Ionis announces FDA acceptance of New Drug Application for donidalorsen for prophylactic treatment of HAE [Yahoo! Finance]
Ionis Pharmaceuticals, Inc. (IONS)
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Source: Yahoo! Finance
Donidalorsen has the potential to be Ionis' second independent commercial launch CARLSBAD, Calif. Nov. 4, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. The FDA has set an action date of August 21, 2025 under the Prescription Drug User Fee Act (PDUFA). The FDA application was based on positive results with monthly and bi-monthly dosing in the pivotal Phase 3 OASIS-HAE and OASISplus (open label extension (OLE) and switch) studies, as well as the ongoing Phase 2 OLE study. HAE is a rare and potentially life-threatening genetic condition that involves recurrent attacks of severe swelling (angioedema) in various parts of the body, including the hands, feet, genitals, s
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- Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) had its "outperform" rating re-affirmed by analysts at Royal Bank of Canada. They now have a $70.00 price target on the stock.MarketBeat
- Ionis enters new chapter in 2025 as commercial-stage biotech with multiple independent product launches anticipated and continued late-stage pipeline momentum [Yahoo! Finance]Yahoo! Finance
- Ionis enters new chapter in 2025 as commercial-stage biotech with multiple independent product launches anticipated and continued late-stage pipeline momentumPR Newswire
- Ionis to present at 43rd Annual J.P. Morgan Healthcare ConferencePR Newswire
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- 11/6/24 - Beat
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Sec Filings
- 2/13/25 - Form SCHEDULE
- 2/7/25 - Form SCHEDULE
- 2/6/25 - Form 4
- IONS's page on the SEC website