Aura Biosciences Shares Rise 8% After Cancer Treatment Gets FDA Fast Track Designation
June 30 2022 - 1:58PM
Dow Jones News
By Chris Wack
Aura Biosciences Inc. shares were up 8% to to $13.52 after the
company said the U.S. Food and Drug Administration has granted Fast
Track designation for belzupacap sarotalocan AU-011, a virus-like
drug conjugate product candidate, for the treatment of non-muscle
invasive bladder cancer.
The stock hit its 52-week low of $11.98 last Thursday.
The company said its planned Phase 1 clinical trial with
belzupacap sarotalocan will evaluate the safety and early proof of
mechanism, assess distribution, local necrosis and evidence of
immune activation.
Aura expects to initiate the trial in the second half of 2022,
with initial Phase 1 data expected in 2023.
Fast Track designation is an FDA process designed to facilitate
the development of products that address high unmet medical needs
and may expedite the review of drugs intended to treat serious or
life-threatening diseases.
Belzupacap sarotalocan has also been previously granted Fast
Track and Orphan Drug designations by the FDA for the treatment of
choroidal melanoma and is currently in Phase 2 clinical development
in this indication.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
June 30, 2022 13:43 ET (17:43 GMT)
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