement in fibrosis. It is included. Associated complications, new or worsening dyslipidemia, accelerated progression to prediabetes or development of diabetes, and worsening glycemic control in diabetic patients.

The outcome of the meeting will provide insights to FDA, which plans to make a similar decision on June 22, 2023. Investors are skeptical because The Intercept has previously faced obstacles in accepting the NDA.

In June 2020, The Intercept received a complete response letter (“CRL”) from the FDA stating that the OCA NDA for the treatment of liver fibrosis by NASH cannot be approved in its current form. The CRL concluded that the predicted benefits of OCA based on surrogate histopathologic endpoints remain uncertain and that the potential risks are sufficiently outweighed to support accelerated approval of treatment for patients with liver fibrosis by NASH. It indicated that the FDA determined that it did not exceed the limit. This analysis is based on data reviewed by government agencies. Subsequently, the FDA will provide Intercept with additional post-interim efficacy and safety data from the ongoing REGENERATE trial to support potential early approval, and continue the trial’s long-term results phase. recommended that

Subsequently, in January 2023, FDA accepted the NDA, indicating that it was considering this as a full Class 2 resubmission, and assigned a target action date of June 22, 2023.

NASH is caused by excessive fat accumulation in the liver, causing chronic inflammation and progressive fibrosis (scarring) that can lead to cirrhosis and ultimately liver failure, cancer and death. It is a serious progressive liver disease.

Nonetheless, the stock is up 11.8% year-to-date, compared with a 7.2% decline for the industry.

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OCA is already approved under the trade name Ocaliba for the treatment of primary biliary cholangitis (in combination with ursodeoxycholic acid). [UDCA]) in adults who have an inadequate response to UDCA alone or as monotherapy for adults who are UDCA intolerant.

The NASH market promises promise despite the lack of an approved treatment, but it is also challenging.

Several athletes are trying to develop treatments for the same condition.

Madrigal Pharmaceuticals, Inc.. MDGL announced that its pipeline candidate resmetilom has received breakthrough therapy designation from the FDA for the treatment of NASH patients with liver fibrosis. Madrigal is currently conducting four Phase 3 clinical trials to demonstrate the safety and efficacy of resmetilom in the treatment of NASH: MAESTRO-NASH, MAESTRO-NAFLD-1, MAESTRO-NAFLD-OLE and MAESTRO-NASH-OUTCOMES. are being implemented.

shares of Viking Therapeutics VKTX recently rose following the company’s announcement of positive topline results from its Phase 2b clinical trial of VK2809 in patients with biopsy-confirmed NASH. The study met its primary endpoint, with patients receiving VK2809 experiencing a statistically significant reduction in liver fat content from baseline to week 12 compared to placebo. VK2809-treated patients showed statistically significant reductions in low-density lipoprotein cholesterol, triglycerides, and atherogenic lipoproteins compared to placebo.

The majority (94%) of treatment-related adverse events in patients receiving VK2809 were reported to be mild or moderate. Viking Therapeutics plans to report 52-week biopsy data from the VOYAGE study in the first half of next year.

Currently, Intercept’s Zack rank is #3 (hold).you can see Here is the complete list of today’s Zacks #1 ranked (strong buy) stocks.

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