Histogenics Corp (NASDAQ: HSGX) shares were losing more than half their market value Wednesday following the release of top-line data from the Phase 3 trial of Neocart, its pipeline candidate to treat knee cartilage damage.
The stock was plunging 67.53 percent to 90 cents at the time of publication.
Histogenics, a developer of restorative cell therapies, said Neocart did not meet the primary endpoint of statistically significant improvement in pain and function in a dual threshold responder analysis a year after treatment relative to microfracture.
In the modified Intent to Treat population, which excludes patients randomized but not treated with Neocart, 74.2 percent showed clinically meaningful improvement in pain and function compared to 62 percent of microfracture patients at one year, which was deemed to be statistically insignificant.
Statistical significance was achieved six months after treatment, according to Histogenics.
Why It's Important
Neocart merges a patient's own cells with a fortified three-dimensional scaffold design to expedite healing and reduce pain.
Histogenics indicated that the candidate's ability to function like cartilage at the time of treatment helps patients to return to work and daily activities more rapidly than current treatment options.
Histogenics said it will request a meeting with the FDA to discuss the data and a potential BLA submission. The company said it plans to present complete study results at upcoming medical conferences.
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