FDA Accepts Ionis' (IONS) NDA for Rare Disease Drug Olezarsen [Yahoo! Finance]
Ionis Pharmaceuticals, Inc. (IONS)
Last ionis pharmaceuticals, inc. earnings: 2/26 07:00 am
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Source: Yahoo! Finance
therapy olezarsen as a potential treatment for adults with familial chylomicronemia syndrome (FCS). The FDA granted priority review to this NDA. A filing designated as a priority review reduces the review period by four months. A final decision is expected by Dec 19, 2024. Management has also stated that the FDA does not plan to hold an advisory committee meeting for Ionis' NDA filing. The NDA is supported by results from the phase III BALANCE study, where FCS patients treated with olezarsen achieved significant triglyceride-lowering and substantial reductions in acute pancreatitis attacks in FCS patients. Management is also planning to submit a similar regulatory filing for olezarsen with the EMA later this year. FCS is a rare genetic disease marked by extremely elevated triglyceride levels. People living with this condition are at high risk of acute pancreatitis in addition to other chronic health issues such as fatigue and severe, recurrent abdominal pain. Olezarsen is one
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News
- She's fighting to stop the brain disease that killed her mother before it gets her. [USA TODAY]USA TODAY
- Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) had its price target raised by analysts at Stifel Nicolaus from $50.00 to $53.00. They now have a "hold" rating on the stock.MarketBeat
- Ionis Pharmaceuticals (IONS) Soars 6.8%: Is Further Upside Left in the Stock? [Yahoo! Finance]Yahoo! Finance
- Ionis announces olezarsen FCS New Drug Application accepted for Priority Review and enrollment in Phase 3 sHTG program completed [Yahoo! Finance]Yahoo! Finance
- Ionis announces olezarsen FCS New Drug Application accepted for Priority Review and enrollment in Phase 3 sHTG program completedPR Newswire
IONS
Earnings
- 5/7/24 - Beat
IONS
Sec Filings
- 6/20/24 - Form 4
- 6/18/24 - Form 8-K
- 6/17/24 - Form 144
- IONS's page on the SEC website