Starpharma's [SPHRY] Australian shares jumped 16% early Monday
after the U.S. FDA granted fast-track status to VivaGel, its
investigational new drug for the prevention of HIV. VivaGel's
New Drug Application (NDA) will receive Priority Review which
has a shorter review time. Under the Fast Track program,
portions of the NDA can be submitted to the FDA before the
application is completed. This early review is expected to
shorten FDA approval times significantly.
VivaGel is currently being developed as a vaginal microbicide
gel to prevent the transmission of genital herpes and HIV. It
was also recently awarded $20 million by a division of the
National Institutes of Health (NIH) to accelerate its
development. We reiterate our Buy rating on SHPRY and believe
the only factor holding back the stock of late has been its
anemic trading volume.
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