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Lisata Therapeutics and GATC advance AI-driven opioid use disorder therapy - ICYMI
Proactiveinvestors NA· 2025-07-12 13:43
Core Insights - Lisata Therapeutics is deepening its collaboration with GATC Health, leveraging complementary strengths in clinical and regulatory expertise alongside AI-powered drug discovery [1][2] - The partnership aims to develop opioid use disorder (OUD) candidates, addressing a significant unmet medical need in the U.S. [3][6] - The MAT platform from GATC Health enhances drug development efficiency by predicting drug performance and identifying potential failures early [4][5] Company Collaboration - The partnership has evolved due to the effective collaboration between Lisata's clinical experience and GATC's bioinformatics capabilities [2] - The focus on OUD as the first joint development target is due to the availability of high-quality addiction data and the identification of novel targets linked to OUD [6] Drug Development Process - Traditional drug development is inefficient, often requiring extensive testing; the MAT platform aims to streamline this process by using AI to prioritize promising candidates [4] - The MAT platform acts as a forecasting tool, allowing for informed decision-making and reducing resource waste [5] Market Potential - The OUD market represents a multibillion-dollar opportunity in North America, with potential for significant revenue through licensing and milestone payments if the drug is successful [9] - The collaboration model between AI firms and biotech companies is expected to become more common, as it allows for innovative approaches to drug development [10]
Sona Nanotech begins clinical trial for late-stage cancer – ICYMI
Proactiveinvestors NA· 2025-07-11 20:33
Core Perspective - Sona Nanotech Inc has initiated its first-in-human clinical trial for its THT therapy aimed at late-stage melanoma patients, marking a significant transition from preclinical to clinical testing [1][2][6] Company Developments - The first patient has been dosed in Santiago, Chile, which is a critical milestone for the company [2][3] - The therapy is classified as a device rather than a drug, designed to enhance tumor visibility to the immune system, potentially leading to tumor shrinkage and improved survival rates [2][4] Clinical Trial Details - The clinical trial will begin with an early feasibility study to assess safety, tolerability, and practical usage of the device, alongside efficacy data [4] - The protocol includes patient check-ins on days 1, 7, 14, 21, and 28, with initial results expected by the end of summer [5] Patient Impact - The therapy aims to help patients who have exhausted other treatment options, focusing on making tumors recognizable to the immune system for potential elimination [6]
Ultragenyx Receives Complete Response Letter from FDA for UX111 AAV Gene Therapy to Treat Sanfilippo Syndrome Type A (MPS IIIA)
Globenewswire· 2025-07-11 20:30
Core Viewpoint - The FDA issued a Complete Response Letter (CRL) for Ultragenyx's Biologics License Application (BLA) for UX111, a gene therapy for Sanfilippo syndrome type A, citing specific chemistry, manufacturing, and controls (CMC) observations that are resolvable [1][2] Group 1: Company Overview - Ultragenyx Pharmaceutical Inc. is focused on developing therapies for rare and ultra-rare genetic diseases, with a diverse portfolio aimed at addressing high unmet medical needs [6] - The company is led by a management team experienced in rare disease therapeutics, emphasizing time- and cost-efficient drug development [7] Group 2: Product Information - UX111 is an in vivo gene therapy in Phase 1/2/3 development for Sanfilippo syndrome type A (MPS IIIA), a rare fatal lysosomal storage disease with no approved treatment [4] - The therapy targets the SGSH enzyme deficiency, which leads to the accumulation of heparan sulfate in the brain, causing neurodegeneration [4] - UX111 is administered via a one-time intravenous infusion using a self-complementary AAV9 vector to deliver a functional copy of the SGSH gene [4] Group 3: Regulatory Status - The FDA's CRL did not raise any issues regarding the clinical data package or clinical inspections, acknowledging the robustness of the neurodevelopmental outcome data and supportive biomarker data [3] - The company plans to address the CMC observations and resubmit the BLA, anticipating a review period of up to 6 months post-resubmission [2][3] Group 4: Disease Context - Sanfilippo syndrome type A (MPS IIIA) affects approximately 3,000 to 5,000 patients in commercially accessible areas, characterized by rapid neurodegeneration and a median life expectancy of 15 years [5] - The disease is caused by biallelic pathogenic variants in the SGSH gene, leading to a deficiency in the sulfamidase enzyme [5]
FibroBiologics to Present at the Advanced Wound Care Summit USA
Globenewswire· 2025-07-11 12:30
HOUSTON, July 11, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 275+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced that Founder and Chief Executive Officer, Pete O’Heeron, will present at the Advanced Wound Care Summit USA in Boston, Massachusetts, on July 15, 2025. The presentation will includ ...
SeaStar Medical Announces $4 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules
Globenewswire· 2025-07-10 19:29
Core Viewpoint - SeaStar Medical Holding Corporation has announced a definitive agreement for the issuance and sale of 5,242,464 shares of common stock at a price of $0.763 per share, along with unregistered warrants to purchase an equal number of shares at an exercise price of $0.638, aiming to raise approximately $4 million for general corporate purposes [1][2]. Group 1: Offering Details - The offering includes a registered direct offering priced at-the-market under Nasdaq rules and a concurrent private placement for unregistered warrants [1][2]. - The gross proceeds from the offering are expected to be around $4 million, with net proceeds intended for general corporate purposes, including working capital and capital expenditures [2]. Group 2: Regulatory and Compliance Information - The shares are being offered under a shelf registration statement previously filed with the SEC, which became effective on December 22, 2023 [3]. - The unregistered warrants are not registered under the Securities Act and cannot be sold in the U.S. without an effective registration statement or applicable exemption [4]. Group 3: Company Overview - SeaStar Medical is focused on transforming treatments for critically ill patients facing organ failure, with its first product, QUELIMMUNE, approved by the FDA in 2024 for life-threatening acute kidney injury in pediatric patients [6]. - The company’s Selective Cytopheretic Device therapy has received Breakthrough Device Designation for six therapeutic indications, indicating a potential for expedited approval processes [6]. - SeaStar is conducting a pivotal trial of its SCD therapy in adult patients with acute kidney injury, a condition affecting over 200,000 adults in the U.S. annually [6].
Celularity & Fountain Life Announce Partnership to Deliver Stem Cell Therapies Under New Florida Law
GlobeNewswire News Room· 2025-07-09 12:30
Fountain Life operates four flagship longevity centers, including two in Florida, where a new state law effective July 1, 2025, authorizes licensed physicians to administer stem cell therapies to members with conditions in orthopedics, wound care, and pain management. FLORHAM PARK, N.J., July 09, 2025 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) ("Celularity"), a regenerative and cellular medicine company focused on addressing age-related and degenerative diseases, announced today that it entered into ...
自身“足迹”最小化 客户“手印”最大化——科德宝集团高管分享可持续发展进展及实践案例
Zhong Guo Hua Gong Bao· 2025-07-09 02:24
Core Insights - The report emphasizes the dual approach of "footprint + handprint" to minimize the company's environmental impact while enhancing the value of its products and solutions for customers [1][3] Group 1: Sustainability Initiatives - The company reported a total energy usage of 2,486 GWh in 2024, remaining stable compared to the previous year, with renewable energy accounting for 38% of total energy consumption, an increase of 2% from the previous year [1] - Carbon dioxide emissions were recorded at 568,000 tons, a reduction of 37,000 tons compared to the previous year [1] - Since 2020, the company has reduced its carbon emissions per million euros in sales by 45%, down to 47.5 tons, and has decreased absolute carbon emissions by approximately 200,000 tons, equivalent to 26% of 2020 levels [1] Group 2: Renewable Energy Projects - As of the end of 2024, the company has established and is operating 44 solar photovoltaic arrays globally, including 9 in China, with 65 additional projects in various planning stages [2] - A new solar project at the company's site in Hangzhou is expected to generate 200,000 kWh annually, reducing carbon emissions by 118.8 tons each year [2] - The company plans to increase the renewable energy usage ratio to 41% at its Suzhou factory by procuring 1.6 million kWh of green electricity in 2024, achieving a 23% reduction in carbon emissions per unit of sales compared to the 2020 baseline [2] Group 3: Energy Efficiency and Product Solutions - The company has identified a potential 30% energy-saving opportunity by analyzing approximately 40% of its total carbon emissions as part of its "Bee-Efficient" initiative launched in 2019 [2] - The Wibak factory in Wuxi achieved a 13% reduction in carbon emissions and a 14% decrease in overall energy consumption compared to the 2023 baseline through system optimizations [3] - In the lubricant sector, the company saved 44 GWh of electricity for Chinese customers in 2024, equivalent to a reduction of 230,000 tons of carbon emissions [3] Group 4: Future Commitments - The company is committed to continuous upgrades in green manufacturing, strengthening local R&D, and expanding talent and cultural investments, with a focus on "taking responsibility" as a core value [4] - The company aims to achieve climate neutrality by 2045, reinforcing its commitment to global climate initiatives [4]
X @Forbes
Forbes· 2025-07-08 22:10
Does Red Light Therapy Work? We Had Dermatologists Weigh Inhttps://t.co/l1iluk4Mu8 https://t.co/K84uM7CKjR ...
Revive Therapeutics Clarifies Completion of Key Nerve Agent Countermeasure Study
Globenewswire· 2025-07-08 21:10
TORONTO, July 08, 2025 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialized life sciences company dedicated to the research and development of therapeutics for infectious diseases and medical countermeasures, hereby clarifies its update regarding the research study assessing Bucillamine as a potential treatment for nerve agent exposure. This study is being conducted in collaboration with Defence R&D Canada – Suffield Research Centr ...
LeMaitre Will Announce Second Quarter 2025 Earnings Results August 5, 2025
Globenewswire· 2025-07-08 20:04
Company Overview - LeMaitre Vascular, Inc. is a provider of devices, implants, and services for the treatment of peripheral vascular disease, which affects over 200 million people globally [3] - The company develops, manufactures, and markets both disposable and implantable vascular devices aimed at vascular surgeons [3] Financial Results Announcement - LeMaitre Vascular will release its second quarter 2025 financial results on August 5, 2025, after market close [1] - A conference call is scheduled for 5:00 PM EDT on the same day to discuss the financial results, business highlights, and company outlook [1] Access to Conference Call - Access to the live conference call requires online registration, after which registrants will receive dial-in information and a PIN [2] - The audio webcast will be available live and for replay through the company's investor relations website [2]