Ocugen(OCGN)

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Ocugen Announces European Medicines Agency Grants Orphan Medicinal Product Designation for Modifier Gene Therapy Candidate OCU410ST for Treatment of ABCA4-Associated Retinopathies including Stargardt Disease
GlobeNewswire News Room· 2024-11-20 12:30
MALVERN, Pa., Nov. 20, 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 the European Medicines Agency (EMA) has granted orphan medicinal product designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19 (RP19), and cone-rod dystrophy 3 (CORD3). “We are d ...
Ocugen Announces Compelling Preliminary Data for OCU410—a Single Dose Novel Modifier Gene Therapy to Treat Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
GlobeNewswire News Room· 2024-11-19 12:02
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) Reports Q3 Loss, Misses Revenue Estimates
ZACKS· 2024-11-14 22:40
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 ...
Ocugen(OCGN) - 2024 Q3 - Quarterly Report
2024-11-14 20:25
Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.01 per share OCGN The Nasdaq Stock Market LLC (The Nasdaq Capital Market) UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________ FORM 10-Q ___________________________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the qu ...
Ocugen(OCGN) - 2024 Q3 - Quarterly Results
2024-11-08 18:43
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].
Ocugen(OCGN) - 2024 Q3 - Earnings Call Transcript
2024-11-08 15:18
Ocugen, Inc. (NASDAQ:OCGN) Q3 2024 Earnings Conference Call November 11, 2024 8:30 AM ET Company Participants Tiffany Hamilton - Head of Corporate Communications Shankar Musunuri - Chairman of the Board, CEO & Co-founder Ramesh Ramachandran - Chief Accounting Officer Huma Qamar - Chief Medical Officer Conference Call Participants Jason McCarthy - Maxim Group Daniil Gataulin - Chardan Operator Good morning and welcome to Ocugen's Third Quarter 2024 Financial Results and Business Update. Please note that this ...
Ocugen Provides Business Update with Third Quarter 2024 Financial Results
GlobeNewswire News Room· 2024-11-08 11:45
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 ...
Ocugen Secures $30 Million in Debt Funding
GlobeNewswire News Room· 2024-11-07 11:30
MALVERN, Pa., Nov. 07, 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 on November 6, 2024, the Company entered into a new $30 million credit facility with Avenue Venture Opportunities Fund, L.P., a fund of Avenue Capital Group. Proceeds from the facility are intended for general corporate purposes, capital expenditures, wo ...
Ocugen Clinical Showcase Highlighting Progress in Retinal Gene Therapy Clinical Trials in New York City on Tuesday, November 12, 2024
GlobeNewswire News Room· 2024-10-28 10:30
Progress on OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP) and new data from Phase 1/2 Preliminary safety and efficacy update on OCU410 Phase 1/2 ArMaDa clinical trial for geographic atrophy (GA) Clinical update on OCU410ST Phase 1/2 GARDian clinical trial for Stargardt disease Featuring patients, investigators and thought leaders MALVERN, Pa., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, develop ...
Data and Safety Monitoring Board Approves Initiation of Phase 2 of OCU410ST GARDian Clinical Trial for Stargardt Disease
GlobeNewswire News Room· 2024-10-22 11:02
Determined the high dose of OCU410ST to be the maximum tolerated doseNo serious adverse events have been reportedApproved proceeding to Phase 2 using high and medium doses of OCU410ST MALVERN, Pa., Oct. 22, 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 the Data and Safety Monitoring Board (DSMB) for the OCU410ST GARDian c ...