The U.S. FDA has granted accelerated approval to Novartis AG’s Fabhalta (iptacopan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The approval strengthens the company’s renal disease presence as it puts two other IgAN treatments through clinical trials.
Vertex Pharmaceuticals Inc. is acquiring Alpine Immune Sciences Inc. for $4.9 billion in cash to gain Alpine’s lead product, phase III-ready povetacicept, which demonstrates best-in-class potential in patients with immunoglobulin A nephropathy (IgAN). Povetacicept (ALPN-303), or “pove,” holds potential “as a pipeline in a product in a number of other serious renal diseases and cytopenias,” Vertex CEO Reshma Kewalramani said during an April 10 conference call, noting that the deal was “just the right fit with just the right assets at just the right phase of development where Vertex can add value.”
Seven new therapies, including two influenza vaccines, were recommended for approval by the EMA’s Committee for Medicinal Products for Human Use during its February 2024 meeting. One of these was sparsentan by CSL Vifor Pharma Inc. and Travere Therapeutics Inc. for the treatment of IgA nephropathy (IgAN), for which the committee has awarded conditional marketing authorization.
Travere Therapeutics Inc. inked a licensing deal with Tokyo-based Renalys Pharma Inc. to develop sparsentan in 13 Asian countries, becoming the latest news to heat up the immunoglobulin A nephropathy (IgAN) therapy space.
Travere Therapeutics Inc. inked a licensing deal with Tokyo-based Renalys Pharma Inc. to develop sparsentan in 13 Asian countries, becoming the latest news to heat up the immunoglobulin A nephropathy (IgAN) therapy space.
Wall Street got what it wanted from Vera Therapeutics Inc. with atacicept in IgA nephropathy (IgAN) and rewarded shares of the Brisbane, Calif.-based firm (NASDAQ:VERA), pushing them to close Jan. 25 at $25.31, up $8.29, or 49%.
Arrowhead Pharmaceuticals Inc. has filed an application in New Zealand seeking clearance to initiate a phase I/IIa trial of ARO-CFB, the company’s investigational RNA interference (RNAi) therapeutic being developed as a potential treatment for complement-mediated renal disease, such as immunoglobulin A nephropathy (IgAN).
Calliditas Therapeutics AB’s full approval from the U.S. FDA for Tarpeyo (budesonide) delayed release capsules in immunoglobulin A nephropathy (IgAN) revived speculation about competitor Travere Therapeutics Inc. which, like Calliditas, has gained accelerated approval for its prospect.
Otsuka Pharmaceutical Co. Ltd.’s sibeprenlimab (VIS-649) met the primary efficacy endpoint in a phase II trial for treating immunoglobulin A nephropathy (IgAN), demonstrating that 12 months of treatment resulted in significant reductions in proteinuria compared to placebo.
