New Drug Submission for AGAMREE® (vamorolone) Accepted for Priority Review by Health Canada for the Treatment of Duchenne Muscular Dystrophy [Yahoo! Finance]
Catalyst Pharmaceuticals, Inc. (CPRX)
Last catalyst pharmaceuticals, inc. earnings: 3/16 05:26 pm
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Source: Yahoo! Finance
Upon approval, vamorolone would be the first and only treatment option indicated for patients diagnosed with Duchenne muscular dystrophy in Canada The Canadian regulatory submission of vamorolone follows approvals in the US in 2023, and the European Union in early 2024 This New Drug Submission reflects Kye Pharmaceuticals' commitment to advancing treatments for rare diseases and serving the unmet needs of Canadian patients MISSISSAUGA, ON April 8, 2025 /PRNewswire/ - Kye Pharmaceuticals, Inc. ("Kye") announced today it has submitted a New Drug Submission (NDS) to Health Canada for the regulatory review and approval of AGAMREE ® (vamorolone). If approved, AGAMREE ® would be the first and only therapy approved by Health Canada with an indication for the treatment of Duchenne muscular dystrophy (DMD). Health Canada has granted AGAMREE ® a priority review and marketing authorization could be granted before the end of 2025. News of the AGAMREE ® priority review was welcomed by natio
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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