Search This Blog

Wednesday, November 5, 2025

Viridian succeeds in financing, BLA application

Completed a comprehensive set of financing transactions in October 2025, securing access to up to $889 million of potential capital across equity, royalty, and credit -

­­ - Successful October submission of Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for veligrotug in thyroid eye disease (TED) and preparing for an anticipated U.S. commercial launch in mid-2026, if approved, under a Priority Review timeline -

- Subcutaneous VRDN-003 topline data readout accelerated to Q1 2026 for REVEAL-1 and narrowed to Q2 2026 for REVEAL-2 for active and chronic TED, respectively; each study exceeded its enrollment target due to strong patient demand -

- Neonatal Fc receptor (FcRn) inhibitor, VRDN-006, showed proof-of-concept IgG reduction and was sparing of albumin and LDL in a phase 1 healthy volunteer clinical trial; half-life extended FcRn inhibitor, VRDN-008, on track for 2025 Investigational New Drug (IND) filing with healthy volunteer data anticipated in 2H 2026 -

- Cash position of approximately $887.9 million as of October 31, 2025, inclusive of upfront payments received in October from license, royalty, and debt agreements, as well as proceeds from the equity offering -

- The company believes its existing cash, potential near-term milestones from the royalty agreement, and anticipated commercial revenues, if both veligrotug and VRDN-003 are approved, are expected to fund its current business plans through profitability -

https://www.biospace.com/press-releases/viridian-therapeutics-reports-third-quarter-2025-financial-results-and-highlights-recent-progress

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.