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Histogenics cell therapy fails main goal in phase 3 trial; stock price plunges

Histogenics Corp. lost more than half of its market value on Sept. 5 after it reported that its restorative cell therapy NeoCart missed the main goal of a late-stage study.

Histogenics' stock price was down 63.90% to $1 per share in pre-market trading on Sept. 5.

NeoCart was being studied as a treatment for knee cartilage damage in a phase 3 trial which narrowly missed hitting the trial's primary endpoint, Histogenics President and CEO Adam Gridley said in a statement.

The Waltham, Mass.-based biotechnology company said NeoCart did not meet the main goal of significant improvement in pain and function one year after treatment as compared to microfracture.

Microfracture is a cartilage repair surgical technique that works by creating tiny fractures in the underlying bone.

"While the NeoCart treatment group exhibited a response as early as three months after treatment that continued through two years, the microfracture response rate was better than expected, which impacted the statistics," Gridley said.

Histogenics still plans to meet with the U.S. Food and Drug Administration for a potential submission of an application to market NeoCart.

"We are pleased with the overall performance of NeoCart in this phase 3 clinical trial and the data confirm the feedback we have received from several of the investigators who participated in the trial. Most importantly, patients treated with NeoCart displayed an early and sustained recovery from pain and return to function that was clinically meaningful," Histogenics Chief Medical Officer Lynne Kelley said in a statement.