Endogenex Inc. has raised $50 million in an extension to its series C financing round to fund the completion of its pivotal Recet clinical study, which is evaluating the use of the company’s non-thermal pulsed electric field system for remodeling the duodenal tissue in adults with type 2 diabetes. The new capital will also be used to support the company's regulatory pathway toward U.S. FDA approval.

Apparently put off by data with a higher dose, investors in Wave Life Sciences Inc. backed away after the company rolled out data from the phase I portion of its first-in-human Inlight trial evaluating 250 mg of WVE-007, an INHBE GalNAc-siRNA prospect, in otherwise healthy overweight or obese adults.

After previous setbacks with the program, investors largely brushed aside ocular-focused Kodiak Sciences Inc.’s anticipated phase III Glow2 data of tarcocimab tedromer in diabetic retinopathy (DR), so the positive top-line superiority results revealed March 26 caught many by surprise as it sets the company up for an accelerated multi-indication BLA submission.

The U.S. FDA has issued a final order to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers from class III to class II, with special controls required.

Repeated promotional claims Patrick Soon-Shiong made about Immunitybio Inc.’s Anktiva – such as “We have now discovered and developed this drug … approved for bladder cancer, but it actually can treat all cancers” – landed the Culver City, Calif., company a strongly worded warning letter from the U.S. FDA.

Chaos continues at the U.S. CDC and its Advisory Committee on Immunization Practices (ACIP) with the resignation of ACIP member Robert Malone and the impending deadline for the president to nominate a new CDC director following the dramatic exit last year of Susan Monarez and months of acting directors.

Maze Therapeutics Inc. continues its journey toward a pivotal program after sharing positive top-line data from the phase II Horizon study with MZE-829, an oral, small-molecule, dual-mechanism APOL1 inhibitor, in patients with broad APOL1-mediated kidney disease (AMKD).

The U.S. FDA approved Corcept Therapeutics Inc.’s oral, selective glucocorticoid receptor antagonist, Lifyorli (relacorilant), nearly four months ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. A short time after the agency approved Lifyorli, it cleared Denali Therapeutics Inc.’s Avlayah (tividenofusp alfa) under the accelerated approval pathway for mucopolysaccharidosis II, also called Hunter syndrome, ahead of the April 5 PDUFA date.

Only a few months after reporting what it called “unprecedented” phase I data for its BCR-ABL1 tyrosine kinase inhibitor in chronic myeloid leukemia, Terns Pharmaceuticals Inc. agreed to an acquisition by Merck & Co. Inc. valued at about $6.7 billion. For Terns, the deal validates the decision last year to switch focus from its metabolic pipeline to oncology and, for Merck, it’s the latest move as the big pharma looks to shore up its offerings ahead of patent expirations for cancer blockbuster drug Keytruda (pembrolizumab).

U.S. lawmakers and industry experts are raising alarm over China’s expanding dominance across the pharmaceutical supply chain, warning that reliance on Chinese inputs poses a growing national security and public health risk.