Histogenics and FDA Conclude Discussions Regarding NeoCart Phase 3 Clinical Trial Data and Regulatory Pathway

- December 24th, 2018

Histogenics (Nasdaq:HSGX), today provided an update on the NeoCart regulatory pathway based on discussions with the U.S. Food and Drug Administration (the FDA). As quoted in the press release: Based on the feedback received from the FDA, while the NeoCart Phase 3 clinical trial resulted in certain compelling data, the FDA indicated that an additional … Continued

Histogenics (Nasdaq:HSGX), today provided an update on the NeoCart regulatory pathway based on discussions with the U.S. Food and Drug Administration (the FDA).

As quoted in the press release:

Based on the feedback received from the FDA, while the NeoCart Phase 3 clinical trial resulted in certain compelling data, the FDA indicated that an additional clinical trial would need to be completed before it would accept a submission of a Biologics License Application (BLA) for NeoCart.  The FDA indicated receptivity to novel clinical trial methodologies and regenerative medicine advanced therapy designations in order to support additional data for a future potential submission.  However, considering the time and funding required to conduct such a trial, Histogenics expects to suspend the development of NeoCart and does not plan to submit a BLA at this time.

In connection with this outcome, Histogenics intends to implement a restructuring plan to reduce costs and has engaged Canaccord Genuity LLC to evaluate the full range of potential strategic alternatives to maximize value for stakeholders, which includes, but is not limited to, acquisitions, business combinations, joint ventures, public and private capital raises, recapitalization, and sale transaction options, including a sale of assets or intellectual property.

Click here to read the full press release.

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