OCU500 will be administered via inhalation and as a nasal sprayCOVID-19 remains a substantial public health threat in the U.S. and around the worldPhase 1 clinical trial is anticipated to start in 2Q 2025 MALVERN, Pa., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the U.S. Food and Drug Administration (FDA) h ...

MALVERN, Pa., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. ("Ocugen" or the "Company") (NASDAQ:OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that the first patient has been dosed in the OCU200 Phase 1 clinical trial for diabetic macular edema (DME). "OCU200 has the potential to change the treatment landscape for DME, diabetic retinopathy (DR), and wet age-related macular degeneration (wet AMD) ...

100% (9/9) of treated evaluable subjects demonstrated improvement or preservation in visual function compared to untreated eyes at both one and two years100% (9/9) of treated evaluable subjects demonstrated improvement or stabilization in mobility testing, which was only performed up to one yearImprovement in visual function was statistically significant (p=0.01, treated vs untreated eyes), regardless of mutation at two yearsFavorable long-term safety and tolerability profile with no serious adverse events ...

MALVERN, Pa., Dec. 11, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen will present at the Oppenheimer Movers in Rare Disease Summit at the Westin Grand Central, New York on Thursday, December 12, 2024. “I have witnessed firsthand the impact that Ocugen’s modifie ...

MALVERN, Pa., Nov. 27, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced that Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen will present at NobleCon20 – Noble Capital Markets’ 20th Annual Emerging Growth Equity Conference at Florida Atlantic University, Executive Education Complex, in Boca Raton, FL—taking place De ...

Core Viewpoint - Ocugen, Inc. has received orphan medicinal product designation from the European Medicines Agency (EMA) for its treatment OCU410ST aimed at addressing ABCA4-associated retinopathies, including Stargardt disease, which currently lacks available therapies [1][2]. Group 1: Regulatory Designation and Benefits - The EMA's orphan medicinal product designation provides various advantages for drug developers, including protocol assistance, reduced regulatory fees, research grants, and 10 years of market exclusivity post-approval [3]. - The U.S. Food and Drug Administration (FDA) had previously granted orphan drug designation to OCU410ST in April 2023, highlighting the drug's significance in treating rare diseases [2]. Group 2: Clinical Trial Progress - Dosing for the first phase of the Phase 1/2 OCU410ST GARDian trial for Stargardt disease has been completed, with the Data and Safety Monitoring Board (DSMB) recommending progression to Phase 2 due to a favorable safety and tolerability profile [4]. - Preliminary data from the Phase 1 dose-escalation portion of the trial indicated an 84% reduction in atrophic lesion growth in treated eyes compared to untreated eyes after six months [5]. Group 3: Future Plans and Technology - Ocugen plans to pursue an accelerated marketing authorization application (MAA) for OCU410ST, indicating a commitment to expedite the drug's availability [7]. - OCU410ST employs an AAV delivery platform for retinal delivery of the RORA gene, representing Ocugen's innovative modifier gene therapy approach that targets multiple physiological functions [6].

MALVERN, Pa., Nov. 19, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced positive preliminary efficacy and safety data from the Phase 1 dose-escalation portion of the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (dAMD). Key findings include: no drug-related s ...

Ocugen (OCGN) came out with a quarterly loss of $0.05 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.06 per share a year ago. These figures are adjusted for non-recurring items.A quarter ago, it was expected that this biotech knee implant developer would post a loss of $0.06 per share when it actually produced a loss of $0.04, delivering a surprise of 33.33%.Over the last four quarters, the company has surpassed consensus EPS estimates two times.Ocugen, which belongs to the ...

Financial Performance - Ocugen closed $30 million in debt financing and $35 million in equity financing during Q3 2024, extending its cash runway into Q1 2026[9]. - Total cash and restricted cash as of September 30, 2024, was $39.0 million, a slight decrease from $39.5 million as of December 31, 2023[9]. - Total operating expenses for Q3 2024 were $14.4 million, down from $16.1 million in Q3 2023, with R&D expenses at $8.1 million and G&A expenses at $6.3 million[10]. - The company reported a net loss of $12.97 million for Q3 2024, compared to a net loss of $11.72 million in Q3 2023[16]. - Total revenue for Q3 2024 was $1.14 million, a decrease from $3.70 million in Q3 2023[16]. Clinical Trials and Developments - The OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa is on track to complete enrollment in 1H2025, with an expanded access program allowing access to approximately 300,000 patients in the U.S., Canada, and Europe[2]. - OCU410 is currently in Phase 2 of the Phase 1/2 ArMaDa clinical trial, targeting geographic atrophy, which affects approximately 2-3 million people in the U.S. and EU[3]. - The FDA has approved the investigational new drug application for OCU200, with plans to initiate the Phase 1 clinical trial this quarter[8]. - The Data and Safety Monitoring Board approved enrollment for the second phase of the OCU410ST GARDian clinical trial[1]. - Ocugen plans to present new data on its clinical trials at an upcoming Clinical Showcase on November 12, 2024[6].

Subsequent to quarter-end, closed $30 million in debt financingOCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP) on track to complete enrollment in 1H2025OCU410 is currently in Phase 2 of the Phase 1/2 ArMaDa clinical trial Data and Safety Monitoring Board (DSMB) for the OCU410ST GARDian clinical trial approved enrollment for the second phase of the Phase 1/2 clinical trialNew data on Phase 1/2 clinical trials for OCU410, OCU410ST and OCU400 to be presented at upcoming Clinical Showcase ...