German Merck's DAX Shares Tumble -- As Phase III MS Study (On BTK Inhibitor Evobrutinib) Is Halted For New Enrollees; Adverse Events.

As ever, I post this here mostly to make clear that this is not the US company. The two are not related, and are in fact engaged in a decades long series of lawsuits about the name "Merck". This is the German KGaA.

In any event, it had an MS candidate in Phase II/III clinical trials, called evobrutinib -- and just saw a safety signal in a few patients. The liver problems seemed to resolve once the medication was discontinued. So -- more study and analysis, to be certain -- before it might ever resume. Here's Reuters, on the topic -- this morning:

. . .Merck shares were 6.3% lower. . . and slid to the bottom of Germany's blue-chip DAX index on news of the setback.

The FDA's decision, Merck said, was in response to laboratory results which suggested drug-induced liver injury during phase III studies. The two cases identified had been asymptomatic and the patients' liver enzymes had fully normalized after discontinuation of the study medication.

"Merck is working closely with the FDA to establish the best path forward for the benefit of patients in current and future trials with evobrutinib," it said in a statement. . . .

A trial testing Sanofi's rival candidate tolebrutinib -- from the $3.7 billion takeover of Principia Biopharma in 2020 -- was put on partial hold by the FDA in June 2022 on concerns over harmful effects on the liver. That meant recruitment of new participants was stopped. . . .

Now you know -- with it almost 80 and sunny -- unseasonably wonderful for mid-April. . . a mountain bike is next on the agenda! Grin. . . .

नमस्ते