'All of us at Aadi are truly proud to be able to offer this treatment to patients living with malignant PEComa,
Aadi has also launched 'Aadi Assist' as its comprehensive patient support program. This program offers resources designed to connect patients with co-pay assistance, referrals, educational resources, verification of benefits and to ensure access to this important drug as quickly and efficiently as possible.
About NCCN
The NCCN is a not-for-profit alliance of 27 leading
About Malignant PEComa
Advanced malignant PEComa, defined by the
About FYARRO
FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) is an mTOR inhibitor indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
About
Aadi is a commercial-stage biopharmaceutical company focused on precision therapies for genetically-defined cancers. Aadi's primary goal is to bring transformational therapies to cancer patients with mTOR pathway driver alterations where other mTOR inhibitors have not or cannot be effectively exploited due to problems of pharmacology, effective drug delivery, safety, or effective targeting to the disease site. In
Based on data from the AMPECT trial with FYARRO and following discussions with the FDA about other emerging data with FYARRO, Aadi has initiated PRECISION 1, a tumor-agnostic registrational trial in mTOR inhibitor-naive solid tumors harboring TSC1 or TSC2 inactivating alterations. Aadi also has ongoing studies to evaluate dosing of FYARRO in combination regimens. More information on Aadi's development pipeline is available on the Aadi website at www.aadibio.com.
Forward-Looking Statements
Aadi cautions you that certain statements included in this press release that are not a description of historical facts are forward-looking statements. These statements are based on Aadi's current beliefs and expectations. Forward-looking statements include statements regarding: our plans and potential for success relating to commercializing FYARRO, the expectations regarding the beneficial characteristics, safety, efficacy and therapeutic effects of FYARRO, our plans related to further development and manufacturing of FYARRO, the timing of additional clinical trials, including the registrational trial in patients harboring TSC1 and TSC2 inactivating alterations, the timing or likelihood of regulatory filings and approvals of FYARRO, including in potential additional indications and potential filings in additional jurisdictions, anticipated reception of FYARRO in the physician community, and the sufficiency of our existing capital resources to fund our future operating expenses and capital expenditure requirements. Actual results could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to Aadi's ability to successfully commercialize; uncertainties associated with the clinical development and regulatory approval of FYARRO, including potential delays in the commencement, enrollment and completion of clinical trials for additional indications; the risk that interim results of clinical trials may not be reproduced and do not necessarily predict final results; the risk that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; the risk that unforeseen adverse reactions or side effects may occur in the course of commercializing, developing and testing FYARRO; risks associated with the failure to realize any value from FYARRO in light of inherent risks and difficulties involved in successfully bringing product candidates to market; risks related to Aadi's estimates regarding future expenses, capital requirements and need for additional financing; and risks related to the impact of the COVID-19 outbreak on Aadi's operations, the biotechnology industry and the economy generally.
Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption 'Risk Factors' in Aadi's Form 10-Q filed on
All forward-looking statements in this press release are current only as of the date hereof and, except as required by applicable law, Aadi undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
FYARRO is a trademark of
For more information about FYARRO, visit: https://fyarro.com/
For more information about Aadi Assist, go to: http://aadiassist.com/.
For more information about the National Comprehensive Cancer Network, go to: https://www.nccn.org/home/about
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