Greenwich LifeSciences Shares Rise After FDA Approves Commercial GP2 for Use
By Connor Hart
Shares of Greenwich LifeSciences climbed after the company said the Food and Drug Administration approved the use of commercially manufactured GP2 in a Phase III trial of its therapy to prevent breast cancer recurrences.
The stock rose 12% to $25 in premarket trading Thursday. Through Wednesday's close, shares are up more than 70% over the past year.
The biopharmaceutical company before the bell said the FDA cleared the first commercial lot of its GP2 immunotherapy for use in the late-stage study, reducing regulatory risk ahead of a planned biologics license application.
"With our manufacturing investments in 2023 and 2024, and now the FDA's review and approval to use the first commercial lot of finished GP2 vials in FLAMINGO-01, we have taken major steps to further de-risk the filing of a biologics license application in the U.S.," Chief Executive Snehal Patel said.
Patel said the company will begin using the new GP2 vials in the coming weeks at all 40 of its U.S. sites. "We have 3 years of stability data to support the GP2 vial expiration date, which may translate to the commercial expiration date of GP2 vials," he added.
Write to Connor Hart at connor.hart@wsj.com
(END) Dow Jones Newswires
January 22, 2026 06:55 ET (11:55 GMT)
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