The drug was approved under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and address an unmet medical need, based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit.
Tag Archive for: fibrosis
Shares of Intercept Pharmaceuticals fell 16% on Monday over concerns about the prospects of the company’s drug to treat a type of fatty liver disease after the regulator’s advisory panel voted to defer an accelerated approval.
Current forms of fibrosis treatment may slow the course of the disease, at best, and are limited by safety concerns. However, Mediar is tackling fibrotic disease from a new angle.
Intercept Pharmaceuticals Inc. said on Friday its treatment for patients with advanced liver scarring due to non-alcoholic steatohepatitis (NASH) failed to meet the main goal of a late-stage study, sending its shares down as much as 21%.
With $165 million in the bank, Capstan Therapeutics launched Wednesday to combine the potency of cell therapy with the precision of genetic medicines against various difficult-to-treat diseases.
A new study published in Science found that the loss of Y chromosomes in white blood cells is associated with an increased risk of dying from heart disease.