Aveo Oncology Shares Drop 7% After Fast Track Designation for Ficlatuzumab
21 September 2021 - 3:50AM
Dow Jones News
By Chris Wack
Aveo Oncology shares were down 7% after the company said the
Food and Drug Administration has granted fast track designation to
ficlatuzumab for the treatment of patients with relapsed or
recurrent head and neck squamous cell carcinoma.
Volume for the stock was 2 million shares at 1:15 p.m. ET,
compared to its 65-day average volume of 433,000 shares. The stock,
which hit its 52-week low of $4.95 on July 27, was trading up
during premarket trading.
The biopharmaceutical company said ficlatuzumab is its
investigational potent humanized immunoglobulin G1 monoclonal
antibody that targets hepatocyte growth factor.
In June, the company reported positive results from a randomized
confirmatory Phase 2 study of ficlatuzumab, alone or in combination
with cetuximab, an EGFR-targeted antibody, in patients with
metastatic head and neck squamous cell carcinoma who relapsed or
were refractory to prior immunotherapy, chemotherapy, and
cetuximab.
Aveo said a shortage of required key raw materials and
manufacturing supplies also used in Covid-19 vaccine manufacturing
has delayed the delivery of the clinical supply of ficlatuzumab.
The company sees the potential start date for a registrational
study in HPV negative head and neck squamous cell carcinoma in
2023, and expects to continue to discuss potential ficlatuzumab
pivotal study designs with the FDA and to continue ongoing
partnership dialogues.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
September 20, 2021 13:35 ET (17:35 GMT)
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