We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Bayer Begins Phase I/II Study on Cell Therapy for Eye Disease
Read MoreHide Full Article
Key Takeaways
BAYRY has started a phase I/IIa study of OpCT-001 for primary photoreceptor degenerative diseases.
OpCT-001 is the first iPSC-derived cell therapy tested in humans for inherited eye conditions.
The CLARICO trial assesses safety, vision impact, and cell engraftment across patient subgroups.
Bayer’s (BAYRY - Free Report) wholly owned subsidiary, BlueRock Therapeutics, announced that the first patient in the phase I/IIa CLARICO study has received OpCT-001, an investigational iPSC-derived cell therapy, which is being developed for the treatment of primary photoreceptor diseases.
Per management, OpCT-001 is the first iPSC-derived cell therapy to be tested in humans for treating certain inherited eye diseases like primary photoreceptor diseases. These diseases include conditions like retinitis pigmentosa and cone-rod dystrophy, which can lead to vision loss in children and adults.
OpCT-001 is designed to restore vision in individuals with primary photoreceptor diseases by transplanting functional retinal cells to replace those cells that have degenerated. OpCT-001 offers a promising novel cell-based therapeutic approach aimed at restoring visual function in patients with primary photoreceptor degenerative diseases.
The two-part interventional CLARICO study will evaluate the safety, tolerability and the effect on clinical outcomes of OpCT-001 in patients with primary photoreceptor disease. The phase I portion of the study will focus on safety and includes a dose-escalation design, while the phase II part of the study is designed to collect additional safety data and explore how OpCT-001 impacts visual function, functional vision and anatomical engraftment across different clinical subgroups.
BAYRY's Stock Performance
Year to date, shares of Bayer have rallied 56.6% against the industry’s decline of 0.7%.
Image Source: Zacks Investment Research
BAYRY's Encouraging Pipeline Progress
Bayer has expanded its pipeline in new modalities to include competencies in cell therapy through the acquisition of BlueRock and in gene therapy through the acquisition of AskBio.
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.
Last September, the FDA cleared the investigational new drug application for OpCT-001. The regulatory body in the United States granted a Fast Track designation to OpCT-001 for the treatment of primary photoreceptor diseases in February 2025.
The successful development of OpCT-001 could help Bayer redefine therapeutic options for patients facing irreversible vision impairment.
Besides OpCT-001, Bayer, with its wholly owned subsidiary BlueRock, is developing bemdaneprocel (BRT-DA01) in a phase III study for the treatment of Parkinson’s disease. Bemdaneprocel is an investigational stem cell-based therapy that surgically implants dopamine-generating nerve cell precursors into the brain.
The FDA has granted Regenerative Medicine Advanced Therapy designation and Fast Track designation to bemdaneprocel for treating Parkinson’s disease.
In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.64 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.85 to $3.13. Year to date, shares of EXEL have rallied 32.6%.
EXEL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 48.60%.
In the past 60 days, estimates for Spero Therapeutics’ loss per share have narrowed from $2.32 to $1.43 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.98 to $1.15. Year to date, shares of SPRO have surged 181.6%.
SPRO’s earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, the average surprise being 8.29%.
In the past 60 days, estimates for Puma Biotechnology’s earnings per share have increased from 60 cents to 65 cents for 2025. During the same time, earnings per share estimates for 2026 have risen from 48 cents to 51 cents. Year to date, shares of PBYI have gained 16.1%.
PBYI’s earnings beat estimates in each of the trailing four quarters, the average surprise being 171.43%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Bayer Begins Phase I/II Study on Cell Therapy for Eye Disease
Key Takeaways
Bayer’s (BAYRY - Free Report) wholly owned subsidiary, BlueRock Therapeutics, announced that the first patient in the phase I/IIa CLARICO study has received OpCT-001, an investigational iPSC-derived cell therapy, which is being developed for the treatment of primary photoreceptor diseases.
Per management, OpCT-001 is the first iPSC-derived cell therapy to be tested in humans for treating certain inherited eye diseases like primary photoreceptor diseases. These diseases include conditions like retinitis pigmentosa and cone-rod dystrophy, which can lead to vision loss in children and adults.
OpCT-001 is designed to restore vision in individuals with primary photoreceptor diseases by transplanting functional retinal cells to replace those cells that have degenerated. OpCT-001 offers a promising novel cell-based therapeutic approach aimed at restoring visual function in patients with primary photoreceptor degenerative diseases.
The two-part interventional CLARICO study will evaluate the safety, tolerability and the effect on clinical outcomes of OpCT-001 in patients with primary photoreceptor disease. The phase I portion of the study will focus on safety and includes a dose-escalation design, while the phase II part of the study is designed to collect additional safety data and explore how OpCT-001 impacts visual function, functional vision and anatomical engraftment across different clinical subgroups.
BAYRY's Stock Performance
Year to date, shares of Bayer have rallied 56.6% against the industry’s decline of 0.7%.
Image Source: Zacks Investment Research
BAYRY's Encouraging Pipeline Progress
Bayer has expanded its pipeline in new modalities to include competencies in cell therapy through the acquisition of BlueRock and in gene therapy through the acquisition of AskBio.
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.
Last September, the FDA cleared the investigational new drug application for OpCT-001. The regulatory body in the United States granted a Fast Track designation to OpCT-001 for the treatment of primary photoreceptor diseases in February 2025.
The successful development of OpCT-001 could help Bayer redefine therapeutic options for patients facing irreversible vision impairment.
Besides OpCT-001, Bayer, with its wholly owned subsidiary BlueRock, is developing bemdaneprocel (BRT-DA01) in a phase III study for the treatment of Parkinson’s disease. Bemdaneprocel is an investigational stem cell-based therapy that surgically implants dopamine-generating nerve cell precursors into the brain.
The FDA has granted Regenerative Medicine Advanced Therapy designation and Fast Track designation to bemdaneprocel for treating Parkinson’s disease.
BAYRY's Zacks Rank & Other Stocks to Consider
Bayer currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the biotech sector are Exelixis (EXEL - Free Report) , Spero Therapeutics (SPRO - Free Report) and Puma Biotechnology (PBYI - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.64 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.85 to $3.13. Year to date, shares of EXEL have rallied 32.6%.
EXEL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 48.60%.
In the past 60 days, estimates for Spero Therapeutics’ loss per share have narrowed from $2.32 to $1.43 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $1.98 to $1.15. Year to date, shares of SPRO have surged 181.6%.
SPRO’s earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, the average surprise being 8.29%.
In the past 60 days, estimates for Puma Biotechnology’s earnings per share have increased from 60 cents to 65 cents for 2025. During the same time, earnings per share estimates for 2026 have risen from 48 cents to 51 cents. Year to date, shares of PBYI have gained 16.1%.
PBYI’s earnings beat estimates in each of the trailing four quarters, the average surprise being 171.43%.