Bayer BAYRY announced that the FDA has accepted its supplemental new drug application (sNDA) for Nubeqa (darolutamide).

The sNDA is seeking label expansion of Nubeqa in combination with androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Year to date, shares of Bayer have lost 44.9% against the industry’s growth of 4.8%.

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Bayer’s Efforts to Expand Nubeqa’s Label

Nubeqa is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation and AR-mediated transcription.

The sNDA submitted is based on positive results from the late-stage ARANOTE  study. Results showed that Nubeqa plus ADT significantly reduced the risk of progression or death in patients with metastatic mHSPC when compared to placebo plus ADT.

We note that Nubeqa is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for those with non-metastatic castration-resistant prostate cancer (nmCRPC).

A potential FDA approval of the sNDA will expand the indication for Nubeqa in patients with mHSPC to include Nubeqa both with and without chemotherapy.

BAYRY is also evaluating darolutamide across various stages of prostate cancer in a broad development program.

The program includes the phase III ARASTEP trial evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer patients who have a positive PSMA PET/CT at baseline and no evidence of metastatic disease by conventional imaging.

Bayer is also evaluating darolutamide in the collaborative phase III DASL-HiCaP trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group. The study evaluates darolutamide as an adjuvant treatment for localized prostate cancer with a very high risk of recurrence.

Bayer’s Efforts to Strengthen Pharma Business

Bayer is looking to strengthen its pharmaceutical portfolio amid generic competition for Xarelto.

Nubeqa is one of Bayer's top drugs and a potential label expansion should further boost sales. The drug generated sales of more than €1 billion in the first nine months of 2024.

Bayer recently entered into a collaboration and license agreement with Cytokinetics CYTK for the exclusive development and commercialization of aficamten in Japan.

Aficamten, a cardiac myosin inhibitor, is being evaluated for the treatment of patients with obstructive and non-obstructive hypertrophic cardiomyopathy (HCM). As per the joint development plan, Bayer plans to conduct a phase III study in Japanese patients with obstructive HCM.

Bayer acquired marketing rights for the cardiovascular candidate, acoramidis, in Europe from BridgeBio.

A new drug application (NDA) for acoramidis has been filed with the FDA, and the regulatory body has set a target action date of Nov. 29, 2024, for the same.

BAYRY also submitted a Marketing Authorization Application (“MAA”) to the EMA for its pipeline candidate, elinzanetant.

The MAA is seeking approval of the candidate for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or adjuvant endocrine therapy.

The FDA also accepted the company’s NDA for elinzanetant, seeking approval for the treatment of moderate-to-severe VMS.

BAYRY’s Zacks Rank & Stock to Consider

BAYRY currently carries a Zacks Rank #3 (Hold).

A better-ranked large-cap pharma stock is Pfizer PFE, which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.85 to $2.92. PFE’s shares have lost 12.2% year to date.

Pfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.

 

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