Histogenics Corp (NASDAQ:HSGX) updated on the NeoCart regulatory course depending on the talks with the U.S. FDA. Depending on the feedback obtained from the U.S. FDA, the FDA stated that an additional clinical study would require to be done before it would give a filing of a Biologics License Application for NeoCart. The FDA showed receptivity to unique clinical study methodologies as well as regenerative medicine advanced treatment designations so as support additional results for a future prospective submission. However, seeing the funding and time needed to conduct such a study, Histogenics anticipates suspending the advancement of NeoCart and does not intend to file a BLA currently.
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In connection with the reported result, Histogenics plans to implement a restructuring program to lower costs and has hired Canaccord Genuity LLC to assess the complete range of prospective strategic options to enhance value for stakeholders, which comprises, but is not confined to, acquisitions, joint ventures, private and public capital raises, recapitalization, sale transaction options and business combinations,, counting a sale of intellectual property or assets. Since these initiatives may not bear result and in light of its restricted cash reserves, the company is considering all prospective options, including restructuring measures, a wind-down of processes, or go for chapter 11 bankruptcy to execute or complete a restructuring deal or liquidation.
The company has also decided not to move ahead at this time with its previous plans to perform a stockholder meeting to enhance its authorized shares as well as a reverse split. It has filed it with a preliminary proxy statement with the U.S. SEC on October 18, 2018. The company has received different ratings from different firms recently. Analysts at HC Wainwright gave a “Buy” call on the shares of Histogenics when they issued a research note last week. Needham analysts restated the stock of Histogenics to “Buy” in a research note they showcased on September 19, 2016 however they have now given a price target of $8 compared to earlier target price of $11.