Histogenics to Meet With FDA to Discuss NeoCart Phase 3 Clinical Trial

Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, today announced that the U.S. Food and Drug Administration (the FDA) has granted a Type C meeting on October 30, 2018 to discuss the top-line results from the NeoCart Phase 3 clinical trial and Histogenics’ planned Biologics License Application submission.  Histogenics submitted its briefing materials regarding the top-line data of the NeoCart Phase 3 clinical trial to the FDA in mid-September 2018, and has been working closely with the FDA to schedule the meeting.  Histogenics expects to provide an update following this meeting in early November 2018, with meeting minutes expected by late November 2018 or early December 2018.  During the third quarter of 2018, Histogenics has sold an aggregate of 3,550,416 shares of common stock in at-the-market offerings pursuant to Histogenics’ equity distribution agreement with Canaccord Genuity Inc. for aggregate net proceeds of $2.72 million after deducting sales agent fees and expenses.  Histogenics believes that its existing cash and cash equivalents will be sufficient to fund its projected cash needs late into the fourth quarter of 2018.

https://www.nasdaq.com/press-release/histogenics-to-meet-with-fda-to-discuss-neocart-phase-3-clinical-trial-data-and-potential-20180926-01038