FDA Approves Expanded Use Of Novartis' Rare Disease Drug Fabhalta For Kidney Disease [Yahoo! Finance]
Oragenics Inc. (OGEN)
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Source: Yahoo! Finance
reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. In December 2023, the FDA approved Fabhalta as the first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria This indication is granted under accelerated approval based on the pre-specified interim analysis of the Phase 3 APPLAUSE-IgAN study, which measured a reduction in proteinuria at nine months compared to placebo. Whether Fabhalta slows kidney function decline in patients with IgAN has not been established. The continued approval of Fabhalta may be contingent upon verification and description of clinical benefit from the ongoing Phase 3 APPLAUSE-IgAN study, evaluating whether Fabhalta slows disease progression as measured by estimated glomerular filtration rate (eGFR) decline over 24 months. The eGFR data are expected at study completion in 2025 and are intended to support traditional FDA approval. IgAN is a progressive, rare
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- Oragenics, Inc. (NYSE: OGEN) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Oragenics, Inc. (NYSE: OGEN) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Oragenics, Inc. (NYSE: OGEN) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Oragenics, Inc. to Present at The Centurion One Capital 2nd Annual Bahamas SummitGlobeNewswire
- Oragenics, Inc. (NYSE: OGEN) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
OGEN
Sec Filings
- 10/31/24 - Form DEFA14A
- 10/31/24 - Form DEF
- 10/18/24 - Form 8-K
- OGEN's page on the SEC website