Catalyst Pharmaceuticals Announces Health Canada’s Acceptance of AGAMREE® New Drug Submission with Priority Review for Sub-Licensee Kye Pharmaceuticals
Catalyst Pharmaceuticals, Inc. (CPRX)
Last catalyst pharmaceuticals, inc. earnings: 3/16 05:26 pm
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Source: GlobeNewswire
CORAL GABLES, Fla., April 08, 2025 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today reported that its sub-licensee in Canada, Kye Pharmaceuticals, Inc. (Kye), has announced that Health Canada has accepted the New Drug Submission (NDS) for AGAMREE®, a novel corticosteroid treatment for Duchenne muscular dystrophy (DMD), for review. The submission has been granted Priority Review, expediting the regulatory process with the potential for marketing authorization before the end of 2025. If approved, AGAMREE would be the first and only treatment option indicated for patients diagnosed with DMD in Canada. “We are pleased that Health Canada has accepted the New Drug Submission for AGAMREE with a Priority Review, recognizing its potential to address a significant
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- Catalyst Pharmaceuticals to Participate in the 44th Annual J.P. Morgan Healthcare ConferenceGlobeNewswire
CPRX
Earnings
- 11/5/25 - Beat
CPRX
Sec Filings
- 12/16/25 - Form 4
- 12/12/25 - Form 144
- 12/10/25 - Form 4
- CPRX's page on the SEC website