Belite Bio Receives Sakigake (Pioneer Drug) Designation of Tinlarebant for Stargardt Disease in Japan

Sakigake designation was established by MHLW to accelerate drug approval process in Japan for innovative drugs with prominent effectiveness targeting serious diseases, in order to make them available to patients in Japan ahead of the rest of the world, by providing (a) prioritized consultation, (b) pre-application consultation, (c) prioritized review, (d) assignment of a review partner, and (e) extension of re-examination period. Stargardt Disease (STGD1) SAN DIEGO, June 12, 2024 (GLOBE NEWSWIRE) -- Belite ...