MALVERN, Pa., May 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 and vaccines, today announced that Arun Upadhyay, PhD, Chief Scientific Officer, Head of Research & Development, Ocugen will speak at the International Society for Cell & Gene Therapy (ISCT) Annual Meeting being held May 29-June 1, 2024 in Vancouver, Canada. “I’m very pleased to present OCU400 data am ...

NEW YORK, May 17, 2024 /PRNewswire/ -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Ocugen, Inc. (NASDAQ: OCGN) between May 8, 2020 and April 1, 2024, both dates inclusive (the "Class Period"), of the important June 10, 2024 lead plaintiff deadline in the securities class action first filed by the Firm. SO WHAT: If you purchased Ocugen securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs throu ...

MALVERN, Pa., May 15, 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 and vaccines, today announced that dosing is complete in the second cohort of its Phase 1/2 GARDian clinical trial for OCU410ST (AAV-hRORA)—a modifier gene therapy candidate being developed for Stargardt disease as a one-time treatment for life. "The completion of dosing for Cohort 2 participants s ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________________ FORM 8-K ___________________________________________________________ CURRENT REPORT Pursuant to Section 13 OR 15 (d) of The Securities Exchange Act of 1934 Date of Report (Date of Earliest Event Reported): April 2, 2024 ___________________________________________________________ OCUGEN, INC. (Exact Name of Registrant as Specified in its Charter) ________________________________ ...

财务数据和关键指标变化 - 研发费用从2023年第一季度的1020万美元下降到2024年第一季度的680万美元 [34] - 管理费用从2023年第一季度的830万美元下降到2024年第一季度的640万美元 [35] - 净亏损从2023年第一季度的1730万美元下降到2024年第一季度的1190万美元 [36] - 现金及现金等价物从2023年12月31日的3950万美元下降到2024年3月31日的2640万美元 [36] 各条业务线数据和关键指标变化 - OCU400已获FDA临床试验IND批准,成为首个进入III期临床的广泛适用于视网膜色素变性的基因疗法 [16][17] - OCU410和OCU410ST针对干性老年性黄斑变性和Stargardt病的II期临床试验正在进行,预计2024年第三季度有临床数据更新 [27][29] - OCU500将通过NIAID支持的临床试验进入I期临床,比较两种给药途径的疗效 [15] 各个市场数据和关键指标变化 - 视网膜色素变性和先天性黑色素性视网膜炎在美欧合计有近30万患者,是一个巨大的未满足医疗需求市场 [22] - 干性老年性黄斑变性在美欧合计有约1900万患者,地理性萎缩约200-300万患者,也是一个重要的市场机会 [26] - Stargardt病在美欧合计约有10万患者 [29] 公司战略和发展方向及行业竞争 - 公司专注于开发基于核受体调节基因的改性基因疗法,可以通过一次性治疗实现长期疗效,在视网膜疾病领域具有广泛应用前景 [12][24][25] - 公司正在推进OCU400、OCU410和OCU410ST的临床开发,并计划根据I/II期试验结果扩大OCU400的适应症至先天性黑色素性视网膜炎 [16][21][24][29] - 公司正在优化细胞治疗平台,为NeoCart自体细胞治疗的III期临床试验生产提供支持 [14] 管理层对经营环境和未来前景的评论 - 公司对2024年的发展前景充满信心,认为这将是公司的丰收之年 [15][31] - 公司正在积极探索战略和有利于股东的机会来增加营运资金 [36] - 公司将继续在相关医学会议上分享见解,并与患者倡导组织合作,以提高对视网膜疾病患者需求的认识 [22] 问答环节重要的提问和回答 问题1 **Arthur He 提问** 对于OCU400的III期试验,在基因无关组中是否有针对每种基因突变的最低患者数要求? [41] **Arun Upadhyay 回答** 我们没有针对每种基因突变预设具体的患者数量要求,而是计划尽可能包括更多的基因突变类型在基因无关组中 [43] 问题2 **Robert LeBoyer 提问** OCU400 III期试验的患者入组进度和数据发布时间节点如何? [47] **Shankar Musunuri 和 Huma Qamar 回答** 我们会定期向市场提供患者入组进度的更新,但由于这是一项受控的临床试验,在试验完成之前无法透露任何疗效数据。我们计划在2026年获得BLA和MAA批准 [49][53][55] 问题3 **Daniil Gataulin 提问** 公司是否计划在OCU400 III期试验中增加先天性黑色素性视网膜炎患者的新组别,以及需要什么样的I/II期数据作为决策依据? [58] **Arun Upadhyay 回答** 我们计划根据I/II期试验结果,单独启动一项针对先天性黑色素性视网膜炎患者的试验。主要依据是安全性和疗效数据 [60][63]

All three first-in-class modifier gene therapy product candidates currently in the clinic with OCU400 Phase 3 in progress OCU400 on track to meet 2026 Biologics License Application (BLA) and Market Authorization Application (MAA) approval targets MALVERN, Pa., May 14, 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, and vaccines, today reported first quarter 2024 financi ...

Table of Contents 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 quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-36751 _________________ ...

MALVERN, Pa., May 10, 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 and vaccines, today announced that its Board of Directors declared a dividend of one one-thousandth of a share of newly designated Series C Preferred Stock, par value $0.01 per share, for each outstanding share of the Company's common stock held of record as of 5:00 p.m. Eastern Time on May 20, 2024. T ...

MALVERN, Pa., May 10, 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 and vaccines, today announced that Dr. Shankar Musunuri, Chairman, Chief Executive Officer and Co-founder, Ocugen, will present at The Citizens JMP Life Sciences Conference taking place at the New York Hilton Midtown from May 13 – 14, 2024. Additionally, Dr. Huma Qamar, Chief Medical Officer, Ocuge ...

MALVERN, Pa., May 02, 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 and vaccines, today announced that Arun Upadhyay, PhD, Chief Scientific Officer, Head of Research & Development, Ocugen will speak at the Retina World Congress (RWC) being held May 9-12, 2024 in Ft. Lauderdale, FL. "This is a terrific opportunity to share the most recent developments in modifier gene t ...