Bayer BAYRY announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (“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.

Year to date, shares of Bayer have lost 21.7% against the industry’s growth of 20.6%.

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BAYRY’s Progress With Elinzanetant

Elinzanetant, a dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist, is in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause or adjuvant endocrine therapy, administered orally once daily.

The EMA submission is based on results from the phase III development program, OASIS, which currently comprises four phase III studies — OASIS 1, 2, 3 and 4.

Data from OASIS 1 and OASIS 2 showed that elinzanetant demonstrated statistically significant reductions in VMS frequency and severity compared to placebo. Elinzanetant also significantly improved sleep disturbances and menopause-related quality of life compared to placebo. The candidate's safety profile was favorable.

Results from the phase III OASIS 3 study further supported efficacy data and sustained safety data of elinzanetant over 52 weeks.

Per a recent survey, 67% of European women reported VMS during their menopause transition.

Last week, the FDA accepted the company’s new drug application for elinzanetant, seeking approval for the treatment of moderate-to-severe VMS.
Bayer continues to submit applications for marketing authorizations of elinzanetant to health authorities globally.

It is also conducting NIRVANA (NCT06112756), an exploratory phase II randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause, as determined by polysomnography.

Approval of New Drugs Key for BAYRY

Bayer wants to strengthen its pharmaceutical portfolio, and the approval of new drugs is important to this end.

A potential approval of elinzanetant in the United States and the EU should be beneficial for BAYRY.

Pipeline setbacks and regulatory setbacks have weighed on the stock in recent times. The late-stage study, OCEANIC-AF, investigating asundexian compared with direct oral anticoagulant Eliquis (apixaban) in patients with atrial fibrillation and at risk for stroke, was stopped early due to the lack of efficacy. This was a major setback, given the candidate’s potential.

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

A new drug application 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.
Bayer is also working on the label expansion of its approved drugs.

On Oct 14, Bayer submitted an application to the EMA for the oral androgen receptor inhibitor, darolutamide.

The company is seeking approval for the use of darolutamide, in combination with androgen deprivation therapy (ADT), in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

We note that darolutamide is already approved for mHSPC, under the brand name Nubeqa, in combination with ADT and docetaxel in more than 80 markets around the world. The compound is also approved in combination with ADT 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 around the world.

BAYRY’s Zacks Rank & Other Stocks to Consider

BAYRY currently carries a Zacks Rank #2 (Buy).

A couple of other top-ranked large-cap pharma companies are Eli Lilly LLY and Novartis NVS, both carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Estimates for Eli Lilly’s 2024 earnings have risen from $13.71 to $15.66 per share over the past 90 days. For 2025, the bottom-line estimate has risen from $19.42 to $24.16 over the same timeframe. Year to date, Lilly’s shares have risen 56.7%.

Estimates for Novartis’ 2024 earnings have risen from $7.31 to $7.52 per share over the past 90 days. For 2025, earnings estimates have increased from $8.21 to $8.27 per share over the same timeframe. Year to date, Novartis’ shares have risen 15.1 %.

 

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