Fibrocell Science Receives Fast Track Designation For FCX-007, Shares Up 29% By Mid-Day
Thursday, January 05, 2017
The pharmaceuticals industry is finally getting some bullish momentum on the prospects of receiving regulatory benefits from the upcoming Republican government in the country. One area of particular interest is the development of gene modifying treatments which is expected to become the mainstay of future advancements in the sector. Fibrocell Science Inc. (NASDAQ:FCSC) is one such gene therapy company which focuses on developing therapies for ailments affecting the skin, connective tissues, and joints.
The company scored a win as it announced that it has received a fast track designation from the FDA for its FCX-007, the Company’s clinical-stage candidate for the treatment of Recessive Dystrophic Epidermolysis Bullosa. Currently there is no FDA approved therapy available for this genetic skin disease.
The company expressed its pleasure at receiving the designation. Fibrocell Science said that FCX-007 has the potential to become the first gene therapy for treating the underlying causes of RDEB. The designation will allow the trial to move in a smoother manner as it entails more frequent meetings with the FDA for discussing the trial development program.
The company will also benefit as the designation may make the therapy eligible for Accelerated Approval or Priority Review, subject to certain conditions. The trial period is further likely to be shorter as the designation offers the opportunity for Rolling Review as well.
This development is expected to boost the fortunes of Fibrocell Science, which struggled after the failed attempt at a second stage azficel-T trial, with the study failing to meet its endpoints. The treatment was being developed for treating the vocal cord scarring leading to chronic or severe dysphonia. The company had then announced to focus on developing FCX-007. With fast track designation under its belt, it seems that the gamble paid off for the company.
The company also has other products in its pipeline. Its portfolio includes drug candidates such as FCX-013, which is being developed for treating linear scleroderma. The company plans to submit an Investigational New Drug application for the drug to the FDA during the fourth quarter of 2017.
Fibrocell Science seems to be on a positive path as the company recently reported its third quarter loss at $0.31 per share, down from a net loss of $0.44 per share it had suffered in the corresponding quarter of the previous year. Significant losses are quite normal for biotechs at this stage of their corporate life.
With the failure of the azficel-T trial as well as other negative developments, the company’s stock price took a tumble of over 80% in the past year. However, the latest news of fast track designation has already boosted the stock price with shares of FCSC up 29% on the day at $0.88 in mid-day trading.
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