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Bayer's (BAYRY) Parkinson's Disease Therapy Gets Fast Track Tag

Bayer Aktiengesellschaft’s BAYRY wholly owned subsidiary, BlueRock Therapeutics LP, announced that the FDA has granted Fast Track designation to its pluripotent stem cell-derived dopaminergic neuron therapy, DA01, for the treatment of Parkinson’s disease (“PD”), a progressive neurodegenerative disorder.

The FDA provides a Fast Track designation to help the development and faster review of drugs which treat serious and unmet medical conditions. The designation will also make the candidate eligible for priority review and accelerated approval upon successful development.

Shares of Bayer have declined 1.7% so far this year against the industry’s growth of 9.8%.

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DA01 is currently being evaluated in a phase I study for advanced PD. The primary goal of the study is to check the safety and tolerability of DA01 cell transplantation at one year post-transplant.

Secondary objectives of the study include the evidence of transplanted cell survival and motor effects at one and two years post-transplant, while investigating continued safety and tolerability at two years as well as assessing the feasibility of transplantation.

Last month, BlueRock Therapeutics dosed the first patient in a phase I study which evaluated DA01 for the treatment of PD. The company is looking to bring a cell therapy approach for PD.

Per the company, PD is the second most common neurodegenerative disorder, affecting 1.3 million people in North America. Hence, if successfully developed and upon potential approval, DA01 can serve an area of unmet medical need and diversify Bayer’s portfolio of marketed drugs.

In June 2021, Bayer’s another wholly owned subsidiary, Asklepios BioPharmaceutical, announced that a parallel gene therapy program, also targeted at providing advanced therapies for PD, is currently recruiting and evaluating patients in an ongoing phase Ib study.

A total of 10 patients have already been enrolled in the given study.

Zacks Rank & Other Stocks to Consider

Bayer currently carries a Zacks Rank #2 (Buy). Other stocks worth considering in the healthcare sector include Roche Holding AG RHHBYRepligen Corporation RGEN and Alexion Pharmaceuticals, Inc. ALXN, all carrying the same Zacks Rank #2 at present. You can see  the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Roche’s earnings estimates have been revised 2.3% upward for 2021 and 1.1% upward for 2022 over the past 60 days. The stock has surged 10.7% year to date.

Repligen’s earnings estimates have been revised 2.2% upward for 2021 and 1.2% upward for 2022 over the past 60 days. The stock has increased 4.1% year to date.

Alexion’s earnings estimates have been revised 0.1% upward for 2021 and 0.1% upward for 2022 over the past 60 days. The stock has rallied 14.9% year to date.

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Roche Holding AG (RHHBY): Free Stock Analysis Report
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