ARTICLE | Product Development
Plus: Madrigal identifies non-invasive efficacy assessment for NASH and updates from Novo and Valneva
By BioCentury Staff
November 10, 2023 11:38 PM UTC
Cargo Therapeutics Inc. (NASDAQ:CRGX) was the latest biotech IPO to dip on its first day of trading. The next-generation CAR T company raised $281.3 million in its offering on NASDAQ after selling 18.8 million shares at $15, the low end of the company’s range for a valuation of $580 million. While shares initially traded up, the stock closed on Friday down $0.47 to $14.53, making it the largest biotech IPO this year to see a first-day drop. Last week, gene therapy play Lexeo Therapeutics Inc. (NASDAQ:LXEO) saw a 9% dip in its first day of trading, but has since traded near its $11 issue price. Cargo’s CD22-targeted CAR T therapy CRG-022 is in Phase II testing to treat relapsed or refractory large B cell lymphoma (LBCL).
Non-alcoholic steatohepatitis could be the next indication in line for a new surrogate endpoint, with data from the registration MAESTRO-NASH study of resmetirom from Madrigal Pharmaceuticals Inc. (NASDAQ:MDGL) showing a strong association between magnetic resonance imaging-protein density fat fraction (MRI-PDFF) and biopsy-measured responses — the typical primary endpoints. In the study, 70% of patients treated with 100 mg of resmetirom achieved a 30% or greater reduction in MRI-PDFF, which is a non-invasive imaging test that assesses liver fat. A 30% or greater reduction in the measure was associated with both NASH resolution (96% of patients) and improvement in fibrosis (88% of patients). Resmetirom is under FDA review for NASH with a March 14 PDUFA date. …