OXB acquires Resilience’s site in North Carolina, an FDA-approved, commercial-scale viral vector manufacturing facility In line with OXB’s previously announced strategy to add US GMP capacity across drug substance and fill-finish to meet growing client demand Strengthens OXB’s global CDMO network and enhances service offering for existing and prospective clientsSupports existing near and medium-term financial guidance Oxford, UK – 7 October 2025: OXB (LSE: OXB), a global quality and innovation-led cell and ...

Key Takeaways CLPT introduced a robotic system integrating its neuro-navigation software with KUKA's arm.CLPT's platform targets biopharma partners launching complex brain-delivered cell and gene therapies.Collaborations and software focus reduce risk, speed timelines, and position CLPT for long-term growth.ClearPoint Neuro (CLPT) recently unveiled the development of its proprietary Robotic Neuro-Navigation System, a move that positions the company to contribute to robotics, neurosurgery, and advanced drug ...

CAMBRIDGE, Mass., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Ernexa Therapeutics (Nasdaq: ERNA), developing innovative cell therapies for the treatment of advanced cancer and autoimmune disease, today announced its upcoming company presentation at the Cell & Gene Meeting on the Mesa, taking place on October 7 in Phoenix, Arizona, and virtually online. “We are honored to participate in the Cell & Gene Meeting on the Mesa, one of the most important gatherings for advancing cell and gene therapies,” said Sanjeev Luther ...

What sets TARA-002 apart is its novel approach. This cell therapy is derived from a cell bank of genetically distinct Streptococcus pyogenes, already approved in Japan as the broad immunopotentiator OK-432. The therapy works through a dual mechanism – directly killing tumor cells while also stimulating an immune response known as immunogenic cell death, thereby amplifying antitumor activity.The first penny stock we’ll look at is Protara Therapeutics, a clinical-stage biotech company focused on developing tr ...

SANTA ANA, Calif., Sept. 18, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) (“NKGen” or the “Company”), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer (“NK”) cell therapeutics, today announced that Paul Y. Song, M.D., Chairman and Chief Executive Officer of NKGen, will present at the 3rd China Great Bay Cell and Gene Therapy Forum, taking place in Guangzhou, China, September 25-26, 2025. Dr. Song will d ...

Core Insights - INmune Bio Inc. has successfully completed its first full-scale pilot commercial manufacturing run of CORDStrom™, a therapy for Recessive Dystrophic Epidermolysis Bullosa (RDEB), marking a significant step towards regulatory submissions and commercialization [1][2][3] Group 1: Product Development - CORDStrom™ is designed to meet the severe unmet needs of RDEB patients, addressing issues such as skin fragility, blistering, and chronic wounds [2] - The therapy has shown promising results in the Phase 2 Mission EB trial, with improvements in itch, pain, wound scores, and quality of life [2] - The successful manufacturing run confirms the scalability and consistency of CORDStrom™ production, ensuring a high-quality, GMP-compliant product [2] Group 2: Regulatory and Commercialization Plans - The company is on track to file a Marketing Authorization Application (MAA) in the UK in the first half of 2026, followed by a Biologics License Application (BLA) in the US [1][3] - The completion of the pilot run is seen as a pivotal moment in the journey to market, reinforcing confidence in delivering a reliable supply chain for global commercialization [3] Group 3: Company Background - INmune Bio Inc. is a clinical-stage company focused on developing treatments that target the innate immune system, with three product platforms including CORDStrom™ [5][6] - The company collaborates with the Cell and Gene Therapy Catapult to enhance its manufacturing capabilities and accelerate its path to commercial production [3][7]

Core Insights - The company believes that cell and gene therapy will be a significant transformation in medicine over the coming decades [1] - The industry has faced challenges, but the company remains optimistic about its progress and future developments [1] Company Perspective - The CEO emphasizes the importance of understanding stock catalysts while focusing on building the business [1] - The company is committed to navigating the complexities of the cell and gene therapy field [1]

Financial Data and Key Metrics Changes - The company is focused on cell and gene therapy, which is expected to transform medicine over the coming decades [6] - The diabetes program is highlighted as potentially one of the most valuable therapies in development, with a large and unsatisfied market [19] Business Line Data and Key Metrics Changes - The company is advancing three categories of therapies: type one diabetes, in vivo CAR T cells, and allogeneic CAR T cells [10][17] - The type one diabetes program aims to provide a single treatment that allows patients to maintain normal blood sugar levels without insulin or immunosuppression [14][19] Market Data and Key Metrics Changes - Type one diabetes affects over nine million people, with estimates suggesting it will grow to fifteen million within fifteen years [12] - The company is optimistic about the scalability of its therapies, particularly in the context of the growing diabetes market [19] Company Strategy and Development Direction - The company aims to overcome allogeneic rejection in cell therapies, which has been a significant challenge in the field [7][17] - The focus is on developing scalable and effective therapies that can be broadly accessible to patients worldwide [62] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenges in the cell and gene therapy space but remains optimistic about the potential of their diabetes program [75] - The company is preparing for an IND filing as early as 2026, contingent on successful completion of necessary studies [58][60] Other Important Information - The company has made significant progress in gene editing and manufacturing processes, which are critical for the success of their therapies [46][48] - The management emphasizes the importance of human data to unlock value in their programs, particularly for CAR T therapies [73] Q&A Session Summary Question: Can you provide an overview of the type one diabetes program and recent data? - The type one diabetes program has shown promising results, with the first patient treated demonstrating functioning cells for over six months [24][28] Question: What are the next steps for the iPSC product? - The company is focused on finalizing the master cell bank and completing the necessary toxicology studies before filing for IND [50][55] Question: How does the company plan to address the challenges in manufacturing stem cell-derived products? - The management highlighted the importance of purity, potency, and yield in manufacturing, which are critical for safety and efficacy [52][53] Question: What is the company's strategy for partnerships in the CAR T space? - The company is exploring partnerships to advance its CAR T programs, recognizing the need for capital to move forward [75][78]

南方财经记者徐小琼 广州报道 8月26日，"中国南沙细胞和基因产业创新发展大会"在广州南沙举行。大会聚焦细胞和基因前沿技术与 产业发展，吸引了逾千家企业报名。大湾区细胞与基因治疗产业公共服务中心、大湾区生物治疗健康效 应评价中心、大湾区临床级种子细胞库在大会期间正式启动，将推动细胞基因产业的标准化、规范化发 展，解决相关技术和管理难题。 广州市委常委、南沙区委书记刘炜在会上表示，南沙将抢抓风口、乘势而上，依托政策温度、研发精 度、临床速度、生态广度、人才高度，全力打造大湾区细胞和基因产业创新高地。诚邀广大企业及人才 深耕南沙热土，在这里播下理想的"种子"，带动更多产业资源、优质项目落子南沙。 （原标题：南沙聚力细胞和基因产业，成立三大中心贯穿研发全链条） 会上，南沙区科技局正式发布南沙生物医药与健康产业地图，聚焦项目要素精准匹配，统筹产业图谱、 空间载体、支持政策、人才供给、金融支持等关键要素资源，帮助企业解决常常碰到的政策不易达、信 息不透明、供需不匹配等堵点难点。目前，南沙已有超 400 家生物医药企业落户，其中细胞与基因企业 超过40家，各类企业和平台相互协作，加速构建完整的细胞基因产业生态体系。 直面 ...

Core Insights - Abeona Therapeutics has received FDA approval for ZEVASKYN™, the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [1][4] - The U.S. launch is on track, with the first patient treatment expected in the third quarter of 2025, supported by strong patient interest and positive insurance coverage [1][2] - As of June 30, 2025, the company reported $226 million in cash and equivalents, expected to fund operations for over two years before ZEVASKYN revenue begins [1][5] Recent Developments - ZEVASKYN was approved by the FDA in April 2025 and is now available at Qualified Treatment Centers (QTCs) [4] - Strong demand for ZEVASKYN has been noted, with over a dozen patients identified for treatment and 100% approval of prior authorization requests submitted [4] - The company has established positive coverage with major insurers, including United Healthcare, covering approximately 16% of the U.S. insured population [4] Financial Results - For the second quarter of 2025, Abeona reported a net income of $108.8 million, significantly up from $7.4 million in the same period of 2024 [8] - Research and development expenses decreased to $5.9 million from $9.2 million year-over-year, primarily due to reclassification of costs [7] - Selling, general, and administrative expenses increased to $17.1 million, reflecting the costs associated with the commercial launch of ZEVASKYN [7] Operational Progress - The company is on track to ramp up ZEVASKYN supply capacity to treat up to 10 patients per month by mid-2026 [4] - Abeona has entered into a licensing agreement for the AAV204 capsid for potential gene therapies in ophthalmology [4] - The company secured $155 million from the sale of its Rare Pediatric Disease priority review voucher, awarded upon FDA approval of ZEVASKYN [4]