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Novartis Fabhalta wins first FDA traditional approval to slow IgAN kidney decline
Novartis has won FDA traditional approval for Fabhalta to slow kidney function decline in adults with primary IgA nephropathy, upgrading a 2024 accelerated label into the first full complement-inhibitor claim on eGFR. The decision moves Novartis ahead of Vera Therapeutics' Trutakna, which received only accelerated approval on 7 July, and lands one day before the Novartis Q2 2026 earnings release. The commercial question is whether Fabhalta's oral, disease-modifying label can convert into a durable IgAN franchise against a widening field of complement, endothelin and B-cell targeted therapies.
Dimerix (ASX: DXB) acquires Phase 2-ready DMX-652 as acute kidney injury deal reshapes renal pipeline
Dimerix has acquired a Phase 2-ready acute kidney injury candidate with an open United States clinical application, giving the biotechnology company a nearer-term catalyst beyond its long-running ACTION3 programme.
Mirador Therapeutics licenses long-acting KP-301 antibody from Kira Pharmaceuticals to enter ANCA-associated vasculitis
Mirador licenses long-acting anti-C5a antibody KP-301 from Kira, with Phase 1 planned in 2026 and an AAV Phase 2 study targeted for 2027.
Takeda’s zasocitinib shows high clearance rates at difficult psoriasis sites
Scalp and palmoplantar clearance rates approached 70% to 77%, but regulatory review, safety labelling and market access will determine the commercial impact.
Eli Lilly (NYSE: LLY) to acquire AtaiBeckley in $3.8bn TRD psychedelic deal
Eli Lilly (NYSE: LLY) to acquire AtaiBeckley for $6.75/share cash plus $2.50 CVR, taking the BPL-003 5-MeO-DMT depression asset to Phase 3 read in 2029.
Valerio Therapeutics and Abivax target next-generation therapies for inflammatory disease
Valerio may gain cash and platform validation from Abivax, but definitive terms and preclinical delivery will decide whether the alliance creates value.
Poolbeg Pharma (AIM: POLB) raises ÂŁ3.5m to fund POLB 001 and oral GLP-1 trials
The discounted placing should fund two potentially value-defining clinical studies through completion, although investors must absorb a larger share base before either programme produces proof-of-concept data.
Biogen stock (NASDAQ: BIIB) falls 8.2%: Can diranersen recover in Phase 3?
Biogen’s diranersen reduced tau and showed its strongest clinical result at the lowest dose, but the Phase 2 study missed its dose-response goal. With $BIIB down 8.2%, July 29 results and the Phase 3 design become the next tests.
Mesoblast (ASX: MSB) clears key treatment milestone ahead of mid-2027 back pain trial readout
Mesoblast has treated at least 300 patients in MSB-DR004, starting the final 12-month clock towards a mid-2027 readout and potential United States filing. The milestone strengthens execution visibility, but it does not provide new efficacy data.
Vectus Biosystems (ASX:VBS) appoints Cardinal Health Regulatory Sciences for VB0004 FDA pathway
Vectus Biosystems has formalised its United States regulatory strategy for VB0004, but financing, clinical execution and evidence of human antifibrotic activity remain the decisive valuation tests.