The quest for metabolic disease assets continues with another player promising top dollar for novel therapeutics that deliver. Copenhagen, Denmark-based Zealand Pharma A/S entered a collaboration and license agreement with newly formed OTR Therapeutics to pursue next-generation small-molecule therapeutics, beyond the Danish firm’s current peptide pipeline candidates focused on the GLP-1, GLP-2, GIP, amylin and glucagon mechanisms.

Rezolute Inc.’s phase III Sunrize study of its only candidate, ersodetug, a fully human monoclonal antibody that binds to allosteric site on insulin receptors, missed its primary and secondary endpoints in treating the ultra-rare disease congenital hyperinsulinism.

Eli Lilly and Co.’s latest phase III results for the obesity and overweight populations suggest its triple agonist, retatrutide, can deliver significant weight loss that, in turn, leads to reduced osteoarthritis knee pain.

With new results from Wave Life Sciences Ltd., Structure Therapeutics Inc. and Ascletis Pharma Inc., obesity management drugs continue to move forward in producing weight loss and move the market.

Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met the primary endpoint showing superior improvements in key cardiometabolic markers in patients with type 2 diabetes compared to Astrazeneca plc’s SGLT2 inhibitor, Farxiga (dapagliflozin), in a head-to-head phase III trial.

Q32 Bio Inc. handed off rights to phase II-stage complement inhibitor ADX-097 in a deal with Akebia Therapeutics Inc. that helps the former extend its cash runway to focus on lead candidate bempikibart in alopecia areata and bolsters the latter’s efforts to build a rare kidney disease pipeline.

The Sept. 4, 2015, at-risk launch of Sandoz Inc.’s Zarxio as the first biosimilar to hit the U.S. market came several months after the FDA had approved the filgrastim biosimilar due to a court battle over the requirements of the 2010 Biologics Price Competition and Innovation Act, which laid out the rules of the road for the new class of follow-on drugs. Ten years later, biosimilar developers are still struggling with some of those rules that were drafted by Congress in an effort to balance competition with innovation in the biologics space. Insulin biosimilars may be the hardest hit.

The U.S. Centers for Medicare & Medicaid Services (CMS) rolled out negotiated costs of the second batch of drugs subject to such bargaining under the Inflation Reduction Act. Wall Street was not surprised to learn that the numbers amount to much greater cuts than the Biden administration managed for 2026. CMS said the adjusted maximum fair prices would have achieved 44% lower net spending had they been implemented in 2024 – 36% if forgiven discounts from the part D redesign of the Medicare prescription drug benefit are figured in. Fifteen drugs are listed.