Market Overview

Histogenics Slips Below $1 Threshold After Knee Cartilage Candidate Fails Late-Stage Study

Histogenics Slips Below $1 Threshold After Knee Cartilage Candidate Fails Late-Stage Study
Related HSGX
The Daily Biotech Pulse: FDA Nod For Mallinckrodt's Pain Drug, AbbVie-Neurocrine Report Positive Elagolix Results
The Daily Biotech Pulse: Mallinckrodt Faces FDA Panel, Reshape's Earnings, Vapotherm To Debut

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. 

What Happened

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.

What's Next

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.

Related Links:

Attention Biotech Investors: Mark Your Calendar For These September PDUFA Dates

The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trials And Earnings

Posted-In: NeocartBiotech News Best of Benzinga


Related Articles (HSGX)

View Comments and Join the Discussion!

Facebook Returns Fire In BlackBerry Legal Battle With Patent Infringement Accusations

Mid-Day Market Update: NASDAQ Down Over 100 Points; ProQR Therapeutics Shares Surge