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Klotho Neurosciences Signs Letter of Intent to Acquire Select Assets from Turn Biotechnologies, Anchored by $300 Million Global Pharma Partnership
Prnewswire· 2025-09-30 12:30
Core Insights - Klotho Neurosciences, Inc. has signed a Letter of Intent to acquire select assets from Turn Biotechnologies, positioning itself as a leader in longevity therapeutics [1][4] - The acquisition includes Turn's ERA platform and eTurna RNA delivery system, aimed at rejuvenating somatic cells for various regenerative therapies [2][4] - Klotho will also gain a partnership with a South Korean pharmaceutical company valued at up to $300 million, highlighting the commercial potential of Turn's technology [3][4] Company Overview - Klotho Neurosciences focuses on developing innovative cell and gene therapies derived from the "anti-aging" Klotho gene, targeting neurodegenerative and age-related disorders [7] - The company aims to expand its therapeutic reach by integrating Turn's technologies, which utilize RNA molecules to reset cellular age [4][5] - Klotho plans to rebrand post-transaction to reflect its broadened mission in addressing aging and related diseases [4] Market Context - The longevity medicine market is rapidly growing, driven by an aging global population projected to reach 2.1 billion by 2050, significantly impacting healthcare costs [5] - Klotho aims to address aging at the cellular level, which is seen as a root cause of various age-related health issues [5]
BioLineRx Ltd. and Hemispherian AS Establish Joint Venture to Develop GLIX1, a First-in-Class, Oral, Small Molecule Targeting DNA Damage Response in Glioblastoma and Other Cancers
Prnewswire· 2025-09-29 11:00
Core Insights - BioLineRx and Hemispherian AS have established a joint venture to develop GLIX1, a first-in-class oral small molecule targeting DNA damage response in glioblastoma and other cancers [1][2][3] - GLIX1 has shown potent anti-tumor activity, excellent blood-brain barrier penetration, and a favorable safety profile in preclinical studies [2][3] - The glioblastoma market opportunity is projected to exceed $3.8 billion annually across the US and EU5 by 2030 [1][7] Joint Venture Details - Hemispherian will contribute the global rights of GLIX1, while BioLineRx will manage and fund all development activities [4] - Hemispherian will hold 60% of the joint venture's share capital, with BioLineRx's stake potentially increasing to 70% based on continued investment [4] Clinical Development Plans - An Investigational New Drug (IND) application for GLIX1 was cleared by the FDA, with a Phase 1/2a study expected to start in Q1 2026 [1][2] - The Phase 1 trial will recruit up to 30 patients with recurrent GBM to establish a maximum tolerated dose and assess safety and preliminary efficacy [9] Market Opportunity - GBM is the most common and aggressive form of primary brain cancer, with a median overall survival of 12-18 months under current standard treatments [5][6] - The annual incidence of GBM is expected to be approximately 18,500 patients in the U.S. and 13,400 across the EU5 by 2030, with total addressable markets estimated at $2.5 billion in the U.S. and $1.3 billion in the EU5 [7]
Evofem Biosciences Honors World Contraception Day
Prnewswire· 2025-09-26 12:15
Core Insights - Evofem Biosciences emphasizes the importance of access to contraception for health, future, and freedom on World Contraception Day [1] - The company aims to challenge the status quo in women's health by providing innovative, hormone-free contraceptive options [2][3] - Evofem's commitment includes education and awareness campaigns to reduce stigma around women's health issues [3][4] Product Offerings - PHEXXI is highlighted as the first and only hormone-free, on-demand contraceptive vaginal gel, applied before sexual activity [6] - SOLOSEC is an FDA-approved single-dose oral treatment for bacterial vaginosis and trichomoniasis, targeting women and individuals aged 12 and older [7] Company Vision and Initiatives - Evofem is dedicated to breaking barriers and expanding global access to women's health products [4] - The "Say Vagina" initiative has reached millions, aiming to improve health education and confront stigma [3][10]
Cardinal Health to Announce First-Quarter Results for Fiscal Year 2026 on October 30
Prnewswire· 2025-09-23 10:45
Financial Results Announcement - Cardinal Health plans to release first-quarter financial results for fiscal year 2026 on October 30, prior to the opening of trading on the New York Stock Exchange [1] - A webcast discussion of these results will begin at 8:30 a.m. Eastern [1] Webcast Access - The webcast and corresponding slide presentation can be accessed via Cardinal Health's Investor Relations page without an access code [2] - Presentation slides and a webcast replay will be available on the Investor Relations page for 12 months [2] Company Overview - Cardinal Health is a distributor of pharmaceuticals and specialty products, a supplier of home-health and direct-to-patient products and services, and an operator of nuclear pharmacies and manufacturing facilities [3] - The company provides performance and data solutions and is a global manufacturer and distributor of medical and laboratory products [3] - Cardinal Health's customer-centric focus drives continuous improvement and leads to innovative solutions that improve people's lives [3]
Allergan Aesthetics Announces Expansion of SKINVIVE by JUVÉDERM® into 35 New Markets, Reinforcing its Commitment to Advancing Global Skin Quality
Prnewswire· 2025-09-23 09:00
Core Insights - Allergan Aesthetics is expanding the rollout of SKINVIVE by JUVÉDERM to 35 additional markets, bringing the total to 57 globally in 2025, highlighting the company's commitment to enhancing skin quality worldwide [1][5][9] - The global skin quality market is valued at $5.2 billion, with a notable shift in consumer behavior towards health-focused aesthetic solutions [2][6] Product and Market Expansion - SKINVIVE is described as the longest-lasting hydrating injectable on the market, providing deep hydration and smoothness with a single treatment [5][6] - The AA Signature™ approach, which includes SKINVIVE, aims to address diverse patient needs and improve skin quality, emphasizing a holistic treatment strategy [3][4] Consumer Insights - Research indicates that 94% of people desire to improve their facial skin quality, with deep hydration being a priority across all age groups [6][15] - Consumers are increasingly gravitating towards aesthetic treatments that yield natural-looking results, reflecting a desire for consistency and realistic outcomes rather than dramatic changes [6][15] Industry Events and Education - The Aesthetic Anti-Aging Medicine World Congress (AMWC) in Dubai will feature discussions on the AA Signature™ approach and its integration into aesthetic practices [4][7] - A dedicated panel of renowned experts will explore the complexities of skin quality and its emotional connections, furthering the educational efforts of Allergan Aesthetics [7]
SOPHiA GENETICS Expands Collaboration with AstraZeneca to Enhance Detection of Breast and Prostate Cancer
Prnewswire· 2025-09-22 12:00
Core Insights - SOPHiA GENETICS expands collaboration with AstraZeneca to enhance diagnosis and treatment of breast and prostate cancer through an optimized next generation sequencing (NGS) solution utilizing AI algorithms to detect genetic mutations in the PIK3CA/AKT1/PTEN pathway [1][5] Group 1: Collaboration Details - The partnership aims to improve the detection of genetic mutations linked to cancer development, particularly focusing on the PTEN gene, which when altered, can lead to cancer and treatment resistance [2] - An optimized NGS solution has been developed that employs AI agents to analyze and detect genomic mutations across the full PTEN gene, with a prototype showing improved sensitivity for complex mutations [2][3] Group 2: Implementation and Future Plans - SOPHiA GENETICS will initiate a Privileged Access Program for selected clinical laboratories to validate the sensitivity of the NGS solution in real-world settings, with broader commercial availability anticipated in 2026 [3] - A multi-center real-world evidence study will be conducted to further assess the effectiveness of the solution, aiming to expand patient access to precision therapies through advanced testing in both tissue and liquid biopsy [3] Group 3: Company Mission and Vision - The collaboration reflects the commitment of both companies to drive innovation in precision oncology, ensuring global patient access to advanced genomic testing and targeted treatments [5] - SOPHiA GENETICS emphasizes its mission to democratize data-driven medicine, translating new cancer insights into actionable solutions for patients worldwide [4]
Alnylam Pharmaceuticals joins Alliance for Genomic Discovery, expanding diverse clinical genomic dataset to drive precision medicine
Prnewswire· 2025-09-18 13:15
Core Insights - Alnylam Pharmaceuticals has joined the Alliance for Genomic Discovery (AGD), which aims to accelerate drug discovery through clinical genomic data [1][2][3] - The AGD dataset will enhance Alnylam's ability to identify new therapeutic targets for RNA interference (RNAi) therapeutics, which work by silencing disease-causing genes [4][5] - The AGD now includes nine members, with Alnylam being the latest addition, and plans to expand its dataset by sequencing an additional 31,250 whole genomes, building on an existing cohort of 250,000 [3][5] Company and Industry Developments - The AGD is led by Illumina and Nashville Biosciences, focusing on leveraging genomic data to drive innovation in therapeutics [2][3] - Alnylam's participation is expected to strengthen the AGD's clinical genomic database, which aims to provide diverse and representative data for drug discovery [5][6] - The alliance has already identified novel therapeutic targets, particularly in autoimmune and neurodegenerative diseases, demonstrating the dataset's value to its members [6][8] Technological Advancements - The AGD utilizes advanced sequencing and data analysis technologies, such as DRAGEN and Illumina Connected Analytics, to enhance the accuracy and speed of genomic insights [6][8] - The alliance plans to incorporate multiomic layers into its dataset, which will facilitate faster target discovery and therapy development [8] - The AGD dataset aims to link diverse genomic data with clinical phenotyping to ensure that discoveries benefit a wide range of populations [5][6]
Aurora Announces Investment into German Manufacturing Facility
Prnewswire· 2025-09-18 11:00
Core Insights - Aurora Cannabis Inc. is investing over five years in operational upgrades at its EU-GMP manufacturing facility in Leuna, Germany, aimed at enhancing flower growth capacity, product quality, and cost efficiency [1][2][6] - The upgrades will strengthen supply chain resilience and expand domestic capabilities in EU-GMP certified manufacturing to meet the growing demand for high-quality medical cannabis in Europe [2][3] Investment Details - The investment will include commissioning additional grow rooms, new irrigation and lighting systems, and transitioning to hang dry and dry trim methods [2][3] - This initiative is part of Aurora's commitment to operational excellence and long-term growth in the European market [2] Market Position - Aurora Leuna is one of only three licensed cultivation facilities in Germany, playing a crucial role in supplying locally grown medical cannabis to an expanding patient base [3] - The expansion will allow Aurora to grow additional cultivars from its genetics library, positioning the company to serve international markets at high standards [3] Company Overview - Aurora Cannabis Inc. operates in the medical and consumer cannabis markets across Canada, Europe, Australia, and New Zealand, with a focus on high-quality products [4] - The company’s brand portfolio includes various medical and adult-use brands, and it has a controlling interest in Bevo Farms Ltd., a leading supplier of propagated agricultural plants [4]
Ascletis Presented Phase III Study Results of First-in-Class FASN Inhibitor Denifanstat (ASC40) for Acne Treatment in the Late Breaking News Sessions of the European Academy of Dermatology and Venereology (EADV) Congress 2025
Prnewswire· 2025-09-17 23:30
Core Insights - Denifanstat (ASC40) has met all primary, key secondary, and secondary efficacy endpoints in treating moderate-to-severe acne compared to placebo [1][6][11] - The drug demonstrated a favorable safety and tolerability profile, with treatment-emergent adverse events (TEAEs) comparable to placebo [1][9] Efficacy Results - The Phase III clinical trial involved 480 patients, randomized into treatment and placebo groups, showing significant improvements in multiple efficacy endpoints after 4 weeks and 12 weeks of treatment [4][6] - Primary endpoints included a treatment success rate of 33.17% for denifanstat compared to 14.58% for placebo, with a p-value of <0.0001 [5][6] - Percent reductions from baseline to week 12 in total lesion count (TLC) and inflammatory lesion count (ILC) were 57.38% and 63.45% for denifanstat, respectively, both statistically significant [6][7] Safety Profile - The incidence of TEAEs was 58.6% for denifanstat and 56.3% for placebo, with most events being mild or moderate [9] - Notable TEAEs included 6.3% dry skin and 5.9% xerophthalmia in the denifanstat group, with no serious adverse events reported [9] Regulatory Progress - Ongoing pre-New Drug Application (NDA) consultation with the China National Medical Products Administration (NMPA) has yielded encouraging feedback, with plans to submit an NDA for denifanstat after consultation completion [2][11] Company Background - Ascletis Pharma Inc. is focused on developing and commercializing innovative therapeutics for metabolic diseases, utilizing advanced drug discovery platforms [13]
Roche receives CE Mark for Accu-Chek SmartGuide Continuous Glucose Monitoring and mySugr App integration, offering an enhanced diabetes management experience
Prnewswire· 2025-09-16 14:00
Accessibility StatementSkip Navigation Initially launched in 2012 in Vienna, Austria, by people with diabetes for people with diabetes, the mySugr app is today available in over 84 countries and 25 languages, enabling users to manage key therapy data. mySugr Glucose Insights, the Accu-Chek SmartGuide integration with the mySugr app, just received CE mark approval and is set to launch in the first countries later this year. Users can view and analyse their CGM glucose values and predictions in one place, alo ...