Ocugen (NasdaqCM:OCGN) Q3 2025 Earnings Call November 05, 2025 08:30 AM ET Speaker2Good morning and welcome to Ocugen's third quarter 2025 financial results and business update. Please note that this call is being recorded at this time. All participant lines are in a listen-only mode. Following the speaker's commentary, there will be a question-and-answer session. I will now turn the call over to Tiffany Hamilton, Ocugen's Head of Corporate Communications. You may begin.Speaker0Thank you, operator. Good mor ...

Conference Call and Webcast Today at 8:30 a.m. ETPhase 2/3 OCU410ST GARDian3 pivotal confirmatory trial is progressing toward 1H 2027 Biologics License Application (BLA) filing with 50% enrollment completed to date European Medicines Agency (EMA) provided acceptability of a single U.S.-based trial for submission of a Marketing Authorization Application (MAA) Executed licensing agreement with Kwangdong Pharmaceutical for exclusive rights in South Korea to OCU400 Sales milestones of $1.5 million for every $15 ...

TSHA-102 granted Breakthrough Therapy designation by FDA Finalized FDA alignment on REVEAL pivotal trial protocol and SAP, including 6-month interim analysis that may expedite BLA submission, which was enabled by the rigorous developmental milestone evaluation in Part A REVEAL Phase 1/2 trials showing an unprecedented response rate Dosing of first patient in REVEAL pivotal trial scheduled for Q4 2025, with enrollment of additional patients expected to continue at multiple sites this quarter Presented new su ...

（来源：一度医药） 转自：一度医药 积极的数据表现曾推动uniQure股价暴涨300%，也让该疗法成为陷入困境的基因治疗领域的重要提振。 AMT-130的审批受阻并非个例，近期FDA对细胞和基因疗法的监管态度正呈现收紧态势。今年7月， Capricor Therapeutics治疗杜氏肌营养不良相关心脏疾病的细胞疗法因"有效性证据不足"遭FDA拒绝； Replimune的黑色素瘤溶瘤病毒疗法也因类似原因被驳回加速审批申请，尽管该公司后续重新提交申请 已获受理。 去年年底，uniQure还与FDA达成协议，获准基于这一1/2期临床试验数据，通过加速审批通道提交BLA 申请。 此次FDA的立场转变完全超出预期。uniQure首席执行官Matt Kapusta表示，FDA的最新反馈与此前提供 的指导意见"存在巨大差异"，公司对此感到意外。FDA认为，仅依靠外部对照组的1/2期数据不足以支 撑上市申请，这与双方此前达成的共识相悖。 受此消息影响，uniQure股价在11月3日盘前交易中暴跌66%。 曾被业内寄予厚望的亨廷顿舞蹈症基因疗法AMT-130，近日遭遇美国FDA的审批急转弯。研发企业 uniQure于11月3 ...

Whales with a lot of money to spend have taken a noticeably bullish stance on uniQure.Looking at options history for uniQure (NASDAQ:QURE) we detected 53 trades.If we consider the specifics of each trade, it is accurate to state that 60% of the investors opened trades with bullish expectations and 35% with bearish.From the overall spotted trades, 16 are puts, for a total amount of $1,759,721 and 37, calls, for a total amount of $3,331,788.Projected Price TargetsBased on the trading activity, it appears that ...

U.S. stocks traded higher this morning, with the Nasdaq Composite gaining 1% on Monday.Following the market opening Monday, the Dow traded up 0.04% to 47,583.87 while the NASDAQ rose 1.01% to 23,964.61. The S&P 500 also rose, gaining, 0.48% to 6,872.88.Check This Out: How To Earn $500 A Month From Pfizer Stock Ahead Of Q3 EarningsLeading and Lagging SectorsConsumer discretionary shares jumped by 1.8% on Monday.In trading on Monday, utilities stocks fell by 0.8%.Top HeadlineON Semiconductor Corporation (NASD ...

-Dr. Mates served as the Chairman, Chief Executive Officer, and Co-founder of Intra-Cellular Therapies, a mental health company, from June 2002 until it was acquired by Johnson & Johnson in 2025-HAYWARD, Calif., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Benitec Biopharma Inc. (NASDAQ: BNTC) (“Benitec” or “Company”), a clinical-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on its proprietary “Silence and Replace” DNA-directed RNA interference (“ddRNAi”) platform, today a ...

PARIS--(BUSINESS WIRE)--Regulatory News: GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the Company's gene therapy GS010/LUMEVOQ® has been granted regulatory authorizations for an Individual Patient Expanded Access in the United States. The authorizations mark the first set of regula. ...

公司财务与活动安排 - 公司将于2025年11月4日美国东部时间上午8:30公布2025年第三季度财务业绩并举行企业最新情况电话会议及网络直播 [1] 公司业务与战略 - 公司是一家临床阶段生物技术公司，专注于开发基于腺相关病毒（AAV）的基因疗法，用于治疗中枢神经系统的严重单基因疾病 [2] - 公司的主要临床项目TSHA-102正在开发中，用于治疗Rett综合征，这是一种尚无获批针对疾病遗传根源的改良疗法的罕见神经发育障碍 [2] - 公司致力于开发变革性药物，以解决严重的未满足医疗需求，并显著改善患者及其护理人员的生活 [2] - 公司管理团队在基因疗法开发和商业化方面拥有成熟经验，并利用其生产工艺及临床和商业上得到验证的AA9衣壳，以加速将治疗从实验室推向临床 [2]

Rocket Pharmaceuticals Inc. (NASDAQ:RCKT) is one of the best NASDAQ stocks under $5 to buy now. On October 14, Rocket Pharmaceuticals announced that the US FDA accepted the resubmission of the Biologics License Application/BLA for KRESLADI (marnetegragene autotemcel; marne-cel). KRESLADI is a lentiviral vector/LV-based investigational gene therapy intended for the treatment of severe Leukocyte Adhesion Deficiency-I (LAD-I), which is a rare genetic immune disorder. The BLA resubmission is supported by posi ...