UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On September 15, 2026, Vera Therapeutics, Inc. (the “Company”) announced that TRUTAKNA™ (atacicept-vymj) met all prespecified endpoints of the final efficacy analysis of the ORIGIN 3 trial in adults with primary IgA nephropathy (“IgAN”) at risk for disease progression. A copy of the press release is furnished as Exhibit 99.1. In connection with the data release, the Company updated its corporate presentation (the “Corporate Presentation”) to include the final efficacy analysis of the ORIGIN 3 trial referenced above. A copy of the Corporate Presentation is furnished as Exhibit 99.2. For important information about forward-looking statements, see the slide titled “Forward-Looking Statements” in Exhibit 99.2 attached hereto.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01, including Exhibits 99.1 and 99.2, shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission (“SEC”) made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
| Item 8.01 | Other Events. |
As noted in Item 7.01, on September 15, 2026, the Company announced that TRUTAKNA met all prespecified endpoints of the final efficacy analysis of the ORIGIN 3 trial in adults with primary IgAN at risk for disease progression. Topline results from the final analysis set of 428 patients are presented below.
|
|
TRUTAKNA |
Placebo |
Treatment effect |
p-value | ||||
| Mean eGFR change from baseline at 52 weeks, mL/min/1.73m2 | -0.1 (95% CI -1.4, 1.2) |
-5.7 (95% CI -7.0, -4.4) |
5.6 (95% CI 3.7, 7.5) |
<0.0001 | ||||
| Annualized eGFR slope through 104 weeks, mL/min/1.73m2/year | -0.6 (95% CI -1.6, 0.4) |
-5.6 (95% CI -6.6, -4.6) |
5.0 (95% CI 3.6, 6.5) |
<0.0001 | ||||
| Composite kidney disease progression event through 104 weeks, n | 11 | 38 | Hazard ratio 0.24 (95% CI 0.12, 0.48) 76% risk reduction |
<0.0001 | ||||
| Dialysis ≥30 days, transplant, or death through 104 weeks, n |
0 | 8 |
These estimated glomerular filtration rate (“eGFR”) results align with the KDIGO treatment goal to reduce the rate of kidney function decline to the physiologic rate (<1 mL/min/1.73m2/year). TRUTAKNA also achieved statistically significant reductions in the hierarchically tested endpoints of proteinuria, galactose-deficient IgA1, and hematuria. TRUTAKNA was well tolerated with a favorable safety profile generally comparable to placebo, consistent with previous results from the ORIGIN program. Rates of overall adverse events and infections or infestations were similar between the TRUTAKNA and placebo groups, and there were no opportunistic infections or clinically relevant hypogammaglobulinemia.
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| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release of Vera Therapeutics, Inc., dated September 15, 2026 | |
| 99.2 | Corporate Presentation, dated September 15, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
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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.
| Vera Therapeutics, Inc. | ||||||
| Dated: September 15, 2026 | ||||||
| By: | /s/ Marshall Fordyce | |||||
| Marshall Fordyce, M.D. | ||||||
| Chief Executive Officer | ||||||
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