Fibrocell Science Receives Fast Track Designation For
FCX-007, Shares Up 29% By Mid-Day
Thursday, Jan 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.
FCX-007, Shares Up 29% By Mid-Day
Thursday, Jan 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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