Xbiome Inc. acquired M-201, a clinical-stage program from Assembly Biosciences Inc., to treat patients with mild to moderate ulcerative colitis as it looks to develop products to address the growing incidence of bowel disease throughout Asia. The company expects to start a phase Ib trial of the oral live biotherapeutic product in the U.S. in 2022 and also plans to run clinical trials in China.

Orphalan SA is laying the ground for a 2023 U.S. launch of Cuvrior for the treatment of Wilson’s disease, following FDA approval of the copper chelating drug. Cuvrior (trientine tetrahydrochloride) is a new salt of trientine that was designed to have superior properties to Syprine (trientine hydrochloride) from Bausch Health Companies Inc. and Cufence from Univar Solutions BV, which are approved as second-line treatments for the rare inherited copper transport disorder, in the U.S. and EU respectively.

The latest in a spate of draft and final guidances released recently by the U.S. FDA could help sponsors developing drugs to treat early stage solid tumor malignancies. 

Protagonist Therapeutics Inc. continues having a tough time. The latest is a steep stock drop after a phase II trial in ulcerative colitis (UC) missed its primary endpoint, but the company insists the data are good enough to move into phase III. Top-line data showed a 450-mg BID dose of PN-943 in treating moderate to severe UC missed its primary endpoint, which was the number of participants achieving clinical remission at week 12 compared to placebo.