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Bayer Shares New Post Hoc Analysis Of Self-Reported Sleep-Related Outcomes with Lynkuet® (elinzanetant) in Women with Moderate to Severe Vasomotor Symptoms at the Menopause Society Annual Meeting

Mon, 26 Oct 2026 16:00:00 -0400

Lynkuet® (elinzanetant) 60 mg capsules is a neurokinin 1 (NK1) receptor and NK3 receptor antagonist FDA-approved for the treatment of moderate to severe vasomotor symptoms (VMS), also known as hot flashes, due to menopause, based on data from the pivotal Phase III safety and efficacy trials, OASIS-1 and -2 and the long-term safety trial OASIS-3.
A pooled post hoc analysis of Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b), a key secondary endpoint of the Phase III OASIS-1 and OASIS-2 trials, evaluated various aspects of sleep disturbance among patients receiving Lynkuet® compared with placebo

Bayer Shares New Post Hoc Analysis Of Self-Reported Sleep-Related Outcomes with Lynkuet® (elinzanetant) in Women with Moderate to Severe Vasomotor Symptoms at the Menopause Society Annual Meeting

Mon, 26 Oct 2026 16:00:00 -0400

Lynkuet® (elinzanetant) 60 mg capsules is a neurokinin 1 (NK1) receptor and NK3 receptor antagonist FDA-approved for the treatment of moderate to severe vasomotor symptoms (VMS), also known as hot flashes, due to menopause, based on data from the pivotal Phase III safety and efficacy trials, OASIS-1 and -2 and the long-term safety trial OASIS-3.
A pooled post hoc analysis of Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b), a key secondary endpoint of the Phase III OASIS-1 and OASIS-2 trials, evaluated various aspects of sleep disturbance among patients receiving Lynkuet® compared with placebo

Bayer Shares New Post Hoc Analysis Of Self-Reported Sleep-Related Outcomes with Lynkuet® (elinzanetant) in Women with Moderate to Severe Vasomotor Symptoms at the Menopause Society Annual Meeting

Mon, 26 Oct 2026 16:00:00 -0400

Lynkuet® (elinzanetant) 60 mg capsules is a neurokinin 1 (NK1) receptor and NK3 receptor antagonist FDA-approved for the treatment of moderate to severe vasomotor symptoms (VMS), also known as hot flashes, due to menopause, based on data from the pivotal Phase III safety and efficacy trials, OASIS-1 and -2 and the long-term safety trial OASIS-3.
A pooled post hoc analysis of Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b), a key secondary endpoint of the Phase III OASIS-1 and OASIS-2 trials, evaluated various aspects of sleep disturbance among patients receiving Lynkuet® compared with placebo

Bayer Shares New Post Hoc Analysis Of Self-Reported Sleep-Related Outcomes with Lynkuet® (elinzanetant) in Women with Moderate to Severe Vasomotor Symptoms at the Menopause Society Annual Meeting

Mon, 26 Oct 2026 16:00:00 -0400

Lynkuet® (elinzanetant) 60 mg capsules is a neurokinin 1 (NK1) receptor and NK3 receptor antagonist FDA-approved for the treatment of moderate to severe vasomotor symptoms (VMS), also known as hot flashes, due to menopause, based on data from the pivotal Phase III safety and efficacy trials, OASIS-1 and -2 and the long-term safety trial OASIS-3.
A pooled post hoc analysis of Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b), a key secondary endpoint of the Phase III OASIS-1 and OASIS-2 trials, evaluated various aspects of sleep disturbance among patients receiving Lynkuet® compared with placebo

ESMO 2026: NUBEQA® (darolutamide) Plus ADT and Radiation Therapy Reduces Risk of Metastasis or Death by 58% in Prostate Cancer Patients at High Risk of Recurrence

Sat, 24 Oct 2026 08:00:00 -0400

Interim analysis results from the Phase III DASL-HiCaP trial show a statistically significant 58% reduction in the risk of metastasis or death with NUBEQA® (darolutamide) versus placebo in addition to androgen deprivation therapy (ADT) and radiation therapy (hazard ratio [HR] 0.42; 95% CI: 0.27–0.66; p=0.0001)
Four-year metastasis-free survival rate in trial reached 95% with NUBEQA compared to 88% with placebo, alongside secondary endpoint improvements and a safety profile consistent with previous studies
Results will be presented as a late-breaking abstract in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026

WHIPPANY, N.J.--(BUSINESS WIRE)-- New late-breaking

ESMO 2026: NUBEQA® (darolutamide) Plus ADT and Radiation Therapy Reduces Risk of Metastasis or Death by 58% in Prostate Cancer Patients at High Risk of Recurrence

Sat, 24 Oct 2026 08:00:00 -0400

Interim analysis results from the Phase III DASL-HiCaP trial show a statistically significant 58% reduction in the risk of metastasis or death with NUBEQA® (darolutamide) versus placebo in addition to androgen deprivation therapy (ADT) and radiation therapy (hazard ratio [HR] 0.42; 95% CI: 0.27–0.66; p=0.0001)
Four-year metastasis-free survival rate in trial reached 95% with NUBEQA compared to 88% with placebo, alongside secondary endpoint improvements and a safety profile consistent with previous studies
Results will be presented as a late-breaking abstract in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026

WHIPPANY, N.J.--(BUSINESS WIRE)-- New late-breaking

ESMO 2026: NUBEQA® (darolutamide) Plus ADT and Radiation Therapy Reduces Risk of Metastasis or Death by 58% in Prostate Cancer Patients at High Risk of Recurrence

Sat, 24 Oct 2026 08:00:00 -0400

Interim analysis results from the Phase III DASL-HiCaP trial show a statistically significant 58% reduction in the risk of metastasis or death with NUBEQA® (darolutamide) versus placebo in addition to androgen deprivation therapy (ADT) and radiation therapy (hazard ratio [HR] 0.42; 95% CI: 0.27–0.66; p=0.0001)
Four-year metastasis-free survival rate in trial reached 95% with NUBEQA compared to 88% with placebo, alongside secondary endpoint improvements and a safety profile consistent with previous studies
Results will be presented as a late-breaking abstract in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026

WHIPPANY, N.J.--(BUSINESS WIRE)-- New late-breaking

ESMO 2026: NUBEQA® (darolutamide) Plus ADT and Radiation Therapy Reduces Risk of Metastasis or Death by 58% in Prostate Cancer Patients at High Risk of Recurrence

Sat, 24 Oct 2026 08:00:00 -0400

Interim analysis results from the Phase III DASL-HiCaP trial show a statistically significant 58% reduction in the risk of metastasis or death with NUBEQA® (darolutamide) versus placebo in addition to androgen deprivation therapy (ADT) and radiation therapy (hazard ratio [HR] 0.42; 95% CI: 0.27–0.66; p=0.0001)
Four-year metastasis-free survival rate in trial reached 95% with NUBEQA compared to 88% with placebo, alongside secondary endpoint improvements and a safety profile consistent with previous studies
Results will be presented as a late-breaking abstract in a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2026

WHIPPANY, N.J.--(BUSINESS WIRE)-- New late-breaking

Bayer to Present New Cardiac Amyloidosis and Heart Failure Data at the Heart Failure Society of America (HFSA) Annual Scientific Meeting

Thu, 08 Oct 2026 15:00:00 -0400

Data from Bayer’s cardiovascular portfolio in heart failure and cardiac amyloidosis will be presented, including late-breaking data for investigational iodine 124 evuzamitide (I 124 evuzamitide) from a Phase III study in patients with suspected cardiac amyloidosis.

WHIPPANY, N.J.--(BUSINESS WIRE)--

Bayer

Summary

Bayer today announced that one late-breaking presentation along with five posters across its cardiovascular programs will be featured at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Phoenix, Arizona, from October 9-12, 2026.

Key Facts

A post-hoc analysis from the Phase III REVEAL study, which evaluated the investigational PET radiotracer I 124

Bayer to Present New Cardiac Amyloidosis and Heart Failure Data at the Heart Failure Society of America (HFSA) Annual Scientific Meeting

Thu, 08 Oct 2026 15:00:00 -0400

WHIPPANY, N.J.--(BUSINESS WIRE)--

Bayer

Summary

Key Facts

A post-hoc analysis from the Phase III REVEAL study, which evaluated the investigational PET radiotracer I 124

Bayer to Present New Cardiac Amyloidosis and Heart Failure Data at the Heart Failure Society of America (HFSA) Annual Scientific Meeting

Thu, 08 Oct 2026 15:00:00 -0400

WHIPPANY, N.J.--(BUSINESS WIRE)--

Bayer

Summary

Key Facts

A post-hoc analysis from the Phase III REVEAL study, which evaluated the investigational PET radiotracer I 124

Bayer to Present New Cardiac Amyloidosis and Heart Failure Data at the Heart Failure Society of America (HFSA) Annual Scientific Meeting

Thu, 08 Oct 2026 15:00:00 -0400

WHIPPANY, N.J.--(BUSINESS WIRE)--

Bayer

Summary

Key Facts

A post-hoc analysis from the Phase III REVEAL study, which evaluated the investigational PET radiotracer I 124

Actress and Menopause Advocate Melissa Joan Hart Partners with Bayer to Raise Awareness about Lynkuet® (elinzanetant), a Prescription Treatment for Moderate to Severe Hot Flashes due to Menopause

Thu, 08 Oct 2026 08:30:00 -0400

Bayer and actress Melissa Joan Hart are partnering to raise awareness about Lynkuet® (elinzanetant) 60mg capsules, a hormone-free prescription treatment for the reduction of moderate to severe hot flashes due to menopause,1 and encourage women to talk with their healthcare provider about treatment options.

Key Points:

Melissa Joan Hart partners with Bayer to help raise awareness about moderate to severe hot flashes due to menopause and to encourage women to discuss treatment options with their healthcare providers.
Lynkuet® (elinzanetant) 60mg capsules is an FDA-approved, hormone-free prescription treatment for the reduction of moderate to severe hot flashes due to menopause.1

Actress and Menopause Advocate Melissa Joan Hart Partners with Bayer to Raise Awareness about Lynkuet® (elinzanetant), a Prescription Treatment for Moderate to Severe Hot Flashes due to Menopause

Thu, 08 Oct 2026 08:30:00 -0400

Key Points:

Melissa Joan Hart partners with Bayer to help raise awareness about moderate to severe hot flashes due to menopause and to encourage women to discuss treatment options with their healthcare providers.
Lynkuet® (elinzanetant) 60mg capsules is an FDA-approved, hormone-free prescription treatment for the reduction of moderate to severe hot flashes due to menopause.1

Actress and Menopause Advocate Melissa Joan Hart Partners with Bayer to Raise Awareness about Lynkuet® (elinzanetant), a Prescription Treatment for Moderate to Severe Hot Flashes due to Menopause

Thu, 08 Oct 2026 08:30:00 -0400

Key Points:

Melissa Joan Hart partners with Bayer to help raise awareness about moderate to severe hot flashes due to menopause and to encourage women to discuss treatment options with their healthcare providers.
Lynkuet® (elinzanetant) 60mg capsules is an FDA-approved, hormone-free prescription treatment for the reduction of moderate to severe hot flashes due to menopause.1

Actress and Menopause Advocate Melissa Joan Hart Partners with Bayer to Raise Awareness about Lynkuet® (elinzanetant), a Prescription Treatment for Moderate to Severe Hot Flashes due to Menopause

Thu, 08 Oct 2026 08:30:00 -0400

Key Points:

Melissa Joan Hart partners with Bayer to help raise awareness about moderate to severe hot flashes due to menopause and to encourage women to discuss treatment options with their healthcare providers.
Lynkuet® (elinzanetant) 60mg capsules is an FDA-approved, hormone-free prescription treatment for the reduction of moderate to severe hot flashes due to menopause.1

FDA accepts Bayer's application to expand Kerendia to CKD without diabetes

Thu, 08 Oct 2026 02:30:20 -0400

Bayer announced that the U.S. Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for Kerendia (finerenone) for the treatment of adults with chronic kidney disease (CKD) who do not have diabetes.

The application is supported by results from the Phase III FIND-CKD trial, which enrolled 1,584 adults with CKD without diabetes. In that trial, Kerendia met its primary endpoint, showing a statistically significant reduction in the rate of kidney function decline, measured by estimated glomerular filtration rate (eGFR) slope, compared with placebo. The mean annual rate of eGFR decline was -3.3 mL/min/1.73 m²/year with Kerendia versus -4.0

FDA accepts Bayer's application to expand Kerendia to CKD without diabetes

Thu, 08 Oct 2026 02:30:20 -0400

U.S. FDA Accepts Bayer’s Supplemental New Drug Application for KERENDIA® (finerenone) to Treat Adults with Chronic Kidney Disease (CKD) Without Diabetes

Thu, 08 Oct 2026 02:30:00 -0400

The supplemental New Drug Application (sNDA) was supported by results from the Phase III FIND-CKD trial investigating KERENDIA® (finerenone) in adults with chronic kidney disease (CKD) without diabetes who were also receiving background standard of care.
More than 37 million adults in the U.S. have CKD, a progressive condition that can lead to cardiovascular complications and kidney failure.i An estimated 50% to 70% of people with CKD do not have diabetes,ii and among those who progress to end-stage kidney disease in the U.S., 63% do not have diabetes.i

WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer

Summary

Bayer announced today that the U.S. Food

U.S. FDA Accepts Bayer’s Supplemental New Drug Application for KERENDIA® (finerenone) to Treat Adults with Chronic Kidney Disease (CKD) Without Diabetes

Thu, 08 Oct 2026 02:30:00 -0400

The supplemental New Drug Application (sNDA) was supported by results from the Phase III FIND-CKD trial investigating KERENDIA® (finerenone) in adults with chronic kidney disease (CKD) without diabetes who were also receiving background standard of care.
More than 37 million adults in the U.S. have CKD, a progressive condition that can lead to cardiovascular complications and kidney failure.i An estimated 50% to 70% of people with CKD do not have diabetes,ii and among those who progress to end-stage kidney disease in the U.S., 63% do not have diabetes.i

WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer

Summary

Bayer announced today that the U.S. Food

U.S. FDA Accepts Bayer’s Supplemental New Drug Application for KERENDIA® (finerenone) to Treat Adults with Chronic Kidney Disease (CKD) Without Diabetes

Thu, 08 Oct 2026 02:30:00 -0400

The supplemental New Drug Application (sNDA) was supported by results from the Phase III FIND-CKD trial investigating KERENDIA® (finerenone) in adults with chronic kidney disease (CKD) without diabetes who were also receiving background standard of care.
More than 37 million adults in the U.S. have CKD, a progressive condition that can lead to cardiovascular complications and kidney failure.i An estimated 50% to 70% of people with CKD do not have diabetes,ii and among those who progress to end-stage kidney disease in the U.S., 63% do not have diabetes.i

WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer

Summary

Bayer announced today that the U.S. Food

U.S. FDA Accepts Bayer’s Supplemental New Drug Application for KERENDIA® (finerenone) to Treat Adults with Chronic Kidney Disease (CKD) Without Diabetes

Thu, 08 Oct 2026 02:30:00 -0400

The supplemental New Drug Application (sNDA) was supported by results from the Phase III FIND-CKD trial investigating KERENDIA® (finerenone) in adults with chronic kidney disease (CKD) without diabetes who were also receiving background standard of care.
More than 37 million adults in the U.S. have CKD, a progressive condition that can lead to cardiovascular complications and kidney failure.i An estimated 50% to 70% of people with CKD do not have diabetes,ii and among those who progress to end-stage kidney disease in the U.S., 63% do not have diabetes.i

WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer

Summary

Bayer announced today that the U.S. Food

Bayer to Invest 2.2 Billion U.S. Dollars in a New Manufacturing Site in the United States

Fri, 02 Oct 2026 15:10:00 -0400

Company plans to build state-of-the-art site in New Albany, Ohio, U.S., to serve patients in the U.S. as well as globally
Bayer expects to create around 600 new high-value jobs in the area
Multi-year investment reinforces U.S. business expansion and adds to more than seven billion dollars in U.S. pharma R&D and manufacturing expenditure over past five years

NEW ALBANY, Ohio--(BUSINESS WIRE)-- Bayer announced on Friday plans to invest 2.2 billion U.S. dollars in a new pharmaceutical manufacturing site in New Albany, Ohio, U.S. Building on more than seven billion dollars in U.S. pharma R&D and manufacturing spend over

Bayer to Invest 2.2 Billion U.S. Dollars in a New Manufacturing Site in the United States

Fri, 02 Oct 2026 15:10:00 -0400

Company plans to build state-of-the-art site in New Albany, Ohio, U.S., to serve patients in the U.S. as well as globally
Bayer expects to create around 600 new high-value jobs in the area
Multi-year investment reinforces U.S. business expansion and adds to more than seven billion dollars in U.S. pharma R&D and manufacturing expenditure over past five years

Bayer to Invest 2.2 Billion U.S. Dollars in a New Manufacturing Site in the United States

Fri, 02 Oct 2026 15:10:00 -0400

Company plans to build state-of-the-art site in New Albany, Ohio, U.S., to serve patients in the U.S. as well as globally
Bayer expects to create around 600 new high-value jobs in the area
Multi-year investment reinforces U.S. business expansion and adds to more than seven billion dollars in U.S. pharma R&D and manufacturing expenditure over past five years