Question · Q4 2025
Rosie asked about the nature of interactions with the FDA regarding the STELLAR-303 NDA, whether an advisory committee is anticipated, and the cadence of initial data disclosures for the earlier stage pipeline and criteria for go/no-go decisions.
Answer
Dana Aftab (EVP of Research and Development) expressed excitement about the NDA acceptance for STELLAR-303 and active engagement with the FDA. She confirmed that non-liver mets data and other updates would be shared with the agency as part of the normal process.
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