UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01. | Other Events. |
On December 16, 2024, Annexon, Inc. (“Annexon” or the “Company”) issued a press release (the “RWE Press Release”) announcing positive topline results from a real-world evidence study of ANX005 in Guillain-Barré Syndrome. Working in collaboration, the International GBS Outcome Study (“IGOS”) investigators and Annexon established a matched cohort of patients treated with ANX005 30 mg/kg in the completed Phase 3 study conducted outside the U.S. with a cohort of real-world patients from the IGOS global registry treated with intravenous immunoglobulin (“IVIg”) or plasma exchange (“PE”). Patients treated with ANX005 30 mg/kg showed faster and greater improvement in muscle strength and disability compared to patients in the matched IGOS cohort treated with IVIg or PE. The comparison also showed that fewer patients treated with ANX005 required mechanical ventilation. Further, ANX005 treated patients were observed to spend less time on ventilation and less time in the intensive care unit. A copy of the RWE Press Release is filed herewith as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated December 16, 2024, titled “Annexon Announces Positive Topline Results from Real-World Evidence Study Comparing ANX005 Treatment to Intravenous Immunoglobulin (IVIg) or Plasma Exchange (PE) in a Matched Patient Cohort for the Treatment of Guillain-Barré Syndrome (GBS).” | |
| 104 | Cover Page Interactive Data File, formatted in inline XBRL. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: December 16, 2024 | Annexon, Inc. | |||||
| By: | /s/ Jennifer Lew | |||||
| Jennifer Lew | ||||||
| Executive Vice President and Chief Financial Officer | ||||||