Summary by Futu AI
Legendary Biotechnology, a non-wholly-owned subsidiary of Kingsway Biotechnology, announced on March 15, 2024 that its CAR-T therapy CARVYKTI (cilta-cel) has received positive recommendations from the U.S. Food and Drug Administration's (FDA) Advisory Committee on Oncology (ODAC) for the treatment of relapses of at least first-line therapy or adult patients with difficult-to-treat multiple myeloma. THIS RECOMMENDATION IS BASED ON DATA FROM THE PHASE 3 CARTITUDE-4 STUDY AND WILL BE SUBJECT TO FINAL REVIEW BY THE FDA. Shares of Legendary Biotechnology are listed on Nasdaq Global Select Markets in the United States. Kingsway Biotechnology reminds shareholders and potential investors to be aware of investment risks and to exercise caution when trading securities. CARVYKTI'S SUPPLEMENTAL BIOPRODUCT LICENSE APPLICATION (SBLA) IS CURRENTLY UNDERGOING FDA REVIEW, WITH AN EXPECTED PDUFA TARGET DATE OF APRIL 5, 2024.