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Aadi Bioscience has closed its previously announced merger with Aerpio Pharmaceuticals and a concurrent $155-million PIPE investment.
Aadi Bioscience, a US-based clinical-stage biopharmaceutical company specializing in the development of precision therapies for genetically defined cancers, announced on Aug. 26, 2021 that it has closed a previously announced merger with US-based Aerpio Pharmaceuticals. Concurrent to the merger closing, Aadi also closed a $155-million private investment in public equity (PIPE) financing of its common stock.
Under the merger, the company will focus on advancing, expanding, and commercializing Aadi’s clinical-stage pipeline, including a lead program for a nanoparticle albumin-bound mammalian target of rapamycin (mTOR) inhibitor, FYARRO (sirolimus albumin-bound nanoparticles for injectable suspension, nab-sirolimus ABI-009).
In a registration trial of FYARRO in advanced malignant perivascular epithelioid cell tumors (PEComa) (the AMPECT trial), FYARRO demonstrated meaningful clinical efficacy in malignant PEComa1, which has the highest known alteration rate of TSC1 or TSC2 genes, according to Aadi’s press release. The drug candidate has received breakthrough therapy, fast-track, and orphan designations from FDA, and a rolling new drug application (NDA) submission was completed in May 2021 for this indication, which FDA accepted in July 2021. The NDA has been granted priority review status and has a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 26, 2021.
“Today’s news represents an important inflection point for Aadi and the development of FYARRO.The completion of the merger, and now becoming a public entity, allows us to take the next step toward commercialization of our pipeline. As we approach our PDUFA date for FYARRO for the treatment of patients with PEComa and prepare to initiate a registrational trial in patients with tumors harboring TSC1 and TSC2 inactivating alterations by year-end, we believe that we are optimally positioned, and look forward to advancing FYARRO to help patients with genetically driven cancers,” said Neil Desai, CEO of the new combined company, in the press release.
Source: Aadi Bioscience