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EXCLUSIVE: GT Biopharma Announces Potential New Indication for GTB-5550, A B7-H3-Targeted Natural Killer Cell Engager, For Multiple Myeloma; FDA Clearance Under Investigator Sponsored Trial Protocol

Benzinga Newsdesk 1 month ago

FDANewsExclusives

FDA clearance of a new IND for GTB-5550 in multiple myeloma (MM) under an investigator sponsored trial (IST) protocolInitiation of Phase 1 trial in MM patients contingent upon timing and receipt of non-dilutive grant

  • FDA clearance of a new IND for GTB-5550 in multiple myeloma (MM) under an investigator sponsored trial (IST) protocol
  • Initiation of Phase 1 trial in MM patients contingent upon timing and receipt of non-dilutive grant funding
  • Phase 1 dose escalation basket trial with GTB-5550 in solid tumor patients continues to actively enroll, with an update anticipated in Q4 2026
  • Unaudited proforma cash balance as of September 15, 2026 of approximately $11 million anticipated to provide sufficient cash runway into Q3 2027

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