2023-03-09 14:07:54 ET
Fulcrum Therapeutics ( NASDAQ: FULC ) lost ~23% on Thursday after the clinical-stage biopharma with its Q4 2022 results shed more light on its recent clinical hold on the sickle cell disease candidate FTX-6058 and announced the departure of medical chief Santiago Arroyo.
Fulcrum ( FULC ) crashed ~56% in February after the company said that the FDA has verbally informed it has placed the Investigational New Drug ( IND ) application for FTX-6058 under full clinical hold.
With no formal Clinical Hold Letter, there were insufficient details surrounding the decision at the time.
However, on Thursday, with its Q4 update, Fulcrum ( FULC ) said that the FDA issued a formal Clinical Hold Letter, and the agency has observed non-clinical and clinical evidence of hematological malignancies.
“The clinical hold noted that the profile of hematological malignancies observed in the non-clinical studies of FTX-6058 is similar to that observed with other inhibitors of PRC2,” the company said.
The earnings release followed the departure of Fulcrum’s ( FULC ) chief medical officer Arroyo who has resigned effective Mar. 07 to pursue another opportunity. Iain Fraser, former Vice President and Clinical Fellow at AlloVir, will replace Arroyo on an interim basis.
Read: Seeking Alpha contributor Stephen Ayers breaks down Fulcrum’s ( FULC ) muscular dystrophy candidate losmapimod.
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Fulcrum plunges 23% after Q4 update as medical chief departs