- Aadi Bioscience announced FDA approval for its injectable drug FYARRO.
- FYARRO is the only FDA-approved therapy for advanced malignant PEComa in adults.
- The AADI stock rose over 62% YTD.
Shares of Aadi Bioscience, Inc. (NASDAQ: AADI) rallied in the premarket trading on Tuesday after the US Food and Drug Administration (FDA) approved its injectable cancer drug FYARRO.
FYARRO is an intravenous drug used in treating metastatic malignant perivascular epithelioid cell tumor (PEComa) in adult patients.
AADI shares traded at US$33.00 at 8:25 am ET on Nov 23, up 29.31% from their previous closing price.
The California-based clinical-stage biopharmaceutical company develops precision treatments for genetically defined cancers.
For instance, it develops therapies for cancer patients with mTOR pathway driver alterations.
FYARRO is the only FDA-approved therapy for advanced malignant PEComa in adults.
Aadi founder and CEO Neil Desai said the company is elated to have received FDA approval for FYARRO. He added that it is an important milestone not only for the firm but also for the PEComa patients. He lauded the research team, the healthcare professionals and the PEComa patients that participated in the clinical studies of FYARRO.
Stock performance and financial of AADI:
Aadi has a market cap of US$533.21 million, with a forward P/E one year of -6.06. Its EPS is US$-13.37. The stocks saw the highest price of US$32.99 and the lowest price of US$0.95 in the last 52 weeks. AADI's trading volume on November 22 was 95,567.
The company reported a net loss of US$87.24 million, or US$9.17 per share in Q3, FY21, compared to a loss of US$3.13 million, or US$1.23 per share in the same quarter of FY20.
As of September 30, 2021, it had cash and cash equivalents of US$161.4 million, up from US$4.5 million as of December 31, 2020.
According to Andrew Wagner, senior oncologist at Dana-Farber Cancer Institute and the principal investigator in the AMPECT registrational trial, the approval of FYARRO provides “physicians with a new weapon" in the treatment of "rare disease", Aadi quoted him as saying in a statement. The AADI stock surged around 62% YTD.