This section highlights FDA-related milestones and regulatory updates for drugs developed by Tango Therapeutics (TNGX).
Over the past two years, Tango Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TNG456, TNG462, and Verzenio. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TNG456 - FDA Regulatory Timeline and Events
TNG456 is a drug developed by Tango Therapeutics for the following indication: In patients with MTAP-deleted solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TNG456
- Announced Date:
- May 21, 2025
- Indication:
- In patients with MTAP-deleted solid tumors
Announcement
Tango Therapeutics, Inc. announced that the first patient has been dosed in the TNG456 Phase 1/2 trial in patients with MTAP-deleted solid tumors, with a focus on glioblastoma (GBM).
AI Summary
Tango Therapeutics, Inc. reached a key milestone by dosing the first patient in its Phase 1/2 trial of TNG456, a novel therapy aimed at treating MTAP-deleted solid tumors, with a specific focus on glioblastoma (GBM). TNG456 is a next-generation, brain-penetrant, MTA-cooperative PRMT5 inhibitor that has shown potential in preclinical studies for its potency, selectivity, and effective brain exposure. With about 45% of GBM cases exhibiting MTAP deletion and GBM patients facing very limited treatment options and low survival rates, this trial offers hope for a new and more precise treatment option. The study is evaluating TNG456 on its own, and in combination with the drug abemaciclib, to assess safety, how the body processes the drug, and its antitumor activity. This step marks an important advancement for patients suffering from these aggressive tumors.
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TNG462 - FDA Regulatory Timeline and Events
TNG462 is a drug developed by Tango Therapeutics for the following indication: MTA-cooperative PRMT5 inhibitor for the treatment of patients with MTAP-deleted cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- TNG462
- Announced Date:
- June 27, 2025
- Indication:
- MTA-cooperative PRMT5 inhibitor for the treatment of patients with MTAP-deleted cancers.
Announcement
Tango Therapeutics, Inc. announced that the first patient has been dosed in the Phase 1/2 trial of TNG462 and Revolution Medicines' daraxonrasib (RAS(ON) multi-selective inhibitor) or zoldonrasib (RAS(ON) G12D-selective inhibitor) in patients with MTAP-deleted and RAS mutant metastatic pancreatic or lung cancer.
AI Summary
Tango Therapeutics announced an important milestone in its fight against cancer. The company has dosed the first patient in a Phase 1/2 trial testing the combination of its drug TNG462 alongside Revolution Medicines’ daraxonrasib (a multi-selective RAS inhibitor) or zoldonrasib (a G12D-selective RAS inhibitor). This trial focuses on patients with metastatic pancreatic or lung cancer that carry both MTAP deletion and RAS mutations, a condition seen in almost all MTAP-deleted pancreatic cancers and about 30% of lung cancers. Preclinical studies have shown that combining these drugs may offer strong therapeutic benefits. Dr. Adam Crystal, Tango’s President of Research and Development, emphasized that early results are promising and the treatment could change the cancer care landscape for patients suffering from these difficult-to-treat forms of cancer.
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Verzenio (abemaciclib) - FDA Regulatory Timeline and Events
Verzenio (abemaciclib) is a drug developed by Tango Therapeutics for the following indication: Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Verzenio (abemaciclib)
- Announced Date:
- February 27, 2025
- Indication:
- Hormone Receptor-Positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer (EBC)
Announcement
Tango Therapeutics, Inc. provided business highlights.
AI Summary
Tango Therapeutics, Inc. shared key business updates as it heads into 2025. The company is advancing its lead PRMT5 program, TNG462, which recently received FDA Orphan Drug Designation for treating pancreatic cancer. Promising early clinical data have been observed, and more detailed data focusing on pancreatic and lung cancers is expected later this year. Tango plans to launch its first TNG462 monotherapy registrational study in pancreatic cancer next year and is set to begin enrollment in combination trials starting in the first half of 2025.
Additionally, the FDA cleared the Investigational New Drug (IND) application for TNG456, a next-generation brain-penetrant MTA-cooperative PRMT5 inhibitor, with Phase 1/2 trials anticipated soon. The company also announced a collaboration with Eli Lilly for evaluating TNG456 in combination with abemaciclib. With a cash position of $258 million, Tango expects to fund its operations into the third quarter of 2026.
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