Quality Assurance Specialist

Revelyx Bio launches to advance YY003, an investigational recombinant botulinum toxin type A in a ready-to-use liquid formulation. August 31, 2026 08:00 ET | Source: Revelyx Bio * Company aims to deliver the first FDA-approved recombinant botulinum neurotoxin type A (rBoNT/A) * Phase II study in moderate-to-severe glabellar lines completed; topline data expected in Q3 2026 * Dustin Sjuts, former President of Revance Therapeutics, has been appointed Chief Executive Officer, bringing 20 years of biopharma leadership in commercial strategy and product launches NASHVILLE, Tenn., Aug. 31, 2026 (GLOBE NEWSWIRE) - Revelyx Bio, Inc., a clinical-stage biopharmaceutical company, today announced its launch following an exclusive licensing agreement with Chongqing Claruvis Pharmaceutical Co., Ltd., for YY003, a ready-to-use liquid formulation of recombinant botulinum toxin type A (rBoNT/A). Under the terms of agreement, Revelyx holds exclusive rights to develop and commercialize YY003 for aesthetic and therapeutic indications globally, excluding mainland China, Hong Kong and Macau. Additionally, the company announced the appointment of Dustin Sjuts as Chief Executive Officer and member of its Board of Directors. "Revelyx is focused on combining YY003's differentiated science with a clear development path to bring next-generation recombinant innovation to an established, fast-growing market," said Dustin Sjuts, Chief Executive Officer of Revelyx Bio. "We will advance our lead asset with disciplined execution across clinical development, regulatory strategy and CMC as we prepare to report topline Phase II results and position the program for late-stage development." From Conventional Fermentation to Precision Genetic Engineering * YY003 is an investigational rBoNT/A formulated as a ready-to-use liquid and presented in a prefilled syringe. Produced via recombinant expression in E. coli rather than traditional Clostridium botulinum culture purification, the manufacturing process offers precise control over neurotoxin identity and purity. The resulting protein is structurally identical to naturally derived neurotoxin, offering the potential for high specific activity and enhanced safety profile. Recombinant manufacturing is a proven, highly scalable platform used to produce biologic medicines for over 40 years. * YY003 builds on Claruvis Pharmaceutical's proprietary recombinant platform, which also underpins Retoxin(R)(YY001). In March 2026, Claruvis secured approval from China's National Medical Products Administration (NMPA) for Retoxin(R) to temporarily improve moderate-to-severe glabellar lines in adults - marking the world's first approved rBoNT/A. Retoxin(R) is currently commercially available in China, with pivotal Phase III data published in Aesthetic Surgery Journal. Claruvis is also advancing Retoxin(R) in a Phase III trial in China for adult upper-limb spasticity secondary to stroke. Phase II Study of YY003 in Moderate-to-Severe Glabellar Lines Completed * The U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug application for YY003 in September 2024. * A randomized, double-blind, vehicle-controlled Phase II study of YY003 in adults with moderate-to-severe glabellar lines has been completed at clinical sites in Australia. * Revelyx expects to report topline results in Q3 2026. "Having founded and led BioBAY, I have seen firsthand the quality and scale of innovation emerging from China's biotechnology ecosystem," said Xianghong Lin, Founding Partner of NRL Capital and original Founder of BioBay. "NRL incubated Revelyx to bring that innovation to global markets by pairing high-potential clinical programs with robust development, regulatory, CMC and commercial leadership required to advance them. YY003 is a compelling first example of this strategy, and Dustin brings the ideal operating experience and vision to lead it through the next stages of global growth." Mr. Sjuts brings over 20 years of experience building and scaling public and private life sciences companies. Through his career, he has advanced biologics, specialty pharmaceuticals and medical technologies from clinical development through manufacturing and commercialization, with deep expertise in injectable therapies and neuromodulators. Most recently, Mr. Sjuts served as President of Revance Therapeutics, where he oversaw commercial, clinical, regulatory and technical operations. During his tenure, he led the FDA approvals and U.S. commercial launches of DAXXIFY(R)(daxibotulinumtoxinA-lanm) for moderate-to-severe glabellar lines and cervical dystonia in adults, as well as the U.S. commercial launch of the RHA(R) Collection of dermal fillers. Before becoming President, he served as the company's Chief Commercial Officer. Earlier, Mr. Sjuts led Galderma's aesthetics business in Greater China from Shanghai and held commercial leadership roles at Allergan. 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(R)(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. Trademarks DAXXIFY(R) is a registered trademark of Revance Therapeutics, Inc. RHA(R) is a registered trademark of TEOXANE SA. Retoxin(R) is a registered trademark of Chongqing Claruvis Pharmaceutical Co., Ltd. Media Inquiries A photo accompanying this announcement is available here.

Revance, a global aesthetics and skincare company, has appointed Melissa O'Connor as senior vice president, global regulatory. O'Connor will report to chief operating officer Nick Crowe and lead the company's global regulatory strategy and organisation. O'Connor brings more than 25 years of experience spanning medical devices, combination products, biologics and human tissue-based products. She holds a Regulatory Affairs Certification and was named a RAPS Fellow in 2022. Most recently, O'Connor served as founding member and chief quality and regulatory officer at StimLabs, where she led quality and regulatory affairs for human tissue-based allografts and medical devices. She previously held regulatory and quality leadership roles at QSpex Technologies and Chemence Medical Products. Revance operates in 60 countries with a portfolio including DAXXIFY, RHA dermal fillers and consumer skincare brands such as PanOxyl and Blue Lizard.