secwatch.observer — SEC 8-K summary
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Issuer:     CATALYST PHARMACEUTICALS, INC. (CPRX)
CIK:        0001369568
Form:       8-K
Filed at:   2024-03-13T23:59:59+00:00
Accession:  0001193125-24-066931
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Catalyst launches AGAMREE (vamorolone) in US for Duchenne Muscular Dystrophy
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- AGAMREE (vamorolone) oral suspension 40 mg/mL now commercially available by prescription for DMD patients aged 2+.
- FDA approved Oct 26, 2023; launch follows approval with nationwide specialty pharmacy network.
- Pivotal Phase 2b VISION-DMD study showed comparable efficacy with reduced bone health and growth side effects vs. standard corticosteroids.
- Catalyst Pathways patient support program provides one-on-one education and financial assistance for eligible patients.
- DMD affects ~11,000–13,000 US patients; ~70% currently on corticosteroid therapy.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1369568/000119312524066931/0001193125-24-066931-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1369568/000119312524066931/d798971d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-066931

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer