Leerink analyst Marc Goodman notes Belite Bio (BLTE) announced China’s NMPA has accepted the NDA for tinlarebant in Stargardt disease based on interim data from the pivotal trial. The firm believes the China NMPA’s willingness to accept an NDA based on interim data is a strong validation that regulators view the dataset positively and reinforces its belief that the full data that will be disclosed later in Q4 2025 will be positive and that tinlarebant will have a high likelihood of approval in Stargardt disease. Leerink has an Outperform rating on Belite Bio.
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