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BCS

Current Report · Items 7.01, 8.01, 9.01 · 8-K

Polaryx Therapeutics, Inc.

PLYXNASDAQEQUITYCurrent

Regulation FD Disclosure · Other Events

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.…

Filed Sep 1, 2026Accepted Sep 1, 2026, 4:30 PM EDTCIK 2075320Accession 0001213900-26-096235
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Company context

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:

Current securities

Recent company filings

  1. Submission of Matters to a Vote of Security HoldersSep 14, 2026
  2. 10-Q filingAug 13, 2026
  3. ARS filingJul 28, 2026
  4. DEFA14A filingJul 28, 2026
  5. DEF 14A filingJul 28, 2026

Registered securities in this filing

Polaryx Therapeutics, Inc. · 8-K · Filed 2026-09-01

As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.

Common Stock, par value $0.0001 per share

Symbol
PLYX
Exchange
NASDAQ
Classification
COMMON
Status
Current
Filing context

Context: AsOf2026-09-01

Dimensions: Not supplied

Accession 000121390026096235 · 1 registered-security cover member

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Disclosure sections

Items 7.01, 8.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

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 ───────────────────────────────────────────────────────────────────────────────────────────────── 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…

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