Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions at the agency.

In a deal that could be worth up to $1 billion for Suzhou Siran Biotechnology Co. Ltd. (Siranbio), GSK plc licensed exclusive worldwide rights to the siRNA oligonucleotide SA-030, which has recently entered phase I trials for cardiometabolic disease.

Three years after Johnson & Johnson handed back rights to an siRNA candidate targeting a genetic driver of metabolic dysfunction-associated steatohepatitis (MASH), Arrowhead Pharmaceuticals Inc. found a new partner in Madrigal Pharmaceuticals Inc., a firm that markets the first U.S. FDA-approved MASH drug, Rezdiffra (resmetirom), and has been building a pipeline in the space.

Entering what Mirum Pharmaceuticals Inc. CEO Chris Peetz called “a new phase of growth and value creation,” the company plans to submit an NDA to the U.S. FDA in the second half of this year, based on phase IIb data from the Vistas trial with oral ileal bile acid transporter (IBAT) inhibitor volixibat in primary sclerosing cholangitis (PSC).

A new molecule combines the action of two incretins, GLP-1 and GIP, hormones that regulate glucose and appetite, with lanifibranor, a triple agonist of peroxisome proliferator activated receptors (PPAR α/γ/δ). GLP-1-GIP-Lani enables targeted delivery of the PPAR agonist to cells that express incretin receptors, enhancing weight loss, improving glucose control and reducing inflammation in obese mice. In these models, it surpassed the effects of GLP-1 receptor agonists such as semaglutide and GLP-1-GIP co-agonists such as tirzepatide in reducing body weight, improving glycemic control and enhancing metabolic outcomes during active treatment.

Three decades of trial-and-error, and the resulting safety data, in the oligonucleotide-based therapeutic space have paved way for the present-day innovations and the promise of “programmable,” precision medicine for patients, speakers at Bio Korea 2026 said April 28.

When the U.S. CMS didn’t get takers for its voluntary Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) model to cover obesity drugs under Medicare Part D, the agency punted. It announced late April 21 that it will indefinitely delay the BALANCE model in Medicare but extend its temporary Medicare GLP-1 Bridge demonstration model through the end of 2027. (The Medicaid BALANCE model will still kick in this year in states that choose to participate in it.)

Kailera Therapeutics Inc.’s “obesity-first” approach continues to resonate with investors, with the company pricing an upsized IPO, offering 39 million shares at $16 apiece for gross proceeds of $625 million. Full exercise of the underwriters’ option could add another $93.8 million, bringing the total to nearly $719 million, easily topping Sana Biotechnology Inc.’s $675.6 million 2021 IPO and setting a new record for U.S. biopharma IPOs, according to BioWorld data.

Genes that are switched on or off in the human brain differ between men and women. Moreover, these differences are not uniform. They vary across cortical regions and cell types. Scientists at the National Institute of Mental Health (NIMH) and the National Institute on Aging (NIA) used single-cell sequencing and unveiled distinct gene expression patterns regulated by hormones and sex chromosomes. This detailed map of the brain’s molecular biology shows how women and men switch on and off more than 3,000 brain genes differently and expands the catalogue of X chromosome genes that escape inactivation.

Wall Street met with satisfaction but not surprise Eli Lilly and Co.’s undeniably positive top-line results from the phase III Achieve-4 study testing the efficacy and safety of Foundayo (orforglipron) compared to insulin glargine in adults with type 2 diabetes and obesity or overweight at increased cardiovascular risk.