HOUSTON, Nov. 20, 2025 (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 announced that it has received both public and private Human Research Ethics Committee (HREC) approvals in Australia for a Phase 1/2 clinical trial evaluating CYWC628 for the Treatment of Re ...

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.

Bio-Techne Conference Call Summary Company Overview - **Company**: Bio-Techne (NasdaqGS: TECH) - **Date**: November 10, 2025 - **Key Speakers**: Kim Kelderman, Jim Hippel, Dave Clair Key Points Financial Performance - **Organic Growth**: The company reported a negative 1% organic growth in the top line, primarily due to a $7 million impact from larger orders in GMP proteins not repeating year over year [3][10] - **EBITDA Margins**: The EBITDA margin stood at 29.9%, indicating strong operational performance despite headwinds [6] Market Dynamics - **Pharmaceutical Market**: Continued to show double-digit growth, with positive trends in funding and deal activity [4] - **Academic Market**: Flat performance, but core business showed strength [4] - **Regional Performance**: - **Europe**: Mid-single digit growth as expected [4] - **U.S.**: Negative low single digits, but showing improvement [4] - **China**: Two consecutive quarters of growth, indicating a positive trend [4] Business Segments - **Core Business**: Flat performance, recovering from previous quarters [5] - **Growth Verticals**: - **Gene Therapy**: Added numerous customers in cell therapy [5] - **Protein Analytics**: Mid-single digit growth [5] - **Molecular Diagnostics**: Mid-single digit growth, with a significant 34% growth in the same quarter last year [5] GMP Proteins - **Customer Concentration**: Two major customers accounted for a significant portion of GMP protein revenue, with a $12 million headwind expected in the next quarter [16] - **Market Conditions**: The biotech market showed improvement, moving from negative 30% to negative 19% [11] Product Innovations - **New Product Introductions**: Strong pipeline of new products across various lines, including ELA and Western Blot instruments, expected to drive future growth [32][33] - **Organoid Market**: The organoid business is projected to grow significantly, with a current estimated revenue of $50 million and a CAGR of 20% [51][52] Future Outlook - **Growth Projections**: The company anticipates low single-digit growth for the year, with expectations for improvement in the second half due to easing headwinds and market stabilization [55][59] - **China Market**: Optimism about sustained growth in China, with a focus on gradual recovery [60][61] Margin Expansion Opportunities - **Divestitures**: The divestiture of Exosome and exiting low-margin businesses like fetal bovine serum are expected to enhance margins [62] - **Operational Efficiency**: Ongoing efforts to optimize manufacturing and improve collaboration across business units are anticipated to drive margin improvements [63][64] Conclusion - Bio-Techne is navigating a challenging market environment with a focus on innovation, customer acquisition, and operational efficiency. The company is optimistic about future growth, particularly in the organoid and cell therapy markets, while managing the impacts of customer concentration and market fluctuations.

Core Insights - ProKidney Corp. presented full results from the Phase 2 REGEN-007 trial, demonstrating the potential of rilparencel to preserve kidney function in patients with advanced chronic kidney disease (CKD) and diabetes [1][2][3] Phase 2 REGEN-007 Overview - The REGEN-007 trial was a multi-center, open-label, randomized study involving two treatment groups, focusing on different dosing regimens of rilparencel [4] - Group 1 followed the dosing schedule of the ongoing Phase 3 PROACT 1 study, while Group 2 tested an exploratory regimen based on disease progression triggers [4] - A total of 87 rilparencel injections were administered to 49 participants, with follow-ups extending up to 18 months post-injection [4] Efficacy and Safety Findings - Rilparencel treatment resulted in a statistically significant 4.6 mL/min/1.73m² (78%) improvement in the annual decline of estimated glomerular filtration rate (eGFR) slope in Group 1 [6][7] - Among Group 1 patients, 63% met key Phase 3 PROACT 1 inclusion criteria, with a 5.5 mL/min/1.73m² (85%) improvement observed in this subgroup [7] - Group 2 showed a 1.7 mL/min/1.73m² (50%) improvement in eGFR slope, although this was not statistically significant [8] - No serious adverse events related to rilparencel were reported, and the safety profile was consistent with previous studies [6][14] Phase 3 PROACT 1 Program Update - The Phase 3 PROACT 1 trial aims to further assess rilparencel's potential to preserve kidney function in patients with advanced CKD and type 2 diabetes [9] - The FDA confirmed that eGFR slope is an acceptable surrogate endpoint for the study, supporting both accelerated and confirmatory approval pathways for rilparencel [9] - More than half of the required 360 patients for the accelerated approval analysis had been enrolled as of August 2025, with topline results expected in Q2 2027 [9] About Chronic Kidney Disease - CKD is a progressive condition affecting approximately 37 million adults in the U.S., with diabetes being the leading cause [11] - ProKidney is targeting patients with Stage 3b/4 CKD and diabetes, a population estimated to include 1 to 2 million individuals in the U.S. [11] - There is a significant unmet need for therapies that can stabilize kidney function and delay or prevent the need for dialysis in advanced CKD patients [11] About ProKidney Corp. - ProKidney is a pioneer in cell therapy for CKD, with rilparencel being a first-in-class autologous cellular therapy currently in Phase 3 trials [12] - The company was founded in 2015 and has a decade of research backing its innovative treatment approach [12]

Prof. Michel Revel, Chief Scientific Officer of NewcelX, added, "Prof. Ben-Hur's involvement with NewcelX brings deep clinical expertise and a shared commitment to advancing innovative cell therapies that address the root causes of neurodegenerative disease." Ronen Twito, Executive Chairman and Chief Executive Officer of NewcelX, stated, "We are honored that Prof. Ben-Hur will join us in NewcelX. His decision reflects confidence in our science and our mission to build a global biotechnology company deliveri ...

Core Insights - Gilead Sciences, Inc. (GILD) reported a 3% year-over-year growth in total revenues for Q3 2025, driven by higher royalty, contract, and other revenues, alongside strong product sales from its HIV franchise and liver disease drug Livdelzi [1][10] Revenue Breakdown - Total revenues include product sales and royalty, contract, and other revenues [1] - Excluding Veklury, product sales increased by 4% to $7.1 billion [2] HIV Franchise Performance - Gilead's HIV franchise remains strong, with flagship therapies Biktarvy and Descovy contributing significantly to revenue growth [3] - Biktarvy sales rose 6% year-over-year to $3.7 billion, capturing over 52% of the U.S. treatment market [4] - Descovy sales increased by 20% year-over-year to $701 million, with approximately 75% of sales for HIV prevention [6] - Newly approved Yeztugo generated $39 million in sales, achieving a 75% coverage goal ahead of schedule [7] - Gilead anticipates approximately 5% HIV revenue growth in 2025, despite challenges from Medicare Part D redesign [7] Liver Disease Portfolio - Sales from the liver disease portfolio increased by 12% to $819 million, primarily due to demand for Livdelzi [9] - Livdelzi surpassed $100 million in quarterly sales for the first time and is now the first-line treatment for second-line PBC in the U.S. [10][11] Cell Therapy Franchise - Sales from the Cell Therapy franchise decreased by 11% to $432 million, missing consensus estimates [12] - Yescarta sales fell by 10% to $349 million, while Tecartus sales decreased by 15% to $83 million due to lower demand [12] Overall Performance and Market Position - Despite declines in Veklury and Cell Therapy sales, the strong performance of the HIV franchise and Livdelzi supports future growth [10][14] - Gilead's shares have surged 32.2% year-to-date, outperforming the industry growth of 12.1% [14]

Core Insights - Gilead Sciences Inc reported adjusted earnings of $2.47 per share, surpassing the consensus estimate of $2.13 [1] - The company achieved revenues of $7.77 billion, exceeding the consensus of $7.45 billion, despite a 2% decline in product sales to $7.3 billion [2] Financial Performance - HIV product sales increased by 4% to $5.3 billion, while liver disease portfolio sales rose by 12% to $819 million [3] - Biktarvy sales grew by 6% to $3.7 billion, and Descovy revenues surged by 20% to $701 million [3] Guidance and Outlook - Gilead raised its fiscal 2025 adjusted earnings guidance from $7.95-$8.25 per share to $8.05-$8.25, compared to the consensus of $8.03 [4] - The sales guidance was also increased from $28.3 billion-$28.7 billion to $28.4 billion-$28.7 billion, exceeding the consensus of $28.84 billion [4] Analyst Ratings - Needham reiterated its Buy rating for Gilead with a price forecast of $133, highlighting upcoming catalysts related to HIV treatment and cell therapy [5] - Cantor Fitzgerald maintained an Overweight rating with a price forecast of $135, while RBC Capital raised its price forecast from $100 to $105 [6] Market Performance - Gilead Sciences shares were up 0.29% at $118.78 at the time of publication [6]