FDA Lifts Hold on LogicBio® SUNRISE Trial

May 9, 2022 By MarketDepth

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LogicBio® Therapeutics, Inc. (Nasdaq: LOGC) today announced that the U.S. Food and Drug Administration had lifted the clinical hold on the company’s LB-001 Investigational New Drug Application.

Stock Surged Over 69%

Shares of LogicBio® Therapeutics, Inc. (Nasdaq: LOGC) surged over 69% during the premarket trading session following the announcement.

FDA Allowing Enrollment

The FDA’s decision allows patient enrollment to resume in the Phase 1/2 SUNRISE trial for pediatric patients with methylmalonic acidemia, and the company has initiated activities to resume dosing as soon as possible.

“We are pleased that the FDA has completed its review of the information we provided and that the hold on our LB-001 IND has been lifted. We look forward to dosing the next patient in our SUNRISE trial, which we expect will occur in the third quarter of 2022.”

Frederic Chereau, president and chief executive officer of LogicBio

Furthermore, the company confirmed that it is reinstating its previous guidance and expects to present interim clinical data from the SUNRISE trial by the end of the second quarter of 2022.