2023-06-23 07:33:10 ET
A day after the FDA rejected its lead asset, obeticholic acid (OCA) for nonalcoholic steatohepatitis (NASH), Intercept Pharmaceuticals ( NASDAQ: ICPT ) announced Friday that the company will halt all NASH-related investments and cut approximately a third of its staff.
Intercept ( ICPT ) expects to begin layoffs in Q3 2023 and complete most staff reductions by the end of 2023.
However, the company intends to strongly support its investments in Ocaliva, an FDA-approved second-line therapy for primary biliary cholangitis (PBC). The management also reiterated 2023 Ocaliva net sales guidance of $310M - $340M.
"We are taking decisive actions that we believe will improve our ability to drive long-term growth and maintain leadership with our PBC business, continue to develop innovative new medicines, and achieve profitability beginning in 2024," CEO Jerry Durso remarked.
Forecasting ~$140M net reduction in annual non-GAAP adjusted operating expenses, the company lowered its non-GAAP adjusted operating expense guidance for 2023 to $350M – $370M. Intercept's ( ICPT ) shares rose ~4% pre-market in reaction to the news.
More details on the updated guidance and restructuring activities are expected during a conference call scheduled for Friday at 8:30 a.m. ET.
More on Intercept
- Intercept Pharmaceuticals to end NASH program following FDA feedback
- Intercept Pharmaceuticals: Do Not Expect PBC Sales To Save The Company
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Intercept to cut one third of staff as NASH program winds down