Cell and gene therapies
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J&J to build $1bn US CGT manufacturing site in Pennsylvania
Yahoo Finance· 2026-02-19 12:02
Johnson & Johnson (J&J) has chosen Pennsylvania as home to its new $1bn cell therapy manufacturing facility, as the Trump administration looks to onshore drug production to the US amid growing global competition. Once operational, the Montgomery County-based, next-generation production site will create more than 500 skilled biomanufacturing roles. The facility’s development will also open up 4,000 construction positions. The Pennsylvania facility will be J&J’s eleventh site within the state, which is alre ...
Senti Biosciences Selected for On-Stage Presentation at Healthcare Conference Taipei 2026
Globenewswire· 2026-02-03 14:00
Core Insights - Senti Biosciences, Inc. has been selected to present at the Healthcare Conference Taipei 2026, showcasing its Gene Circuit technology platform and strategic priorities [1][2][3] Company Overview - Senti Bio is a clinical-stage biotechnology company focused on developing next-generation cell and gene therapies using its proprietary Gene Circuit platform [1][4] - The company aims to create therapies that precisely target and kill cancer cells while sparing healthy cells, enhancing specificity to target tissues, and allowing control post-administration [4] Presentation Details - The presentation is scheduled for February 10, 2026, from 10:30 AM to 10:40 AM local time, and will last for eight minutes [2] - The focus will be on the Gene Circuit technology, pipeline progress, and opportunities for partnerships in investment, research and development, manufacturing, and clinical collaboration [2][3] Strategic Importance - The conference will gather global investors and strategic partners, providing a platform for Senti Bio to discuss potential collaborations aimed at advancing transformative therapeutic programs [3]
Cellectis Announces 2026 Strategy and Catalysts
Globenewswire· 2026-01-08 21:30
Core Insights - Cellectis is focusing on advancing its late-stage allogeneic CAR-T therapies, particularly lasme-cel and eti-cel, with significant clinical trials and partnerships expected to drive growth in 2026 [2][3][4]. Clinical Development - The pivotal Phase 2 trial for lasme-cel in relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) has commenced, with interim data anticipated in Q4 2026 [2][3]. - Lasme-cel has shown a 68% overall response rate (ORR) and a 56% complete remission rate in early trials, indicating strong efficacy [5]. - The NATHALI-01 trial for eti-cel in relapsed/refractory non-Hodgkin lymphoma (NHL) reported an 88% ORR and a 63% complete remission rate, with further data expected in Q4 2026 [6]. Strategic Partnerships - Cellectis is collaborating with AstraZeneca to develop up to 10 novel cell and gene therapy products targeting high unmet medical needs, leveraging Cellectis' gene editing and manufacturing capabilities [4]. Financial Position - The company projects that its cash reserves will sustain operations into the second half of 2027, indicating a stable financial outlook [8]. Upcoming Events - Cellectis management will participate in the J.P. Morgan Healthcare Conference from January 12-15, 2026, for investor meetings [9].
Cellectis Announces Arbitral Decision in Dispute with Servier
Globenewswire· 2025-12-15 21:51
Core Insights - Cellectis announced a decision from the Arbitral Tribunal regarding its arbitration with Servier related to the License Agreement established on March 6, 2019 [1][2] - The Tribunal partially terminated the License Agreement concerning product UCART19 V1 and mandated Cellectis to engage in discussions for a direct license at Allogene's request [2] Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing cell and gene therapies using its gene-editing platform [3] - The company specializes in allogeneic CAR T immunotherapies, aiming to provide off-the-shelf gene-edited CAR T-cells for cancer treatment [3] - Cellectis maintains in-house manufacturing capabilities, positioning itself as a comprehensive player in the gene editing value chain [3] Company Locations and Listings - Cellectis is headquartered in Paris, France, with additional locations in New York and Raleigh, NC [4] - The company is publicly traded on the Nasdaq Global Market under the ticker CLLS and on Euronext Growth under the ticker ALCLS [4]
Abeona Therapeutics® Announces Appointment of Mohamad Tabrizi as Chief Business Officer
Globenewswire· 2025-12-15 12:30
Core Viewpoint - Abeona Therapeutics Inc. has appointed Mohamad Tabrizi as Senior Vice President and Chief Business Officer to enhance corporate strategy and business development efforts [1][2]. Group 1: Appointment and Role - Mohamad Tabrizi will lead the company's corporate strategy and business development functions, focusing on driving operational efficiency [1]. - Tabrizi has extensive experience in strategic planning and business development, which the company aims to leverage for optimizing operations and forming value-creating partnerships [2]. Group 2: Professional Background - Tabrizi previously worked in the venture capital sector as a General Partner and Managing Director at Pandect Bioventures and the Berkeley Catalyst Fund, where he led investment activities and operational roles [2]. - He has a strong track record in corporate development and capital markets, having executed 20 transactions at Nektar Therapeutics and led over 40 transactions as a healthcare investment banker, raising more than $5 billion [3]. Group 3: Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases, including its product ZEVASKYN, the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa [4]. - The company operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of ZEVASKYN [4].
Abeona Therapeutics® Reports Third Quarter 2025 Financial Results and Corporate Updates
Globenewswire· 2025-11-12 12:30
Core Insights - Abeona Therapeutics Inc. reported financial results and operational progress for Q3 2025, highlighting the anticipated launch of ZEVASKYN and its growing patient demand [1][2][3] Financial Performance - As of September 30, 2025, the company had $207.5 million in cash, cash equivalents, restricted cash, and short-term investments, which is expected to fund operations for over two years [3][6] - R&D spending for Q3 2025 was $4.2 million, a decrease from $8.9 million in Q3 2024, primarily due to costs capitalized into inventory [7] - SG&A expenses increased to $19.3 million in Q3 2025 from $6.4 million in Q3 2024, reflecting increased headcount and costs associated with the ZEVASKYN launch [7] - The net loss for Q3 2025 was $(5.2) million, or $(0.10) per share, compared to a net loss of $(30.3) million, or $(0.63) per share, in Q3 2024 [8][14] Product Development and Launch - The launch of ZEVASKYN has been scaled to meet patient needs, with the first anticipated patient treatment shifted to Q4 2025 due to an optimized release assay [2][4] - Patient demand for ZEVASKYN has more than doubled, with approximately 30 eligible patients identified at the first two Qualified Treatment Centers (QTCs) [4] - The company has activated three QTCs, including Children's Hospital Colorado, and is onboarding additional centers across the U.S. [4] - Coverage decisions from major commercial health plans have been made, covering approximately 60% of all RDEB patients, indicating early market acceptance [4] Strategic Initiatives - The pipeline program ABO-503 has been selected for the FDA Rare Disease Endpoint Advancement Pilot Program, enhancing communication and collaboration with the FDA [2][5] - The management team has been strengthened with the appointment of James A. Gow, MD, as Senior Vice President, Head of Clinical Development & Medical Affairs [5] Balance Sheet Highlights - Total assets as of September 30, 2025, were $231.1 million, up from $108.9 million as of December 31, 2024 [16][17] - Current liabilities totaled $22.2 million, with total liabilities at $59.9 million [16][17]
Drug Development Inputs & Services Stocks Q3 Recap: Benchmarking Repligen (NASDAQ:RGEN)
Yahoo Finance· 2025-11-07 03:31
Core Insights - The article discusses the Q3 earnings results of Repligen and its peers, highlighting the overall performance of the drug development inputs and services sector [1] Industry Overview - Companies in drug development inputs and services are essential in the pharmaceutical and biotechnology value chain, providing support for drug discovery, preclinical testing, and manufacturing [2] - The industry benefits from stable demand due to pharmaceutical companies outsourcing non-core functions, often through medium to long-term contracts [2] - Future growth is expected from increasing investments in biologics, cell and gene therapies, and advancements in precision medicine, which will drive demand for sophisticated tools and services [2] - Outsourcing trends in drug development are growing for cost efficiency and agility, benefiting the industry [2] - Potential challenges include pricing pressures from healthcare cost containment efforts and an evolving regulatory environment that could impact innovation and client activity [2] Company Performance - The seven drug development inputs and services stocks tracked reported strong Q3 results, with revenues exceeding analysts' consensus estimates by 3.1% [3] - Repligen reported revenues of $188.8 million for Q3, representing a year-on-year increase of 21.9%, surpassing analysts' expectations by 3.8% [5] - Despite strong earnings, Repligen's stock has decreased by 10.1% since the earnings report, currently trading at $144.50 [6]
Abeona Therapeutics® Announces Permanent J-Code for ZEVASKYN® (prademagene zamikeracel)
Globenewswire· 2025-10-30 14:45
Core Insights - Abeona Therapeutics has received a permanent HCPCS J-code for its gene therapy ZEVASKYN, which will enhance reimbursement processes and patient access starting January 1, 2026 [1][2] Company Overview - Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases [7] - ZEVASKYN (prademagene zamikeracel) is the first and only autologous cell sheet-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB) [3][4] Product Details - ZEVASKYN is designed to treat wounds in adult and pediatric patients suffering from RDEB, a severe skin disease caused by defects in the COL7A1 gene [3][4] - The therapy involves inserting the correct COL7A1 gene into a patient's skin cells ex vivo, leading to the production of functional type VII collagen [3] - Clinical results indicate that ZEVASKYN provides meaningful wound healing and pain reduction with a single application [3] Regulatory and Market Impact - The assignment of a unique J-code by CMS is expected to simplify claims and reimbursement processing, thereby supporting hospital adoption and patient access for ZEVASKYN [2] - J-codes are crucial for identifying non-orally administered medications in healthcare settings, streamlining medical billing and reimbursement processes [2]
Abeona Therapeutics® Appoints James A. Gow, MD, MBA, MS, MHCM, as Senior Vice President, Head of Clinical Development & Medical Affairs
Globenewswire· 2025-10-20 12:30
Core Insights - Abeona Therapeutics Inc. has appointed Dr. James A. Gow as the Senior Vice President, Head of Clinical Development & Medical Affairs, effective immediately [1][2] - Dr. Gow brings over 20 years of experience in clinical development and medical affairs, with a focus on gene therapy, particularly in ophthalmology [2] - The company is advancing its pipeline of cell and gene therapies for serious diseases, including its lead product ZEVASKYN, which is the first autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa [3] Company Overview - Abeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases [3] - The company operates a fully integrated cGMP manufacturing facility in Cleveland, Ohio, which is responsible for the commercial production of ZEVASKYN [3] - Abeona's development portfolio includes adeno-associated virus (AAV)-based gene therapies targeting ophthalmic diseases with significant unmet medical needs [3]
Cellectis to Report Second Quarter 2025 Financial Results on August 4, 2025
Globenewswire· 2025-07-28 20:30
Company Overview - Cellectis is a clinical-stage biotechnology company focused on developing life-saving cell and gene therapies using its gene-editing platform [2][3] - The company is pioneering an allogeneic approach for CAR T immunotherapies in oncology, offering off-the-shelf and ready-to-use gene-edited CAR T-cells for cancer treatment [2][3] - Cellectis has in-house manufacturing capabilities, making it one of the few end-to-end gene editing companies that control the entire cell and gene therapy value chain [2] Financial Reporting - Cellectis will report its financial results for the second quarter of 2025 on August 4, 2025, after the close of the US market [1] - An investor conference call and webcast will take place on August 5, 2025, at 8:00 AM ET, to discuss the second quarter results and provide updates on business activities [2] Contact Information - Media contacts include Pascalyne Wilson and Patricia Sosa Navarro for communications inquiries [4] - Investor relations inquiries can be directed to Arthur Stril, the Chief Financial Officer & Chief Business Officer [4]