Ocugen's Q4 Earnings: A Mixed Bag of Results and Progress
Generado por agente de IAMarcus Lee
miércoles, 5 de marzo de 2025, 7:31 am ET1 min de lectura
OCGN--
Ocugen, Inc. (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, reported its fourth quarter and full year 2024 financial results along with a general business update on March 5, 2025. The company's earnings snapshot provides insights into its clinical progress, regulatory accomplishments, and financial performance.
Ocugen's earnings per share (EPS) for the fourth quarter of 2024 was $0.00, beating the consensus estimate of -$0.05 by $0.05. However, the company's revenue for the quarter was $1.14 million, which was lower than the $6.04 million reported in the fourth quarter of 2023. This decrease in revenue can be attributed to various factors, including the company's clinical development activities and related timelines.
One of the key developments for OcugenOCGN-- was the alignment with the FDA on a Phase 2/3 pivotal confirmatory clinical trial for OCU410ST for Stargardt disease. This accelerated regulatory pathway is expected to save significant costs in addressing disease burden even sooner than anticipated. The OCU410ST Phase 2/3 clinical trial will randomize 51 subjects, with 34 receiving a single, subretinal, 200-μL injection of OCU410ST and 17 serving as untreated controls. One-year data will be utilized for the BLA filing planned for 2027.
Positive 2-year long-term data across multiple mutations of retinitis pigmentosa (RP) from the Phase 1/2 clinical trial of OCU400 demonstrated a durable and statistically significant (p=0.005) improvement in visual function (LLVA) in all evaluable treated subjects at two years when compared to untreated eyes. OCU400 remains on track to meet the first half of 2025 recruitment completion and potential BLA/MAA filings by mid-2026.
In parallel with clinical milestones, Ocugen achieved considerable regulatory accomplishments, including orphan medicinal product designation (OMPD) from the European Medicines Agency (EMA) for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19 (RP19), and cone-rod dystrophy 3 (CORD). The company also received positive opinions from the EMA's Committee for Advanced Therapies (CAT) for OCU400, OCU410, and OCU410ST.
Ocugen, Inc. (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, reported its fourth quarter and full year 2024 financial results along with a general business update on March 5, 2025. The company's earnings snapshot provides insights into its clinical progress, regulatory accomplishments, and financial performance.
Ocugen's earnings per share (EPS) for the fourth quarter of 2024 was $0.00, beating the consensus estimate of -$0.05 by $0.05. However, the company's revenue for the quarter was $1.14 million, which was lower than the $6.04 million reported in the fourth quarter of 2023. This decrease in revenue can be attributed to various factors, including the company's clinical development activities and related timelines.
One of the key developments for OcugenOCGN-- was the alignment with the FDA on a Phase 2/3 pivotal confirmatory clinical trial for OCU410ST for Stargardt disease. This accelerated regulatory pathway is expected to save significant costs in addressing disease burden even sooner than anticipated. The OCU410ST Phase 2/3 clinical trial will randomize 51 subjects, with 34 receiving a single, subretinal, 200-μL injection of OCU410ST and 17 serving as untreated controls. One-year data will be utilized for the BLA filing planned for 2027.
Positive 2-year long-term data across multiple mutations of retinitis pigmentosa (RP) from the Phase 1/2 clinical trial of OCU400 demonstrated a durable and statistically significant (p=0.005) improvement in visual function (LLVA) in all evaluable treated subjects at two years when compared to untreated eyes. OCU400 remains on track to meet the first half of 2025 recruitment completion and potential BLA/MAA filings by mid-2026.
In parallel with clinical milestones, Ocugen achieved considerable regulatory accomplishments, including orphan medicinal product designation (OMPD) from the European Medicines Agency (EMA) for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19 (RP19), and cone-rod dystrophy 3 (CORD). The company also received positive opinions from the EMA's Committee for Advanced Therapies (CAT) for OCU400, OCU410, and OCU410ST.
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