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Aadi Bioscience, Inc. (NASDAQ: AADI) is a commercial-stage precision oncology company focused on the development and commercialization of therapies for cancers with alterations in the mTOR pathway. The company's lead asset, FYARRO® (sirolimus albumin-bound nanoparticles for injectable suspension), is an mTOR inhibitor targeting cancers driven by genetic alterations in mTOR pathway genes. Aadi is committed to bringing transformational therapies to cancer patients with mTOR pathway driver alterations such as those in the TSC1 or TSC2 genes.
Aadi Bioscience has received FDA approval for FYARRO® for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). FYARRO® is designed to improve delivery, stability, solubility, and targeting compared to traditional mTOR inhibitors and is being evaluated in various clinical trials. The company's innovative approach combines nanoparticle albumin-bound (nab) technology with the potent mTOR inhibitor, sirolimus.
The company's clinical pipeline includes the Phase 2 PRECISION1 trial, a tumor-agnostic registration-intended study exploring nab-sirolimus in patients with solid tumors harboring TSC1 or TSC2 inactivating alterations. The trial is expected to complete enrollment by the end of 2024, with interim analysis anticipated in Q3 2024.
In addition to PRECISION1, Aadi is conducting two other Phase 2 trials: one in advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole, and another in neuroendocrine tumors (NETs). Endometrial cancer is a common type of gynecologic cancer, and nab-sirolimus has shown promise in combination therapies for these difficult-to-treat cancers.
Financially, Aadi's Q1 2024 revenue from FYARRO® sales reached $5.4 million, reflecting a strong market presence as the preferred treatment for malignant PEComa. The company's robust financial position, with $88.3 million in cash and short-term investments as of March 2024, is expected to fund operations into Q4 2025.
Headquartered in Los Angeles, Aadi Bioscience is led by a team of industry veterans with extensive experience in developing and commercializing blockbuster oncology products. The company's mission is to unlock the full potential of mTOR inhibition and bring hope to patients with genetically-defined cancers.
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.
Aadi Bioscience, Inc. (AADI) announced encouraging results from two presentations at the 2021 CTOS Annual Meeting regarding FYARRO™ (nab-sirolimus) for advanced malignant PEComa. In an Expanded Access Program, 25% of patients exhibited a partial response, with a 63% clinical benefit rate. The AMPECT trial's final analysis reported a 39% overall response rate in mTOR-naïve patients and a median duration of response exceeding 36 months. FYARRO is awaiting FDA review, with a PDUFA date set for November 26, 2021, after receiving Breakthrough Therapy and Fast-Track designations.
Aadi Bioscience, Inc. (Nasdaq: AADI) reported key updates on November 10, 2021, including the FDA's Priority Review for FYARRO with a PDUFA target date of November 26, 2021. The company completed a merger with Aerpio Pharmaceuticals and secured $155 million in PIPE financing, enhancing its financial foundation with $161.4 million in cash. Operating expenses surged to $87.3 million for Q3 2021, largely due to a $74.2 million impairment charge. Aadi announced key executive appointments and plans to initiate a registrational trial for ABI-009 in early 2022, focusing on genetically-defined cancers.
Aadi Bioscience, a clinical-stage biopharmaceutical company, will participate in the Jefferies London Healthcare Conference and the Piper Sandler Virtual Healthcare Conference. The Jefferies Conference will feature a pre-recorded presentation available on demand from November 18, with a webcast link provided. The Piper Sandler Conference begins on November 22, also featuring a pre-recorded presentation. Aadi's lead product, FYARRO™, targets genetically-defined cancers related to mTOR pathway alterations, receiving FDA designations and priority review for an NDA submitted in May 2021.
Aadi Bioscience, a clinical-stage biopharmaceutical company, has appointed Scott Giacobello as Chief Financial Officer, effective November 28, 2021. Previously CFO at GW Pharmaceuticals, Giacobello's experience includes pivotal roles in financial strategy and operational success. His leadership is expected to bolster Aadi's commercialization efforts for its lead product, FYARRO, aimed at treating malignant PEComa, with a PDUFA action date on November 26, 2021. Aadi is focused on targeted therapies for genetically-defined cancers impacted by mTOR pathway alterations.
Aadi Bioscience (AADI) has appointed Dr. Loretta M. Itri as Chief Medical Officer. Dr. Itri brings a wealth of experience, having formerly led the development and approval of TRODELVY at Immunomedics. She will focus on advancing Aadi's lead product, FYARRO (nab-sirolimus), targeting genetically-defined cancers, notably PEComa, with a PDUFA target date set for November 26, 2021. Aadi aims to broaden the applications of FYARRO following promising clinical trials, having received FDA's Breakthrough Therapy and Fast-Track designations.
Aadi Bioscience announced the publication of results from its AMPECT study of ABI-009 (formerly nab-sirolimus) for treating malignant perivascular epithelioid cell tumors (PEComa). Published in the Journal of Clinical Oncology, the study showed a 39% overall response rate in evaluable patients, with some experiencing responses lasting over 2.5 years. FDA has a New Drug Application under review for ABI-009, with a target action date of November 26, 2021. The positive results highlight ABI-009 as a potential new treatment option in a space lacking approved therapies.
Aadi Bioscience, a clinical-stage biopharmaceutical company, announced that its CEO, Neil Desai, Ph.D., will present at H.C. Wainwright’s 2nd Annual Precision Oncology Conference on October 20, 2021, at 1 pm ET. The presentation will discuss Aadi's leading product, FYARRO™, which targets genetically-defined cancers with mTOR pathway alterations. The company has completed a rolling NDA submission for FYARRO, receiving FDA Breakthrough Therapy and Priority Review designations, with a PDUFA target date set for November 26, 2021.
Aadi Bioscience (AADI) will present a poster at the AACR-NCI-EORTC Virtual International Conference from October 7-10, showcasing preclinical data on nab-sirolimus (ABI-009) targeting PTEN and TSC2 deletions. The study suggests superior effectiveness of nab-sirolimus compared to sirolimus and everolimus. The company is focused on developing therapies for cancers with mTOR pathway alterations, with FYARRO receiving significant FDA designations and an upcoming New Drug Application review due by November 26, 2021.
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