HuidaGene Goes Dark After CRISPR Trial, Execs Exit

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- HuidaGene CEO Alvin Luk presented early data from one of the world's first CRISPR trials for children with Duchenne muscular dystrophy at the American Society for Gene and Cell Therapy's annual convention in New Orleans, with results from the first two patients described as not impressive.
- HuidaGene used a Chinese regulatory pathway that lets hospitals launch studies without government regulator oversight, letting it surge ahead of similar U.S. efforts that had stalled on technical challenges.
- HuidaGene issued no press releases for 15 months after the conference, with CEO Alvin Luk and CTO TJ Cradick—both of whom had joined or held the roles briefly—departing quietly last summer.
- A clinical trial registry listing was updated in February to mark the study "complete," but the fate of the remaining patients was unclear until STAT's investigation prompted the Shanghai-based company to issue an update on Wednesday.
- The trial targeted Duchenne muscular dystrophy, described in the article as an intractable, fatal disease, with Luk saying the early data indicated enough benefit to justify testing a higher dose.
Why it matters: HuidaGene's ability to advance a CRISPR trial in children while operating outside government regulator oversight—and then go dark for 15 months as executives departed—exposes a transparency gap that lets Chinese gene-editing startups outpace U.S. trials without equivalent public accountability for patient outcomes.
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