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Day: December 8, 2025

Orchestra BioMed Announces AVIM Therapy and Virtue SAB Program Presentations at ICI Meeting

Joint presentation by Orchestra BioMed and Medtronic leadership to discuss ongoing strategic collaboration for development and commercialization of AVIM Therapy for treatment of uncontrolled hypertension in patients indicated for a pacemakerNEW HOPE, Pa., Dec. 08, 2025 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical innovation company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced three presentations at the 2025 Innovation in Cardiology Intervention (“ICI”) meeting in Tel Aviv, Israel, including two presentations focused on Atrioventricular Interval Modulation Therapy (“AVIM Therapy”) and one focused on Virtue® Sirolimus AngioInfusion™ Balloon (“Virtue SAB”). The AVIM Therapy presentations...

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Kymera Therapeutics Announces Positive Results from BroADen Phase 1b Clinical Trial of KT-621, a First-in-Class, Oral STAT6 Degrader, in Patients with Moderate to Severe Atopic Dermatitis

KT-621 achieved deep STAT6 degradation across both the 100 mg and 200 mg dose groups tested, with median reductions of 94% and 98% in skin and blood, respectively, demonstrating strong translation from healthy volunteers to atopic dermatitis (AD) patients KT-621 achieved strong reductions in disease-relevant Type 2 biomarkers in blood, including TARC (median reduction of 74% in patients with baseline TARC levels comparable to dupilumab AD studies), Eotaxin-3, IL-31, IgE, and in core Type 2 inflammation and AD disease-relevant gene sets in skin lesions Robust clinical activity was observed across all disease endpoints measured including mean 63% EASI reduction and mean 40% peak pruritus NRS reduction for all patients Patients with comorbid asthma showed a median 56% reduction in FeNO and meaningful improvements in asthma control, and those...

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Cardiff Oncology to Present at Sidoti’s Year-End Virtual Investor Conference

SAN DIEGO, Dec. 08, 2025 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, today announced that company management will present and host one-on-one meetings at Sidoti’s Year-End Virtual Investor Conference, which is taking place from December 10-11, 2025. Details of the presentation can be found below. Presenter: Mark Erlander, PhD (CEO) Date: 12/11/2025Time: 4:00 PM ET Interested parties can register for and access the live webcast for the conferences by visiting the “Events” section of the Cardiff Oncology website. The webcast replay will be available after the conclusion of the presentation. About Cardiff Oncology, Inc. Cardiff Oncology is a clinical-stage biotechnology company leveraging PLK1 inhibition,...

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Gaming and Leisure Properties Expands Board of Directors With Appointment of Michael Borofsky

WYOMISSING, Pa., Dec. 08, 2025 (GLOBE NEWSWIRE) — Gaming and Leisure Properties, Inc. (NASDAQ: GLPI) (the “Company”), announced today that Michael Borofsky has been appointed to the Board of Directors as a new independent director, effective immediately, subject to receipt of customary regulatory approvals. The appointment of Mr. Borofsky expands the Board of Directors to eight members, seven of whom are considered independent according to the listing standards of the Nasdaq Stock Exchange. Michael Borofsky is the founder of Mithrandir Ventures, a diversified family office with investments in gaming, healthcare, software and climate tech. Michael’s primary focus is on building high cash flow generating businesses with leading market positions and helping companies innovate and evolve through emerging technologies. Peter Carlino,...

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eToro Group Reports Selected November Business Metrics

NEW YORK, Dec. 08, 2025 (GLOBE NEWSWIRE) — eToro Group Ltd. (“eToro”, or the “Company”) (NASDAQ: ETOR), the trading and investing platform, is reporting the below selected monthly business metrics for November 2025.Assets under Administration (AUA) were $18.8B, up 9% year-over-year. Funded accounts were 3.79M, up 10% year-over-year.* Capital Markets/ECC ActivityTotal number of trades was 46.3M, up 16% year-over-year;   Invested amount per trade was $269, down 13% year-over-year;Crypto ActivityTotal number of trades was 5.0M, down 48% year-over-year; Invested amount per trade was $264, down 28% year-over-year;Interest Earning Assets were $7.6B, up 21% year-over-year. Total Money Transfers was $1.1B, unchanged year-over-year.  November**  2024   2025   YoY ChangeTrading Activity                     Number...

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Agios Provides Update on U.S. sNDA for Mitapivat in Thalassemia

CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) — Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has not yet issued a regulatory decision on the supplemental New Drug Application (sNDA) for mitapivat for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia and that the sNDA remains under active review. The Prescription Drug User Fee Act (PDUFA) goal date issued by the FDA was December 7, 2025. Agios is collaborating closely with the FDA to finalize the labeling documents and Risk Evaluation and Mitigation Strategy (REMS) materials. The FDA has not requested, and the company has not submitted,...

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14 G/T Au Within 47m of Gold-Bearing Skarn from 26m Depth in 300m Step-Out at Birch Cu-Au Project

VANCOUVER, British Columbia, Dec. 08, 2025 (GLOBE NEWSWIRE) — Yukon Metals Corp. (CSE: YMC, FSE: E770, OTCQB: YMMCF) (“Yukon Metals” or the “Company”) is pleased to announce results from the last two holes of the 2025 drill program at its 100% owned 7,000-hectare Birch Copper-Gold Project (“Birch”), located 65 kilometers northeast of Burwash Landing, one of 17 assets across 43,000 hectares held in the Yukon. The Company has received assays from two additional drill holes, BR25-003 and BR25-006, expanding the mineralized footprint by 300m and introducing a substantial gold component to the system. Highlights:Hole BR25-003, drilled 300 meters northeast of Hole 1, intersected 47.4 meters of 0.43 g/t Au in gold-bearing stratigraphy from 26.6m below surface, including 1 meter from 71m grading 14.35 g/t Au, significantly expanding...

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Copper Road signs Four Separate Option Agreements Consolidating the Ben Nevis Volcanic Complex into a Single Claim Group

TORONTO, Dec. 08, 2025 (GLOBE NEWSWIRE) — Copper Road Resources Inc. (TSX-V: CRD) (“Copper Road” or the “Company”) is pleased to announce that it has signed a non-binding Letter of Intent (“LOI”) to option 174 cell claims (within 495 provincial grid cells) with a spatial exploration extent of approximately 10,232 hectares (“ha”), including 13 contiguous mining rights only patents for an additional 210 ha to the operational project area. The property includes parts of Ben Nevis, Clifford, Elliott, Arnold and Katrine townships, located in northeastern Ontario (Figure 1). This transaction consists of four (4) separate option agreements representing the first ever consolidation of the entire Ben Nevis Volcanic Complex into a single claim group holding. The transaction is expected to close within 30 days. Brian...

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Ocular Therapeutix™ Announces Plans to Accelerate NDA Submission Timeline for AXPAXLI™ in Wet AMD

Ocular intends to submit AXPAXLI New Drug Application (NDA) for wet AMD shortly after year one data from SOL-1, if positive SOL-1 topline data remain on track for 1Q 2026 Ocular plans to leverage the 505(b)(2) regulatory pathway for new drug approvals which has the potential to shorten the review timeline for AXPAXLI If approved, AXPAXLI could be the first TKI to be commercialized in wet AMD, with a potential superiority label and best-in-class durability BEDFORD, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) — Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, announced that following recent public statements from U.S. Food and Drug Administration (FDA) leadership and other recent interactions with the FDA’s Division of Ophthalmology, the Company now...

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Vaxcyte Doses First Participants in the OPUS Phase 3, Noninferiority Trial Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults

Trial Design Finalized in Consultation and Alignment with U.S. Food and Drug Administration  Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines Through Head-to-Head Safety, Tolerability and Immunogenicity Comparisons of VAX-31 with Capvaxive (PCV21) and Prevnar 20 (PCV20), the Current Standards of Care Company Expects to Report Topline Safety, Tolerability and Immunogenicity Data for OPUS Phase 3, Noninferiority Trial in the Fourth Quarter of 2026 and Initiate Additional Phase 3 Studies in 2026 with Readouts in 2027, Supporting Planned BLA Submission VAX-31 is Designed to Cover ~95% of Invasive Pneumococcal Disease (IPD) and ~88% of Pneumococcal Pneumonia in U.S. Adults Aged 50+, with Potential to Provide an Incremental 14-34% Broader IPD Coverage and 19-31% Broader Pneumonia Coverage than Standard-of-Care...

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