Monopar delays ALXN1840 NDA to mid-2026 amid FDA dialogue; raises $92M, extends runway to 2027

Filed March 27, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 31, 2025 · ~1 min read

Key Changes

• high

  NDA submission for ALXN1840 pushed from early 2026 to mid-2026 as FDA requests additional information and continued dialogue before filing; no assurance of acceptance or approval.

  Business: NDA timing verify on EDGAR →
• high

  Raised $91.9M net in September 2025 public offering, extending cash runway from December 2026 to December 2027; cash and investments more than doubled to $140.4M.

  MD&A: Capital raise verify on EDGAR →
• high

  Presented pooled long-term ALXN1840 data at three major conferences (EASL, ANA, AASLD) showing sustained neurological and hepatic benefit over 6 years and improved copper balance, addressing prior Alexion termination concerns.

  Business: Clinical data verify on EDGAR →