SELLAS Receives FDA Rare Pediatric Disease Designation For Galinpepimut-S In Pediatric Acute Myeloid Leukemia, Enabling Eligibility For Priority Review Voucher Valued At ~$100M Upon Approval
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SELLAS Life Sciences Group has received the FDA Rare Pediatric Disease Designation for its drug Galinpepimut-S, aimed at treating pediatric acute myeloid leukemia. This designation makes SELLAS eligible for a Priority Review Voucher, potentially valued at $100 million upon drug approval.
October 15, 2024 | 12:46 pm
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SELLAS Life Sciences Group's drug Galinpepimut-S has received FDA Rare Pediatric Disease Designation, which could lead to a Priority Review Voucher worth approximately $100 million upon approval.
The FDA designation is a significant regulatory milestone for SELLAS, as it not only validates the potential of Galinpepimut-S but also opens the door to a Priority Review Voucher. This voucher is highly valuable, estimated at $100 million, and can accelerate the drug's review process, making it a positive development for the company's stock.
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