Genitourinary

The mineralocorticoid receptor antagonist, which will be a key driver at the German group in the post-Xarelto world, significantly delayed kidney disease progression in non-diabetic patients in another successful late-stage trial.

Clinical Data Readout: With a median follow-up of 6.5 months, updated findings from a Phase I/II study of DB-1311 (BNT324) in heavily pretreated mCRPC patients worldwide showed a median radiographic progression-free survival of 11.3 months and a median overall survival of 22.5 months.

Do Zydus and Lupin’s settlements of Myrbetriq (mirabegron) US patent litigation with Astellas constitute a win or a loss?

Boehringer Ingelheim hopes TPRC6 inhibition can provide a disease-modifying therapy for focal segmental glomerulosclerosis, which has no approved therapy. The smallest dose used in its Phase II study showed the highest response rate.

The non-hormonal drug could be a big step forward in treating pain associated with the condition, but the Chinese company may still need a partner for its Phase III studies and eventual commercialization.

The Alfasigma subsidiary will voluntarily take Ocaliva off the market after a request from the US FDA, which put Intercept’s trials of the primary biliary cholangitis drug on a clinical hold.

Otsuka bested Vera on Phase III immunoglobulin A nephropathy data for proteinuria, but analysts wonder if the difference is especially meaningful.

Purespring has just raised $105m from an investor syndicate who are betting it can develop the first gene therapy for kidney disease and learn from setbacks experienced in the space.

Gazyva could add the autoimmune condition to its label following a Phase III hit, but it might struggle to differentiate itself from Benlysta and Lupkynis.    

Following the pivotal data on Alnylam’s Amvuttra, all eyes turn to the next amyloidosis readout – that of AstraZeneca and Ionis’ Wainua. And the UK major’s ambitions do not stop there.    

The big pharma’s second selection in the alliance shows novel cardiovascular therapies are high on its priority list

With $150m in series A funding, the Versant- and Novartis-backed start-up is betting it can overcome the challenges to getting RNA medicines into the kidney.

The start-up launched last year with Phase III-ready upacicalcet, which has nearly completed two pivotal trials in secondary hyperparathyroidism and for which it has exclusive rights outside of Asia.

In this week's podcast edition of Five Must-Know Things: Amgen positions for obesity and diabetes; BMS returns TIGIT asset in pipeline reshuffle; is Kerendia the next jewel in Bayer’s crown?; Japan pharma firms cut jobs; and Sun Pharma seeks GLP-1 partner.

A Phase III trial testing pegcetacoplan in patients with two rare kidney diseases demonstrated impressive efficacy, outperforming what Novartis showed with Fabhalta in a similar trial.

US FDA approval in IgAN is just the first step in a much larger renal disease strategy for the company, which includes additional kidney indications for Fabhalta.

Major Japanese firm picks up US drug discovery platform company Jnana in apparent bid to strengthen discovery capabilities and build its mid-stage R&D presence in the renal area. 

The UK major has raised its full-year sales and earnings forecast on strong demand in the second quarter for its cancer, rare disease and cardiovascular medicines.

Akebia said it had set the price for Vafseo at about $15,500 per year, meant to reflect its potential value in dialysis as well as eventually in non-dialysis patients.

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.