RESEARCH TRIANGLE PARK, N.C., June 02, 2026 (GLOBE NEWSWIRE) — Merakris Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to MTX-001, the Company’s lead biologic candidate for the treatment of chronic, non-infected venous stasis ulcers, commonly known as venous leg ulcers (VLU).
Fast Track designation is granted to a select group of development-stage therapeutics that the FDA determines have the potential to address serious conditions and unmet medical needs. The FDA’s decision to grant Fast Track designation reflects the Agency’s recognition that MTX-001 is being developed for a condition with substantial unmet medical need and may warrant an expedited development and review pathway.
The designation provides Merakris with enhanced opportunities to interact with the FDA throughout development and creates the potential for a rolling review of a future Biologics License Application (BLA). Under a rolling review framework, portions of a BLA may be submitted and reviewed as they are completed, allowing regulatory review activities to begin before the entire application package is finalized.
“Receiving Fast Track designation is a significant regulatory milestone for Merakris and further validates both the substantial unmet medical need in venous leg ulcer treatment and the potential of MTX-001 as a novel biologic therapy,” said Christopher Broderick, Chief Executive Officer of Merakris Therapeutics. “Beyond the designation itself, Fast Track creates opportunities for more frequent FDA engagement and the potential for rolling review, which may allow important elements of our clinical and manufacturing programs to be reviewed earlier in the regulatory process.”
Broderick continued, “We believe one of the most meaningful aspects of Fast Track designation is the opportunity to engage proactively with the FDA on CMC and regulatory readiness activities. For biologic therapies such as MTX-001, earlier alignment on manufacturing and quality expectations can help de-risk development, improve regulatory efficiency, and strengthen our path toward commercialization.”
Venous leg ulcers are among the most prevalent chronic wounds worldwide, affecting an estimated 600,000 to 1 million patients annually in the United States and resulting in billions of dollars in healthcare expenditures associated with prolonged treatment, recurrence, hospitalization, and lost productivity. Despite the large patient population and significant healthcare burden, treatment options remain limited, and healing outcomes remain suboptimal for many patients.
MTX-001 is an investigational biologic therapy being developed to address underlying biological deficiencies associated with impaired wound healing. The therapy is designed to deliver a concentrated profile of regenerative bioactive factors intended to support tissue repair, accelerate healing, and improve outcomes for patients with chronic wounds.
In addition to rolling review eligibility, Fast Track designation may also make MTX-001 eligible for Priority Review and other expedited regulatory pathways, subject to FDA determination and future clinical results.
About MTX-001
MTX-001 is a first-in-class injectable biologic drug candidate purified from cell-free amniotic fluid. It is currently being evaluated in a multicenter Phase 2 trial (NCT04647240) for venous leg ulcers (VLUs) and is also available through an Expanded Access Program (EAP) for cutaneous wounds (NCT06730022). Part 1 of the Phase 2 study, published in the International Wound Journal in March 2025, demonstrated favorable safety and early efficacy signals, including wound closure and symptom improvement.
About Merakris Therapeutics
Merakris Therapeutics is a regenerative medicine company focused on developing innovative biologic therapies for chronic wounds and other conditions characterized by impaired tissue repair. Through its proprietary biologics platform, the Company is advancing therapies designed to address significant unmet medical needs while creating long-term value for patients, providers, and shareholders.
Forward-Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of Merakris’ products, or regarding potential future revenues from any such product. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Merakris’ management believes that any forward-looking statements in this press release are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Merakris, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and advisors and on the global economy as a whole. Fast Track designation does not guarantee accelerated approval, Priority Review, or ultimate marketing approval by the FDA.
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