Sellas announces u.s. fda rare pediatric disease designation (rpdd) granted to galinpepimut-s (gps) for the treatment of pediatric acute myeloid leukemia

- gps currently investigated in phase 3 regal trial in adult aml patients – interim analysis anticipated in q4 2024 - - rpdd provides eligibility for gps to receive a priority review voucher (prv) upon marketing approval that can be transferred/sold to other parties – - recent valuations for prvs remain attractive (~$100 million/each) – new york, oct. 15, 2024 (globe newswire) -- sellas life sciences group, inc. (nasdaq: sls) (“sellas” or the “company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the u.s. food and drug administration (fda) has granted rare pediatric disease designation (rpdd) to galinpepimut-s (gps), an immunotherapeutic targeting wilms tumor-1 (wt1), for the treatment of pediatric acute myeloid leukemia (aml). “gps has already demonstrated promise in clinical settings for aml, and we believe its potential could extend to pediatric patients,” said angelos stergiou, md, scd h.c.
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