TPTX - TPTX STOCK NEWS

Turning Point Therapeutics (TPTX) has received FDA clearance for its Investigational New Drug (IND) application concerning the combination of elzovantinib and aumolertinib in treating EGFR mutant MET-amplified advanced non-small cell lung cancer (NSCLC). The company plans to initiate the Phase 1b/2 SHIELD-2 trial in mid-2022, which will evaluate safety and preliminary efficacy in patients previously treated with osimertinib. Aumolertinib is already approved in China for specific NSCLC treatments. This development may enhance anti-tumor activity and address resistance issues in a subset of lung cancer patients.

Turning Point Therapeutics (TPTX) announced strong enrollment in the TRIDENT-1 Phase 2 study of repotrectinib, targeting ROS1-positive NSCLC, completing a 60-patient cohort. Anticipated topline data from this cohort is expected in 2Q 2022, alongside pre-NDA discussions with the FDA. The Phase 1 data for TKI-naïve patients indicated a duration of response ranging from 5.6 to over 42 months. The company confirmed sufficient cash reserves to fund operations into 2H 2024, supporting ongoing clinical trials and pipeline advancements.

Turning Point Therapeutics (NASDAQ: TPTX) announced regulatory updates on its drug candidates, repotrectinib and elzovantinib, following recent FDA meetings. Repotrectinib, a ROS1/TRK inhibitor, has received breakthrough therapy designation and the FDA advised a pre-NDA meeting to discuss BICR results from ongoing studies. Elzovantinib, targeting MET/CSF1R/SRC, is advancing towards a Phase 2 trial following favorable discussions with the FDA regarding dosage and study design. The company is committed to providing further updates once enrollment targets are met.

Turning Point Therapeutics (NASDAQ: TPTX) announced participation in two healthcare conferences. President and CEO Athena Countouriotis, M.D., will present at the Jefferies London Healthcare Conference on November 16 at 7:20 a.m. ET and engage in a virtual fireside chat at the Evercore ISI 4th Annual HealthCONx Conference on November 30 at 1 p.m. ET. Both events will be available via webcast on the company's investor page. Turning Point focuses on precision oncology, with therapies targeting genetic drivers of cancer, including their lead drug repotrectinib for non-small cell lung cancer.

Turning Point Therapeutics (TPTX) presented updated preliminary clinical data for its lead candidates repotrectinib and elzovantinib at the AACR-NCI-EORTC Conference. The company is set for multiple FDA interactions in Q4 2021 and 1H 2022 regarding these candidates. Financially, TPTX reported a net loss of $66.3 million for Q3 2021, up from $17.7 million in Q3 2020. R&D expenses rose to $48.9 million, driven by development efforts. TPTX holds $1.0 billion in cash and equivalents, projected to support operations into 2024.

Turning Point Therapeutics (NASDAQ: TPTX) has appointed Adam Levy, Ph.D., MBA, as senior vice president of Investor Relations and Corporate Communications, effective immediately. With over 20 years of experience in investor relations and corporate strategy from companies like Ziopharm Oncology and Gilead Sciences, Levy aims to enhance Turning Point's communication strategy. Additionally, Scott Lipman has been promoted to chief of staff, having previously contributed significantly to business development and investor relations since joining in 2020. These appointments are aimed at strengthening the company's precision oncology vision.

Turning Point Therapeutics (NASDAQ: TPTX) will report its third quarter financial results on November 9, 2021, after U.S. market close. A conference call hosted by President and CEO Athena Countouriotis, M.D., will occur at 1:30 p.m. PT/4:30 p.m. ET to discuss the results and provide updates. Interested parties can access the call via webcast on the company’s website or by phone. Turning Point is focused on precision oncology, developing therapies targeting genetic drivers of cancer, with promising candidates like repotrectinib and elzovantinib in active trials.

Turning Point Therapeutics (TPTX) has announced promising early clinical data for repotrectinib, a treatment targeting pediatric tumors with ALK, ROS1, or NTRK alterations. Presented at the virtual SIOP Congress, the Phase 1/2 CARE study demonstrated confirmed responses in 3 out of 4 TKI-naïve patients. The drug was well tolerated, with an ongoing Phase 1 dose-finding in patients under 12 and a Phase 2 study for those aged 12-25. The company also shared preclinical insights suggesting repotrectinib's potential in neuroblastoma, enhancing its therapeutic pipeline.

Turning Point Therapeutics (TPTX) and EQRx have announced a clinical collaboration to evaluate elzovantinib (TPX-0022) in combination with aumolertinib for treating EGFR mutant MET-amplified advanced non-small cell lung cancer (NSCLC). Turning Point will sponsor a Phase 1b/2 trial to assess safety, tolerability, and effectiveness, with EQRx supplying aumolertinib at no cost. The trial is set to begin in 2022, pending FDA IND application. Preliminary data indicates a potential increase in anti-tumor activity through this combination.