Renal

Memo Therapeutics is sharpening its focus on its lead antibody Potravitug, for BK polyomavirus (BKPyV) in kidney transplant patients as it prepares for Phase III trials and doubles down on patient engagement.

CEO Renée Aguiar-Lucander tells Scrip that the Swedish team is well-equipped to take its desensitisation treatment for the adult kidney transplant to market in the US.

A China-only Phase III study for the anti-BAFF/APRIL fusion protein marks the latest positive dataset for the drug, which Vor licensed from China-based RemeGen in June.

Trojan Bio’s proprietary platform, based on engineered antibodies that activate the immune system to fight cancer in the same way as common viral infections, won Biomed Israel's 2025 biopharma start-up award. CEO and cofounder Anat Burkovitz said the technology is attracting investors' attention.

After posting encouraging Phase II results, the company plans to meet with the US FDA about using data from an ongoing Phase III study for an accelerated approval.

The San Diego biotech’s lead product candidate is an antisense oligonucleotide-based therapy slated to enter Phase III development in the third quarter.

The approval of another Novartis drug with a different mechanism means the company is further cornering multiple parts of IgAN pathogenesis.

The German firm’s chairman, Hubertus von Baumbach, is adopting a ‘wait-and-see’ approach to the threat of pharma tariffs.

Novartis US president Victor Bultó talked to Scrip about the company’s efforts to reach patients with rare kidney diseases who are candidates for Fabhalta.

The agency reaffirmed support for a hemoglobin A1C endpoint for glycemic control in type 1 diabetes, but the diabetic ketoacidosis risk with sotagliflozin is so concerning that it is looking for additional benefits in patients with chronic kidney disease, a targeted subpopulation.

Some panelists favored use in T1D patients with mild chronic kidney disease, even though that was not the original indication Lexicon proposed, which was rejected in an 11-3 vote.

The Zynquista application in type 1 diabetes received a complete response letter in 2019. This time, Lexicon seeks approval for patients with T1D and chronic kidney disease. FDA review staff said making definitive conclusions about the magnitude of glucose-lowering effects in this population is difficult, and the risk of diabetic ketoacidosis remains.