Given the greenlight, Greenwich LifeSciences (NASDAQ: GLSI) gets FDA fast track for breast cancer therapy
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Shares of Greenwich LifeSciences (NASDAQ: GLSI) surged 26% in premarket trading on Wednesday after the company announced its breast cancer therapy received a key regulatory designation.
The cancer therapy developer said its GLSI-100 treatment obtained “fast track” designation from the U.S. Food and Drug Administration (FDA).
This designation is designed to accelerate the development and review process for drugs targeting serious conditions with unmet medical needs.
GLSI-100 is currently being evaluated in a late-stage clinical trial for patients with HER2-positive breast cancer who have the HLA-A02 genotype and have completed standard treatment protocols.
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