HOUSTON, Jan. 07, 2026 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 270+ 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 issued the following letter to shareholders. Fellow Shareholders, Looking back on 2025, I'm reminded of something I've always believed: the best way to predict the future is to invent it. At ...

Core Insights - Kyverna Therapeutics, Inc. is set to host a live webcast and conference call on December 15, 2025, to discuss topline results from the Phase 2 KYSA-8 clinical trial for KYV-101 in stiff person syndrome [1][2] Company Overview - Kyverna Therapeutics is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases, with its lead candidate KYV-101 advancing through late-stage clinical development [4] - KYV-101 is a fully human, autologous, CD19 CAR T-cell therapy designed for potency and tolerability, aiming for deep B-cell depletion and immune system reset [3][4] - The company is also conducting registrational trials for myasthenia gravis and has ongoing Phase 1/2 trials for lupus nephritis, with plans to explore additional indications such as multiple sclerosis and rheumatoid arthritis [4]

Core Viewpoint - Capricor Therapeutics, Inc. experienced a significant stock surge of 342.30 percent following the announcement of positive topline data from its Phase 3 HOPE-3 trial for Deramiocel, a cell therapy aimed at treating Duchenne muscular dystrophy [1] Group 1: Stock Performance - Capricor's shares rose by $21.77 to reach $28.13 on Wednesday, compared to a previous close of $6.36 [2] - The stock opened at $30.00 and has fluctuated between $21.50 and $40.37 during the trading day, with a trading volume of 39.80 million shares [2] - The company's 52-week stock range is between $4.30 and $40.37 [2] Group 2: Clinical Trial Results - The HOPE-3 trial demonstrated statistically significant improvements in both skeletal and cardiac function [1] - The results reinforced the durability of the findings observed in the earlier HOPE-2 studies [1]

Financial Data and Key Metrics Changes - The company guided for approximately $150 million in sales for the first half of the year, with less than $100 million expected for the fourth quarter, indicating a strong start to the launch [2] - The operating margin improved to roughly 50% in the third quarter, reflecting a disciplined cost focus and operational efficiency [36][39] Business Line Data and Key Metrics Changes - The HIV prevention business collectively grew 42% year over year, with Descovy growing 32% year over year in HIV prevention [6] - Sunlenca's launch is expected to drive steady, consistent, durable growth similar to Biktarvy, which had $3.5 billion in sales in the third quarter [3] Market Data and Key Metrics Changes - The CDC estimates that at least 2.2 million people in the U.S. would benefit from HIV prevention, indicating a significant market opportunity [8] - Currently, about 500,000 people are on HIV prevention therapy, suggesting substantial room for market expansion [12] Company Strategy and Development Direction - The company is focused on changing prescriber habits and building awareness for the new injectable options versus oral medications [2][5] - There is a strong emphasis on expanding the HIV prevention market, with plans for specific advertising campaigns to raise awareness [5][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of the HIV prevention market, noting that the market is just beginning to develop [7][9] - The company highlighted the importance of building awareness and transitioning patients from existing therapies to new options [12][13] Other Important Information - The patent settlement for Biktarvy extends exclusivity until at least 2036, providing long-term stability for the company [15] - The company has a deep pipeline of next-generation HIV treatment alternatives, with multiple programs in clinical development [16][18] Q&A Session Summary Question: Can you discuss the strategy for educating patients and physicians on the benefits of the injectable option? - Management acknowledged that changing habits takes time and emphasized the importance of building a sales force and healthcare educators to raise awareness [5] Question: Where is the demand for Sunlenca coming from in the early days of the launch? - The company noted that there has been a surprising number of naive patients starting on Sunlenca, as well as patients switching from generic Truvada and other long-acting options [10][11] Question: What are the plans for Anito-cel in terms of clinical development? - Management confirmed that there are plans to move Anito-cel into earlier lines of treatment, with significant market opportunities identified [25][26] Question: Can you provide an update on Trodelvy's regulatory submissions and growth potential? - The company expects to receive an updated label for Trodelvy next year, which should drive significant growth [28] Question: How is the company approaching business development, particularly in China? - Management highlighted a shift towards innovative assets in China and noted that a significant portion of their corporate development interest is now sourced from that region [33][34]

Financial Data and Key Metrics Changes - The company guided for approximately $150 million in sales for the first half of the year, with less than $100 million expected for the fourth quarter, indicating a strong start to the launch [2] - The operating margin improved to roughly 50% in the third quarter, reflecting a disciplined cost focus and operational efficiency [36][39] Business Line Data and Key Metrics Changes - The HIV prevention business collectively grew 42% year over year, with Descovy growing 32% year over year in HIV prevention [6] - Sunlenca's launch is expected to drive steady, consistent, durable growth similar to Biktarvy, which had $3.5 billion in sales in the third quarter [3] Market Data and Key Metrics Changes - The CDC estimates that at least 2.2 million people in the U.S. would benefit from HIV prevention, indicating a significant market opportunity [8] - Currently, about 500,000 people are on HIV prevention therapy, suggesting substantial room for growth in the market [12] Company Strategy and Development Direction - The company is focused on changing prescriber habits and building awareness for the new injectable options versus oral medications [2][5] - There is a strong emphasis on expanding the HIV prevention market, with plans for specific advertising campaigns to raise awareness [5][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential of the HIV prevention market, noting that the market is just beginning to develop [7][9] - The company highlighted the importance of building awareness and transitioning patients from existing therapies to new options [12][13] Other Important Information - The patent settlement for Biktarvy extends exclusivity until at least 2036, providing long-term stability for the company [15] - The company has a deep pipeline of next-generation HIV treatment alternatives, with multiple programs in clinical development [16][18] Q&A Session Summary Question: Can you discuss the strategy for educating patients and physicians on the benefits of the injectable option? - Management acknowledged that changing habits takes time and emphasized the importance of building a sales force and healthcare educators to raise awareness [5] Question: Where is the demand for Sunlenca coming from in the early days of the launch? - The company noted that there has been a surprising number of naive patients starting on Sunlenca, as well as patients switching from generic Truvada and other long-acting options [10][11] Question: What are the plans for Anito-cel and its market potential? - Management indicated that Anito-cel is expected to launch in the fourth-line plus market by the end of next year, with significant growth opportunities in multiple myeloma [24][25] Question: Can you provide an update on Trodelvy's regulatory submissions and growth potential? - The company expects updated label expansion filings for Trodelvy in the U.S. next year, which should drive significant growth [28] Question: How is the company approaching business development, particularly in China? - Management highlighted a shift towards more innovative assets in China and noted that a significant portion of their corporate development interest is now sourced from that region [33][34]

Core Viewpoint - FibroBiologics has received necessary regulatory approvals for a Phase 1/2 clinical trial of CYWC628 aimed at treating refractory diabetic foot ulcers, marking a significant milestone in the company's development of fibroblast-based therapies [1][5]. Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, focusing on developing therapeutics for chronic diseases using fibroblast cells and fibroblast-derived materials. The company holds over 270 patents issued and pending across various clinical pathways [1][11]. Clinical Trial Details - The approved clinical trial is a prospective, multicenter, randomized study designed to evaluate the safety, tolerability, and efficacy of CYWC628, a topically administered allogeneic fibroblast cell-based therapy for refractory diabetic foot ulcers. The trial will enroll 120 patients across 10 sites in Australia [1][3]. - Participants will receive treatment for up to 12 weeks, either with standard of care plus a low or high dose of CYWC628, or standard of care alone [3][10]. Trial Management - Southern Star Research, a full-service Australian CRO, will manage all aspects of the CYWC628 trial, continuing its partnership with FibroBiologics [2]. Expected Outcomes - The trial will assess wound healing outcomes, efficacy of response, and safety parameters through regular clinical and imaging evaluations. An interim analysis will be conducted after a predefined number of participants complete six weeks of treatment to evaluate primary safety and efficacy endpoints [4][10]. - The study aims to provide key clinical data supporting CYWC628 as a novel therapy for chronic wound management, addressing a significant unmet need in this area [5].

Summary of Gilead Sciences Conference Call Company Overview - **Company**: Gilead Sciences (NasdaqGS:GILD) - **Event**: Jefferies Healthcare London Conference - **Date**: November 19, 2025 Key Points Industry and Company Performance - Gilead has experienced significant growth in its base business over the past three years, with base revenues (excluding COVID antiviral) growing 7% in 2023 and 5% in the current year despite a $1.1 billion headwind from Medicare Part D reform, indicating a potential 9%-10% growth in the base business [3][4] - The company has diversified its portfolio into virology, HIV, oncology, and inflammation, with a notable increase in R&D spending, which has more than doubled since 2016 [2][3] Capital Allocation and M&A Strategy - Gilead is focused on building a commercial infrastructure around assets rather than pursuing bolt-on acquisitions, with an annual business development budget of over $1 billion for partnerships and small acquisitions [5][6] - Recent acquisitions include a STAT6 degrader for inflammation and an in vivo cell therapy company, Interius, for a couple hundred million dollars [6] - The company is prioritizing late-stage, de-risked assets that synergize with its existing commercial infrastructure, with no major patent cliffs until 2036 [7][8] Market Dynamics and Opportunities - Gilead is increasingly looking to China for partnerships and acquisitions, with over half of its business development priorities for 2025 coming from Chinese companies, a significant increase from 5% five years ago [9][10] - The launch of Yeztugo, a long-acting HIV prevention drug, is underway, with $54 million in sales reported and guidance of nearly $100 million for the fourth quarter [11][14] - The HIV prevention market is transitioning from daily oral medications to long-acting injectables, with over 75% of covered lives having unrestricted access to Yeztugo [15][16] Product Launch and Market Potential - Yeztugo is positioned to open a new chapter in HIV prevention, with groundbreaking studies showing 100% and 99.9% prevention rates in different populations [12][13] - The CDC has recently doubled its estimates for the addressable PrEP market from 1.2 million to 2.2 million, indicating significant growth potential [33] - Gilead expects the market to be split 50% oral and 50% injectables by 2030, with ongoing development of a once-yearly injectable version of Yeztugo [32][35] Future Pipeline and Innovations - Gilead is advancing multiple late-stage trials in its HIV treatment portfolio, including a new daily combination regimen and a six-month infusion treatment for patients not controlled on existing therapies [38][41] - The company is also developing anito-cel, a BCMA cell therapy for multiple myeloma, with plans to file for approval by the end of 2025 and launch by late 2026 [44][46] Manufacturing and Competitive Advantage - Gilead has built a robust manufacturing infrastructure for cell therapies, with the capacity to treat up to 24,000 patients by 2026, providing a competitive edge in reliability and speed compared to competitors [46][47] Additional Insights - The company emphasizes the importance of adherence in HIV prevention, noting that long-acting injectables guarantee adherence, which is a significant advantage over daily oral medications [36] - Gilead's approach to market growth is characterized by steady, durable, and consistent growth rather than rapid spikes, reflecting a long-term strategy for its product launches [27][28]

Accessibility StatementSkip Navigation In his role on the SAB of NewcelX, Prof. Shefner will provide strategic guidance on the Company's programs in ALS, including the clinical development of AstroRx®, and will support the integration of neuromuscular and neurodegenerative disease expertise into the Company's broader platform of cell therapy and neuroscience innovation. ZURICH and NESS ZIONA, Israel, Nov. 17, 2025 /PRNewswire/ -- NewcelX Ltd. (Nasdaq: NCEL) ("NewcelX" or "the Company"), a clinical-stage bio ...

Financial Data and Key Metrics Changes - Research and development expenses increased to $936,000 in Q3 2025 from $931,000 in Q3 2024, and increased to $3.8 million for the nine months ended September 2025 from $3.0 million for the same period in 2024, driven by the closeout of the CardiAmp heart failure study and new enrollment in the CardiAmp heart failure II trial [14] - Selling general and administrative expenses decreased to $0.6 million in Q3 2025 from $0.8 million in Q3 2024, and decreased to $2.4 million for the nine months ended September 2025 from $2.8 million for the same period in 2024, primarily due to lower compensation and professional services [15] - Net loss was $1.5 million for Q3 2025 compared to $1.7 million for Q3 2024, and $6.2 million for the nine months ended September 2025 compared to $5.5 million for the same period in 2024 [15] - Net cash used in operations decreased to $1.5 million in Q3 2025 from $1.7 million in Q3 2024, and for the nine months ended September 2025 decreased to $4.9 million from $5.5 million for the same period in 2024 [16] Business Line Data and Key Metrics Changes - The CardiAmp heart failure II clinical study is actively enrolling, with four centers currently involved and three having randomized their first patients [8][28] - The CardiAmp cell therapy in chronic myocardial ischemia trial showed an average increase in exercise tolerance of 80 seconds and an 82% reduction in angina episodes at the six-month primary endpoint [10] Market Data and Key Metrics Changes - Japan's PMDA has shown interest in heart failure therapies due to its aging population and limited options for treatment, which may enhance the market potential for the CardiAmp system [6][38] Company Strategy and Development Direction - The company is focused on advancing regulatory submissions for the CardiAmp cell therapy and Helix delivery system, with plans for a meeting with the FDA regarding the approvability of the CardiAmp system [7][13] - The company is pursuing non-dilutive funding for the CardiALLO allogeneic mesenchymal stem cell therapy, with expectations of clarity on funding in Q1 2026 [11][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for the CardiAmp heart failure II program, citing strong clinical data and support from physicians involved in previous trials [28][38] - The company is in a waiting mode for formal clinical consultations with Japanese regulatory authorities, with most preparatory work completed [35] Other Important Information - The company ended the quarter with $5.3 million in cash, which is expected to provide a runway into Q2 2026 without additional financing [16] Q&A Session Summary Question: Clarification on CardiAmp CMI data - The CardiAmp CMI data includes five patients enrolled at their primary endpoint out to six months, with compelling results compared to previous data [18][19] Question: Recruitment challenges for CardiAmp heart failure II trial - Enrollment is proceeding smoothly, aided by cell population analysis to set dosages, with no significant challenges reported [23][24] Question: Next steps for Japanese regulatory approval - The key hurdle is a formal clinical consultation to determine if existing clinical data is sufficient for safety and efficacy in Japan [33][34]

Summary of CRISPR Therapeutics FY Conference Call Company Overview - **Company**: CRISPR Therapeutics (NasdaqGM:CRSP) - **Key Speakers**: Rajiv Prasad (CFO), Naimesh Patel (CMO) - **Event**: 2025 Healthcare Innovations Conference Core Industry Insights - **Industry**: Biotechnology, specifically focusing on gene editing and therapeutic innovations Key Points and Arguments Financial Performance and Pipeline Progress - The launch of **CASGEVY** is performing well, with **Vertex** projecting over **$100 million** in revenues for 2025 and significant growth anticipated in 2026 with nearly **300 patients** initiated in the treatment journey [4][6] - The company has a robust pipeline, including the **CTX310 program** targeting **ANGPTL3**, showing a **55% reduction in triglycerides** and a **50% reduction in LDL** [4][5] - The company maintains a strong financial position with **$1.94 billion** on the balance sheet, allowing for continued execution across various programs [5][6] Factor XI Program - The **Factor XI program** aims to provide specific and potent inhibition of clot formation with limited bleeding risk, targeting populations at risk for clots who currently do not take anticoagulants due to bleeding risks [7][8] - The program is expected to progress with significant readouts in the next **12 months**, potentially de-risking the target for cardiovascular medicine [5][12] Gene Editing and Safety Concerns - Following safety concerns in the gene editing sector, CRISPR has reassured stakeholders that their **CTX310 profile** remains strong and differentiated from competitors like **Intellia** [15][16] - The company has not observed similar adverse reactions in their trials, providing confidence in their platform's safety [20] Market Positioning and Differentiation - CRISPR aims to differentiate its products through **durability** and **reversibility** of treatments, particularly in the context of anticoagulation therapies [10][11] - The company is strategically positioned to observe competitors' pricing and de-risking strategies before launching its products, allowing for informed decision-making [13][14] Future Directions and Trials - The **CTX310 program** is in a dose escalation study, with plans to establish safety and optimal dosing for various patient populations [22][23] - The company is exploring the potential of gene editing for **Lp(a)** levels, which are genetically determined and linked to long-term cardiovascular risk, with ongoing trials expected to provide insights into treatment efficacy [32][33] Upcoming Data and Expectations - Data from the **CTX112 program** in autoimmune diseases is expected in the fourth quarter, with preliminary results showing promising T cell expansion and potential for long-term remission in patients [45][46] Additional Important Insights - The company is actively working on **in vivo CAR-T** approaches and **ADC** strategies in collaboration with Vertex, indicating a commitment to advancing innovative therapies [42][43] - The market for gene editing and RNA modalities is evolving, with increasing recognition of their synergistic potential, as evidenced by recent acquisitions in the sector [30] This summary encapsulates the critical insights and developments discussed during the conference call, highlighting CRISPR Therapeutics' strategic positioning, pipeline advancements, and market outlook.