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BRISBANE, Calif. - Vera Therapeutics , Inc. (NASDAQ:VERA), a late-stage biotechnology company with a market capitalization of $1.7 billion, is on schedule to announce primary endpoint results from its Phase 3 ORIGIN trial for atacicept, a drug intended to treat IgA Nephropathy (IgAN), in the second quarter of 2025. Analysts maintain a strong buy consensus with price targets ranging from $25 to $107 per share. The company plans to submit a Biologics License Application (BLA) to the U.S. FDA for accelerated approval in the second half of 2025.
The announcement came as part of Vera’s business highlights and financial results for the year ended December 31, 2024. The company has received FDA Breakthrough Therapy Designation for atacicept in IgAN, which could signify a substantial improvement over existing therapies.
Vera reported a net loss of $152.1 million for 2024, with a net loss per diluted share of $2.75. This compares to a net loss of $96.0 million in 2023. Operating expenses for research and development rose to $126.2 million from $78.2 million the previous year. The company ended the year with $640.9 million in cash, cash equivalents, and marketable securities, which is believed to be sufficient to fund operations through the potential approval and commercial launch of atacicept. According to InvestingPro data, Vera maintains a strong financial position with more cash than debt and a healthy current ratio of 13.76, indicating robust liquidity. For deeper insights into Vera’s financial health metrics and 13 additional ProTips, consider exploring InvestingPro’s comprehensive analysis tools.
Atacicept is a recombinant fusion protein that targets cytokines involved in B-cell survival and autoantibody production associated with autoimmune diseases. The Phase 2b ORIGIN trial met its primary and key secondary endpoints, showing significant proteinuria reductions and stabilization of eGFR compared to placebo.
The company also announced an expanded clinical development program for atacicept across multiple autoimmune kidney diseases, including primary membranous nephropathy, focal segmental glomerulosclerosis, and minimal change disease, starting in 2025.
Vera’s leadership team has been strengthened with industry veterans to support the clinical pipeline development, planned FDA submission, and potential commercial launch. The company anticipates full enrollment for the ongoing pivotal ORIGIN 3 trial in the second quarter of 2025, with a commercial launch expected in 2026 if regulatory approvals are granted. InvestingPro analysis indicates the stock is currently trading near its 52-week low, with recent technical indicators suggesting oversold conditions. Discover more detailed market analysis and real-time updates with an InvestingPro subscription.
This report is based on a press release statement from Vera Therapeutics. The company’s forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those projected. Vera does not undertake any obligation to update these statements, except as required by law.
In other recent news, Vera Therapeutics has garnered attention from analysts regarding its treatment for IgA Nephropathy (IgAN). Evercore ISI maintained its Outperform rating on the company, setting a price target of $75, citing the potential of Vera’s atacicept therapy. The firm emphasized the unique mechanism of action and promising two-year data of atacicept, despite recent competitive developments from Otsuka. Meanwhile, Cantor Fitzgerald reiterated its Overweight rating with a $107 price target, highlighting the promising data on atacicept’s ability to stabilize kidney function for up to 96 weeks.
The anticipation is building around the Phase 3 ORIGIN trial results for atacicept, expected in the second quarter of 2025, which are crucial for assessing the drug’s efficacy and safety. However, Vera Therapeutics faces competition from Otsuka’s sibeprelimab, which is anticipated to enter the market before atacicept. Analysts note that sibeprelimab’s once-monthly self-administered prefilled syringe could be perceived as more convenient compared to atacicept’s weekly autoinjector. The market is closely monitoring these developments, with significant interest in upcoming data releases from both companies.
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