Bayer BAYRY announced that it has met the primary endpoint of radiological progression-free survival (rPFS) in its late-stage study evaluating the safety and efficacy of darolutamide in combination with androgen deprivation therapy (ADT) without docetaxelin patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The phase III ARANOTE study enrolled 669 patients who were randomized to receive 600mg of darolutamide twice daily or matching placebo in addition to ADT.
Per the data readout, the combo therapy of darolutamide and ADT significantly increased rPFS compared with placebo plus ADT. Treatment with the investigational combo was overall well tolerated and demonstrated a safety profile that was consistent with that observed in previously completed studies in advanced prostate cancer.
Please note that Bayer’s darolutamide is already approved under the brand name Nubeqa for the treatment of patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease in more than 85 countries. It is also approved in combination with ADT and docetaxel for the treatment of patients with mHSPC in more than 80 markets, including the United States, Japan, the EU and China.
In response to the encouraging news, the stock gained 3.3% on Jul 17. Year to date, shares of BAYRY have plunged 21.1% against the industry’s 23.4% growth.
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Subject to approval, the company will be able to cater to individual mHSPC patient needs by tailoring customized darolutamide/ADT treatment plans with or without docetaxel.
Bayer will present detailed results of the ARANOTE study at an upcoming scientific congress. Bayer also intends to submit the study data to global health authorities to support regulatory applications seeking label expansion of darolutamide in men with mHSPC.
The ARANOTE study is part of a comprehensive clinical development program for darolutamide, evaluating the same across various stages of prostate cancer. It includes the phase III ARASTEP study evaluating darolutamide plus ADT in hormone-sensitive high-risk biochemical recurrence prostate cancer compared with ADT alone.
Additionally, darolutamide is also being evaluated in a separate late-stage study in collaboration with the Australian and New Zealand Urogenital and Prostate Cancer Trials Group to assess its use as an adjuvant treatment for localized prostate cancer with a very high risk of recurrence.
Prostate cancer is the second most prevalent cancer and the fifth leading cause of cancer-related deaths among men globally. Per Bayer, approximately 1.4 million men were diagnosed with prostate cancer in 2020 and around 375,000 men died from the disease worldwide.
Bayer Aktiengesellschaft Price and Consensus
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Zacks Rank & Stocks to Consider
Bayer currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. ANIP, Adaptive Biotechnologies Corporation ADPT and RAPT Therapeutics, Inc. RAPT, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals 2024 earnings per share (EPS) have improved from $4.41 to $4.44. EPS estimates for 2025 have improved from $4.85 to $5.42. Year to date, shares of ANIP have jumped 14.2%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 53.90%.
In the past 60 days, estimates for Adaptive Biotechnologies’ 2024 loss per share have narrowed from $1.30 to $1.29, while loss per share estimates for 2025 have narrowed from $1.08 to $1.02. Year to date, shares of ADPT have lost 11.2%.
ADPT’s earnings beat estimates in two of the trailing four quarters, meeting the same once and missing on the remaining occasion, the average surprise being 0.65%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $2.94 to $2.93. Loss per share estimates for 2025 have narrowed from $2.06 to $2.05. Year to date, shares of RAPT have plunged 85.4%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.
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