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Investing.com -- Intellia Therapeutics shares were hit with downgrades after the company paused dosing in two late-stage trials of its gene-editing therapy following a severe liver injury that met the criteria for Hy’s Law, a sign of potentially serious drug-induced liver damage.
Shares of the company lost 42% on Monday. It was down marginally in Tuesday premarket trading
The company said dosing in its Phase III MAGNITUDE-1 and MAGNITUDE-2 studies for transthyretin amyloidosis (ATTR) had been voluntarily paused after a patient in the cardiomyopathy trial was hospitalized with abdominal pain and elevated liver enzymes.
RBC, Bernstein and William Blair all downgraded the stock to neutral-equivalent ratings on rising safety concerns that outweigh near-term benefits.
RBC said the new case “tilts the risk-benefit profile unfavorably” given several approved ATTR therapies already exist.
Bernstein cut its probability of success estimates and said Intellia’s platform safety was becoming “too big a risk,” as it downgraded at the stock on Market Perform.
William Blair said it remained confident in the drug’s efficacy but downgraded pending clarity on whether the liver toxicity is tied to the specific gene target or the broader CRISPR platform. It downgraded the stock to Market Perform.
Intellia’s trial pause was not requested by the U.S. FDA, and the company said it expects discussions with regulators to take several weeks.