Vera Therapeutics Announces Successful Completion of Phase 3 Trial for Atacicept; Plans to Submit BLA for FDA Approval in IgA Nephropathy by Q4 2025

Reuters

06-02

Vera <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Announces Successful Completion of Phase 3 Trial for Atacicept; Plans to Submit BLA for FDA Approval in IgA Nephropathy by Q4 2025

On June 2, 2025, Vera Therapeutics, Inc. announced that its ORIGIN Phase 3 trial for atacicept, aimed at treating immunoglobulin A nephropathy (IgAN) in adults, successfully met its primary endpoint. Participants receiving atacicept achieved a 46% reduction in proteinuria from baseline and a 42% reduction compared to placebo. Vera plans to submit a Biologics License Application $(BLA.AU)$ for accelerated approval to the FDA in the fourth quarter of 2025, potentially paving the way for a U.S. approval and commercial launch in 2026. The company is preparing for a potential commercial launch and further development in additional indications for autoimmune kidney diseases. Vera will host an investor call and webcast to discuss these findings and the regulatory pathway.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Vera Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9461377-en) on June 02, 2025, and is solely responsible for the information contained therein.

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Participants receiving atacicept achieved a 46% reduction in proteinuria from baseline and a 42% reduction compared to placebo. Vera plans to submit a Biologics License Application <a href=\"https://laohu8.com/S/BLA.AU\">$(BLA.AU)$</a> for accelerated approval to the FDA in the fourth quarter of 2025, potentially paving the way for a U.S. approval and commercial launch in 2026. The company is preparing for a potential commercial launch and further development in additional indications for autoimmune kidney diseases. Vera will host an investor call and webcast to discuss these findings and the regulatory pathway.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Vera Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9461377-en) on June 02, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00BGHQF748.EUR","symbol_name":"GUINNESS GLOBAL MONEY MANAGERS \"C\" (EUR) ACC","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250602:nNDL77rwLR:1","article_id":"2540070764","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2540070764","pubTimestamp":1748860227,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Vera Therapeutics Announces Successful Completion of Phase 3 Trial for Atacicept; Plans to Submit BLA for FDA Approval in IgA Nephropathy by Q4 2025. 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Participants receiving atacicept achieved a 46% reduction in proteinuria from baseline and a 42% reduction compared to placebo. Vera plans to submit a Biologics License Application $(BLA.AU)$ for accelerated approval to the FDA in the fourth quarter of 2025, potentially paving the way for a U.S. approval and commercial launch in 2026. The company is preparing for a potential commercial launch and further development in additional indications for autoimmune kidney diseases. Vera will host an investor call and webcast to discuss these findings and the regulatory pathway.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Vera Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9461377-en) on June 02, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"code":"91000000","status":"200"}}}