Arcellx's Lead Product Candidate Hit By FDA Clinical Hold For Multiple Myeloma, Stock Falls
Portfolio Pulse from Vandana Singh
The FDA has placed a clinical hold on Arcellx Inc's (NASDAQ:ACLX) iMMagine-1 Phase 2 clinical program for CART-ddBCMA, a drug for relapsed or refractory multiple myeloma, following a recent patient death. Arcellx is working with the FDA to amend the protocol. Kite, a Gilead Sciences Inc (NASDAQ:GILD) company, announced a collaboration with Arcellx in December 2022 to co-develop and co-commercialize CART-ddBCMA.

June 20, 2023 | 12:19 pm
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NEGATIVE IMPACT
Arcellx's iMMagine-1 Phase 2 clinical program for CART-ddBCMA is on clinical hold by the FDA following a patient death, causing the stock to fall.
The FDA's clinical hold on Arcellx's lead product candidate, CART-ddBCMA, is a significant setback for the company. The hold was placed following a patient death, which raises concerns about the safety and efficacy of the drug. This news is likely to negatively impact investor sentiment and the stock price in the short term.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100
NEGATIVE IMPACT
Gilead Sciences' subsidiary, Kite, is collaborating with Arcellx to co-develop and co-commercialize CART-ddBCMA, which is now on clinical hold by the FDA.
Gilead Sciences' subsidiary, Kite, has a strategic collaboration with Arcellx to co-develop and co-commercialize CART-ddBCMA. The FDA's clinical hold on the drug may negatively impact the progress of this collaboration and could potentially affect Gilead's stock price in the short term.
CONFIDENCE 90
IMPORTANCE 60
RELEVANCE 70
NEGATIVE IMPACT
2seventy Bio Inc's Phase 1 trial of the PLAT-08 study of SC-DARIC33 in Acute Myeloid Leukemia (AML) has been paused by Seattle Children's after a patient death.
The news about 2seventy Bio Inc is not directly related to the FDA's clinical hold on Arcellx's CART-ddBCMA. Therefore, there is no relevance or impact on TSVT's stock price in this context.
CONFIDENCE 0
IMPORTANCE 0
RELEVANCE 0