Ocugen公司业务介绍 - 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[4] Shankar Musunuri博士参加Emerging Growth Virtual Healthcare Equity Conference - Ocugen公司宣布董事长、首席执行官和联合创始人Shankar Musunuri博士将参加由Noble Capital Markets举办的Emerging Growth Virtual Healthcare Equity Conference的炉边聊天[1] Ocugen公司临床发展进展 - Musunuri博士将展示公司最近的业务和临床发展进展，包括FDA批准启动OCU400第三期临床试验，这是一种用于治疗视网膜色素变性症（RP）患者的修饰基因疗法[2]

MALVERN, Pa., April 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 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed the study design, endpoints and planned statistical analysis of the pivotal OCU400 Phase 3 liMeliGhT clinical trial for retinitis pigmentosa (RP) and provi ...

Ocugen公司新闻 - Ocugen公司宣布其候选药物OCU410的早期至中期研究的数据和安全监控委员会（DSMB）已批准在治疗患有地理性萎缩（GA）的患者中使用OCU410的中剂量进行剂量递增阶段的治疗，这标志着确定OCU410最佳剂量方案的关键一步[1] - 公司股价在4月5日最后一个交易日上涨了21.2%，并在公告后的盘后交易中继续上涨了2.7%[2] - OCU410利用AAV传递平台进行视网膜传递RORA基因，该基因在治疗GA中起重要作用，公司认为OCU410有潜力成为首个一次性修饰基因治疗GA的候选药物，股价年初以来已飙升218.3%[4]

Ocugen (NASDAQ:OCGN) stock rose about 10% over the weekend. This comes after the company won U.S. Food and Drug Administration (FDA) clearance to advance its rare eye disease treatment to a Phase 3 trial.OCU400 is a gene therapy being developed for retinitis pigmentosa (RP). RP causes the retina at the back of the eye to break down over time, eventually resulting in blindness.Shares of OCGN are up more than 7% as of this writing, at around $1.90 per share and a market capitalization of roughly $485 million. ...

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 t ...

Established Low Dose as Safe and Tolerable Dose in Current OCU410 Clinical TrialDSMB 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 p ...

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 were ...

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 ...