Ocugen公司与FDA合作 - Ocugen公司宣布美国食品和药物管理局（FDA）已批准其进行OCU400第三期临床试验的IND修订[1] - Ocugen与FDA合作开发了敏感的移动性课程LDNA，以允许早期至晚期疾病患者参与第三期临床试验[5] OCU400基因治疗项目 - OCU400是第一个进入第三期临床试验的基因治疗项目，具有广泛的RP适应症[3] - OCU400是基于NHR基因NR2E3的公司基因不可知修饰基因治疗产品[7]

Ocugen公司股价表现 - Ocugen公司股价在2024年已经上涨超过218%，市值超过4.69亿美元[1] 疫苗行业竞争 - Ocugen因其疫苗创新在疫情期间备受关注，但由于竞争激烈，未能成为疫苗行业的主要参与者，导致股东提起诉讼，但该诉讼在三月被法官驳回[2] OCU410药物试验 - Ocugen公司推进OCU410药物的试验，该药物用于治疗眼部疾病地理性萎缩，目前已经显示出耐受性迹象，预计将在第四季度获得全面批准[3] OCU410药物竞争 - OCU410药物将与其他公司生产的Soyfovre和Izervay竞争，如果获得批准，将在美国市场上与这些药物竞争[4]

Biotechnology firm Ocugen (NASDAQ:OCGN) — which specializes in developing gene therapies to address blindness diseases — saw its shares move higher on an encouraging clinical development. An advisory committee responsible for overseeing safety matters approved Ocugen to use a medium dosage of its retinal therapeutic. Subsequently, OCGN stock moved higher on the positive implications. According to the company’s press release, Ocugen received a green light from the Data and Safety Monitoring Board (DSMB) for ...

Established Low Dose as Safe and Tolerable Dose in Current OCU410 Clinical Trial DSMB Approval to Proceed with Medium Dose Cohort Dosing Malvern, Pa., April 05, 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 the Data and Safety Monitoring Board (DSMB) for the Phase 1/2 ArMaDa clinical trial for OCU410 recently convened and approved to ...

Shares of once high-flying biotech company Ocugen (NASDAQ:OCGN) are seeing some selling pressure again today. At the time of writing, OCGN stock is down over 9% on a business update provided by the company. Ocugen noted that Phase 3 trials of its OCU400 gene therapy drug are expected to commence in April, and other positive designation-related news was put forward. However, in this release, the company also revealed it would need to restate some of its financial statements. The company noted that errors wer ...

Received alignment with FDA for broad retinitis pigmentosa (RP) indication in Phase 3 clinical trial of OCU400—first gene therapy program to receive a broad indication for RP. OCU400 Phase 3 clinical trial expected to commence in April 2024. Regenerative Medicine Advanced Therapy (RMAT) designation granted by FDA to OCU400 Completed Cohort 1 dosing for OCU410 and OCU410ST gene therapy clinical studies for geographic atrophy (GA) and Stargardt disease, respectively MALVERN, Pa., April 02, 2024 (GLOBE NEWSWIR ...

Established Low Dose as Safe and Tolerable Dose in Current OCU410ST Clinical Trial DSMB Determination to Proceed with Medium Dose Cohort Dosing MALVERN, Pa., April 01, 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 the Data Safety and Monitoring Board (DSMB) for the OCU410ST clinical trial recently convened and approved to proceed dosi ...

公司信息 - Ocugen公司将于2024年4月2日上午8:30在东部时间举行电话会议和网络直播，提供截至2023年12月31日的财务业绩更新[1] - 参与者可通过拨打电话号码(800) 715-9871（美国）和(646) 307-1963（国际）参与电话会议，会议ID为4947142[2] - Ocugen公司是一家专注于发现、开发和商业化新型基因和细胞疗法、生物制剂和疫苗的生物技术公司，致力于改善全球患者的健康并为他们带来希望[3]

Ocugen公司任命首席医疗官 - Ocugen公司宣布任命Dr. Huma Qamar为首席医疗官（CMO）[1] - Dr. Qamar在临床研究领域拥有丰富的背景，曾在耶鲁大学、哈佛大学和宾夕法尼亚大学等知名学府贡献专业知识[2] - Dr. Qamar在多个治疗领域具有专业知识，包括基因和细胞治疗、疫苗、肿瘤学、风湿病学、皮肤病学、神经学、心脏病学、肝病学和传染病等[3] Ocugen公司的专注领域 - Ocugen公司专注于发现、开发和商业化新型基因和细胞疗法，致力于改善全球患者的健康，通过创新科学路径对患者的生活产生影响[4]

MALVERN, Pa., March 13, 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 first cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV-hRORA)—a modifier gene therapy candidate being developed for geographic atrophy (GA), an advanced stage of dry age related macular degeneration (dAMD). GA affects appro ...