Perivascular epithelioid cell tumour

Aadi Bioscience Announces Financial Results for the First Quarter 2024 and Provides Corporate Update

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星期三, 五月 8, 2024
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LOS ANGELES, May 8, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage, precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, today announced financial results for the first quarter ended March 31, 2024, and highlighted recent corporate progress.

Key Points: 
  • We look forward to providing the two-thirds interim analysis in the third quarter, and full results in early 2025.
  • The impacts to sales in the first quarter are well-understood events and we expect to return to sales growth in Q2."
  • The Aadi management team is hosting a conference call and webcast today at 8:30 am EDT (5:30 am PDT) to provide a corporate update and discuss results for the first quarter 2024.
  • Participants may access a live webcast of the call on the "Investors & News" page of the Aadi Bioscience website at aadibio.com .

Aadi Bioscience Presents New Subgroup Analysis of Patients with Advanced Malignant PEComa of Gynecologic Origin Treated with nab-Sirolimus at Society of Gynecologic Oncology (SGO)

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星期日, 三月 17, 2024
TSC1, Ovarian cancer, AADI, Endometrial cancer, Perivascular epithelioid cell tumour, EEC, Cervical cancer, Patient, Neoplasm, Cancer, Trial of the century, University, SGO, MD, Malignancy, Society, Safety, Gynecologic Oncology (journal), TSC2, FDA, Glomus tumor, Aadi, Pharmaceutical industry

LOS ANGELES, March 17, 2024 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, today announced patients in the AMPECT trial whose malignant perivascular epithelioid cell tumor (PEComa) had gynecologic origins experienced efficacy and safety consistent with the overall study population. The AMPECT trial formed the basis for the FDA approval of the company's nab-sirolimus, FYARRO®, for advanced malignant PEComa regardless of mutational status. This new subgroup analysis will be presented during an oral plenary at the Society of Gynecologic Oncology (SGO) Annual Meeting in San Diego, CA on March 17, 2024.

Key Points: 
  • The AMPECT trial formed the basis for the FDA approval of the company's nab-sirolimus, FYARRO®, for advanced malignant PEComa regardless of mutational status.
  • This new subgroup analysis will be presented during an oral plenary at the Society of Gynecologic Oncology (SGO) Annual Meeting in San Diego, CA on March 17, 2024.
  • "Overactivation of the mTOR pathway has been implicated in gynecological cancers," said Loretta Itri, MD, Chief Medical Officer at Aadi.
  • "nab-Sirolimus is a nanoparticle albumin-bound (nab) mTOR inhibitor under investigation in TSC1- and TSC2-mutated tumors as well as other mTOR-driven tumors.

Aadi Bioscience to Present Multiple Posters on nab-Sirolimus at the 2023 American Association for Cancer Research (AACR) Annual Meeting

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星期五, 四月 14, 2023
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LOS ANGELES, April 14, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced the presentation of three posters at the 2023 American Association for Cancer Research Annual Meeting (AACR), taking place April 14-19, 2023, in Orlando, FL.

Key Points: 
  • LOS ANGELES, April 14, 2023 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced the presentation of three posters at the 2023 American Association for Cancer Research Annual Meeting (AACR), taking place April 14-19, 2023, in Orlando, FL.
  • nab-Sirolimus 100 mg/m2 will be given weekly intravenously over 30 minutes on Days 1 and 8 of each 21-day cycle.
  • Full session and meeting details are available through the AACR Annual Meeting planner: AACR Annual Meeting 2023 | Meetings | AACR .
  • Each poster will be made available following the date of presentation at AACR, on the investor relations page of the Aadi website at www.aadibio.com

Aadi Bioscience Appoints Mohammad Hirmand, M.D. to Board of Directors

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星期一, 三月 27, 2023
Nuvelo, ARCA, Biotechnology, Cancer, Pfizer, Bristol Myers Squibb, Perivascular epithelioid cell tumour, AADI, Harvard Medical School, Economics, Acquisition, TSC2, Patient, Peloton, Supergene, Growth, Merck, BMS, Merck & Co., Therapy, Cornell University, Medivation, Enzalutamide, Aadi, TSC1, Pharmaceutical industry

"We welcome Mohammad to our Board at an exciting time for Aadi, as we advance the development of FYARRO for unmet clinical needs beyond our approved indication of PEComa.

Key Points: 
  • "We welcome Mohammad to our Board at an exciting time for Aadi, as we advance the development of FYARRO for unmet clinical needs beyond our approved indication of PEComa.
  • Mohammad is a world-class clinical development leader in oncology and will be a great complement to our board and partner with our highly experienced team," said Caley Castelein, M.D., Aadi Board Chairman.
  • "Mohammad has been instrumental in the development of Medivation's Xtandi and Welireg (belzutifan), when at Peloton Therapeutics.
  • "I am excited to join Aadi's Board of Directors in their mission to unlock the potential of nab-sirolimus in addressing mTOR-driven diseases," said Dr. Hirmand.

Aadi Bioscience Announces Leadership Transition

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星期五, 三月 3, 2023
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Scott Giacobello, currently the Company's Chief Financial Officer, has been appointed to serve as Interim Chief Executive Officer and President in addition to his current responsibilities.

Key Points: 
  • Scott Giacobello, currently the Company's Chief Financial Officer, has been appointed to serve as Interim Chief Executive Officer and President in addition to his current responsibilities.
  • In addition, Neil Desai, Ph.D., the Founder of Aadi Bioscience and its President and CEO prior to Mr. Delaney, continues to serve as the Executive Chairman and a member of the Board of directors and will assist with the leadership transition.
  • Mr. Giacobello said, "I look forward to my continued work with the Aadi board and management team, executing on our mission of developing FYARRO for significant unmet needs in oncology.
  • Prior to joining Aadi in 2021, Mr. Giacobello's background included fulfilling key financial and operational roles with a long history of leadership in commercial stage growth companies.

Aadi Bioscience Presents PRECISION 1 Trial in Progress Poster and AMPECT Trial Final Analysis at the Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting

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星期四, 十一月 17, 2022
AES, Adult, Durability, Cancer, Growth, ORR, Dor, Patient, Safety, Risk, FDA, Progression-free survival, Perivascular epithelioid cell tumour, Annual report, PFS, Annual general meeting, Pharmacology, Failure, COVID-19, Sarcoma, DCR, AE, Genta (company), AADI, Pharmaceutical industry

LOS ANGELES, Nov. 17, 2022 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today presented three posters on completed and ongoing clinical trials for nab-sirolimus at the Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting, taking place November 16-19, 2022 in Vancouver, Canada. nab-sirolimus (FYARRO®) is a novel mTOR inhibitor that leverages albumin-bound nanoparticle technology and is approved for the treatment of locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Key Points: 
  • "The trial-in-progress poster presents the design of our PRECISION 1 trial, while our two additional posters provide long-term analysis from our AMPECT trial that demonstrates nab-sirolimus' durability of response and long-term safety.
  • Overall Response Rate (ORR), Disease Control Rate (DCR), and Progression Free Survival (PFS) were consistent with prior analysis of nab-sirolimus in AMPECT.
  • Aadi and its collaborators present data on the adverse event (AE) management in the AMPECT trial over three years after the primary analysis was presented.
  • nab-Sirolimus was generally well-tolerated, and the majority of the AEs due to nab-sirolimus treatment in the AMPECT trial were manageable.

Aadi Bioscience Announces Planned Leadership Transition

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星期二, 十一月 8, 2022
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"I have had the opportunity to work with Brendan since he joined Aadi as Chief Operating Officer in September 2021.

Key Points: 
  • "I have had the opportunity to work with Brendan since he joined Aadi as Chief Operating Officer in September 2021.
  • Since that time his expertise and leadership have been instrumental in building the organization in preparation for the growth that lies ahead," saidNeil Desai, Ph.D., Founder, President and Chief Executive Officer ofAadi Bioscience.
  • Going forward, Brendan will assume leadership of the Company as we continue to gain momentum on all of these fronts.
  • Dr. Desai is the founder of Aadi Bioscience and has served as its President and CEO since 2011.

Aadi Bioscience to Present at Upcoming Investor Conferences

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星期四, 十一月 3, 2022
NASDAQ, TSC2, FDA, Conference, Aadi, TSC1, Adult, CEO, GMT, Patient, Company, Cancer, AADI, Perivascular epithelioid cell tumour, Q&A, Pharmaceutical industry, Security (finance)

Aadi is a commercial-stage biopharmaceutical company focused on precision therapies for genetically defined cancers to bring transformational therapies to cancer patients with mTOR pathway driver alterations.

Key Points: 
  • Aadi is a commercial-stage biopharmaceutical company focused on precision therapies for genetically defined cancers to bring transformational therapies to cancer patients with mTOR pathway driver alterations.
  • Aadi received FDA approval in November of 2021 and in February of 2022 commercialized FYARRO for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
  • Aadi has also initiated PRECISION 1, a Phase 2 tumor-agnostic registration-intended trial in mTOR inhibitor-nave malignant solid tumors harboring TSC1 or TSC2 inactivating alterations.
  • More information on the Company's development pipeline is available on the Aadi website at www.aadibio.com and connect with us on Twitter and LinkedIn .

Aadi Bioscience to Report Third Quarter 2022 Results and Corporate Update

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星期三, 十一月 2, 2022
TSC2, Adult, AADI, Conference, Cancer, Aadi, Perivascular epithelioid cell tumour, Telephone, ID, NASDAQ, TSC1, Company, FDA, Patient, Webcast, Pharmaceutical industry

LOS ANGELES, Nov. 2, 2022 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced that it will host a conference call and live webcast on Wednesday, November 9, 2022 at 8:30 am ET (5:30 am PT) to report third quarter 2022 financial results and provide recent corporate updates.

Key Points: 
  • LOS ANGELES, Nov. 2, 2022 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced that it will host a conference call and live webcast on Wednesday, November 9, 2022 at 8:30 am ET (5:30 am PT) to report third quarter 2022 financial results and provide recent corporate updates.
  • Participants may access a live webcast of the call on the "Investors & News" page of theAadi Biosciencewebsite at aadibio.com .
  • Aadi has also initiated PRECISION 1, a Phase 2 tumor-agnostic registration-intended trial in mTOR inhibitor-nave malignant solid tumors harboring TSC1 or TSC2 inactivating alterations.
  • More information on the Company's development pipeline is available on the Aadi website at www.aadibio.com and connect with us on Twitter and LinkedIn .

Aadi Bioscience Announces Improved Anti-Tumor Activity of KRAS Inhibitors in Combination with Nab-sirolimus at the 34th EORTC-NCI-AACR Symposium

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星期四, 十月 27, 2022
Time, NSCLC, Review, NASDAQ, TSC1, Mirati, Private Securities Litigation Reform Act, Cancer, EORTC, MTOR, KRAS, Forward-looking statement, AMG510, FDA, Perivascular epithelioid cell tumour, Patient, LinkedIn, Adult, Company, Partnership, AADI, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Risk, Everolimus, Food, TSC2, Mutation, Twitter, Safety, Pharmaceutical industry, Aadi

LOS ANGELES, Oct. 27, 2022 /PRNewswire/ -- Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage biopharmaceutical company focused on developing and commercializing precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today presented preclinical combination data of KRAS inhibitors and nab-sirolimus at the 34th EORTC-NCI-AACR Symposium. Nab-sirolimus is a novel albumin-bound nanoparticle form of the mTOR inhibitor sirolimus and is approved for the treatment of locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).

Key Points: 
  • The mTOR pathway is often activated in patients with the KRAS mutation and contributes to adaptive resistance to KRAS inhibitors.
  • This study investigated the preclinical antitumor activity of mTOR inhibitors nab-sirolimus or everolimus in combination with sotorasib or adagrasib in KRASG12C-mutated cancer xenografts.
  • "These preclinical results demonstrate that nab-sirolimus has the potential to significantly improve the antitumor activity of adagrasib or sotorasib, two of the most promising KRAS inhibitors today.
  • In contrast, everolimus in combination with the KRAS inhibitors was not as effective.