BRISBANE, Calif. - Vera Therapeutics, Inc. (NASDAQ: VERA), a biotechnology firm specializing in immunological disease treatments with a market capitalization of $1.5 billion, has reached a pivotal milestone by completing enrollment for its ORIGIN Phase 3 trial, which evaluates atacicept in IgA Nephropathy (IgAN) patients. According to InvestingPro data, the company’s stock has seen significant volatility, declining over 40% year-to-date, though analysts maintain a strong buy consensus with price targets ranging from $34 to $107. The trial has enrolled 431 participants, and the company anticipates primary efficacy endpoint data within this quarter.
The ORIGIN 3 trial is a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of atacicept—a recombinant fusion protein targeting B-cell modulators—for individuals with IgAN who are at a heightened risk of disease progression. InvestingPro analysis shows the company maintains strong financial health with a current ratio of 25.67, indicating robust liquidity to support its clinical development programs. The primary efficacy endpoint is a 36-week interim analysis of proteinuria changes in a subset of at least 200 participants.
Following the trial’s completion, Vera Therapeutics plans to file a Biologics License Application for accelerated approval with the U.S. FDA in the second half of 2025. If approved, the company expects a Prescription Drug User Fee Act (PDUFA) date and a potential commercial launch in 2026.
The ORIGIN Phase 2b trial previously demonstrated that atacicept significantly reduced proteinuria and stabilized kidney function over 96 weeks, suggesting it could be a leading therapy for IgAN. The drug has also been granted FDA Breakthrough Therapy Designation, which indicates its potential to substantially improve treatment over existing options for IgAN patients.
Participants in the ORIGIN 3 trial receive weekly subcutaneous injections of either atacicept 150 mg or a placebo over 104 weeks, followed by a 52-week open-label extension. Secondary efficacy endpoints include changes in kidney function measured through 104 weeks.
Vera Therapeutics is also conducting the ORIGIN Extend trial to provide extended access to atacicept and gather long-term safety and efficacy data. Atacicept’s development is part of Vera’s broader mission to offer new treatments that address the root causes of immunological diseases.
The company’s statements regarding its expectations for the ORIGIN 3 trial, regulatory submissions, and the potential commercialization of atacicept are forward-looking and subject to risks and uncertainties that could cause actual results to differ materially. While the company holds more cash than debt on its balance sheet, InvestingPro data reveals that analysts do not anticipate profitability this year, with projected EPS of -$3.26. For deeper insights into Vera’s financial health and additional ProTips, investors can access comprehensive analysis through InvestingPro’s advanced analytics platform. These include the inherent risks of the clinical trial process and regulatory approval, as well as broader economic and geopolitical factors.
This news is based on a press release statement from Vera Therapeutics.
In other recent news, Vera Therapeutics reported financial results for the year ending December 31, 2024, with a net loss of $152.1 million, up from $96.0 million in 2023. Despite this, the company ended the year with $640.9 million in cash, which it anticipates will support operations through the potential approval and commercial launch of its IgA Nephropathy (IgAN) treatment, atacicept. Guggenheim analysts have increased their price target for Vera Therapeutics to $61, maintaining a Buy rating, citing the company’s financial strength and ongoing progress in its Phase 3 ORIGIN 3 trial. Evercore ISI also maintained an Outperform rating with a $75 target, emphasizing the unique mechanism of action of atacicept and its potential in the IgAN market. Cantor Fitzgerald expressed confidence in atacicept’s data, maintaining an Overweight rating with a $107 price target, noting the drug’s potential to stabilize kidney function for up to 96 weeks.
Vera Therapeutics plans to announce primary endpoint results from its Phase 3 ORIGIN trial in the second quarter of 2025 and aims to file a Biologics License Application (BLA) with the FDA later that year. The company has received FDA Breakthrough Therapy Designation for atacicept, which is seen as a promising development in IgAN treatment. However, recent updates from competitor Otsuka about its drug sibeprelimab have raised concerns about market competition. Otsuka’s drug, anticipated to enter the market before atacicept, is expected to be self-administered monthly, potentially offering a more convenient option for patients. Investors are closely monitoring these developments as both companies prepare to release additional data, which will be crucial in assessing the competitive landscape for IgAN treatments.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.