By Chris Wack

Shares of Aadi Bioscience Inc. fell 5% to $24.28 after it said the Food and Drug Administration approved Fyarro sirolimus protein-bound particles for injectable suspension albumin-bound for intravenous use to treat adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor.

Volume for the stock was 1.9 million shares at 12:45 p.m. EST, compared to its 65-day average volume of 80,000 shares. The stock had been up 50% in premarket trading.

The company said Fyarro is the first and only FDA-approved treatment for advanced malignant PEComa in adults.

Aadi said that in a Phase 2 registrational trial, the overall response rate as assessed by independent review was 39%, with two patients achieving a complete response after prolonged follow-up.

The median duration of response hasn't been reached with a median follow-up of 36 months, and a range of 5.6 to 55.5+ months and ongoing. Among responders, 92% had a response lasting greater than or equal to six months, 67% had a response lasting greater than or equal to 12 months, and 58% had a response lasting greater than or equal to two years.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

11-23-21 1317ET