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Bayer Reports Positive Safety Data on Parkinson's Disease Drug
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Bayer Ag (BAYRY - Free Report) and its wholly owned subsidiary BlueRock Therapeutics LP announced positive 24-month data from an early-stage study on experimental candidate bemdaneprocel (BRT-DA01).
Bemdaneprocel, an investigational cell therapy, is being evaluated for the treatment of Parkinson's disease.
exPDite is a multi-center, multi-site, open-label, non-randomized, non-controlled phase I study.
Data from the phase I exPDite study at 24 months continue to show a favorable safety profile in all 12 participants in the trial’s high and low-dose cohorts.
Year to date, shares of Bayer have lost 8.1% against the industry’s growth of 20.1%.
Image Source: Zacks Investment Research
BAYRY’s Parkinson's Disease Drug Found Safe at 24 Months
The exPDite trial is designed to assess the safety and tolerability of bemdaneprocel. The study is now complete.
Twelve subjects diagnosed with Parkinson’s disease received surgical transplantation of one of two different dose levels of bemdaneprocel to the post-commissural putamen bilaterally, and administration of a one-year immunosuppression regimen.
Cohort A (five subjects) received a dose of 0.9 million cells per putamen. Cohort B (seven subjects) received 2.7 million cells per putamen. The safety and tolerability were assessed at 12 months as the primary endpoint, along with evidence of cell survival and motor effects. The feasibility of transplantation was also assessed. Assessments were repeated at 18 months with final assessments at 24 months.
The safety profile of bemdaneprocel at 24 months is consistent with the earlier observed findings. Data demonstrated that bemdaneprocel continues to be well-tolerated by patients, with no adverse events reported related to bemdaneprocel.
Results showed that even after discontinuing immunosuppression therapy at 12 months, as outlined in the study’s protocol, transplanted cells continue to survive and engraft in the brain.
Secondary clinical endpoints related to motor symptoms also continue to show positive trends from baseline through the duration of follow-up. Notably, there are more encouraging trends in the high-dose cohort than those in the low-dose cohort.
These were assessed by the MDS-Unified Parkinson’s Disease Rating Scale Part II and III (MDS-UPDRS Part II & III) and the Hauser PD Diary tools used to assess Parkinson’s disease severity in motor symptoms.
A mean reduction of 21.9 months as compared with baseline was observed in the high-dose cohort on the 24-month measurement of the effects of bemdaneprocel on motor symptoms using MDS-UPDRS Part III measured in the “OFF”-medication state. The low-dose cohort showed a mean decrease of 8.3 points.
The positive trends demonstrated at 24 months suggest that bemdaneprocel could potentially offer sustained benefits for movement impairments caused by the disease.
In May 2024, the FDA granted the Regenerative Medicine Advanced Therapy (“RMAT”) designation to bemdaneprocel. The designation from the FDA enables expedited development review and development planning guidance from senior managers working with the FDA’s Center for Biologics Evaluation and Research.
The candidate was also granted Fast Track Designation from the FDA.
BAYRY’s Encouraging Pipeline Progress
Bayer is looking to strengthen its pharmaceutical portfolio amid generic competition for Xarelto.
In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer.
Bayer, together with its subsidiaries BlueRock and AskBio, is developing preclinical and clinical cell and gene therapies.
Apart from bemdaneprocel, Bayer has another cell therapy candidate in its pipeline, OpCT-001, for the treatment of primary photoreceptor disease. The candidate has been cleared by the FDA to begin phase I clinical testing.
The successful development of new drugs is important for Bayer. The company is working on the label expansion of its approved drugs.
Pipeline setbacks and regulatory setbacks have weighed on the stock in recent times. The late-stage study, OCEANIC-AF, investigating asundexian compared with direct oral anticoagulant Eliquis (apixaban) in patients with atrial fibrillation and at risk for stroke, was stopped early due to the lack of efficacy. This was a major setback, given the candidate’s potential.
Bayer had earlier acquired marketing rights for the cardiovascular candidate acoramidis in Europe from BridgeBioBBIO. The rights were acquired from Eidos Therapeutics Inc., BridgeBio International GmbH and BridgeBio Europe B.V.
A new drug application for acoramidis has been filed with the FDA, and the regulatory body has set a target action date of Nov. 29, 2024, for the same.
Estimates for Eli Lilly’s 2024 earnings have risen from $13.79 to $16.49 per share over the past 60 days. For 2025, the bottom-line estimate has risen from $19.44 to $23.97 over the same timeframe. Year to date, Lilly’s shares have risen 48.9%.
Estimates for PFE’s 2024 earnings have risen from $2.38 to $2.62 per share over the past 60 days. For 2025, the bottom-line estimate has risen from $2.74 to $2.85 over the same timeframe.
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Bayer Reports Positive Safety Data on Parkinson's Disease Drug
Bayer Ag (BAYRY - Free Report) and its wholly owned subsidiary BlueRock Therapeutics LP announced positive 24-month data from an early-stage study on experimental candidate bemdaneprocel (BRT-DA01).
Bemdaneprocel, an investigational cell therapy, is being evaluated for the treatment of Parkinson's disease.
exPDite is a multi-center, multi-site, open-label, non-randomized, non-controlled phase I study.
Data from the phase I exPDite study at 24 months continue to show a favorable safety profile in all 12 participants in the trial’s high and low-dose cohorts.
Year to date, shares of Bayer have lost 8.1% against the industry’s growth of 20.1%.
Image Source: Zacks Investment Research
BAYRY’s Parkinson's Disease Drug Found Safe at 24 Months
The exPDite trial is designed to assess the safety and tolerability of bemdaneprocel. The study is now complete.
Twelve subjects diagnosed with Parkinson’s disease received surgical transplantation of one of two different dose levels of bemdaneprocel to the post-commissural putamen bilaterally, and administration of a one-year immunosuppression regimen.
Cohort A (five subjects) received a dose of 0.9 million cells per putamen. Cohort B (seven subjects) received 2.7 million cells per putamen. The safety and tolerability were assessed at 12 months as the primary endpoint, along with evidence of cell survival and motor effects. The feasibility of transplantation was also assessed. Assessments were repeated at 18 months with final assessments at 24 months.
The safety profile of bemdaneprocel at 24 months is consistent with the earlier observed findings. Data demonstrated that bemdaneprocel continues to be well-tolerated by patients, with no adverse events reported related to bemdaneprocel.
Results showed that even after discontinuing immunosuppression therapy at 12 months, as outlined in the study’s protocol, transplanted cells continue to survive and engraft in the brain.
Secondary clinical endpoints related to motor symptoms also continue to show positive trends from baseline through the duration of follow-up. Notably, there are more encouraging trends in the high-dose cohort than those in the low-dose cohort.
These were assessed by the MDS-Unified Parkinson’s Disease Rating Scale Part II and III (MDS-UPDRS Part II & III) and the Hauser PD Diary tools used to assess Parkinson’s disease severity in motor symptoms.
A mean reduction of 21.9 months as compared with baseline was observed in the high-dose cohort on the 24-month measurement of the effects of bemdaneprocel on motor symptoms using MDS-UPDRS Part III measured in the “OFF”-medication state. The low-dose cohort showed a mean decrease of 8.3 points.
The positive trends demonstrated at 24 months suggest that bemdaneprocel could potentially offer sustained benefits for movement impairments caused by the disease.
In May 2024, the FDA granted the Regenerative Medicine Advanced Therapy (“RMAT”) designation to bemdaneprocel. The designation from the FDA enables expedited development review and development planning guidance from senior managers working with the FDA’s Center for Biologics Evaluation and Research.
The candidate was also granted Fast Track Designation from the FDA.
BAYRY’s Encouraging Pipeline Progress
Bayer is looking to strengthen its pharmaceutical portfolio amid generic competition for Xarelto.
In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer.
Bayer, together with its subsidiaries BlueRock and AskBio, is developing preclinical and clinical cell and gene therapies.
Apart from bemdaneprocel, Bayer has another cell therapy candidate in its pipeline, OpCT-001, for the treatment of primary photoreceptor disease. The candidate has been cleared by the FDA to begin phase I clinical testing.
The successful development of new drugs is important for Bayer. The company is working on the label expansion of its approved drugs.
Pipeline setbacks and regulatory setbacks have weighed on the stock in recent times. The late-stage study, OCEANIC-AF, investigating asundexian compared with direct oral anticoagulant Eliquis (apixaban) in patients with atrial fibrillation and at risk for stroke, was stopped early due to the lack of efficacy. This was a major setback, given the candidate’s potential.
Bayer had earlier acquired marketing rights for the cardiovascular candidate acoramidis in Europe from BridgeBio BBIO. The rights were acquired from Eidos Therapeutics Inc., BridgeBio International GmbH and BridgeBio Europe B.V.
A new drug application for acoramidis has been filed with the FDA, and the regulatory body has set a target action date of Nov. 29, 2024, for the same.
BAYRY’s Zacks Rank & Other Stocks to Consider
BAYRY currently carries a Zacks Rank #2 (Buy).
A couple of other top-ranked large-cap pharma companies are Eli Lilly (LLY - Free Report) and Pfizer (PFE - Free Report) . While LLY sports a Zacks Rank #1 (Strong Buy), PFE carries a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Estimates for Eli Lilly’s 2024 earnings have risen from $13.79 to $16.49 per share over the past 60 days. For 2025, the bottom-line estimate has risen from $19.44 to $23.97 over the same timeframe. Year to date, Lilly’s shares have risen 48.9%.
Estimates for PFE’s 2024 earnings have risen from $2.38 to $2.62 per share over the past 60 days. For 2025, the bottom-line estimate has risen from $2.74 to $2.85 over the same timeframe.