Alignment Reached on Key Elements of the Phase 3 Program to Support a 505(b)(2) NDA Submission
10XB-101 Now has Clear Regulatory Path Forward
LA JOLLA, Calif., Sept. 14, 2026 (GLOBE NEWSWIRE) — Leios Therapeutics (“Leios” or “The Company”), a clinical-stage biotechnology company focused on innovative aesthetic therapies, today announced the successful outcome of its End-of-Phase 2 (“EoP2”) meeting with the U.S. Food and Drug Administration (“FDA”), achieving overall alignment on the Phase 3 development program for 10XB-101, the Company’s investigational treatment for the improvement in the appearance of moderate-to-severe submental fat fullness in adults.
“We are pleased with the successful outcome of the EoP2 meeting with the FDA, providing us with a clear path to Phase 3 and to registration for 10XB-101,” said Ted White, Chief Executive Officer of Leios Therapeutics. “We now have alignment on the key elements of our pivotal program, including trial design options, dose selection and the size of the safety database to support a potential 505(b)(2) New Drug Application (“NDA”). Together with our progress in manufacturing, expanding intellectual property protection and recent regional licensing agreements with BNC Korea and affiliates of China Medical System Holdings Limited (“CMS”) in China, we are well positioned to continue advancing 10XB-101 toward registration and bring this new, innovative treatment option to the millions of adults bothered by submental fat fullness.”
The EoP2 meeting provided Leios with clear FDA feedback on the development requirements for 10XB-101 for the treatment of moderate-to-severe submental fat fullness in adults. An agreement was reached with the FDA about a defined path toward a potential NDA submission. Importantly, the FDA confirmed the following:
- Trial design flexibility, including the acceptability of either a single adequately powered pivotal trial or two Phase 3 trials.
- Selection of Phase 3 dose up to 4%.
- Agreement on study design, primary and secondary efficacy endpoints.
- Alignment on study size, and total number of exposures.
The positive EoP2 outcome follows a series of value-driving milestones for Leios in 2026, including the closing of exclusive regional licensing and strategic investment agreements with BNC Korea and affiliates of China Medical System Holdings Limited covering South Korea and China, respectively — together representing the world’s largest aesthetic markets outside the United States. Under the agreements, development costs in the licensed territories are assumed by the respective licensees. Leios has also filed patent applications in two additional families that, if granted, could provide protection for 10XB-101 through 2044 and 2047, respectively.
About 10XB-101
10XB-101 is being developed as a best-in-class minimally invasive injectable treatment designed to reduce focal fat deposits and enhance body contouring outcomes. Its active ingredient, polidocanol, is a synthetic, non-ionic detergent that induces targeted adipolysis: following injection in a defined pattern, it disrupts fat cell membranes, allowing the destroyed cells to be naturally absorbed by the body. Leios has completed Phase 2 trials in the submental fat reduction indication.
About Leios Therapeutics
Leios Therapeutics is a clinical-stage biotechnology company dedicated to developing innovative therapies for aesthetic indications. The Company’s mission is to deliver scientifically differentiated products that offer meaningful benefits to patients, healthcare providers and partners.
For more information, please visit www.leiostherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding the development, regulatory approval and commercialization of 10XB-101, including the planned Phase 3 program and potential 505(b)(2) NDA submission, manufacturing plans, licensing partnerships and intellectual property protection. These statements are based on Leios’s current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially, including clinical trial outcomes, changes in regulatory requirements, manufacturing and financing challenges, partner performance and the ability to secure patent protection. Alignment with the FDA does not guarantee regulatory approval. Forward-looking statements speak only as of the date of this release, and Leios undertakes no obligation to update them, except as required by applicable law.
FOR MORE INFORMATION, PLEASE CONTACT:
Ryan Kelly
rkelly@leiostherapeutics.com
