South Korea's Helixmith reaches a milestone with a US FDA nod to use a new in-house developed formulation for its plasmid DNA therapeutic Engensis, said to be more suited to mass production, in its upcoming Phase III trials for diabetic peripheral neuropathy.

Resmetirom, Madrigal’s THRβ agonist, demonstrates safety and tolerability, and succeeds on secondary efficacy endpoints in a study serving as a precursor to the firm’s pivotal Phase III trial.

AASLD Briefing: While working on new biopsy reviews to address CRL, Intercept also might consider filing for approval in cirrhotic patients if REVERSE study succeeds. Plus other updates on NASH programs.

At EASL 2021, Akero presented efruxifermin data showing benefit in cirrhotic NASH patients and strong liver fat reduction, but may be challenged in the FGF21 analog class by 89Bio.