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Biotech Stocks Facing FDA Decision In November 2021

Aadi Bioscience
Aadi Bioscience

The FDA decision on Aadi Bioscience Inc.’s (AADI) Fyarro, proposed for the treatment of advanced malignant perivascular epithelioid cell tumor, is expected on November 26, 2021.

Fyarro is a nanoparticle albumin-bound form of sirolimus in injectable suspension formulation. It is based on similar technology as Celgene’s chemotherapy drug Abraxane.

Advanced perivascular epithelioid cell tumors, or advanced PEComas, are a rare subset of soft tissue sarcomas, for which there are no approved drugs. If approved, Fyarro will be the first FDA-approved therapy for the treatment of patients with this disease, according to Aadi.

Fyarro has the potential to achieve peak sales of $2 billion by 2035, according to H.C. Wainwright & Co. analyst Robert Burns.

AADI closed Thursday’s trading at $27.36, up 1.22%.