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Bayer's (BAYRY) Elinzanetant Meets Goals in Third Phase III Study
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Bayer AG (BAYRY - Free Report) announced positive top-line results of the phase III study, OASIS 3, evaluating the efficacy and long-term safety of pipeline candidate elinzanetant compared to placebo.
Elinzanetant, a dual neurokinin-1,3 (NK-1,3) receptor antagonist, is in late-stage clinical development for the non-hormonal treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, administered orally once daily.
OASIS 3 is the third phase III study in the OASIS clinical development program. The study randomized 628 postmenopausal women between 40 and 65 years across 83 sites in nine countries.
Results of the study showed that elinzanetant successfully met the primary endpoint, demonstrating a statistically significant reduction in the frequency of moderate to severe VMS (also known as hot flashes) from baseline to week 12 compared to placebo.
Per management, the OASIS 3 study provides additional supporting efficacy data as well as long-term safety data of elinzanetant, complementing positive top-line results of OASIS 1 and 2 studies.
In January, Bayer announced top-line data of the first two phase III studies, OASIS 1 and 2 (NCT05042362 and NCT05099159), which met all primary and key secondary endpoints.
Bayer intends to submit the data from the OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations of elinzanetant for the treatment of moderate to severe VMS associated with menopause.
The late-stage clinical development program of elinzanetant, OASIS, currently comprises four phase III studies — OASIS 1, 2, 3 and 4.
Bayer Aktiengesellschaft Price, Consensus and EPS Surprise
OASIS 4 is an expansion of the clinical phase III program. It investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for the treatment or prevention of breast cancer.
The phase III program was based on positive data from two phase II studies — RELENT-1 and SWITCH-1.
Elinzanetant is a key candidate in Bayer’s pipeline. The successful development and commercialization of elinzanetant is imperative to Bayer, given the recent setbacks.
Bayer is also evaluating elinzanetant in an exploratory phase II study, NIRVANA, to evaluate the efficacy and safety of the candidate in women with sleep disturbances associated with menopause.
The acquisition of KaNDy Therapeutics Ltd. in 2020 added elinzanetant to Bayer’s pipeline.
Shares of BAYRY have plunged 54.9% in the past year against the industry’s growth of 30.1%.
Image Source: Zacks Investment Research
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 (AF) and at risk for stroke, was stopped early due to the lack of efficacy. This was a major setback, given the candidate’s potential.
Moreover, one of the top drugs in the pharmaceutical division, Xarelto, is facing generic competition.
The ongoing glyphosate litigation in the United States has adversely impacted Bayer’s cash position due to high legal costs. Following a review of the company’s capital allocation priorities to reduce debt, BAYRY plans to amend its dividend policy to pay out only the legally required minimum for three years.
Bayer is now looking to expand its portfolio amid these challenges. The company recently acquired the exclusive marketing rights for cardiovascular candidate, acoramidis, in Europe from BridgeBio.
Zacks Rank & Stocks to Consider
Bayer currently has a Zacks Rank #5 (Strong Sell).
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 to 30 cents. In the past year, shares of ADMA have rallied 99.7%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met the same once, delivering an average surprise of 85.00%.
In the past 60 days, loss estimates for GLPG have narrowed from $1.68 per share to 39 cents. Galapagos beat on earnings in three of the trailing four quarters and missed the same once, delivering an average surprise of 91.97%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.40. In the past year, shares of ANIP have surged 70.3%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 109.06%.
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Bayer's (BAYRY) Elinzanetant Meets Goals in Third Phase III Study
Bayer AG (BAYRY - Free Report) announced positive top-line results of the phase III study, OASIS 3, evaluating the efficacy and long-term safety of pipeline candidate elinzanetant compared to placebo.
Elinzanetant, a dual neurokinin-1,3 (NK-1,3) receptor antagonist, is in late-stage clinical development for the non-hormonal treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, administered orally once daily.
OASIS 3 is the third phase III study in the OASIS clinical development program. The study randomized 628 postmenopausal women between 40 and 65 years across 83 sites in nine countries.
Results of the study showed that elinzanetant successfully met the primary endpoint, demonstrating a statistically significant reduction in the frequency of moderate to severe VMS (also known as hot flashes) from baseline to week 12 compared to placebo.
Per management, the OASIS 3 study provides additional supporting efficacy data as well as long-term safety data of elinzanetant, complementing positive top-line results of OASIS 1 and 2 studies.
In January, Bayer announced top-line data of the first two phase III studies, OASIS 1 and 2 (NCT05042362 and NCT05099159), which met all primary and key secondary endpoints.
Bayer intends to submit the data from the OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations of elinzanetant for the treatment of moderate to severe VMS associated with menopause.
The late-stage clinical development program of elinzanetant, OASIS, currently comprises four phase III studies — OASIS 1, 2, 3 and 4.
Bayer Aktiengesellschaft Price, Consensus and EPS Surprise
Bayer Aktiengesellschaft price-consensus-eps-surprise-chart | Bayer Aktiengesellschaft Quote
OASIS 4 is an expansion of the clinical phase III program. It investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for the treatment or prevention of breast cancer.
The phase III program was based on positive data from two phase II studies — RELENT-1 and SWITCH-1.
Elinzanetant is a key candidate in Bayer’s pipeline. The successful development and commercialization of elinzanetant is imperative to Bayer, given the recent setbacks.
Bayer is also evaluating elinzanetant in an exploratory phase II study, NIRVANA, to evaluate the efficacy and safety of the candidate in women with sleep disturbances associated with menopause.
The acquisition of KaNDy Therapeutics Ltd. in 2020 added elinzanetant to Bayer’s pipeline.
Shares of BAYRY have plunged 54.9% in the past year against the industry’s growth of 30.1%.
Image Source: Zacks Investment Research
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 (AF) and at risk for stroke, was stopped early due to the lack of efficacy. This was a major setback, given the candidate’s potential.
Moreover, one of the top drugs in the pharmaceutical division, Xarelto, is facing generic competition.
The ongoing glyphosate litigation in the United States has adversely impacted Bayer’s cash position due to high legal costs. Following a review of the company’s capital allocation priorities to reduce debt, BAYRY plans to amend its dividend policy to pay out only the legally required minimum for three years.
Bayer is now looking to expand its portfolio amid these challenges. The company recently acquired the exclusive marketing rights for cardiovascular candidate, acoramidis, in Europe from BridgeBio.
Zacks Rank & Stocks to Consider
Bayer currently has a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the healthcare sector are ADMA Biologics, Inc. (ADMA - Free Report) , Galapagos (GLPG - Free Report) , and ANI Pharmaceuticals, Inc. (ANIP - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 to 30 cents. In the past year, shares of ADMA have rallied 99.7%.
ADMA Biologics’ earnings beat estimates in three of the trailing four quarters and met the same once, delivering an average surprise of 85.00%.
In the past 60 days, loss estimates for GLPG have narrowed from $1.68 per share to 39 cents. Galapagos beat on earnings in three of the trailing four quarters and missed the same once, delivering an average surprise of 91.97%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have improved from $4.06 to $4.40. In the past year, shares of ANIP have surged 70.3%.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 109.06%.