Two sNDAs, one from Bristol Myers Squibb Co. (BMS) and the other from Mirum Pharmaceuticals Inc., have received U.S. FDA approval to further expand their treatment indications.

As widely expected, Madrigal Pharmaceuticals Inc.’s resmetirom picked up the first U.S. FDA approval for treating nonalcoholic steatohepatitis (NASH), an advanced form of nonalcoholic fatty liver disease that has been steadily increasing in global prevalence. Branded Rezdiffra, the liver-directed THR-beta agonist gained accelerated approval for use in conjunction with diet and exercise to treat adults with noncirrhotic NASH with moderate to advanced liver fibrosis, specifically stages F2 and F3.

Akero Therapeutics Inc.’s phase IIb data with FGF21 analogue efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) kept interest alive in the face-off between the company and 89bio Inc. with pegozafermin, another FGF21 drug targeting MASH, for which a phase III study is planned.

Positive phase III data from Ironwood Pharmaceuticals Inc. with once-weekly glucagon-like peptide-2 analogue apraglutide failed to impress Wall Street, and shares of the Boston-based firm (NASDAQ:IRWD) closed Feb. 29 at $9.43, down $5.69, or 37.6%. The experiment called Stars tested apraglutide to reduce parenteral support in adults with short bowel syndrome with intestinal failure. Rare and severe, the condition affects about 18,000 adults in the U.S., Europe and Japan. Based on the latest data, Ironwood plans to submit an NDA to the U.S. FDA and other regulatory filings.

Inventiva SA has halted enrollment in its pivotal phase III Nativ3 trial with nonalcoholic steatohepatitis (NASH) candidate lanifibranor after a patient experienced raised liver enzymes indicative of autoimmune hepatitis. The resulting delays to the study could spell trouble for the firm, which estimates its cash runway will only see it through to the start of the third quarter 2024.

Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.

Seeking to rejuvenate itself after recent disappointments, Gilead Sciences Inc. proposes to bolster its liver portfolio by taking over Cymabay Therapeutics Inc. for $32.50 per share in cash, a total equity value of $4.3 billion. The arrangement brings aboard seladelpar for second-line primary biliary cholangitis (PBC) including pruritis (itch), which is under priority review by the U.S. FDA, with a decision due this year.

The approval by the U.S. FDA in October of Pfizer Inc.’s Velsipity (etrasimod), an oral sphingosine-1-phosphate receptor modulator for moderately-to-severely active ulcerative colitis, brought renewed attention to the inflammatory bowel disease (IBD) landscape, where the hunt goes on for new alternatives. Among the promising soldiers in the march is Paris-based Abivax SA, which closed its IPO the same month.

As the company’s phase II study in idiopathic pulmonary fibrosis continues, Pliant Therapeutics Inc.’s investors looked hard at 12-week interim data from the 320-mg dose group of Integris-PSC, a multinational, randomized, double-blind, placebo-controlled phase II trial testing bexotegrast in primary sclerosing cholangitis and suspected moderate to severe liver fibrosis.

Becoming the first treatment for children ages 1 to 11 with eosinophilic esophagitis (EE), Sanofi SA and Regeneron Pharmaceuticals Inc.’s IL-4/IL-13 inhibitor Dupixent (dupilumab) was cleared by the U.S. FDA on Jan. 25.