Aadi Bioscience, Inc. - AADI STOCK NEWS

Aadi Bioscience, Inc. reported first quarter 2022 financial results, highlighting net product sales of $2.3 million from the launch of FYARRO in February.

The company emphasizes strong demand and favorable physician awareness. Operating expenses surged to $16.1 million, with a net loss of $13.9 million, compared to $5.5 million in Q1 2021. Aadi initiated dosing in the PRECISION 1 trial, targeting TSC1/TSC2 gene alterations, and expects initial clinical data in 2023. Aadi anticipates cash reserves will fund operations into 2024.

Aadi Bioscience has announced collaborations with leading next-generation sequencing (NGS) companies, including Foundation Medicine and Tempus, to enhance enrollment in its PRECISION 1 trial. This Phase 2 registrational trial focuses on patients with advanced cancer exhibiting inactivating alterations in the TSC1 and TSC2 genes, with a projected US incidence of 12,000 patients. The partnerships aim to improve patient identification and enrollment speed for the trial, which evaluates nab-sirolimus. Preliminary data from the trial is expected in the first half of the following year.

Aadi Bioscience, Inc. (Nasdaq: AADI) announced the approval of a permanent J-code (J9331) for its drug FYARRO™ effective July 1, 2022. This J-code improves the reimbursement process for FYARRO, which treats adult patients with malignant perivascular epithelioid cell tumors (PEComa). The standardization will apply across Medicare and private insurance, facilitating claims submissions. FYARRO is the first approved treatment for PEComa and is now included in the NCCN Clinical Practice Guidelines as a preferred regimen. Aadi emphasized the significance of this milestone for patient access and commercial rollout.

Aadi Bioscience (Nasdaq: AADI) will report its Q1 2022 results on May 12, 2022, before the market opens. Following this, a conference call will be held at 8:30 am EDT to discuss the results and provide a corporate update. Aadi focuses on precision therapies for cancers related to mTOR pathway gene alterations. The company’s FYARRO™ has received FDA approval for treating a rare tumor and is now commercially available. Aadi is also advancing its clinical pipeline with the launch of the PRECISION 1 trial targeting specific solid tumors.

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.