YD Bio Announces FDA Grant of INTERACT Meeting Request for YDB-LMSCEV-001, an Investigational Extracellular Vesicle Candidate for Dry Eye Disease

Rhea-AI Summary

YD Bio (Nasdaq: YDES) announced that the FDA granted its request for early regulatory feedback on dry-eye candidate YDB-LMSCEV-001. Written responses are expected by January 4, 2027, rather than an in-person meeting. The investigational eye drop uses extracellular vesicles, naturally occurring particles derived from donor limbal stem cells, for moderate-to-severe dry eye disease.

The submission includes nine questions: seven on manufacturing and quality controls and two on early animal-study design. INTERACT advice is informal and non-binding, preceding a formal pre-IND meeting. YD Bio has established laboratory-scale donor master cell banks and completed initial laboratory and mouse studies. It also submitted a proposed follow-up animal study for review. The company plans to use FDA feedback to refine manufacturing and confirming animal studies, preparing for studies needed to apply for human trials.

Positive

• Minor point. Forward-looking: it has not happened yet and may not happen.FDA granted an INTERACT request for YDB-LMSCEV-001, with written feedback expected by January 4, 2027.
• Minor pointLaboratory-scale donor master cell banks established; initial laboratory and mouse studies completed.
• Minor pointProposed follow-up animal study submitted to the FDA for review.
• Minor point. Forward-looking: it has not happened yet and may not happen.YD Bio plans to refine manufacturing and confirming animal studies using FDA feedback before a pre-IND meeting.

Negative

• Minor pointINTERACT feedback is informal and non-binding, preceding a formal pre-IND meeting.

Key Figures

Written FDA response: Expected by January 4, 2027 Questions submitted to FDA: 9 questions

Written FDA response

Expected by January 4, 2027

INTERACT meeting request; Written Response Only format

Questions submitted to FDA

9 questions

7 on chemistry, manufacturing, and controls; 2 on early animal-testing design

Key Terms

interact, cber, pre-ind, ind enabling studies, +1 more

5 terms

interact regulatory

"the FDA has granted its request for an INTERACT meeting"

To engage or communicate with one or more people, systems, or entities in a way that produces a mutual or two-way effect; interactions can be verbal, written, electronic, transactional, or operational. In financial and corporate contexts, it commonly describes communications between parties (for example, a company and regulators, shareholders, customers, or trading systems) or how one system or action influences another; it does not imply any particular outcome, formality, or legal status of the exchange.

cber regulatory

"CBER acknowledged receipt of the Company’s meeting request"

The Center for Biologics Evaluation and Research (CBER) is the U.S. Food and Drug Administration office that reviews and regulates biological products such as vaccines, blood products, cell and gene therapies, and related devices. Investors care because CBER decisions — like approvals, safety warnings, or clinical trial holds — can quickly change a biotech or pharmaceutical company’s value; think of CBER as the traffic controller whose signals determine whether a product can move forward to market or must stop for more checks.

pre-ind regulatory

"before a formal pre-IND meeting"

"Pre-ind" is short for "pre-indication" and refers to the period before a formal announcement or official signal that a significant change or event is about to happen, such as a company preparing to release important news. For investors, it can signal a time of increased activity or uncertainty, as market participants try to interpret hints and anticipate future developments. Recognizing pre-ind conditions helps investors make more informed decisions ahead of major shifts.

ind enabling studies regulatory

"studies required to eventually apply for human clinical trials (“IND enabling studies”)"

Studies and experiments carried out before first testing a drug or biologic in humans to generate the data regulators require for an Investigational New Drug (IND) application. They typically include laboratory and animal tests of toxicity, pharmacology, and pharmacokinetics, plus manufacturing and formulation work (chemistry, manufacturing and controls), and are designed to show that human clinical trials can be started safely and that the product can be made consistently. IND‑enabling studies provide the evidence needed to request regulatory permission to begin human dosing but do not guarantee regulatory approval or clinical success.

chemistry, manufacturing, and controls regulatory

"seven on chemistry, manufacturing, and controls"

Chemistry, manufacturing, and controls (CMC) is the detailed documentation of how a drug or medical product is made, tested, and kept consistent — like a recipe, factory checklist, and quality-control plan combined. Investors care because strong CMC means regulators are more likely to approve the product and the company can reliably scale production, while weak or incomplete CMC raises the risk of approval delays, production problems, extra costs, or recalls.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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FDA agrees to provide written guidance by January 4, 2027, to support development of YDB-LMSCEV-001

TAIPEI, Taiwan, Nov. 12, 2026 (GLOBE NEWSWIRE) -- YD Bio Limited (“YD Bio” or the “Company”) (Nasdaq: YDES), a biotechnology company advancing DNA methylation-based cancer detection and ophthalmologic innovations, today announced that the U.S. Food and Drug Administration (the “FDA”) has granted its request for an INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) meeting.

Through this program, the FDA will provide early written regulatory feedback on YDB-LMSCEV-001, the Company’s investigational biologic eye drop for moderate-to-severe dry eye disease. This early-stage product uses extracellular vesicles (“EVs”), naturally occurring particles derived from healthy donor eye stem cells specifically known as allogeneic human limbal mesenchymal stem cells (“LMSCs”).

In a letter dated November 9, 2026, CBER (the FDA’s Center for Biologics Evaluation and Research) acknowledged receipt of the Company’s meeting request and briefing package submitted on October 21, 2026, and agreed to provide feedback via a Written Response Only format, with answers expected by January 4, 2027.

Key Highlights

• Meeting Granted: CBER agreed to YD Bio’s request for an INTERACT meeting via a Written Response Only format.
• Timeline: Written feedback is expected by January 4, 2027.
• Scope of Questions: YD Bio asked the FDA nine specific questions: seven on chemistry, manufacturing, and controls, covering topics such as cell bank qualification, donor eligibility, and product safety and consistency; and two on the design of early animal testing (nonclinical proof-of-concept).
• Goal: The feedback will help finalize manufacturing and preclinical plans before a formal pre-Investigational New Drug (“pre-IND”) meeting, which is the key regulatory step before human trials.
  
  

Early Regulatory Engagement for an Emerging Technology

The INTERACT program allows developers of highly innovative medical products to obtain early, informal, and non-binding advice from the FDA before a formal pre-IND meeting. Because EV-based therapies remain an emerging class of biologics, early guidance on the characterization and manufacture of such products is a critical developmental step.

Current Progress & Next Steps

To date, YD Bio has established laboratory-scale donor master cell banks for stem cells and completed initial lab and mouse studies for dry eye disease. The Company also submitted a proposed follow-up proof-of-concept animal study to the FDA for review.

Once the FDA provides a written response, YD Bio plans to incorporate the feedback to optimize its manufacturing processes and finalize the design of its confirming animal studies. This is expected to prepare the Company for the studies required to eventually apply for human clinical trials (“IND enabling studies”).

Taiwan-based YC Biotech Co., Ltd. (“YC Biotech”) consulted on the FDA submission, with YD Bio USA, Inc., a subsidiary of the Company, acting as U.S. agent and formal liaison with the FDA, building on the partnership for regulatory collaboration previously announced on February 25, 2026.

“For a product class as new as extracellular vesicles, we believe the most useful time to hear from the FDA is before the clinical manufacturing process and before specifications are fixed,” said Dr. Ethan Shen, Founder, Chairman and Chief Executive Officer of YD Bio. “We appreciate CBER’s agreement to provide written feedback on YDB-LMSCEV-001, and we intend to use its responses to shape our manufacturing, potency and nonclinical plans as we work toward a pre-IND meeting.”

About YDB-LMSCEV-001

YDB-LMSCEV-001 is an investigational topical ophthalmic biologic candidate composed of extracellular vesicles derived from allogeneic human LMSCs, which is being developed for moderate-to-severe dry eye disease. YDB-LMSCEV-001 is an investigational product and has not been approved for marketing by the FDA or any other regulatory authority. Its safety and efficacy have not been established.

About YD Bio Limited

YD Bio is a U.S.-anchored public biotechnology company building an integrated healthcare platform spanning regulated molecular diagnostics, clinical services, precision medicine, and life science commercialization. The Company operates DNA methylation–based oncology testing programs in the United States under a laboratory-developed test strategy and supports pharmaceutical and biotechnology partners through compliant life science distribution and clinical trial supply chain services. In addition, the Company maintains regulated ocular health commercialization operations and a consumer health distribution platform in Asia. For more information, visit ir.ydesgroup.com and follow the Company on Facebook, X, Threads, Instagram and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are intended to be covered by the safe harbor provisions created by the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing and content of the FDA’s written responses, the anticipated incorporation of any FDA feedback by the Company, the regulatory timelines related to the products discussed on this press release, and any planned development activities for YDB-LMSCEV-001 specifically, including a confirmatory proof-of-concept study, a potential pre-IND meeting, IND-enabling studies, a future IND application, and the continued partnership with YC Biotech. Forward-looking statements are not guarantees of future performance and can be identified by words such as “aim,” “intend,” “seek,” “believe,” “designed to,” “expects,” “anticipates,” “plans,” “may,” “could,” “will” and other similar expressions. Forward-looking statements are based on management’s current belief based on currently available information. Such statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s control, and actual results may differ materially from those expressed or implied due to a variety of factors. For example, the FDA’s responses under the INTERACT program will be informal and non-binding, may not address all of the Company’s questions, and may not be favorable; and there can be no assurance as to their timing or content, or that the FDA will agree with any of the Company’s proposals at a pre-IND meeting or otherwise. YDB-LMSCEV-001 is at the preclinical stage; preclinical results are not necessarily predictive of clinical results, and no clinical safety or efficacy of YDB-LMSCEV-001 has been established. In addition, additional risks and uncertainties that could materially affect results include, but are not limited to, the Company’s ability to incorporate any feedback from regulatory agencies, including the FDA, and comply with their requirements; the Company’s ability to secure necessary supplies and materials, successfully establish a clinical manufacturing process and complete product characterization, potency assay development and IND-enabling studies, and secure any necessary funding; continued cooperation by the Company’s partners, including YC Biotech; competition; changes in the regulatory landscape; geopolitical tensions; macroeconomic conditions, and other risks and uncertainties described in YD Bio’s filings with the U.S. Securities and Exchange Commission (the “SEC”). The Company cautions investors not to place undue reliance on such forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update any forward-looking statements, except as required by law, and encourages investors to review the risk factors in its Annual Report on Form 20-F and other SEC filings.

For investor and media inquiries, please contact:

YD Bio Limited
Investor Relations
Email: investor@ydesgroup.com

WFS Investor Relations Inc.
Email: services@wfsir.com
Phone: +1 628 283 9214

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When will YD Bio receive FDA feedback on YDB-LMSCEV-001?

FDA written responses on YDB-LMSCEV-001 are expected by January 4, 2027. The agency granted a Written Response Only format under INTERACT, an early regulatory advice program that precedes a formal pre-IND meeting.

What questions did YD Bio submit to the FDA for YDB-LMSCEV-001?

YD Bio submitted nine questions: seven on chemistry, manufacturing and controls, and two on early animal-study design. Manufacturing topics include cell bank qualification, donor eligibility, and product safety and consistency.