Polaryx Therapeutics, a late-stage clinical biotech company developing drugs for lysosomal storage disorders, today announces the appointment of Lisa L. Bollinger, M.D. as Chief Medical Officer, effective October 16, 2025. With over 30 years of experience in pediatric drug development and regulatory affairs, Dr. Bollinger is a highly accomplished pediatrician with a proven track record of success working within the U.S. FDA and in leading biotechnology and pharmaceutical companies.

Polaryx Therapeutics, a late-stage clinical biotech company developing drugs for lysosomal storage diseases, announces the appointment of Eddy Zhu, Ph.D., as Chief CMC Officer. With extensive experience in commercial manufacturing, pharmaceutical development and regulatory approvals, Dr. Zhu is a highly accomplished scientific professional with a proven track record of success as a leader in technical R&D excellence, resulting in numerous peer-reviewed publications, multiple formulation patents, and regulatory approval.

Polaryx Therapeutics, a late-stage clinical biotech company developing drugs for lysosomal storage diseases, announces the appointment of Ronald Moss, MD, as Chief Medical Officer, and G. Michael Landis, CPA as Chief Financial Officer. Dr. Moss is a highly respected clinical development executive with a successful track record of managing clinical programs, including neurological indications, from early stage to approval. Mr. Landis is an accomplished financial executive who holds an over 25-year track record of public company expertise, capital market transactions, investor relations, and financial reporting.

Polaryx Therapeutics, a late-stage clinical biotech company developing drugs for lysosomal storage diseases, announced the appointment of Shrijay Vijayan (Jay), Ph.D., as the Chief Business Development Officer. Dr. Vijayan is a highly experienced biomedical technology commercialization executive with an extensive industry network and more than 20 years of technical expertise.

Polaryx Therapeutics, a late-stage clinical biotech company developing drugs for lysosomal storage diseases, announced the appointment of Alex Yang, J.D., LL.M., as the Chief Executive Officer. Mr. Yang, who has served as the Chair of the Board, will succeed Hahn-Jun Lee, M.Sc., Ph.D., who will continue serving on the Board of Directors and as the company’s Chief Scientific Officer.

• Lead drug candidate, PLX-200, approved for single pivotal trial in CLN2 and single registrational trial in CLN3.
• Completed development of novel, patient-friendly oral solution and continuing research and development of buccal formulation
• Exploring partnership opportunities to accelerate clinical development

Polaryx Therapeutics, Inc. (“Polaryx”), a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation for PLX-200 to treat Krabbe disease.

PARAMUS, NEW JERSEY, UNITED STATES, Aug. 30, 2021 /PRNewswire/ — Polaryx Therapeutics, Inc. (“Polaryx”), a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation for PLX-200 to treat GM2 gangliosidoses.

PARAMUS, NEW JERSEY, UNITED STATES, Feb. 10, 2021 /PRNewswire/ — Polaryx Therapeutics, Inc., a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that it has received both Rare Pediatric Disease and Orphan Drug Designations for the treatment of Krabbe Disease (a.k.a. Globoid Cell Leukodystrophy) with PLX-300 from the U.S. Food and Drug Administration (FDA).

PARAMUS, NEW JERSEY, UNITED STATES, Dec. 18, 2020 /PRNewswire/ — Polaryx Therapeutics, Inc., a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that it has received from the U.S. Food and Drug Administration (FDA) both Rare Pediatric Disease and Orphan Drug Designations for the treatment of Niemann Pick Disease Types A and B, known as Acid Sphingomyelinase Deficiency with PLX-300.

PARAMUS, NEW JERSEY, UNITED STATES, Nov. 25, 2020 /PRNewswire/ — Polaryx Therapeutics, Inc., a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that it has received from the U.S. Food and Drug Administration (FDA) both Rare Pediatric Disease and Orphan Drug designations for the treatment of GM2 gangliosidosis with PLX-300.

PARAMUS, NEW JERSEY, UNITED STATES, Aug. 20, 2020 /PRNewswire/ — Polaryx Therapeutics Inc., a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to PLX-200 for the treatment of Juvenile Neuronal Ceroid Lipofuscinosis (JNCL/CLN3) patients.

PARAMUS, NEW JERSEY, UNITED STATES, April 8, 2020 /PRNewswire/ — Polaryx Therapeutics, a biotech company developing patient-friendly, small molecule therapeutics for lysosomal storage disorders, announced today that the Company has received an Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA) to study PLX-200 treatment on Juvenile Neuronal Ceroid Lipofuscinosis (JNCL or CLN3) patients.

PARAMUS, NEW JERSEY, UNITED STATES, Jan. 20, 2020 /PRNewswire/ — Polaryx Therapeutics, a biotech company developing patient-friendly small molecule therapeutics for lysosomal storage disorders announced today that the Company has received an Investigational New Drug Application (IND) approval from the U.S. Food and Drug Administration (FDA) for the treatment of LINCL patients with PLX-200.

This new drug candidate will be used for the treatment of patients with Late Infantile Neuronal Ceroid Lipofuscinosis.

Hahn-Jun Lee, President and CEO of Polaryx Therapeutics Inc., speaks at BIO-Europe® 2019 in Hamburg about how the company accelerates the availability of treatment options for underserved patients, and what the scientific rationale is behind their products.

Renowned pharmaceutical industry publication, Biopharma Dealmakers, has featured Polaryx Therapeutics in their June 2017 edition. Click here to view the publication.

To introduce Polaryx Therapeutics and its technology, GHP magazine has interviewed the Polaryx team. Click now to see the June 2017 GHP magazine edition. Polaryx Therapeutics is featured on pages 26-27.

This new drug candidate will be used for the treatment of patients with Late Infantile Neuronal Ceroid Lipofuscinosis.

Polaryx Therapeutics, Inc. is a biotech company developing patient-friendly oral small molecule therapeutics for Late Infantile Neuronal Ceroid Lipofuscinosis (LINCL) and other forms of NCL, commonly known as Batten disease. Neuronal Ceroid Lipofuscinoses qualify as rare pediatric diseases under Section 529 of the Food, Drug, and Cosmetic Act.

PARAMUS, NEW JERSEY, UNITED STATES, Dec. 18, 2020 /PRNewswire/ — Polaryx Therapeutics, Inc., a biotech company developing small molecule therapeutics for lysosomal storage disorders, announced today that it has received from the U.S. Food and Drug Administration (FDA) both Rare Pediatric Disease and Orphan Drug Designations for the treatment of Niemann Pick Disease Types A and B, known as Acid Sphingomyelinase Deficiency with PLX-300.