Shares of biotechnology company Arcellx (NASDAQ:ACLX) are sliding lower today after the U.S. Food and Drug Administration (FDA) placed a clinical hold on its investigational new drug (IND) targeted for the treatment of relapsed or refractory multiple myeloma (rrMM).
The development comes after the death of a patient and Arcellx believes, “limitations on bridging therapy are contributing factors” for the regulatory body’s action.
Further, Arcellx is now working with the healthcare regulator on amending the protocol and expanding options for patients. Notably, the FDA has given clearance for continuing dosing in patients who have undergone lymphodepletion to the company.
The company is also looking at possible improvements to the Phase 2 study which is evaluating the overall patient response rate over a 24-month duration as a primary objective.
Overall, the Street has a $49.90 consensus price target on ACLX alongside a Strong Buy consensus rating. Arcellx shares have climbed nearly 138% over the past year while short interest in the stock remains elevated at about 19.4% at present.
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