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In February, the agency placed a partial clinical hold on the VELA trial due to reported visual adverse events, consisting of transient, reversible episodes of light sensitivity and blurred vision, observed in a limited number of patients.
Patients already enrolled in the trial have continued receiving the study drug.
“With a focus on patient safety, we have worked diligently with the FDA over the last several weeks to resolve the partial clinical hold by updating adverse event monitoring and management procedures. We will now collaborate closely with investigators to resume patient enrollment,” said Becker Hewes, Chief Medical Officer at Blueprint Medicines. “We look forward to presenting initial dose escalation data from the VELA trial in the second quarter of 2023.”
Price Action: BPMC shares closed at $42.57 on Tuesday.
