Bayer Accelerates Growth With siRNA, AI Deals and Pipeline Progress

German pharma giant Bayer AG BAYRY has entered into a collaboration and global licensing agreement with Soufflé Therapeutics to develop a heart-targeted small interfering RNA (siRNA) therapy in a move to fortify its presence in next-generation genetic medicines.

The collaboration is aimed at advancing a siRNA-based treatment for a rare form of dilated cardiomyopathy, a condition with limited therapeutic options.

The financial terms of the agreement were not disclosed.

Soufflé Therapeutics brings a proprietary platform designed to enable cell-selective delivery of siRNA therapies, addressing one of the biggest challenges in precise delivery of medicines to target tissues. Its ability to engineer cell-specific ligands that transport siRNA directly into heart cells could reduce off-target effects and the need for frequent dosing.

The agreement deepens Bayer’s relationship with Soufflé beyond its initial investment through Leaps by Bayer. Through this collaboration, Bayer aims to further bolster its cardiovascular portfolio while entering the fast-evolving siRNA space by leveraging Soufflé Therapeutics’ capabilities.

Bayer’s Collaboration With Cradle

Bayer is actively seeking to enhance its R&D capabilities through strategic collaborations.

Earlier in the week, Bayer and Cradle announced that they have entered into a three-year strategic collaboration to deploy Cradle’s scientific AI software platform for protein engineering.

Under the agreement, Bayer will integrate Cradle’s generative AI technology into its existing R&D workflows to accelerate lead generation and optimization across its therapeutic antibody pipeline.

Bayer selected Cradle’s platform to help advance higher-quality molecules into clinical development more quickly by reducing optimization cycles, enhancing molecular potency, safety and manufacturability, and increasing the probability of technical success as the company pursues more complex mechanisms of action.

As part of the collaboration, Cradle will provide Bayer’s antibody scientists with full access to its AI software platform, supporting integrated design–test–learn cycles and coordinated execution across internal laboratories and external partners.

Updates From Bayer’s AskBio

Bayer’s AskBio recently announced that the FDA has accepted its investigational new drug (IND) application for AB-1009, an adeno-associated virus (AAV) gene therapy being developed for late-onset Pompe disease (LOPD).

AskBio is a gene therapy company, wholly owned and operating independently as a subsidiary of Bayer.

With IND clearance, the program has advanced into a phase I/II study in the United States. AskBio has initiated a clinical trial in the United States to explore the safety of AB-1009. The company anticipates recruiting its first patient in early 2026.

The therapy has received both Fast Track and Orphan Drug designations in the United States.

Pompe disease is a rare, progressive and debilitating genetic disorder affecting an estimated 5,000 to 10,000 patients worldwide.

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

Bayer’s Recent Performance Impressive

Bayer has put up a stellar performance in the past year. The stock has surged 123.7%, outpacing the industry’s growth of 20.9%.

The impressive performance can be attributed to new drug approvals and encouraging pipeline progress.

Bayer’s new products, such as prostate cancer drug Nubeqa and kidney disease drug Kerendia (finerenone), continue to maintain their impressive momentum in the Pharmaceutical division and offset the negative impact of a decline in Xarelto sales, 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.

Meanwhile, Bayer recently obtained FDA approval of elinzanetant for the treatment of moderate to severe menopause-related vasomotor symptoms (VMS, also known as hot flashes) under the brand name Lynkuet. The drug was also approved by the European Commission. Lynkuet is already approved in the UK.

The approval of elinzanetant is a significant boost for the company.

The FDA recently granted accelerated approval to Hyrnuo (sevabertinib) for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have human epidermal growth factor receptor 2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

Bayer is making good pipeline progress as well. The new drug application for investigational contrast agent, gadoquatrane, had been accepted for review in both the United States and China. Gadoquatrane is being developed for use in contrast-enhanced magnetic resonance imaging of the central nervous system and other body regions in adults and pediatric patients, including term neonates.

Bayer also received a boost recently as pipeline candidate asundexian met primary efficacy and safety endpoints in late-stage OCEANIC-STROKE Study in secondary stroke prevention. Bayer will work with health authorities worldwide to submit marketing authorization applications seeking approval for the candidate.

Earlier this week, the FDA and the Center for Drug Evaluation (“CDE”) in China granted Breakthrough Therapy Designation to sevabertinib as a first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with human epidermal growth factor receptor 2 (HER2) activating mutations.

BAYRY's Zacks Rank & Stocks to Consider

Bayer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharma/ biotech sector are CorMedix CRMD and Amicus Therapeutics FOLD, both carrying 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 CorMedix’s 2025 EP6 have increased from $2.49 to $2.88. CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.

In the past 60 days, estimates for Amicus Therapeutics’ 2026 EPS have decreased to 65 cents from 70 cents. Shares of FOLD have gained 51.1% in a year. 

 

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