Biopharmaceutical giant Gilead Sciences Inc (NASDAQ: GILD) found its stock in a bind after announcing a pause in the enrollment of tumor studies. The Food and Drug Administration (FDA) swiftly requested a partial clinical hold on these trials. Gilead is now reassessing the benefit-risk of magrolimab across all ongoing trials and will provide an update on this evaluation as soon as feasible.

Patients already enrolled in the Gilead-sponsored ELEVATE solid tumor studies and deriving clinical benefit may continue to choose receiving magrolimab following reconsenting to the study with their healthcare provider. However, this pause impacts multiple Phase 2 studies in head and neck squamous cell carcinoma, solid tumors, triple-negative breast cancer, and colorectal cancer. Furthermore, the enrollment hold also applies to investigator-sponsored studies with magrolimab in solid tumors.

Just last week, Gilead discontinued the Phase 3 ENHANCE-3 study of magrolimab in acute myeloid leukemia (AML) and received a full clinical hold on all magrolimab studies in myelodysplastic syndromes (MDS) and AML from the FDA. As a result, Gilead will not be pursuing further development of magrolimab in hematologic cancers.

Moreover, in September, Gilead stopped its ENHANCE-2 study in acute myeloid leukemia (AML) with TP53 mutations, evaluating magrolimab plus azacitidine. Earlier in August, the FDA placed a partial clinical hold on initiating new patients in U.S. studies evaluating magrolimab to treat acute myeloid leukemia (AML), leading to a cascade of challenges for the company.

These regulatory setbacks follow Gilead’s report of weak earnings results and soft guidance earlier in the month, compounding the company’s woes. All in all, GILD shares are down 2.22% at $71.74, reflecting investor concerns over the recent upheaval at the company.