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Ocugen (OCGN) Up as DSMB Allows Cohort 2 Dosing in GA Study
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Ocugen, Inc. (OCGN - Free Report) announced that the Data and Safety Monitoring Board (“DSMB”) for the early to mid-stage study of its investigational candidate, OCU410, has approved the initiation of dosing with the medium dose of OCU410 in the dose-escalation phase of the study to treatpatients with geographic atrophy (GA). Per management, this marks a critical step forward in determiningthe optimal dosing regimen of OCU410.
The company’s shares jumped 21.2% in the last trading session on Apr 5 and continued to gain another 2.7% in the after-market hours following the announcement.
Ocugen previously reported positive outcomes from Cohort 1 of the phase I/II ArMaDa study, in which three GA patients, to date, were dosed with the low dose (2.5×1010 vg/mL) of OCU410. Per the data readout, no adverse events related to treatment with OCU410 have been reported to date, deeming the low dose of the candidate as safe and tolerable.
Ocugen’s OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA gene, which plays an important role in treating GA. The company believes that OCU410 has the potential to become the first one-time modifier gene therapy for GAwith a single sub-retinal injection.
Year to date, shares of OCGN have skyrocketed 218.3% against the industry’s 2.7% decline.
Image Source: Zacks Investment Research
The planned phase I/II ArMaDa study is evaluating the safety of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases, the phase I dose-ranging study and the phase II dose-expansion study.
Following the DSMB’s approval, the company is currently gearing up to enroll and dose three additional patients in Cohort 2 of the phase I portion of the study with the medium dose (5×1010 vg/mL) of OCU410. Contingent upon positive Cohort 2 results, the company will further enroll and dose three more patients in Cohort 3 with the high dose (1.5 ×1011 vg/mL) of the candidate.
In the phase II portion of the ArMaDa study, enrolled GA patients will be randomized equally into either one of two OCU410 treatment groups or to an untreated control group.
Per Ocugen, currently approved GA therapies have significant limitations as they require multiple injections per year and only target one pathway contributing to GA.
OCU410, on the other hand, regulates multiple pathways involved with the disease, including lipid metabolism, inflammation, oxidative stress and membrane attack complex (complement), which are expected to offer greater therapeutic benefit.
GA is an advanced form of dry age-related macular degeneration, which can cause progressive and irreversible loss of retinal tissue, potentially leading to a loss of visual function over time. Per Ocugen, GA affects approximately one million people in the United States.
Please note that Ocugen shares are also rising in the pre-market hours today after the company announced that the FDA has cleared its investigational new drug amendment to initiate a late-stage study on a different modifier gene therapy product candidate, OCU400, which is being developed for retinitis pigmentosa (RP).
The planned phase III study is expected to enroll approximately 150 RP patients, comprising one arm of 75 patients with the RHO gene mutation and the other arm with 75 patients who are gene agnostic. In each arm, RP patients will be further randomized in the ratio of 2:1 to receive either a 2.5 x 1010 vg/eye dose of OCU400 or remain untreated in the control group, respectively.
The company expects to gain FDA approval for OCU400 to treat the RP indication in 2026.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 50 cents. Year to date, shares of ADMA have soared 41.4%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has remained constant at $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share has remained constant at 6 cents. Year to date, shares of FGEN have surged 82.8%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.49 to $3.35. The estimate for Annovis’ 2025 loss per share is currently pegged at $2.82. Year to date, shares of ANVS have plunged 40.6%.
ANVS’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.
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Ocugen (OCGN) Up as DSMB Allows Cohort 2 Dosing in GA Study
Ocugen, Inc. (OCGN - Free Report) announced that the Data and Safety Monitoring Board (“DSMB”) for the early to mid-stage study of its investigational candidate, OCU410, has approved the initiation of dosing with the medium dose of OCU410 in the dose-escalation phase of the study to treatpatients with geographic atrophy (GA). Per management, this marks a critical step forward in determiningthe optimal dosing regimen of OCU410.
The company’s shares jumped 21.2% in the last trading session on Apr 5 and continued to gain another 2.7% in the after-market hours following the announcement.
Ocugen previously reported positive outcomes from Cohort 1 of the phase I/II ArMaDa study, in which three GA patients, to date, were dosed with the low dose (2.5×1010 vg/mL) of OCU410. Per the data readout, no adverse events related to treatment with OCU410 have been reported to date, deeming the low dose of the candidate as safe and tolerable.
Ocugen’s OCU410 utilizes an AAV delivery platform for the retinal delivery of the RORA gene, which plays an important role in treating GA. The company believes that OCU410 has the potential to become the first one-time modifier gene therapy for GAwith a single sub-retinal injection.
Year to date, shares of OCGN have skyrocketed 218.3% against the industry’s 2.7% decline.
Image Source: Zacks Investment Research
The planned phase I/II ArMaDa study is evaluating the safety of unilateral subretinal administration of OCU410 in subjects with GA and will be conducted in two phases, the phase I dose-ranging study and the phase II dose-expansion study.
Following the DSMB’s approval, the company is currently gearing up to enroll and dose three additional patients in Cohort 2 of the phase I portion of the study with the medium dose (5×1010 vg/mL) of OCU410. Contingent upon positive Cohort 2 results, the company will further enroll and dose three more patients in Cohort 3 with the high dose (1.5 ×1011 vg/mL) of the candidate.
In the phase II portion of the ArMaDa study, enrolled GA patients will be randomized equally into either one of two OCU410 treatment groups or to an untreated control group.
Per Ocugen, currently approved GA therapies have significant limitations as they require multiple injections per year and only target one pathway contributing to GA.
OCU410, on the other hand, regulates multiple pathways involved with the disease, including lipid metabolism, inflammation, oxidative stress and membrane attack complex (complement), which are expected to offer greater therapeutic benefit.
GA is an advanced form of dry age-related macular degeneration, which can cause progressive and irreversible loss of retinal tissue, potentially leading to a loss of visual function over time. Per Ocugen, GA affects approximately one million people in the United States.
Please note that Ocugen shares are also rising in the pre-market hours today after the company announced that the FDA has cleared its investigational new drug amendment to initiate a late-stage study on a different modifier gene therapy product candidate, OCU400, which is being developed for retinitis pigmentosa (RP).
The planned phase III study is expected to enroll approximately 150 RP patients, comprising one arm of 75 patients with the RHO gene mutation and the other arm with 75 patients who are gene agnostic. In each arm, RP patients will be further randomized in the ratio of 2:1 to receive either a 2.5 x 1010 vg/eye dose of OCU400 or remain untreated in the control group, respectively.
The company expects to gain FDA approval for OCU400 to treat the RP indication in 2026.
Ocugen, Inc. Price and Consensus
Ocugen, Inc. price-consensus-chart | Ocugen, Inc. Quote
Zacks Rank and Stocks to Consider
Ocugen currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech industry are ADMA Biologics (ADMA - Free Report) , FibroGen (FGEN - Free Report) and Annovis Bio (ANVS - Free Report) . While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN and ANVS carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2024 earnings per share (EPS) has remained constant at 30 cents. During the same period, the estimate for ADMA’s 2025 EPS has remained constant at 50 cents. Year to date, shares of ADMA have soared 41.4%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 85%.
In the past 30 days, the Zacks Consensus Estimate for FibroGen’s 2024 loss per share has remained constant at $1.09. During the same period, the estimate for FibroGen’s 2025 loss per share has remained constant at 6 cents. Year to date, shares of FGEN have surged 82.8%.
FGEN beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Annovis’ 2024 loss per share has narrowed from $3.49 to $3.35. The estimate for Annovis’ 2025 loss per share is currently pegged at $2.82. Year to date, shares of ANVS have plunged 40.6%.
ANVS’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average negative surprise of 15.70%.