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INOVIO to Report First Quarter 2025 Financial Results on May 13, 2025
Prnewswire· 2025-04-29 12:05
Core Points - INOVIO, a biotechnology company, focuses on developing and commercializing DNA medicines for HPV-associated diseases, cancers, and infectious diseases [1][3] - The company will release its first quarter 2025 financial results on May 13, 2025, after market close [1] - A live conference call and webcast will follow the financial results release at 4:30 p.m. ET, including a Q&A session with analysts [1][2] Company Overview - INOVIO's technology is designed to optimize the design and delivery of DNA medicines that enable the body to produce its own disease-fighting tools [3] - The company aims to protect and treat individuals from HPV-related diseases and other infectious diseases through its innovative approach [3]
Solid Biosciences to Present at the American Society of Gene and Cell Therapy’s 28th Annual Meeting
Globenewswire· 2025-04-29 12:00
Core Insights - Solid Biosciences Inc. is set to present data from the Phase 1/2 INSPIRE DUCHENNE trial for SGT-003, a gene therapy for Duchenne muscular dystrophy, at the ASGCT Annual Meeting in May 2025 [1][2] - The company emphasizes its commitment to advancing precision genetic medicines for rare diseases, showcasing significant progress in capsid design and therapeutic approaches [2] Presentation Details - Oral presentations will include insights from the INSPIRE DUCHENNE trial and the mechanism of action of AAV-SLB101, a novel muscle-tropic capsid [3] - Poster presentations will cover various topics, including gene delivery efficiency and characterization of AAV capsids [4][5] About Duchenne - Duchenne muscular dystrophy is a severe genetic condition affecting approximately 1 in every 3,500 to 5,000 live male births, with an estimated prevalence of 5,000 to 15,000 cases in the U.S. [6] About SGT-003 - SGT-003 is an investigational gene therapy featuring a microdystrophin construct and a next-generation capsid, AAV-SLB101, designed to enhance muscle transduction while minimizing liver targeting [7] - Nonclinical studies suggest that SGT-003 could be a leading candidate for treating Duchenne due to its unique design features [7] About INSPIRE DUCHENNE - The INSPIRE DUCHENNE trial is a first-in-human, open-label study aimed at evaluating the safety and efficacy of SGT-003 in pediatric patients with Duchenne [8] About Solid Biosciences - Solid Biosciences focuses on developing gene therapy candidates for rare neuromuscular and cardiac diseases, with a mission to improve the lives of patients affected by these conditions [9]
Novartis continues strong momentum with double-digit sales growth, robust margin expansion and multiple approvals in Q1  
Globenewswire· 2025-04-29 05:00
Core Insights - Novartis reported a strong start to Q1 2025 with a 15% increase in sales and a 27% rise in core operating income, driven by key brands and innovation milestones [2][6][8] - The company achieved significant growth in priority brands, with notable performances from Kisqali, Kesimpta, and Leqvio, which are expected to drive growth through 2030 [2][6][12] - Novartis raised its full-year 2025 guidance, expecting high single-digit sales growth and low double-digit growth in core operating income [6][24] Financial Performance - Net sales reached USD 13.2 billion, a 12% increase year-over-year, with a 15% increase in constant currencies [8][27] - Core operating income was USD 5.6 billion, up 23%, with a core operating income margin of 42.1% [10][27] - Free cash flow increased by 66% to USD 3.4 billion, reflecting higher net cash flows from operating activities [11][27] Key Growth Drivers - Major contributors to sales growth included Entresto (+22% cc), Kisqali (+56% cc), and Leqvio (+72% cc) [6][12][15] - The top 20 brands collectively generated USD 10.8 billion in sales, reflecting a 17% increase [15][27] - The company continues to focus on expanding its presence in priority markets such as the US, China, Germany, and Japan [5][12] Innovation and R&D - Novartis achieved several innovation milestones, including FDA approvals for Pluvicto, Vanrafia, and Fabhalta [6][16] - The company is advancing its pipeline with global submissions for remibrutinib and ongoing trials for OAV101 IT, showing promising results [17][19] - The acquisition of Anthos Therapeutics aligns with Novartis' strategy to enhance its cardiovascular portfolio [19] Capital Structure and Shareholder Returns - In Q1 2025, Novartis repurchased 24.8 million shares for USD 2.6 billion as part of a larger share buyback program [21] - Net debt increased to USD 22.3 billion, primarily due to dividend payments and share repurchases [22] - The company maintains a strong capital structure with a focus on shareholder returns [20][22]
Mesoblast Appoints Corporate Finance Leader Lyn Cobley To Board
Globenewswire· 2025-04-28 23:44
Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for severe inflammatory diseases, utilizing proprietary mesenchymal lineage cell therapy technology [4][6] - The company has received FDA approval for RYONCIL (remestemcel-L), the first mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease in pediatric patients [5][6] Recent Developments - Mesoblast appointed Lyn Cobley to its Board of Directors, who brings over 30 years of experience in the financial services industry, including senior roles at major banks [1][3] - Cobley expressed enthusiasm about Mesoblast's recent FDA approval and the company's potential for future growth, including commercialization and new indications for prevalent diseases [3] Strategic Initiatives - The company is focused on developing additional cell therapies for various indications, including adult SR-aGvHD and biologic-resistant inflammatory bowel disease, as well as rexlemestrocel-L for heart failure and chronic low back pain [6] - Mesoblast has established commercial partnerships in key markets such as Japan, Europe, and China [6] Intellectual Property and Manufacturing - Mesoblast holds a strong global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to last until at least 2041 in major markets [7] - The company utilizes proprietary manufacturing processes to produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability for patients worldwide [8]
Relay Therapeutics to Announce First Quarter 2025 Financial Results and Corporate Highlights on May 5, 2025
Globenewswire· 2025-04-28 20:05
CAMBRIDGE, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, will report first quarter 2025 financial results and corporate highlights after the U.S. financial markets close on Monday, May 5, 2025. About Relay Therapeutics Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicine company transforming the dru ...
Tempus AI Stock Surges 43% in Q1: Buy Now or Wait for Earnings?
ZACKS· 2025-04-28 20:00
Core Viewpoint - Tempus AI, Inc. is set to report its first-quarter fiscal 2025 results, with expectations of a revenue of $248.08 million and a loss of 27 cents per share, reflecting a steady consensus estimate over the past 90 days [2][3]. Financial Performance - In the last reported quarter, Tempus AI had an adjusted loss of 18 cents, which was wider than the Zacks Consensus Estimate of a loss of 15 cents per share, with an average negative earnings surprise of 6.46% over the trailing three quarters [1]. - The company experienced a 43% gain in stock price during the first quarter of 2025, outperforming the broader industry gain of 2.1% and the S&P 500 decline of 4.9% [4][5]. Growth Drivers - The Genomics unit is expected to report strong growth, building on over 30% growth in the previous quarter, while Data and Services revenues are anticipated to have accelerated by 44.6% year over year [10]. - Strategic acquisitions, including Ambry Genetics for $600 million and Deep 6 AI, are expected to enhance Tempus's capabilities in diagnostics and data analytics, contributing positively to financial performance [11][18]. EBITDA and Cash Flow - Tempus AI reported an adjusted EBITDA of -$7.8 million in the fourth quarter of 2025, marking a $27.3 million year-over-year improvement, with expectations of positive adjusted EBITDA of $5 million for the full year 2025 [12]. - The cumulative operating cash outflow improved to $189 million at the end of the fourth quarter of 2024, down from $214.3 million a year ago, indicating a trend towards positive cash flow [13]. Long-term Prospects - The company is advancing precision medicine through AI applications, with a focus on creating Intelligent Diagnostics to enhance personalized care and accelerate therapeutic development [14]. - The launch of the AI-enabled personal health concierge app, olivia, positions Tempus to benefit from the shift towards patient-centric healthcare [15]. - The FDA approval of the xT CDx test strengthens Tempus's oncology portfolio, likely increasing demand for its diagnostic services [16]. Market Position and Valuation - Tempus AI's stock is currently trading at a forward price-to-sales ratio of 6.81, which is higher than the industry average of 5.15, indicating an expensive valuation compared to peers [20]. - Despite the high valuation, the AI market's projected exponential growth positions Tempus AI to capitalize on expanding opportunities in the healthcare sector [21].
SOPHiA GENETICS Announces Expanded Collaboration with AstraZeneca to Accelerate Liquid Biopsy Testing Globally from AACR
Prnewswire· 2025-04-28 16:00
Core Insights - SOPHiA GENETICS announced an expansion of its collaboration with AstraZeneca to enhance the global deployment of MSK-ACCESS® powered with SOPHiA DDM™, extending its reach to 30 clinical institutions in 2025 [1][3] Group 1: Collaboration and Expansion - The collaboration aims to accelerate the deployment of innovative liquid biopsy testing, which detects actionable genomic alterations from a single blood draw [2][3] - The expanded rollout will contribute to AstraZeneca's global real-world evidence initiatives and validate the clinical impact of decentralized liquid biopsy testing [3][4] Group 2: Technology and Performance - MSK-ACCESS® powered with SOPHiA DDM™ utilizes advanced algorithms to analyze circulating tumor DNA (ctDNA), supporting real-time cancer monitoring and treatment selection [2][4] - Data presented at AACR demonstrated the consistent accuracy and precision of the decentralized test across various laboratory settings, addressing historical site-to-site discordance issues [4][5] Group 3: Strategic Vision - The collaboration reflects a significant step toward scaling next-generation oncology diagnostics globally, with a shared ambition to enhance accessibility and impact of liquid biopsy technologies [5]
Kura Oncology Announces First Patients Dosed in Phase 1 Combination Trial of Ziftomenib for the Treatment of Advanced GIST
Globenewswire· 2025-04-28 11:30
Core Insights - Kura Oncology has initiated the KOMET-015 Phase 1 clinical trial to evaluate ziftomenib in combination with imatinib for patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure [1][3] - The combination of ziftomenib and imatinib has shown robust and durable antitumor activity in both imatinib-sensitive and imatinib-resistant GIST preclinical models [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being a key investigational menin inhibitor [8] - The company has received Breakthrough Therapy Designation from the FDA for ziftomenib in treating relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) [7][8] Clinical Trial Details - The KOMET-015 trial is designed to assess the safety, tolerability, and preliminary antitumor activity of ziftomenib combined with imatinib in adults with GIST who have shown disease progression on imatinib [3][4] - The trial will evaluate primary objectives including safety and tolerability, and secondary endpoints such as overall response rate (ORR) and progression-free survival (PFS) [3] Market Context - Approximately 4,000 to 6,000 new cases of GIST are diagnosed annually in the U.S., with limited treatment options available for advanced cases [2][5] - Most patients develop resistance to imatinib within two years, highlighting the need for new therapeutic options [2][6] Preclinical Findings - Preclinical studies indicate that the combination of ziftomenib and imatinib exerts antitumor activity through a synthetic lethal mechanism, targeting vulnerabilities in GIST tumors [2][3] - The combination has the potential to delay or overcome resistance to imatinib in patients [2]
Veri Medtech (VRHI) Retains PCAOB Auditor
Globenewswire· 2025-04-28 11:30
NEW YORK, April 28, 2025 (GLOBE NEWSWIRE) -- Veri Medtech Holdings, Inc. (OTC Markets: (“VRHI”) ("Veri Medtech") announced today that it has retained Salberg & Company, P.A., as its PCAOB auditor, in furtherance of the uplisting process. For more information, please visit: http://www.salbergco.com. "Veri Medtech (VRHI) continues to execute on its mission to be the premier provider of healthcare technology services and products worldwide. Retaining Salberg & Company is an important strategic next step in the ...
XORTX Announces Grant of European Patent
Globenewswire· 2025-04-28 11:00
Patent Supporting Gout and Autosomal Dominant Polycystic Kidney Disease Programs CALGARY, Alberta, April 28, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the "Company") (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease , is pleased to announce receipt of notification that the patent "Xanthine Oxidase Inhibitor Formulations" will be granted by the European Patent Of ...