LogicBio Therapeutics Inc (NASDAQ: LOGC) shares are trading higher by 63.48% at $0.81 after the company announced the FDA lifted the clinical hold on its LB-001 Investigational New Drug Application, allowing patient enrollment to resume in the Phase 1/2 SUNRISE trial for pediatric patients with methylmalonic acidemia.
"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," said Frederic Chereau, president and chief executive officer of LogicBio. "We look forward to dosing the next patient in our SUNRISE trial, which we expect will occur in the third quarter of 2022."
LogicBio Therapeutics says, as previously disclosed, the FDA placed the IND for LB-001 on clinical hold following the occurrence of two serious adverse events, categorized as cases of thrombotic microangiopathy (TMA), in the company's SUNRISE trial. LogicBio Therapeutics says both cases of TMA were resolved within weeks.
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LogicBio Therapeutics is a genome editing company focused on developing medicines to durably treat rare diseases in patients with significant unmet medical need using GeneRide, its proprietary technology platform.
According to data from Benzinga Pro, LogicBio Therapeutics has a 52-week high of $5.24 and a 52-week low of $0.39.
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