Aadi Bioscience Inc Stock Price, News & Analysis

Aadi Bioscience, a biopharmaceutical company focusing on precision therapies for genetically-defined cancers, will participate in the Jefferies 'Biotech on the Bay' Summit on April 26-27, 2022, in Miami, FL. CEO Neil Desai and the executive team will be available for one-on-one meetings. The company aims to provide transformational therapies for cancer patients with mTOR pathway alterations. Aadi's drug FYARRO received FDA approval in November 2021 and was commercially launched in February 2022, targeting advanced perivascular epithelioid cell tumors. Aadi has also initiated a registrational trial, PRECISION 1.

Aadi Bioscience announced a study estimating that by 2030, approximately 12,000 advanced cancer patients in the U.S. will have definite TSC1 or TSC2 mutations. The study, presented at the AACR Annual Meeting, evaluated cancer data from over 30 solid tumors. It found TSC1 alterations most common in bladder, kidney, and lung cancers, while TSC2 was prevalent in hepatobiliary, ovarian, and soft tissue sarcomas. Neil Desai, CEO of Aadi, mentioned the company's ongoing PRECISION 1 trial on nab-sirolimus targeting these mutations, with preliminary data expected next year.

Aadi Bioscience (Nasdaq: AADI) has received FDA Fast Track designation for nab-sirolimus, aimed at treating adult and adolescent patients with Tuberous Sclerosis Complex (TSC1 and TSC2) alterations. The company has initiated the PRECISION 1 Phase 2 trial, targeting approximately 120 patients with solid tumors having these genetic mutations. Preliminary results are anticipated in the first half of 2023. This designation aims to expedite the drug's development for patients lacking approved treatment options, potentially impacting over 10,000 advanced cancer patients annually.

Aadi Bioscience, Inc. (AADI) reported its financial results for Q4 and the full year of 2021, ending with $149.0 million in cash. The company launched FYARRO, the only FDA-approved treatment for malignant PEComa, added to NCCN Guidelines as the preferred therapy. The PRECISION 1 trial for nab-sirolimus targeting TSC1 and TSC2 alterations is now open for enrollment. However, Q4 operating expenses rose to $16.9 million, and the net loss for FY 2021 reached $110.7 million, significantly impacted by a $74.2 million impairment charge.

Aadi Bioscience, a biopharmaceutical company focused on precision therapies for genetically-defined cancers, announced CEO Neil Desai will participate in a panel discussion on Tumor-Agnostic Development at Cowen's 42nd Annual Health Care Conference, held virtually from March 7-9, 2022. The discussion is scheduled for March 8 at 12:50 PM EST. Aadi's FYARRO, recently FDA-approved for specific cancer treatments, showcases the company's commitment to innovative therapies targeting mTOR pathway alterations. A replay of the panel will be accessible on Aadi's website for 30 days.

Aadi Bioscience has launched FYARRO™, the first FDA-approved treatment for malignant PEComa, a rare cancer. Recently included in the NCCN Guidelines as the only preferred mTOR inhibitor for this cancer, FYARRO offers hope for patients with previously no specific treatment options. The company announces the opening of the PRECISION-1 study, targeting tumor types with TSC1 or TSC2 alterations. Aadi also introduced Aadi Assist, a patient support program to facilitate access to FYARRO.

Aadi Bioscience, a biopharmaceutical firm, announced that its CEO, Neil Desai, Ph.D., will present at the H.C. Wainwright BioConnect Conference from January 10-13, 2022. The presentation will be accessible starting January 10 at 7:00 a.m. ET. Aadi focuses on precision therapies for genetically-defined cancers, especially those with mTOR pathway alterations. After receiving FDA approval for FYARRO, an mTOR inhibitor for treating PEComa, the company plans to initiate a tumor-agnostic trial in 2022 and further studies on FYARRO's dosing in combination regimens.

Aadi Bioscience announced FDA approval for FYARRO, an mTOR inhibitor, as the first approved treatment for adult patients with malignant PEComa, an aggressive sarcoma. The approval allows for intravenous use of FYARRO in patients with locally advanced unresectable or metastatic PEComa. The Phase 2 AMPECT trial showed a 39% overall response rate, with some patients experiencing durable responses lasting over two years. The launch is set for Q1 2022, and an investor call is scheduled for today at 8:30 AM ET.

Aadi Bioscience announced positive results at the CTOS 2021 Annual Meeting for FYARRO™ (nab-sirolimus) treating advanced malignant PEComa patients. An Expanded Access Program reported a 25% partial response rate and a 63% clinical benefit rate among patients previously treated with mTOR inhibitors. The AMPECT trial showed a median response duration of over 36 months, with some patients converting to complete responses. Aadi is awaiting a PDUFA target date of November 26, 2021, for regulatory approval.