{"id":561078,"date":"2026-07-21T17:05:20","date_gmt":"2026-07-21T17:05:20","guid":{"rendered":"https:\/\/www.newsbeep.com\/ie\/561078\/"},"modified":"2026-07-21T17:05:20","modified_gmt":"2026-07-21T17:05:20","slug":"vertexs-iga-nephropathy-drug-derisked-after-novartis-vera-approvals","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ie\/561078\/","title":{"rendered":"Vertex\u2019s IgA nephropathy drug derisked after Novartis, Vera approvals"},"content":{"rendered":"

The odds are ever in favor of Vertex Pharmaceuticals\u2019 povetacicept, under regulatory review for IgA nephropathy, after key FDA approvals in recent weeks.<\/p>\n

Friday, the agency granted full approval<\/a> to Novartis\u2019 Fabhalta for IgAN, making it the only complement inhibitor indicated to slow the worsening of kidney function for the disease. Fabhalta was first granted accelerated approval in August 2024<\/a>. Just days before the full approval, the FDA also cleared<\/a> Vera Therapeutics\u2019 atacicept\u2014now branded as Trutakna\u2014for IgAN.<\/p>\n

These approvals, analysts at BMO Capital Markets said, are likely to provide a tailwind for Vertex\u2019s povetacicept, an application for which is being reviewed by the FDA with a target action date of Nov. 30<\/a>\u2014and could help make up for the biotech\u2019s late entry into the market.<\/p>\n

\u201cVertex may not be first to the game,\u201d the analysts said in a July 17 note, \u201cbut is likely to benefit from ongoing educational\/awareness-enhancing efforts from competing manufacturers.\u201d Also in Vertex\u2019s favor is the biotech\u2019s \u201cinternational footprint\u201d and \u201chistory of commercial execution,\u201d BMO said.<\/p>\n

Povetacicept is a fusion protein therapeutic that works by inhibiting both BAFF and APRIL cytokines, in turn suppressing the immune pathways that drive IgAN. In March, topline Phase 3 data showed a 49.8% decrease<\/a> in urine protein creatinine ratio (UPCR), an indicator of kidney damage, at 36 weeks in patients on povetacicept versus placebo.<\/p>\n

Analysts are keeping a close eye on how povetacicept\u2019s review goes, with BMO in a May 5 note telling investors<\/a> that an approval could trigger an evolution of Vertex\u2019s business in a way \u201cthat may be nothing short of iconic.\u201d<\/p>\n

<\/p>\n

\"Stones<\/p>\n

<\/a><\/p>\n

\n While some analysts may regard Vertex Pharmaceuticals\u2019 first quarter results as \u201cunremarkable,\u201d BMO Capital Markets wrote on Monday, the second half of 2026 could be big for the biotech, with the potential approval of IgAN therapy povetacicept.\n <\/p>\n

May 5, 2026<\/p>\n

\u00a0\u00b7\u00a0<\/p>\n

2 min read<\/p>\n

\u00a0\u00b7\u00a0<\/p>\n

Fabhalta\u2019s full approval now provides the benchmark for povetacicept moving forward, the group wrote on Friday. Data from Novartis\u2019 Phase 3 APPLAUSE-IgAN study showed that over two years of follow-up, Fabhalta resulted in significant and clinically meaningful improvements in kidney function, as measured by the estimated glomerular filtration rate (eGFR).<\/p>\n

This outcome \u201csets the efficacy bar Vertex will need to exceed for durable differentiation\u201d when the company presents two-year data for povetacicept next year, BMO wrote. The firm is nevertheless confident in povetacicept, pointing to the drug\u2019s \u201csuperior reductions in UPCR.\u201d Although there have been no head-to-head studies comparing povetacicept and Fabhalta, Novartis\u2019 drug elicited a 44% UPCR reduction in APPLAUSE-IgAN, leading to its accelerated approval.<\/p>\n

\u201cIt is widely accepted that the extent of UPCR reduction generally increases the likelihood of more meaningful long-term eGFR outcomes,\u201d BMO said. Given povetacicept\u2019s superior UPCR benefits, \u201cwe could potentially see even greater slowing in eGFR decline from the asset.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"The odds are ever in favor of Vertex Pharmaceuticals\u2019 povetacicept, under regulatory review for IgA nephropathy, after key…\n","protected":false},"author":2,"featured_media":561079,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33],"tags":[103,61,60,371],"class_list":["post-561078","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-health","tag-ie","tag-ireland","tag-medication"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/561078","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/comments?post=561078"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/posts\/561078\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media\/561079"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/media?parent=561078"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/categories?post=561078"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ie\/wp-json\/wp\/v2\/tags?post=561078"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}