Cellectis cleared to resume UCART123 trial

7 November 2017

The US Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on Phase I trials of UCART123 in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).

News of the clinical hold saw the shares of the products developer, French biotech Cellectis (Nasdaq: CLLS), plummet 20%, as the setback put the company and its approach way behind Novartis (NOVN: VX) and Kite in the race to become an early leader in the CAR-T therapies space. Bothe Novartis and Kite (now part of Gilead Sciences [Nasdaq: GILD]) have now had their respective CAR-T therapies - Kymriah (tisagenlecleucel) infusion and Yescarta (axicabtagene ciloleucel) - approved in the USA.

However, in after-hours trading in New York on Monday the stock gained 7.96% to $28.36, and it was up 6.08% at 24.42 euros in today’s morning trading in Paris.

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