LogicBio Therapeutics Shares Skyrocket As FDA Lifts Clinical Hold On Its Pediatric Trial

The FDA has lifted the clinical hold on LogicBio Therapeutics Inc's LOGC LB-001 Investigational New Drug Application (IND) to resume patient enrollment in Phase 1/2 SUNRISE trial in pediatric methylmalonic acidemia patients.
Methylmalonic acidemia is an inherited disorder in which the body cannot process certain proteins and fats (lipids) properly.
The FDA acknowledged that the company satisfactorily addressed all clinical hold issues in its letter.
The company plans to start dosing in Q3 2022.
Related: Why Did LogicBio Therapeutics Shares Plunge To 52-Week Low Today?
In connection with the lifting of the clinical hold, LogicBio amended the SUNRISE protocol to reflect its dialogue with the FDA.
LogicBio expects to proceed with dosing after implementing the changes to the SUNRISE protocol, which include enhanced monitoring measures and the use of a complement inhibitor if there are laboratory findings indicating a potential TMA.
LogicBio plans to treat the next patients, who may be as young as six months old, at the 5e13 vg/kg dose and continually assess safety outcomes.
Outlook: LogicBio is reinstating its previous guidance and expects to present interim clinical data from the SUNRISE trial by the end of Q2 of 2022.
Price Action: LOGC shares are up 64.7% at $0.82 during the premarket session on the last check Monday.