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Bayer (BAYRY) Elinzanetant Meets Goals in Late-Stage Studies
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Bayer AG (BAYRY - Free Report) announced that the late-stage studies on the investigational compound elinzanetant were successful.
Elinzanetant is the first dual neurokinin-1,3 receptor antagonist in late-stage clinical development for the non-hormonal treatment of moderate to severe vasomotor symptoms (“VMS”), also known as hot flashes associated with menopause, administered orally once daily.
The phase III studies, OASIS 1 and 2 are double-blind, randomized, placebo-controlled multicenter studies investigating the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause as compared with placebo. OASIS 1 and 2 randomized 396 and 400 postmenopausal women, respectively, between 40 and 65 years, across 184 sites in 15 countries.
Data from these studies showed that elinzanetant successfully met all four primary endpoints in both studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12 compared with placebo.
OASIS 1 and 2 also achieved all three key secondary endpoints, showing a statistically significant reduction in the frequency of VMS from baseline to week 1, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo.
The safety profile observed in the OASIS 1 and 2 studies is overall consistent with previously published data on elinzanetant.
The late-stage clinical development program of elinzanetant, OASIS, currently comprises four phase III studies: OASIS 1, 2, 3 and 4. OASIS 3 is also investigating the efficacy and safety of elinzanetant 120 mg in women with moderate to severe VMS associated with menopause.
OASIS 4 study 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 successful development of additional candidates is imperative for Bayer, given the recent setbacks.
Shares of BAYRY have lost 28.9% in the past six months against the industry’s growth of 13.8%.
Image Source: Zacks Investment Research
Bayer stopped 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 due to the lack of efficacy.
The decision to stop the study was based on the recommendation of the study’s Independent Data Monitoring Committee (“IDMC”) as part of the ongoing surveillance, which showed an inferior efficacy of asundexian versus the control arm. This was a major setback, given the candidate’s potential.
Nevertheless, IDMC recommends continuing the phase III OCEANIC-STROKE study as planned.
Moreover, one of the top drugs in the pharmaceutical division, Xarelto, is facing generic competition.
The ongoing glyphosate litigation in the United States is also an overhang on the shares.
Zacks Rank & Stocks to Consider
Bayer currently has a Zacks Rank #5 (Strong Sell).
Entrada’s loss per share estimates for 2023 have narrowed from $2.07 to 9 cents in the past 60 days. The same for 2024 has narrowed from $2.35 to $2.04 during the same time frame.
Regeneron’s earnings estimates for 2024 have increased to $43.66 from $41.60 in the past 30 days. Shares of REGN have gained 29.8% in the past six months.
Loss estimates for Acadia have narrowed to 33 cents from 41 cents for 2023 and earnings estimates for 2024 are currently pinned at $1.04 per share. ACADIA shares have gained 22.5% in the past six months.
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Bayer (BAYRY) Elinzanetant Meets Goals in Late-Stage Studies
Bayer AG (BAYRY - Free Report) announced that the late-stage studies on the investigational compound elinzanetant were successful.
Elinzanetant is the first dual neurokinin-1,3 receptor antagonist in late-stage clinical development for the non-hormonal treatment of moderate to severe vasomotor symptoms (“VMS”), also known as hot flashes associated with menopause, administered orally once daily.
The phase III studies, OASIS 1 and 2 are double-blind, randomized, placebo-controlled multicenter studies investigating the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause as compared with placebo. OASIS 1 and 2 randomized 396 and 400 postmenopausal women, respectively, between 40 and 65 years, across 184 sites in 15 countries.
Data from these studies showed that elinzanetant successfully met all four primary endpoints in both studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12 compared with placebo.
OASIS 1 and 2 also achieved all three key secondary endpoints, showing a statistically significant reduction in the frequency of VMS from baseline to week 1, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo.
The safety profile observed in the OASIS 1 and 2 studies is overall consistent with previously published data on elinzanetant.
The late-stage clinical development program of elinzanetant, OASIS, currently comprises four phase III studies: OASIS 1, 2, 3 and 4. OASIS 3 is also investigating the efficacy and safety of elinzanetant 120 mg in women with moderate to severe VMS associated with menopause.
OASIS 4 study 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 successful development of additional candidates is imperative for Bayer, given the recent setbacks.
Shares of BAYRY have lost 28.9% in the past six months against the industry’s growth of 13.8%.
Image Source: Zacks Investment Research
Bayer stopped 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 due to the lack of efficacy.
The decision to stop the study was based on the recommendation of the study’s Independent Data Monitoring Committee (“IDMC”) as part of the ongoing surveillance, which showed an inferior efficacy of asundexian versus the control arm. This was a major setback, given the candidate’s potential.
Nevertheless, IDMC recommends continuing the phase III OCEANIC-STROKE study as planned.
Moreover, one of the top drugs in the pharmaceutical division, Xarelto, is facing generic competition.
The ongoing glyphosate litigation in the United States is also an overhang on the shares.
Zacks Rank & Stocks to Consider
Bayer currently has a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the healthcare sector are Entrada Therapeutics (TRDA - Free Report) , Regeneron Pharmaceuticals (REGN - Free Report) and Acadia Pharmaceuticals (ACAD - Free Report) . TRDA and REGN sport a Zacks Rank #1 (Strong Buy), and ACAD carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Entrada’s loss per share estimates for 2023 have narrowed from $2.07 to 9 cents in the past 60 days. The same for 2024 has narrowed from $2.35 to $2.04 during the same time frame.
Regeneron’s earnings estimates for 2024 have increased to $43.66 from $41.60 in the past 30 days. Shares of REGN have gained 29.8% in the past six months.
Loss estimates for Acadia have narrowed to 33 cents from 41 cents for 2023 and earnings estimates for 2024 are currently pinned at $1.04 per share. ACADIA shares have gained 22.5% in the past six months.