"This latest regulatory achievement further validates our efforts to bring INO-3107 to RRP patients around the world and shows that our cross functional development team is meeting the highest of standards in pursuit of that goal," said Cheryl Elder, INOVIO's Senior Vice President of Regulatory Affairs. "We're pleased to receive confirmation that our development efforts in Europe continue to make progress." INO-3107 is designed to elicit an antigen-specific T cell response against both HPV-6 and HPV-11 prot ...

RRP is a rare degenerative disease that causes small growths (papillomas) in the respiratory tract. Generally, non-cancerous papillomas can cause severe and life-threatening airway obstruction and respiratory complications. Inovio believes that the Innovation Passport designation grant further bolsters the potential of INO-3107 to "transform" the treatment paradigm for RRP patients. The company, however, plans to initiate a confirmatory study of INO-3107 for RRP before submitting the BLA to the FDA. Apart f ...

Inovio Pharmaceuticals (INO) shares rallied 19% in the last trading session to close at $11.04. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 2.1% loss over the past four weeks. Earnings and revenue growth expectations certainly give a good sense of the potential strength in a stock, but empirical research shows that trends in earnings estimate revisions are strongly correlated with near-term stock price mo ...

"The U.K. Innovation Passport designation is yet another recognition of the promise of INO-3107 to potentially transform the treatment paradigm for RRP patients," said Dr. Jacqueline Shea, INOVIO's President and Chief Executive Officer. "We are honored to receive this designation, which offers us enhanced access to regulators and development tools that could accelerate the timeline for achieving U.K. regulatory approval of INO-3107. We look forward to continuing our discussions with the ILAP partners as we ...

This press release contains certain forward-looking statements relating to our business, including our plans to develop and commercialize DNA medicines and expectations regarding our research and development programs, including the planned submission of a BLA in the second half of 2024 and the planned commercial launch of INO-3107 if regulatory approval is obtained. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent ...

The stock option has an exercise price of $8.08, which is equal to the closing price of INOVIO's common stock on June 28, 2024. The stock option will vest and become exercisable with respect to one-fourth of the shares underlying the stock option on the Grant Date, and an additional one-fourth of the shares underlying the stock option on the first, second, and third anniversaries of the Grant Date. The vesting of the stock option will be subject to the employee's continued employment with INOVIO on the appl ...

文章核心观点 - 公司被纳入罗素2000指数,这表明公司近期取得的进展和战略目标的价值 [1][2] - 公司计划在2024年下半年提交INO-3107加速审批申请,并准备在2025年实现商业化 [2] - 公司还在推进其他产品候选药物的后续工作,包括INO-3112、INO-5401和INO-4201 [2] 公司概况 - 公司专注于开发和商业化DNA疫苗,用于治疗和预防HPV相关疾病、癌症和传染病 [5] - 公司的技术优化了创新DNA疫苗的设计和递送,使身体能够制造自己的抗病工具 [5] 罗素指数相关 - 罗素指数是广泛被投资经理和机构投资者用作指数基金和主动投资策略的基准 [3] - 截至2023年12月,约有10.5万亿美元的资产以罗素美国指数为基准 [3] - 罗素指数的成分主要由客观的市值排名和风格属性决定 [4]

PLYMOUTH MEETING, Pa., June 4, 2024 /PRNewswire/ -- INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, today announced that INOVIO's President and CEO, Dr. Jacqueline Shea, and Chief Medical Officer, Dr. Michael Sumner will participate in a virtual fireside chat hosted by Sudan Loganathan, Ph.D., Managing Director and equity research analyst at Stephens, Inc. The f ...

INOVIO is a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases. INOVIO's technology optimizes the design and delivery of innovative DNA medicines that teach the body to manufacture its own disease- fighting tools. For more information, visit www.inovio.com. Contacts Media: Jennie Willson, (267) 429-8567, [email protected] Investors: Thomas Hong, (267) 440-4298, [email protected] SOURCE INOV ...

业绩总结 - Inovio是一家临床阶段的生物技术公司，开发DNA药物来帮助治疗和预防HPV相关疾病、癌症和传染病[5] - INO-3107的机制是产生具有溶解潜力的靶向抗原特异性T细胞，能够寻找并摧毁HPV感染的细胞，防止乳头状瘤再生[6] - RRP在美国的患者人数约为14,000人，发病高峰分别在7岁、30岁和60岁左右[8] - INO-3107的临床数据显示，32名患者中有81%的患者在治疗后的一年内手术次数减少，28%的患者在第一次治疗后根本不需要手术[10] - INO-3107获得了突破性药物认定，FDA要求提交完整的CMC包和其他相关文件，预计在今年下半年提交BLA[12] - 确认性试验的设计与完成的Phase 1/2试验有许多相同之处，但增加了安慰剂对照组，以满足FDA的要求[14] - INO-3107的商业化计划已经展开，公司正在进行医疗保健提供者和患者群体的分析，准备推出新疗法[26] - INO-3107的潜在价格水平尚早讨论，但患者对替代手术的需求非常高，平均每位患者每年手术费用约为72,000美元[29] - INO-3107受到专利保护，拥有广泛的专利组合，包括DNA质粒组分和设备，专利有效期延伸至2041年和2040年代中期[32] - 公司预计INO-3107的销售能够支持其他候选药物的开发，目前现金储备可支持至2025年第三季度[33]