Brief: Belite Bio Submits IND Application To FDA For Approval
19/07/2022 21:55
July 19 (Reuters) - Belite Bio Inc BLTE.O :
* BELITE BIO SUBMITS INVESTIGATIONAL NEW DRUG (IND)
APPLICATION TO
FDA FOR APPROVAL TO PROCEED WITH LBS-008 PHASE 3 CLINICAL TRIAL
FOR THE TREATMENT OF STARGARDT DISEASE
* BELITE BIO - LBS-008 GRANTED FAST TRACK DESIGNATION, RARE
PEDIATRIC DISEASE DESIGNATION (RPD) IN U.S., ORPHAN DRUG
DESIGNATION IN U.S. AND EUROPE
* BELITE BIO INC - COMPANY HAS ADDITIONAL PLANS TO SUBMIT
CLINICAL
TRIAL APPLICATION ACROSS OTHER JURISDICTIONS
* BELITE BIO - GLOBAL PHASE 3 TRIAL APPROVED FOR PATIENT
ENROLLMENT IN UNITED KINGDOM, SWITZERLAND, HONG KONG, TAIWAN,
AUSTRALIA, ENROLLMENT COMMENCED
* BELITE BIO INC - A 2-YEAR PHASE 2 TRIAL IN ADOLESCENT
STGD1 AND
A GLOBAL PHASE 3 TRIAL IN ADOLESCENT STGD1 ARE ONGOING
Source text for Eikon: ID:nGNX193GpM
Further company coverage: BLTE.O
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