Bayer announced on Tuesday its plans to launch two new drugs this year, focusing on cardiology and women’s health as part of its strategy to bolster its pharmaceuticals division amid a significant debt load.
The company emphasized its commitment to research and development, having made substantial investments aimed at accelerating medical innovation and creating a distinct pipeline for sustainable growth across critical therapeutic areas such as oncology, cardiovascular health, neurology, rare diseases, and immunology.
Bayer is making notable strides in its cell and gene therapy initiatives, reaching important milestones in clinical trials, particularly for Parkinson’s disease.
“The year 2025 will mark a pivotal moment for Bayer Pharmaceuticals, and we are fully committed to harnessing the potential of our pipeline,” stated Stefan Oelrich, a member of Bayer AG’s Board of Management and President of the Pharmaceuticals Division. “Our growth strategy is proceeding as planned, delivering significant value. This year, we’re poised to introduce several innovative products with blockbuster potential to the market.”
Through meticulous evaluation and prioritization, Bayer is advancing crucial programs with substantial promise. By concentrating on areas with significant unmet medical needs and high value potential, the company has enhanced the quality of its pipeline.
In a recent media briefing, Bayer’s leadership team shared their intentions to introduce new treatment options. One such option includes a novel treatment for transthyretin amyloid cardiomyopathy, which will soon enter the European market.
Additionally, Bayer plans to provide a new treatment for patients suffering from heart failure with a left ventricular ejection fraction of 40% or above, a prevalent form of heart failure, by the end of 2025. The company is also focusing on an innovative hormone-free treatment designed to alleviate moderate to severe vasomotor symptoms in menopausal women, as well as a new therapy for men with metastatic hormone-sensitive prostate cancer, thus reinforcing its leadership in this domain.
“We are on the cusp of a transformative era in medicine, confident that we can revolutionize patient care through groundbreaking innovations and a robust product portfolio. Our aim is to accelerate patient access to these new medicines. With each development, we move closer to our vision of treating the untreatable, curing diseases, and providing hope,” shared Christine Roth, Executive Vice President of Global Product Strategy and Commercialization and a member of Bayer’s Pharmaceuticals Leadership Team.
During Pharma Media Day, Bayer highlighted significant advancements, including treatments for transthyretin amyloid cardiomyopathy and heart failure, as well as an upcoming hormone-free option for menopausal symptoms. Regulatory approval for a promising oncology treatment is anticipated in 2025, reinforcing the company’s dedication to health innovation.
Dr. Christian Rommel, Ph.D., a member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Research and Development, noted significant evolutions in R&D due to their strategic transformation, allowing for a competitively structured and distinctive pipeline.
“Our recent late-stage Phase III trials have generated positive results, highlighting the benefits of our improved capabilities and clearly defined strategic priorities,” Dr. Rommel said.
“We have restructured our early pipeline for long-term growth, enabling us to advance targeted treatments that could greatly enhance patient outcomes. We are prepared to introduce innovative therapies that will profoundly impact patients’ lives while fostering sustainable business growth.”
Focused on Advancements in Oncology
Bayer is concentrating on three scientific domains crucial for addressing unmet needs in cancer care: targeted radiopharmaceuticals (specifically targeted alpha therapies), next-generation immuno-oncology, and precision molecular oncology.
Within these areas, the company is fostering first-in-class, highly innovative projects. Targeted radionuclide therapy (TRT) remains a strategic priority for Bayer, building on a decade of experience with targeted alpha therapy for metastatic castration-resistant prostate cancer (mCRPC).
Bayer’s expanding TRT pipeline includes novel targeting strategies that merge alpha radionuclides with various targeting mechanisms such as antibodies and small molecules. Currently, two TRT candidates are undergoing Phase I clinical trials, including actinium-225-based PSMA-targeting options for mCRPC patients.
Investments in R&D and platform companies over recent years have significantly enriched Bayer’s pipeline. The acquisition of Vividion’s Tavros Therapeutics enables Bayer to leverage chemoproteomics technology to target previously undruggable areas, with ongoing Phase I trials addressing solid tumors and hematologic malignancies.
Advancing Cardiovascular Therapies
Bayer is committed to pioneering precision cardiology by exploring innovative approaches across diverse modalities. Through their dedication, the company aims to address high unmet needs in cardiovascular diseases while potentially reversing life-altering conditions.
By complementing in-house expertise with external collaborations, Bayer aims to enhance its R&D proficiency and develop groundbreaking cardiovascular therapies to meet significant medical demands.
Through AskBio, a wholly owned subsidiary, Bayer is developing a gene therapy aimed at treating congestive heart failure. This acquisition has granted Bayer access to an advanced gene therapy platform with proven efficacy and world-class manufacturing capabilities, currently progressing with its Phase II assets.
Innovations in Women’s Health
Bayer is dedicated to enhancing the therapeutic options available for menopausal women by investing in innovative treatments. In 2025, the company plans to introduce a new hormone-free therapy aimed at addressing moderate to severe vasomotor symptoms (hot flashes) associated with menopause and certain breast cancer treatments.
Recent Phase III clinical studies indicate improvements in sleep disturbances and overall quality of life for women during menopause. “This treatment could fulfill crucial unmet medical needs for women experiencing menopause or menopause-related symptoms induced by treatments. We expect to submit regulatory applications globally, anticipating potential launches in the U.S. and Europe this year,” Bayer announced.
Exploring New Treatments for Parkinson’s Disease
Bayer, in collaboration with BlueRock Therapeutics, is advancing an investigational cell therapy that aims to address Parkinson’s disease through the surgical implantation of dopamine-generating nerve cell precursors into the brain.
Following positive Phase I outcomes, this candidate is moving directly to Phase III clinical development, having received a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for its innovative potential. Additionally, Bayer is advancing an adeno-associated viral (AAV)-based gene therapy with AskBio aimed at delivering the human glial cell line-derived neurotrophic factor (GDNF) transgene to restore dopamine-producing neuron function in the brain.
This therapy is currently in Phase II, with participant randomization underway in clinical trials. The preliminary clinical evidence has earned it an RMAT designation from the FDA, highlighting its potential to slow disease progression and enhance motor outcomes in moderate Parkinson’s patients. The treatment has also received FDA Fast Track designation and the Innovation Passport designation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA), underscoring its potential to meet the pressing global needs in Parkinson’s treatment.
