For the time being, Madrigal Pharmaceuticals Inc.’s Rezdiffra (resmetirom) stands alone as the only U.S. FDA approved treatment for treating nonalcoholic steatohepatitis (NASH). But new and positive data from multiple companies show Madrigal may soon have company.

Ipsen SA picked up U.S. FDA accelerated approval for its Genfit SA-licensed elafibranor, making it the first new drug in eight years for treating primary biliary cholangitis, though a potential competitor lurks just around the corner.

About a year ago, when Seres Therapeutics Inc. won U.S. FDA approval of oral microbiome therapy Vowst (live fecal microbiota spores), the drug – meant to prevent recurrent Clostridioides difficile infection – was hailed as first in the space, and launch plans sounded ambitious. In July 2021, Seres inked a deal with Nestlé Health Science SA, of Lutry, Switzerland, to jointly commercialize Vowst in the U.S. and potentially Canada. But shares of Cambridge, Mass.-based Seres (NASDAQ:MCRB) closed May 8 at 75 cents, down 36 cents, or 32%, after the firm provided an update on sales, roughly flat quarter over quarter.

In a deal that could exceed $1 billion for Ochre Bio Ltd., the U.K.-based liver disease therapy developer will collaborate with Boehringer Ingelheim GmbH. In the meantime, Hepion Pharmaceuticals Inc. shut down its lead candidate’s phase IIb study while looking for a lifeline.

Microbiome specialist Enterobiotix Ltd. has raised £27 million (US$34.2 million) in a series B round as it starts a phase II trial of EBX-102-02 in the treatment of irritable bowel syndrome.

The possibility for expanding Bristol Myers Squibb Co.’s S1P modulator, Zeposia (ozanimod), into Crohn’s disease took a hit on disappointing data from the initial analysis of its Yellowstone study, the first of two phase III trials. Results showed the study failed to meet the primary endpoint, defined as clinical remission as measured by the Crohn’s Disease Activity Index at week 12.

Benevolentai Ltd. is betting on its oral phosphodiesterase 10 inhibitor BEN-8744 as having first-in-class potential for moderate to severe ulcerative colitis, after healthy volunteers in a phase Ia trial remained free of central nervous system-associated side effects.