Power Alley: Zydus Posts Good But Not Great Data, In Primary Biliary Cholangitis Space (Other On-Market Competitors Include Gilead and Intercerpt)...

Each of the three other on market competitors have posted more impressive response data [but one of them now comes with an FDA mandated boxed warning].

Still, Zydus will enter a market that is not yet even remotely saturated. There are approximately 7.6 million to 13 million sufferers world-wide -- with an incidence rate of about 18 cases per 100,000 population. . . dotting the globe. So we shall as ever see how it progresses, when Zydus meets with FDA after New Years. Here's the latest, from Fierce reporting:

. . .Zydus Therapeutics has racked up a phase 2b/3 win in primary biliary cholangitis (PBC), clearing the path to a filing to establish the company as a challenger to Gilead Sciences, Intercept Pharmaceuticals and Ipsen.

The phase 3 part of the trial randomized 149 people to receive the PPAR agonist saroglitazar or placebo. After 52 weeks of daily oral dosing, 48.5% of patients on the Zydus drug met the biochemical response, achieving the primary endpoint of the trial. Zydus plans to discuss the data with the FDA with hopes of filing for approval in the first quarter of 2026. . . .

Now you know -- and I'm blogging from a coffee corner, at the tiny Burlington, Vermont airfield -- heading back to the city of big shoulders this noon-time. [Always sad to leave the lake house, but] the steel and glass canyons call -- if for nothing else, to catch up on Abrego, and the Guatemalan teenagers' plights in the tiny hands of Tangerine 2.0. Onward.

नमस्ते