Bayers, Nubeqa

Bayer's Nubeqa Posts Strong Prostate Cancer Numbers, but the Survival Story Is Still Unwritten

Published on 10/25/2026 at 20:31 | Editorial boerse-global.de
Phase III DASL-HiCaP data show Darolutamid cut metastasis or death risk by 58%, but overall survival benefit was not statistically significant.
Bayer AG (DE000BAY0017): Aquarellmalerei der Skyline von Leverkusen mit Industrieanlagen am Rhein Illustration mit AI erstellt.

Bayer's Darolutamid has delivered a statistically significant win in high-risk prostate cancer — just not the one that would settle the argument. The Phase III DASL-HiCaP trial, presented yesterday at the ESMO congress, showed that adding the drug to standard treatment cut the risk of metastases or death by 58% in 1,106 patients with very high relapse risk.

The combination tested Darolutamid alongside androgen deprivation therapy and radiotherapy, with the control arm receiving placebo plus the same standard treatments. After four years, metastasis-free survival stood at 95% on the drug versus 88% on placebo — a gap the trial's authors can call significant.

That endpoint, however, measures the appearance of metastases or death. It is not the same as proving patients live longer. Overall survival at four years came in at 97% for Darolutamid and 95% for placebo, a difference that did not reach statistical significance. Longer follow-up will be needed before any survival benefit can be described as confirmed, and the trend observed so far should not be read as one.

A regulatory gap sits between the data and the revenue line

Darolutamid is not yet approved for this treatment setting, meaning the study's positive readout does not translate into a marketable indication today. The drug also showed an advantage on PSA progression and death risk, reinforcing the primary result, but tolerability tells a more mixed story: grade 3 or higher adverse events occurred in 43% of patients on Darolutamid against 36% in the placebo group. Better disease control, in other words, arrives with a heavier side-effect burden.

Should investors sell immediately? Or is it worth buying Bayer?

The commercial stakes are far from trivial. Nubeqa generated roughly EUR 1.63 billion in the first half of 2026, up about 60% year on year. The new data strengthen the clinical foundation for broader use, though Bayer has not quantified any additional revenue effect — and cannot, until regulators weigh in.

JPMorgan holds its line ahead of the quarterly print

Against that backdrop, JPMorgan reaffirmed its "Overweight" rating on Bayer on 16 October, keeping a price target of EUR 61. The note, issued before the upcoming quarterly figures, carried no upgrade to the target or change in rating. Bayer shares closed Friday at EUR 43.92.

Elsewhere in the pipeline, the company reported consistent effects on proteinuria and loss of kidney function from the Phase III FIND-CKD study of Finerenon, covering chronic kidney disease patients without diabetes. Those findings were presented at ASN Kidney Week 2026.

Bayer's third-quarter 2026 results are scheduled for 3 November, with the release at 07:30 CET and a conference call at 14:00 CET the same day. On the agricultural side, the company published a study on the competitiveness of farming in the European Union and the United Kingdom, finding that production growth in European arable farming trails that of key agricultural markets.

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