Darolutamide

Bayer likely to launch heart drug Acoramidis in EU soon, CHMP recommends approval based on Phase III results. The drug treats ATTR-CM, showing positive impact on cardiovascular endpoints. Bayer acquired European marketing rights in March. Analysts estimate peak sales at EUR 260 million by 2030, aiding in offsetting declining sales of Xarelto.

The FDA accepted Bayer's sNDA for Nubeqa (darolutamide), an oral ARi for metastatic hormone-sensitive prostate cancer, based on positive Phase III ARANOTE trial results. Nubeqa, in combination with ADT, met the trial's primary endpoint of radiological progression-free survival. If approved, Nubeqa's indication would expand to include mHSPC with or without chemotherapy.

Bayer files application with EMA for darolutamide, an ARi, to use with ADT in hormone-sensitive metastatic prostate cancer patients. Darolutamide is already approved in over 80 markets for mHSPC with ADT and docetaxel, and in over 85 countries for nmCRPC with ADT.

Bayer seeks EU approval for Nubeqa in metastatic hormone-sensitive prostate cancer, based on Phase III Aranote trial data showing significant radiographic progression-free survival (rPFS) improvement. Nubeqa is already approved for mHSPC and high-risk mCRPC, with strong sales growth expected to surpass $1 billion in 2024.

The drug and biotech industry thrives on M&A, new drug launches, and pipeline successes, with obesity drugs from Novo Nordisk and Eli Lilly leading. Large drugmakers like Eli Lilly, AstraZeneca, Pfizer, Sanofi, and Bayer are profitable and innovative, focusing on areas like weight loss, inflammation, and Alzheimer’s. Despite headwinds such as pipeline setbacks and macroeconomic uncertainty, investment in drug/biotech stocks has surged. The Zacks Large Cap Pharmaceuticals industry ranks in the top 19% of Zacks industries, outperforming the Zacks Medical Sector but slightly underperforming the S&P 500.

Bayer submits sNDA to FDA for NUBEQA in combination with ADT for mHSPC, aiming to expand its use beyond current indications.

The drug and biotech sector has outperformed the broader market, driven by new drug launches, pipeline successes, and increased M&A activity. Eli Lilly's obesity drugs have been particularly successful. Despite headwinds like pipeline setbacks and economic uncertainty, the sector has seen a surge in investments. Five large drugmakers—Pfizer, Eli Lilly, AstraZeneca, Bayer, and Sanofi—are recommended for portfolio growth, with strong financials and robust pipelines.

NUBEQA® (darolutamide) plus ADT showed a 46% reduction in risk of progression or death in the Phase III ARANOTE trial for metastatic hormone-sensitive prostate cancer (mHSPC), with no new safety signals observed. Results were published in The Journal of Clinical Oncology.

NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) significantly improved radiological progression-free survival (rPFS) in the Phase III ARANOTE trial for metastatic hormone-sensitive prostate cancer, reducing the risk of progression or death by 46% (HR 0.54; 95% CI 0.41-0.71; P<0.0001) compared to placebo plus ADT. The results were consistent with NUBEQA's established safety profile, with no new safety signals observed.

Bayer will present new prostate cancer data, including a Phase III ARANOTE trial analysis of NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC), at the ESMO Congress 2024 in Barcelona.