Bayer Advances AB-1002 Study, Highlights Pharma Growth Strategy

Bayer BAYRY’s wholly owned subsidiary, AskBio Inc., announced the completion of patient enrollment in the mid-stage GenePHIT study evaluating AB-1002 for heart failure with reduced ejection fraction (HFrEF).

The study enrolled 173 participants, marking a key milestone in the program’s development.

Bayer is shaping the future of cardiology through next-generation assets.

AB-1002 is an investigational, single-dose gene therapy delivered directly to the heart that drives production of a modified form (I-1c) of the natural protein inhibitor-1, intended to inhibit protein phosphatase 1, an enzyme associated with heart failure.

More on BAYRY's Cardiovascular Study

GenePHIT is a phase II, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of a one-time dose of the investigational gene therapy AB-1002, delivered via antegrade intracoronary infusion. The study has enrolled adults over 18 with non-ischemic cardiomyopathy, New York Heart Association (NYHA) Class III heart failure and reduced ejection fraction. It is designed to assess cardiovascular-related mortality as well as changes from baseline in NYHA class, left ventricular ejection fraction and six-minute walk distance.

Initial results are anticipated in the first half of 2027.

AskBio previously evaluated AB-1002 in a Phase 1, non-randomized, sequential dose-escalation trial in patients with NYHA Class III non-ischemic HFrEF.

It is advancing a clinical-stage pipeline of gene therapies targeting cardiovascular, CNS, and neuromuscular diseases, including heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s and Pompe disease.

Bayer’s Efforts to Strengthen Cardiovascular Portflio

The European Commission ("EC") recently approved a label expansion of Kerendia (finerenone) in the European Union for the treatment of adults with heart failure (HF) with left ventricular ejection fraction (LVEF) ≥40%, i.e. HF with mildly reduced (HFmrEF) or HFpEF.

We remind investors that finerenone is already marketed as Kerendia — or as Firialta in certain countries — and is approved in more than 100 countries, including China, Europe, Japan, and the United States, for the treatment of adults with chronic kidney disease (CKD) associated with type II diabetes (T2D).

Asundexian, an investigational, once daily, oral Factor XIa inhibitor, is being evaluated as a potential treatment for secondary stroke prevention.

Top-line data from the late-stage OCEANIC-STROKE study demonstrated that it met both safety and efficacy endpoints, representing the first successful phase III study for a Factor XIa inhibitor. With FDA Fast Track designation already granted, asundexian is viewed as a potential blockbuster opportunity in a market where recurrent stroke risk remains high.

The European Commission granted marketing authorization for Beyonttra (acoramidis), marketed by Bridge Bio in the United States, to treat wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

Bayer also has exclusive rights in Japan to aficamten from Cytokinetics CYTK. The candidate is a cardiac myosin inhibitor in development for hypertrophic cardiomyopathy.

Last month, Cytokinetics won FDA approval for aficamten for the treatment of patients with obstructive HCM in the United States, under the brand name Myqorzo.

Strategic partnerships and licensing deals further enhance Bayer’s precision cardiology portfolio.

Bayer Highlights Growth Strategy

At its Pharma Media Day 2026, Bayer outlined a strong growth outlook driven by five key catalysts, a record 2025 performance, and multiple upcoming pipeline milestones.

Bayer’s recent turnaround has been phenomenal and it is now looking to expand its diverse portfolio.

Shares of Bayer have surged 92.2% over the past year compared with the industry’s gain of 17.3%.

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The company reported five approvals in 2025 (three new products and two new indications) and six positive phase III readouts, reinforcing confidence in its innovation strategy.

Bayer expects its Pharmaceuticals division to return to mid-single-digit growth from 2027 and target operating margins approaching 30% by 2030, supported by a science-driven, AI-enabled operating model.

Bayer’s portfolio is anchored by five major assets: asundexian, Nubeqa (prostate cancer), Finerenone, Beyonttra and Lynkuet (a dual NK1/NK3 antagonist approved for menopause-related vasomotor symptoms).

Bayer’s rejuvenated pipeline includes precision oncology, cardiovascular therapies, and next-generation modalities: targeted alpha therapy 225Ac-PSMA-Trillium for advanced prostate cancer, VVD-214, a WRN inhibitor for MSI-high tumors, GIRK4 inhibitor (BAY 3670549) for atrial fibrillation and sevabertinib, a TKI for HER2-mutant lung cancer.

Bayer is also advancing imaging innovation, including adoquatrane, a low-dose MRI contrast agent recently approved in Japan, and molecular tracers AT-01 and AT-05 for amyloidosis diagnosis.

BAYRY has also expanded its pipeline into new modalities of cell therapy through the acquisition of BlueRock, and in gene therapy, through the AskBio buyout.

This includes AB-1002, AB-1005 (phase II) for Parkinson’s disease, bemdaneprocel (phase III) for Parkinson’s Disease and OpCT-001 (early-stage) for retinal diseases.

Overall, Bayer’s diversified pipeline, strategic partnerships, and focus on innovation position it for sustained growth through the decade.

The strong performance of Nubeqa and Kerendia has enabled the company to combat the decline in sales of oral anticoagulant Xarelto, which is co-developed with Johnson & Johnson JNJ.

Xarelto is marketed by Johnson & Johnson in the United States. Bayer earns license revenues from JNJ for Xarelto sales in the United States.

Another key drug, Eylea, continues to face pressure from generics. The introduction of Eylea 8 mg, with its extended dosing intervals, has partially offset the decline and supported overall performance.

Please note that Bayer’s HealthCare unit co-develops Eylea with Regeneron REGN, which records net product sales of Eylea in the United States. BAYRY records net product sales of Eylea outside the country. REGN records its share of profits and losses from Eylea sales outside the United States.

Zacks Rank

Bayer currently carries a Zacks Rank #5 (Strong Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


 

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