Vera Therapeutics, Inc（VERA）资讯与事件

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VERA 资讯

5.008-07Globenewswire

Vera Therapeutics Grants Stock Awards to New Executives

5.008-06Globenewswire

Vera Therapeutics Announces Chief Regulatory Officer Transition

6.507-15CNBC

Kratos Defense Stock Considered Undervalued by Analysts

7.507-10NASDAQ.COM

Key Developments in Biotech Sector This Week

9.007-08NASDAQ.COM

Vera Therapeutics Receives FDA Accelerated Approval for TRUTAKNA

8.007-07NASDAQ.COM

Freedom Holding Corp Sees Surge in Options Trading Volume

8.507-07stocktwits

Vera Therapeutics' Trutakna Receives FDA Approval for IgAN

8.507-07Newsfilter

TRUTAKNA Receives FDA Accelerated Approval for IgAN Treatment

9.007-07seekingalpha

Vera Therapeutics' Kidney Therapy Receives FDA Approval

8.507-06stocktwits

Vera Therapeutics' Atacicept FDA Decision Approaches, Stock Rises

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VERA 事件

8/10 17:30

Vera Therapeutics Launches TRUTAKNA for IgAN Patients

"The accelerated approval and commercial launch of TRUTAKNA represent transformative milestones for Vera Therapeutics and are the result of years of hard work and dedication. We are extremely grateful to the patients, investigators, employees, and collaborators who have contributed to this moment," said Marshall Fordyce, Founder and Chief Executive Officer of Vera Therapeutics. "We are thrilled that TRUTAKNA is available to eligible patients as the first and only therapy to inhibit both BAFF and APRIL in IgAN patients. We are focused on a successful U.S. launch of TRUTAKNA, and we continue to advance the ORIGIN 3 program in support of a potential full approval."

7/9 08:30

Vera Therapeutics Chief Regulatory Officer William Turner Retires, Nancy Boman Succeeds

Vera Therapeutics (VERA) announced a planned transition of the chief regulatory officer position. William Turner, current chief regulatory officer of Vera Therapeutics, is planning to retire and transition to the role of strategic advisor in the third quarter of this year after a successful tenure at the company, including the recent accelerated approval of Vera Therapeutics' first therapy in IgA nephropathy, Trutakna. Nancy Boman will succeed Turner as chief regulatory officer of Vera Therapeutics. Most recently, she served as the chief regulatory officer at Kyverna Therapeutics (KYTX).

7/7 12:30

FDA Approves Vera Therapeutics' Trutakna for IgA Nephropathy

The U.S. Food and Drug Administration has approved Trutakna to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression. Trutakna is injected subcutaneously once weekly. The efficacy and safety of Trutakna were evaluated in a randomized, double-blind, placebo-controlled clinical trial in adults with biopsy-confirmed IgA nephropathy. Patients were randomly assigned to either Trutakna 150 mg injected subcutaneously once weekly or placebo. The primary efficacy endpoint assessed the change from baseline in proteinuria after 9 months of treatment in the first 203 patients who had the opportunity to reach the month 9 visit. At 9 months, patients in the Trutakna group had an average 46% reduction in proteinuria as compared to an proteinuria in the placebo group. The FDA approval was granted to Vera Therapeutics.

6/2 11:50

Vera Therapeutics Aligns with FDA on Revised eGFR Analysis Plan

Vera Therapeutics announced it has aligned with the U.S. Food and Drug Administration on a revised, earlier ORIGIN 3 eGFR analysis plan to support full approval for atacicept in adults with IgAN. "The eGFR results are now expected in the third quarter of 2026. Pending these results, Vera Therapeutics plans to submit an sBLA for full approval in the fourth quarter of 2026. Alignment with the FDA on a revised eGFR analysis plan follows a recent workshop hosted by the National Kidney Foundation which included clinicians, researchers, regulators, and patient advocates. In addition, the alignment with the FDA has been supported by the eGFR results from the ORIGIN Phase 2b trial of atacicept in IgAN," the company stated. "We are excited for the potential to deliver the first approved therapy targeting both BAFF and APRIL in adults with IgAN, and to bring forward the eGFR analysis to potentially support full approval of atacicept in this indication at an earlier date," said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics.

5/7 09:00

Vera Therapeutics Advances Atacicept for Potential FDA Accelerated Approval

"The team at Vera Therapeutics is focused on execution as we advance atacicept toward potential FDA accelerated approval in IgAN," said Marshall Fordyce, Founder and CEO of Vera Therapeutics. "During the first quarter, we made meaningful progress across key pre-commercial activities, including in sales, marketing, market access, compliance, and commercial operations, to support a successful U.S. launch, pending regulatory approval. We are excited for atacicept to potentially be the first approved drug targeting both BAFF and APRIL in IgAN patients."

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