Revelyx Bio Reports Positive Topline Phase 2 Results for YY003, a Recombinant, Ready-to-Use Liquid Botulinum Toxin Type A, in Moderate-to-Severe Glabellar Lines

• Study met its primary endpoints: 80.8% of participants receiving 40 U achieved the composite response at Week 4 versus 0% with vehicle (p<0.001); YY003 was well tolerated, with no treatment-related serious adverse events.
• Key secondary endpoints were also met: At Week 4, 92.3% of participants receiving 40 U achieved a score of none or mild on the Facial Wrinkle Scale as assessed by investigators. In addition, no neutralizing antibodies were detected in any participant.
• Early onset approaching maximal effect: 90.4% of participants receiving 40 U achieved a score of none or mild by Week 1 versus 3.8% for vehicle (p<0.001), comparable to Week 4 result of 92.3%.
• Company plans to advance YY003 toward an End-of-Phase-2 meeting with the U.S. Food and Drug Administration (FDA).
  
  

NASHVILLE, Tenn., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Revelyx Bio, Inc., a clinical-stage biopharmaceutical company, today reported positive topline results from a Phase 2 clinical trial of YY003, an investigational recombinant botulinum toxin type A in a ready-to-use liquid formulation, in adults with moderate-to-severe glabellar lines. The trial met its primary endpoints and key secondary endpoints.

“These positive Phase 2 results mark an important milestone for YY003 and our partnership with Claruvis,” said Dustin Sjuts, Chief Executive Officer of Revelyx Bio. “YY003 brings together recombinant technology and a liquid formulation in a way we believe could meaningfully advance innovation in the botulinum toxin category. Our next step is to request an End-of-Phase-2 meeting with the FDA to discuss the proposed Phase 3 dose and pivotal-development program. We are grateful to the investigators and participants whose contributions made this study possible.”

YY003 Phase 2 Study Design

The two-part study (YY003-001-US01; NCT06481475) randomized 153 adults at three clinical sites in Australia under a U.S. Investigational New Drug application. Part A evaluated safety and tolerability across three dose levels. In Part B, 129 participants were randomized in a double-blind, vehicle-controlled evaluation of the two doses (30 U and 40 U) selected by an independent data monitoring committee.

The study’s primary endpoints included safety and the composite response rate at Week 4, defined as the proportion of participants achieving a score of none or mild on the Facial Wrinkle Scale and at least a two-grade improvement from baseline, as assessed independently by both the investigator and the participant.

Key secondary endpoints included response rates as assessed by investigators, participants, and an independent review committee; the proportion of participants achieving a score of none or mild; patient-reported onset of effect; global aesthetic improvement; patient satisfaction at each post-treatment visit; and immunogenicity.

Topline Clinical Results

• Composite response rates were 80.8% at 40 U and 66.7% at 30 U with YY003, compared with 0% for vehicle (p<0.001 for each dose versus vehicle) at Week 4.
• At week 4, 92.3% of participants receiving 40 U achieved a score of none or mild on the Facial Wrinkle Scale as assessed by investigators (p<0.001 vs. vehicle).
• 90.4% of participants receiving 40 U achieved a score of none or mild by Week 1 — approaching the week 4 result of 92.3% — compared with 3.8% for vehicle.
• 94.2% of participants receiving 40 U reported improvement on the Global Aesthetic Improvement Scale versus 0% for vehicle.
• 90.4% reported satisfaction with the appearance of their frown lines versus 7.7% for vehicle.
• No neutralizing antibodies were detected in any participant, and only one out of 106 participants was positive for anti-drug antibodies (0.9%), while maintaining a clinical response.
  
  

Safety Results

YY003 was generally safe and well tolerated in this study. The most common treatment-related adverse events were injection-site reactions and headache. No treatment-related serious adverse events occurred, and there were no discontinuations due to adverse events in any group.

“The data are compelling, particularly since the study incorporated a rigorous primary endpoint requiring both the investigator and the participant to independently record at least a two-grade improvement,” said Professor Gregory Julian Randal Goodman, Director of Dermatology Institute of Victoria, President of Australasian Society of Cosmetic and Procedural Dermatologists, and principal investigator in the study. “YY003 has the potential to become the world’s first ready-to-use liquid recombinant type A botulinum toxin. In addition to the encouraging efficacy and safety findings observed in this study, its liquid formulation may offer a practical benefit in the clinic by eliminating manual reconstitution and simplifying product preparation.”

“These Phase 2 results provide encouraging clinical evidence for YY003 and are consistent with the profile we have seen across our recombinant platform,” said Dr. Wu Yang, Chief Scientific Officer of Claruvis Pharmaceutical. “Recombinant BoNT/A provides a therapeutic protein with high purity through innovative design and a well-controlled manufacturing process. We look forward to working with Revelyx to advance YY003 into a Phase 3 clinical program.”

Recombinant Manufacturing

YY003 is produced using recombinant expression in E. coli rather than by purifying neurotoxin from cultures of Clostridium botulinum. The process is designed to provide control over the identity and purification of the expressed neurotoxin. The resulting neurotoxin is structurally identical to the naturally derived protein. YY003 is supplied as a ready-to-use liquid, which removes the manual reconstitution step required for botulinum toxin type A products currently approved in the United States.

About Revelyx Bio

Revelyx Bio, Inc. is a private, clinical-stage biopharmaceutical company developing and advancing differentiated therapies sourced from Asia-Pacific innovators for the United States and other global markets. The Company combines selective in-licensing with expertise in clinical development, regulatory strategy, chemistry, manufacturing and controls (CMC), and commercialization. Its lead program, YY003, is an investigational recombinant botulinum toxin type A in a ready-to-use liquid formulation being developed for aesthetic and therapeutic indications. Revelyx holds exclusive rights to develop and commercialize YY003 in all territories outside mainland China, Hong Kong, and Macau. Learn more at www.revelyx.com or connect with us on LinkedIn.

About Claruvis

Chongqing Claruvis Pharmaceutical Co., Ltd., a subsidiary of MingMed Biotechnology, is a biopharmaceutical company dedicated to developing recombinant botulinum toxin products for aesthetic and therapeutic indications. Claruvis developed Retoxin^® (YY001), the world’s first approved recombinant botulinum toxin type A (rBoNT/A), and continues to advance a robust pipeline powered by its proprietary recombinant neurotoxin technology. For more information, visit MingMed Biotechnology at https://www.ming-med.com/en.

Forward Looking Statements

This press release contains forward-looking statements about Revelyx Bio, Inc. (“Revelyx Bio”), including statements regarding the potential benefits and commercial prospects of YY003, its investigational recombinant botulinum toxin type A injection; plans to request an End-of-Phase-2 meeting with the U.S. Food and Drug Administration (“FDA”) and the anticipated timing and outcome of that meeting; and the potential design, timing, and initiation of a Phase 3 clinical program.

These statements reflect current expectations and involve risks and uncertainties that could cause actual results to differ materially, including risks relating to clinical trial results, safety, and timing; regulatory decisions and guidance, including possible FDA requirements for additional studies, data, or changes to the proposed development program; manufacturing and supply; reliance on development partners; intellectual property; competition; and the availability of additional capital. Results from this Phase 2 study are not necessarily predictive of results in subsequent studies or following repeat treatment, and regulatory approval is not assured.

Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this press release. Except as required by applicable law, Revelyx Bio undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

Trademarks

Retoxin^® is a registered trademark of Chongqing Claruvis Pharmaceutical Co., Ltd. Revelyx Bio™ is a trademark of Revelyx Bio, Inc.

Media Inquiries

info@revelyx.com

YY003 is an investigational product and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.