Belite Bio Announces Multi-Market Submission of Marketing Authorization Applications Via the Access Consortium Pathway for Tinlarebant for the Treatment of Stargardt Disease Type 1
Belite Bio submitted Marketing Authorization Applications for tinlarebant in Stargardt disease type 1 to regulators in Singapore, the UK, and Switzerland via the Access Consortium pathway. The filings run in parallel with accepted NDAs in the US (Priority Review, PDUFA target action date February 12, 2027) and Japan under the SAKIGAKE designation.
Key figures
- Drug Name
- tinlarebant (LBS-008)
- Phase Of Trial
- Phase 3
- Markets filed
- ["Singapore","United Kingdom","Switzerland"]
- Pdufa target date
- February 12, 2027
- Regulatory pathway
- Access Consortium (HSA, MHRA, Swissmedic)
AI analysis
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