Nxera Pharma submits MAA for AGAMREE in South Korea
- Reports
- 2
- Developments
- 1
- Repetition
- 50%
New informationRepeats or wire copies
What happened
Nxera Pharma submitted a Marketing Authorization Application to South Korea’s Ministry of Food and Drug Safety for AGAMREE (vamorolone), which is used to treat Duchenne muscular dystrophy. This submission followed the drug receiving Orphan Drug Designation and Global Innovative Products on Fast Track designation from the MFDS in June 2026. Nxera is targeting marketing authorization in South Korea in 2027, with a commercial launch expected in 2028.
From manilatimes.net
Why it matters
The application targets a priority review pathway designed to accelerate the review of innovative medicines for rare diseases. Santhera Pharmaceuticals will receive sales payments, milestone payments, and royalties on net sales of AGAMREE in the licensed territories.
From manilatimes.net
Who's involved
- Catalyst PharmaceuticalsNot mentioned in this licensing event
- Richard J. DalyNot mentioned in this licensing event
- FDANot mentioned in this licensing event
- SECNot mentioned in this licensing event
- SERBNot mentioned in this licensing event
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- Catalyst PharmaceuticalsSpeculative
Could potentially affect future funding or investment in drug development
Possible ripples
Who this could reach next, traced step by step from the reporting. Possibilities worth considering, not forecasts.Keep exploring
The entities involved
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Catalyst Pharmaceuticals
company in Coral Gables, United States
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