Bayer Reports Positive Data on Cell Therapy for Parkinson's Disease

Bayer AG’s BAYRY wholly owned, independently operated subsidiary BlueRock Therapeutics LP announced positive 36-month data from an early-stage study of bemdaneprocel, an investigational cell therapy for the treatment of Parkinson's disease.

Bemdaneprocel (BRT-DA01) is an investigational cell therapy designed to replace the dopamine-producing neurons that are lost in Parkinson’s disease.

Data showed that the safety profile at 36 months is consistent with earlier findings, demonstrating that it continues to be well tolerated by patients, with no adverse events reported related to the therapy or surgical procedure.

More on BAYRY’s Parkinson’s Disease Candidate

The data from the phase I study also showed that F-Dopa imaging suggests that transplanted cells continue to survive and engraft in the brain after discontinuing immunosuppression therapy at 12 months, as outlined in the study’s protocol.

Secondary clinical endpoints related to motor symptoms continued to show positive trends from baseline through the duration of follow-up, with more encouraging trends in the high-dose cohort than those in the low-dose cohort.

In the high-dose cohort (n=7), the 36-month measurement of the effects of bemdaneprocel on motor symptoms using the MDS-UPDRS Part III measured in the “OFF”-medication state, showed a mean reduction of 17.9 points compared with baseline. The low-dose cohort showed a mean decrease of 13.5 points. Per BAYRY, both of these are clinically meaningful.

The patients enrolled in both cohorts continue in the long-term Continued Evaluation Study.

Bemdaneprocel was granted Fast Track Designation in 2021 by the FDA. The agency also granted Regenerative Medicine Advanced Therapy designation to bemdaneprocel in 2024.

A phase III study to assess the efficacy, safety and overall impact of bemdaneprocel compared with sham surgery control is currently enrolling participants.

BAYRY's Encouraging Pipeline Progress

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, together with its subsidiaries, BlueRock and AskBio, is developing preclinical and clinical cell and gene therapies for treating various diseases, including retinal disorders, congestive heart failure and Parkinson's disease, among others.

BlueRock is also OpCT-001 for the treatment of primary photoreceptor diseases. OpCT-001 has been granted Fast Track designation by the FDA and is being tested in a phase I clinical study.  

Year to date, shares of Bayer have surged more than 64% compared to the industry’s decline of 10%.

Meanwhile, Bayer’s new products, such as Nubeqa and Kerendia, continue to maintain their impressive momentum in the pharmaceutical division and offset the negative impact of a decline in Xarelto sales.

Labels of these key drugs should boost the top-line growth. The FDA earlier expanded Nubeqa’s label for a third indication for patients with advanced prostate cancer. The regulatory body also approved label expansion of Kerendia for the treatment of adult patients with heart failure and a left ventricular ejection fraction (LVEF) of 40% or more.

Elinzanetant had been approved in the United Kingdom and Canada for the treatment of moderate to severe menopause-related vasomotor symptoms (VMS, also known as hot flashes) under the brand name Lynkuet.

Approval of new drugs should further boost sales from the pharma business and offset the sales decline of oral anticoagulant Xarelto, co-developed with Johnson & Johnson JNJ.

In the U.S. market, Xarelto is marketed by Johnson & Johnson. Bayer earns license revenues from JNJ for Xarelto sales in the United States.

BAYRY's Zacks Rank & Other Stocks to Consider

Bayer currently sports a Zacks Rank #1 (Strong Buy). Some other top-ranked stocks in the pharma/biotech sector are Amicus Therapeutics FOLD and Spero Therapeutics SPRO, each sporting the same rank as Bayer. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Amicus Therapeutics’ 2025 earnings per share have remained constant at 31 cents. Earnings per share estimates for 2026 have increased from 68 cents to 69 cents during the same period. Amicus Therapeutics’ earnings beat estimates in one of the trailing four quarters while missing the same on the remaining three occasions, the average negative surprise being 24.38%.

In the past 60 days, estimates for Spero Therapeutics’ loss per share have narrowed from $1.43 to 79 cents for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.15 to 74 cents. Year to date, shares of SPRO have surged 121.4%.

 

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This article originally published on Zacks Investment Research (zacks.com).

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