Item 7.01 Regulation FD Disclosure. On September 1, 2026, Polaryx Therapeutics, Inc. (the “Company”), announced the appointment of Will Charlton, M.D., M.A.S., as its Chief Medical Officer, effective September 1, 2026. A copy of the Company’s press release announcing Dr. Charlton’s appointment is furnished as Exhibit 99.1 to this Current Report on Form 8-K.…
We are a clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, disease-modifying therapies for rare, pediatric lysosomal storage disorders (“LSDs”). Our therapeutic philosophy is centered on delivering safe, effective, and patient-friendly treatments that address the underlying pathophysiology of these catastrophic diseases and their significant unmet need. Our multi-modal approach integrates small molecule therapies, including a combination therapy, and a gene therapy, positioning us to potentially address both the genetic and downstream pathological features of LSDs. Our small molecule drug candidates share target indications, as well as similar modes of action, that have been demonstrated to address lysosomal dysfunction, neuroinflammation, and neuronal loss in our validated animal models that closely mimic human clinical phenotypes. Our most advanced product candidate, PLX-200, targets several LSDs and we intend to launch a Phase 2 proof-of-concept basket trial which may enhance PLX-200’s potential to become the standard of care across multiple LSDs. Our drug candidate pipeline includes:
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Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On September 1, 2026,
Polaryx Therapeutics, Inc. (the “Company”), announced the appointment of Will Charlton, M.D., M.A.S., as its Chief Medical
Officer, effective September 1, 2026. A copy of the Company’s press release announcing Dr. Charlton’s appointment is furnished
as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this
Item 7.01 and including Exhibit 99.1 furnished herewith shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934 and shall not be incorporated by reference into any filing under the Securities Act of 1933 or the Exchange Act,
except as expressly set forth by specific reference therein.
Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events.
On August 27, 2026, the
Company appointed Will Charlton, M.D., M.A.S. as its Chief Medical Officer, effective September 1, 2026.
Dr. Charlton is a board-certified
pediatric endocrinologist with experience in endocrinology, rare disease, growth disorders, and metabolic disease and spent over a decade
in clinical practice.
Prior to joining Polaryx,
from March 2025 to June 2026, Dr. Charlton served as Senior Vice President, Clinical Development, Skeletal Dysplasia at Tyra Biosciences,
where he led a Phase 2 rare disease clinical trial program through key milestones and developed a multi-indication clinical development
plan to guide long-term growth strategy. Prior to Tyra Biosciences, Dr. Charlton worked as Chief Medical Officer at Spruce Biosciences
from March 2022 to January 2025, where he redesigned the congenital adrenal hyperplasia (“CAH”) program to focus on pediatric
patients and delivered dose-finding and registrational-stage studies. Prior to Spruce Biosciences, Dr. Charlton served from November 2020
to March 2022 as Vice President, Clinical Development at 89bio, where he repositioned clinical strategy and led clinical development for
pegozafermin across MASH and severe hypertriglyceridemia (SHTG).
Item 9.01 Financial
Statements and Exhibits
(d) Exhibits
Exhibit No. Exhibit Title or Description
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99.1 Press Release, dated September 1, 2026
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
Filed exhibits (1)
EX-99.1 (by filename) ea030392801ex99-1.htm
Exhibit 99.1
Polaryx Therapeutics Appoints Dr. Will Charlton
as Chief Medical Officer
Dr. Charlton brings over 15 years of rare disease
and pediatric drug development experience including CMO and clinical development roles
Appointment further strengthens clinical leadership
and execution capabilities ahead of planned SOTERIA Phase 2 initiation in Q4 2026
PARAMUS, N.J., September 1, 2026 (GLOBE NEWSWIRE)
-- Polaryx Therapeutics, Inc. (Nasdaq: PLYX), a clinical-stage biotechnology company developing novel, disease-modifying therapies
for rare pediatric lysosomal storage disorders (“LSDs”), today announced the appointment of Will Charlton, M.D., M.A.S. as
Chief Medical Officer, effective September 1, 2026. With nearly two decades of leadership experience as a Chief Medical Officer and in
senior clinical development roles, Dr. Charlton is a board-certified pediatric endocrinologist with extensive experience in rare diseases
and pediatric drug development spanning the full drug development lifecycle.
Prior to joining Polaryx, Dr. Charlton served
as Senior Vice President, Clinical Development, Skeletal Dysplasia at Tyra Biosciences, where he led a Phase 2 rare disease clinical trial…