Articles from Sydnexis, Inc.

Sydnexis, Inc. (www.sydnexis.com), a pre-commercial stage biopharmaceutical company, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for its proprietary low-dose atropine formulation, SYD-101, for slowing the progression of pediatric myopia. Santen SA licensed the rights from Sydnexis to commercialize SYD-101 under the brand name Ryjunea® in the regions of Europe, Middle East, and Africa (EMEA). Santen SA is the Switzerland-based affiliate of Santen Pharmaceutical Co., Ltd., a Japan-based company specialized in eye health, offering innovative products and services in over 60 countries worldwide.

Sydnexis, Inc. (www.sydnexis.com), a pre-commercial stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for SYD-101 and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 23, 2025. If approved, SYD-101 would be the first and only pharmaceutical option for the treatment of progression of pediatric myopia in the United States.

Sydnexis, Inc., (www.sydnexis.com) a pre-commercial stage biopharmaceutical company focused on the treatment of progression of pediatric myopia, is excited to announce the appointment of Perry J. Sternberg as Chief Executive Officer and as a member of the Board of Directors. An accomplished pharma/biotech executive with over 30 years in the industry and 15 years in eye care, Perry will provide invaluable leadership experience to help guide Sydnexis’ strategic direction and next phase of growth.

Sydnexis, Inc., a clinical stage biopharmaceutical company with a proprietary formulation of low dose atropine for the treatment of progressive myopia, today announced the completion of a $45 million Series B financing led by Visionary Ventures, Blue Stem Capital, and SC Master Fund, with participation from existing investors RA Capital Management, Longitude Capital, and Medicxi. The financing will be used to fund Sydnexis’ lead candidate, SYD-101, through completion of the fully enrolled pivotal Phase 3 STAAR study for the treatment of progressive myopia in children.