Gene therapy biotech Kriya Therapeutics has acquired Tramontane Therapeutics, a startup focused on metabolic diseases. Tramontane brings a gene therapy that’s a potential one-time treatment for the fatty liver disease NASH.
The FDA again rejected Intercept Pharmaceuticals’ application seeking accelerated approval for its NASH drug and asked for more data. Instead, the biotech will stop all work in that fatty liver disease and focus on drugs for other serious but rare liver conditions.
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89bio reported its NASH drug candidate met the main endpoints of a mid-stage clinical trial. In addition to demonstrating efficacy and safety according to measures the FDA says are needed to support a regulatory submission, 89bio says the results also show its drug could offer a dosing edge over potential rivals.
The Aligos Therapeutics pipeline reprioritization comes after clinical trial setbacks to two hepatitis B drug candidates led the biotech to end both programs. Still intact is a Merck research collaboration focused on developing NASH therapies.
Akero Therapeutics’ experimental NASH drug, efruxifermin, met the main and secondary goals of Phase 2b clinical trial. The biotech will still need to show that the drug’s efficacy can hold up in a pivotal study, but the results so far are a positive sign for the NASH field, which has been marred by clinical trial failures.
Two years after the stinging FDA rejection of its drug for the fatty liver disease NASH, Intercept Pharmaceuticals has more safety and efficacy data from a pivotal study that could support resubmission of a new drug application. The biotech said it will meet with the FDA later this month.
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An NGM Biopharmaceuticals drug candidate for the fatty liver disease NASH failed a Phase 2b study less than a year after the company reported positive results from an earlier mid-stage study. The biotech will now focus on programs in eye diseases and cancer that are partnered with Merck.
ARCH Ventures and LS Polaris Innovation Fund led the round, which the company will use to develop the tech in diseases like NASH, its lead indication.