Welcome to our dedicated page for Aadi Bioscience news (Ticker: AADI), a resource for investors and traders seeking the latest updates and insights on Aadi Bioscience stock.
Aadi Bioscience, Inc. (Nasdaq: AADI) is a precision oncology company whose news flow reflects both commercial-stage activity and a significant strategic transformation. Company press releases describe Aadi as focused on applying technology to efficiently deliver improved precision oncology therapies for people living with difficult-to-treat cancers.
News coverage for AADI has included financial results and earnings updates, such as quarterly reports highlighting FYARRO® product sales and operating performance. Investors can also find announcements about upcoming webcasts where Aadi discusses quarterly and full-year results and provides corporate updates.
A key theme in recent Aadi news has been its business transformation. The company has reported a strategic plan involving the sale of its FYARRO business and associated infrastructure to KAKEN Pharmaceutical, the in-licensing of a three-asset, preclinical antibody-drug conjugate (ADC) portfolio from WuXi Biologics and HANGZHOU DAC, and a PIPE financing. Related news items include the filing of a definitive proxy statement, the scheduling and outcome of a Special Meeting of Stockholders, and the closing of the PIPE financing.
Additional AADI news highlights pipeline and clinical developments, such as updates on the PRECISION1 tumor-agnostic trial of nab-sirolimus and decisions to halt or adjust trials based on data and strategic priorities. The company also issues releases on leadership and governance changes, including the appointment of a Chief Scientific Officer with extensive ADC experience and the addition of board members with backgrounds in ADC development.
For investors and followers of oncology therapeutics, the AADI news stream provides insight into how the company is shifting from FYARRO commercialization toward an in-licensed ADC portfolio, while managing capital through private placements and strategic transactions. Regular news items offer context on Aadi’s evolving pipeline, financing activities, and corporate direction.
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.
Aadi Bioscience announced the appointment of Brendan Delaney as the new Chief Operating Officer (COO). Delaney, with extensive experience in oncology-focused roles, previously served as Chief Commercial Officer at Constellation Pharmaceuticals, facilitating its $1.4 billion acquisition by MorphoSys AG. His background includes significant contributions to the launches of key oncology drugs, such as TRODELVY, acquired by Gilead for $21 billion. Aadi aims to leverage Delaney's expertise to prepare for the launch of its product ABI-009 for malignant PEComa, with a PDUFA action date set for November 26, 2021.
Aadi Bioscience, Inc. (AADI) has appointed Emma Reeve as the new Audit Committee Chair on its Board of Directors. With over 25 years of experience in the pharmaceutical and biotech sectors, Reeve has a proven track record in transitioning companies from private to public. Notably, she was CFO of Constellation Pharmaceuticals, which raised over $600 million and was sold for approximately $1.7 billion. Her expertise is seen as crucial as Aadi prepares for the potential commercialization of its lead candidate, FYARRO™, targeting genetically-defined cancers with mTOR pathway gene alterations.
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