Welcome to our dedicated page for YD Bio news (Ticker: YDES), a resource for investors and traders seeking the latest updates and insights on YD Bio stock.
YD Bio Limited (NASDAQ: YDES) is a biotechnology company that regularly issues news on DNA methylation‑based cancer detection, precision diagnostics, ophthalmologic innovations, and stem cell and exosome therapies. Its press releases describe progress across oncology diagnostics, limbal stem cell–derived exosome platforms, and clinical‑trial supply operations, giving investors and observers insight into how the company is advancing its programs.
News updates for YD Bio often cover developments in its collaboration with EG BioMed, including expansion of the OkaiDx™ cfDNA‑methylation blood‑based testing platform for cancers such as pancreatic, colorectal, and breast cancer. Announcements have detailed CLIA and CAP accreditation for EG BioMed’s U.S. laboratory, expanded state‑by‑state access to laboratory‑developed tests, and clinical research data for early pancreatic cancer detection assays that remain under validation and are not yet FDA‑cleared or approved.
Another recurring theme in YD Bio’s news is ophthalmology. Releases describe milestones in limbal stem cell and exosome‑based platforms, FDA 510(k) clearance for Exovisse contact lenses, over‑the‑counter monograph compliance for Exovisse artificial tears, and planned clinical programs for eye conditions. The company also reports on regulatory filings such as Drug Master Files for limbal stem cells and exosomes, as well as planned clinical studies in Taiwan and regulatory strategies in the United States.
Corporate and capital markets developments appear in YD Bio’s news flow as well, including the closing of its business combination with Breeze Holdings Acquisition Corp., listing on the Nasdaq Global Market, and a non‑binding Memorandum of Understanding to merge with EG BioMed. Readers following YDES news can expect coverage of scientific presentations, intellectual property updates, facility plans such as a proposed California operations center, and governance or auditor changes disclosed through SEC reports and press releases.
YD Bio (Nasdaq: YDES) entered a non-binding MOU to merge with EG BioMed to build an integrated, DNA methylation–driven oncology platform combining diagnostics, real-world clinical data, and AI-enabled drug discovery.
The transaction is anticipated to close in 2026 and is subject to customary closing conditions, regulatory approvals, and definitive agreements. EG BioMed brings a DNA methylation diagnostics platform, AI biomarker algorithms, and certified clinical lab infrastructure, with clinical adoption at three affiliated Taipei Medical University centers. Expected integration benefits and revenue or cost synergies remain conditional and are not assured.
YD Bio (Nasdaq: YDES) announced completion of key CMC activities and filing of Drug Master Files with the FDA for its Limbal Stem Cell (LSC) and LSC-derived exosome platforms, and outlined a 2026 catalyst-driven clinical and commercial roadmap.
The company operates CLIA/CAP laboratory services across 46 U.S. states, expects 2026 milestones for ophthalmology INDs and OkaiDx pancreatic clinical validation, and reported issued breast cancer patents in 28 countries plus a U.S. pancreatic patent.
YD Bio (Nasdaq: YDES) announced plans to establish a California operations center and new U.S. facilities to accelerate clinical development, regulatory engagement and commercial access for DNA methylation cancer diagnostics, exosome therapeutics and ophthalmologic programs.
The site is in site evaluation with city not finalized; the company will recruit U.S. regulatory, clinical and operations staff and activate the site in phases. YD Bio said the center will support FDA interactions, clinical trial coordination, market access, and align with a partner’s recent NT$210 million ($6.72M) U.S. GMP plant investment.
YD Bio (Nasdaq: YDES) exhibited at the 9th Healthcare Expo Taiwan in Taipei from Dec 4–7, 2025, presenting its DNA methylation-based OkaiDx cancer detection platform, multi-biomarker early detection, next-generation precision diagnostics, and ophthalmology stem cell/exosome programs at Booth No. 4F, M1004.
The company reported 1,500+ visitors and 541 on-site surveys over four days, held discussions with distributors from China, Hong Kong, Indonesia, and Dubai, and engaged hospital leaders about using EG BioMed US Inc.'s CLIA-certified, CAP-accredited U.S. lab as a global central lab for precision cancer testing.
YD Bio (Nasdaq: YDES) expanded U.S. access to its OkaiDx™ blood-based testing platform to include pancreatic and colorectal cancer detection across 44 states via EG BioMed’s CLIA/CAP lab in Washington, supported by a nationwide telehealth physician network and at‑home blood collection.
The company reported clinical results from an EG BioMed study (IRB ID: N202105091): 93.8% sensitivity for early‑stage (I–II) PDAC, 100% sensitivity in late‑stage PDAC, 97.3% specificity in healthy controls, and 97.7% overall accuracy in a 100‑patient PDAC / 500‑control dataset. The pancreatic test is not FDA cleared and results remain under validation.
YD Bio (Nasdaq: YDES) announced U.S. ophthalmology regulatory and clinical milestones on Nov 24, 2025 that establish its first commercial entry into U.S. eye care and advance limbal stem cell (LSC) exosome therapeutics.
Key achievements: Exovisse Contact Lenses received FDA 510(k) clearance as a Class II device; Exovisse Artificial Tears were developed in compliance with the FDA OTC Final Monograph M018 for nationwide OTC distribution; and YD Bio enrolled its LSC and LSC-derived exosomes in an FDA Drug Master File to support future therapeutics.
YD Bio (NasdaqGM: YDES) announced support for U.S. access to OkaiDx™, a cfDNA‑methylation blood test for post‑treatment breast cancer monitoring, now available through affiliate EG BioMed’s CLIA/CAP‑certified laboratory as a research‑use‑only (RUO) assay.
The company will coordinate commercialization, researcher engagement and sample logistics to enable testing for research laboratories, academic groups and industry partners. Independent validation reported 95.1% accuracy, 89.4% sensitivity and 96.5% specificity. OkaiDx™ is not FDA cleared and is not intended to diagnose, treat, cure or prevent disease.
YD Bio (Nasdaq: YDES) rang the Nasdaq Opening Bell on October 20, 2025 to mark its listing on the Nasdaq Global Market. The company said the listing strengthens its capital base, elevates its global profile and accelerates commercialization of DNA methylation cancer-detection tests and exosome-based ophthalmologic therapies.
YD Bio highlighted exclusive 20-year licenses from EG Biomed and 3D Global Biotech, plans to expand R&D and a Seattle-based CLIA and CAP certified laboratory, and indicated the listing will support product launches and long-term value for patients and investors.
YD Bio (Nasdaq: YDES) announced that its business partner EG BioMed achieved CAP accreditation for its CLIA-certified laboratory in Bothell, Washington (CLIA Certificate #50D2316600) on October 10, 2025. CAP accreditation, alongside existing CLIA certification, confirms laboratory quality standards and strengthens EG BioMed’s ability to deliver advanced laboratory-developed tests (LDTs) supporting YD Bio’s DNA methylation-based pancreatic and breast cancer detection programs in the U.S.
YD Bio highlighted that this accreditation positions the companies to expand their diagnostic portfolio for early cancer detection and monitoring. EG BioMed’s Chief R&D Officer presented new circulating cell-free DNA biomarker findings at AACR (September 28–October 1, 2025) relevant to metastatic pancreatic cancer monitoring.
YD Bio Limited (NASDAQ:YDES) reported its H1 2025 financial results, marked by strategic developments despite financial headwinds. The company's net revenue decreased 9% to $204,007, while operating expenses increased significantly to $2.0 million, resulting in a net loss of $1.9 million.
Key developments include securing $13.2 million in PIPE financing through a business combination with Breeze Holdings, advancing DNA methylation-based cancer detection technology, and expanding into ophthalmologic innovations. The company launched a pancreatic cancer screening LDT and plans to introduce a breast cancer recurrence monitoring LDT. Additionally, YD Bio is developing corneal stem-cell and exosome-based treatments for various eye conditions, with clinical trials planned for 2027.
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