EDGAR2/9/2021, 5:30:00 AM
Insider transactionEDGAR2/9/2021, 5:30:00 AM
Insider transactionEDGAR2/9/2021, 5:30:00 AM
Insider transactionEDGAR2/9/2021, 5:30:00 AM
Insider transactionEDGAR2/9/2021, 5:30:00 AM
Filing 8k materialEDGAR2/9/2021, 5:30:00 AM
Insider transactionEDGAR2/26/2021, 5:30:00 AM
Insider transactionEDGAR2/26/2021, 5:30:00 AM
Insider transactionEDGAR3/1/2021, 5:30:00 AM
Filing 8k materialEDGAR3/30/2021, 5:30:00 AM
Filing 8k materialEDGAR5/13/2021, 5:30:00 AM
Earnings releaseEDGAR5/13/2021, 5:30:00 AM
Filing 8k materialEDGAR6/14/2021, 5:30:00 AM
Filing 8k materialEDGAR8/16/2021, 5:30:00 AM
Filing 8k materialEDGAR9/29/2021, 5:30:00 AM
Filing 8k materialEDGAR9/30/2021, 5:30:00 AM
Insider transactionEDGAR9/30/2021, 5:30:00 AM
Insider transactionEDGAR9/30/2021, 5:30:00 AM
Insider transactionEDGAR9/30/2021, 5:30:00 AM
Insider transactionEDGAR9/30/2021, 5:30:00 AM
Insider transactionEDGAR9/30/2021, 5:30:00 AM
Insider transactionEDGAR9/30/2021, 5:30:00 AM
Insider transactionEDGAR10/12/2021, 5:30:00 AM
Insider transactionEDGAR11/9/2021, 5:30:00 AM
Filing 8k materialEDGAR11/15/2021, 5:30:00 AM
Earnings releaseEDGAR11/15/2021, 5:30:00 AM
Filing 8k materialEDGAR1/19/2022, 5:30:00 AM
Filing 8k materialEDGAR1/28/2022, 5:30:00 AM
Insider transactionEDGAR1/28/2022, 5:30:00 AM
Insider transactionEDGAR1/28/2022, 5:30:00 AM
Insider transactionEDGAR1/28/2022, 5:30:00 AM
Insider transactionEDGAR3/3/2022, 5:30:00 AM
Earnings releaseEDGAR3/3/2022, 5:30:00 AM
Filing 8k materialEDGAR3/21/2022, 5:30:00 AM
Filing 8k materialEDGAR5/16/2022, 5:30:00 AM
Filing 8k materialEDGAR5/16/2022, 5:30:00 AM
Earnings releaseEDGAR6/1/2022, 5:30:00 AM
Filing 8k materialEDGAR6/8/2022, 5:30:00 AM
Insider transactionEDGAR6/8/2022, 5:30:00 AM
Insider transactionEDGAR6/8/2022, 5:30:00 AM
Insider transactionEDGAR6/17/2022, 5:30:00 AM
Filing 8k materialEDGAR6/21/2022, 5:30:00 AM
Insider transactionEDGAR6/21/2022, 5:30:00 AM
Insider transactionEDGAR6/21/2022, 5:30:00 AM
Insider transactionEDGAR6/21/2022, 5:30:00 AM
Insider transactionEDGAR6/21/2022, 5:30:00 AM
Insider transactionEDGAR6/21/2022, 5:30:00 AM
Insider transactionEDGAR7/6/2022, 5:30:00 AM
Insider transactionEDGAR7/27/2022, 5:30:00 AM
Filing 8k materialEDGAR7/28/2022, 5:30:00 AM
Insider transactionEDGAR8/8/2022, 5:30:00 AM
Filing 8k materialEDGAR8/8/2022, 5:30:00 AM
Earnings releaseEDGAR8/16/2022, 5:30:00 AM
Insider transactionEDGAR8/16/2022, 5:30:00 AM
Filing 8k materialEDGAR8/16/2022, 5:30:00 AM
Insider transactionEDGAR8/18/2022, 5:30:00 AM
Insider transactionEDGAR8/18/2022, 5:30:00 AM
Insider transactionEDGAR9/8/2022, 5:30:00 AM
Insider transactionEDGAR9/8/2022, 5:30:00 AM
Insider transactionEDGAR11/9/2022, 5:30:00 AM
Filing 8k materialEDGAR11/9/2022, 5:30:00 AM
Earnings releaseEDGAR11/28/2022, 5:30:00 AM
Insider transactionEDGAR12/23/2022, 5:30:00 AM
Filing 8k materialEDGAR12/23/2022, 5:30:00 AM
Insider transactionEDGAR12/23/2022, 5:30:00 AM
Insider transactionEDGAR12/28/2022, 5:30:00 AM
Insider transactionEDGAR12/28/2022, 5:30:00 AM
Insider transactionEDGAR1/5/2023, 5:30:00 AM
Filing 8k materialEDGAR2/3/2023, 5:30:00 AM
Insider transactionEDGAR2/3/2023, 5:30:00 AM
Insider transactionEDGAR2/3/2023, 5:30:00 AM
Insider transactionEDGAR2/3/2023, 5:30:00 AM
Insider transactionEDGAR3/2/2023, 5:30:00 AM
Filing 8k materialEDGAR3/13/2023, 5:30:00 AM
Filing 8k materialEDGAR3/27/2023, 5:30:00 AM
Filing 8k materialEDGAR3/27/2023, 5:30:00 AM
Earnings releaseEDGAR5/15/2023, 5:30:00 AM
Filing 8k materialEDGAR5/15/2023, 5:30:00 AM
Earnings releaseEDGAR5/15/2023, 5:30:00 AM
Filing 8k materialEDGAR6/2/2023, 5:30:00 AM
Insider transactionEDGAR6/2/2023, 5:30:00 AM
Insider transactionEDGAR6/2/2023, 5:30:00 AM
Insider transactionEDGAR6/14/2023, 5:30:00 AM
Insider transactionEDGAR6/14/2023, 5:30:00 AM
Filing 8k materialEDGAR6/14/2023, 5:30:00 AM
Insider transactionEDGAR6/14/2023, 5:30:00 AM
Insider transactionEDGAR6/14/2023, 5:30:00 AM
Insider transactionEDGAR6/14/2023, 5:30:00 AM
Insider transactionEDGAR6/14/2023, 5:30:00 AM
Insider transactionEDGAR6/14/2023, 5:30:00 AM
Insider transactionEDGAR8/3/2023, 5:30:00 AM
Filing 8k materialEDGAR8/8/2023, 5:30:00 AM
Earnings releaseEDGAR8/8/2023, 5:30:00 AM
Filing 8k materialEDGAR10/10/2023, 5:30:00 AM
Filing 8k materialEDGAR11/14/2023, 5:30:00 AM
Earnings releaseEDGAR11/14/2023, 5:30:00 AM
Filing 8k materialEDGAR11/17/2023, 5:30:00 AM
Insider transactionEDGAR12/4/2023, 5:30:00 AM
Insider transactionEDGAR12/4/2023, 5:30:00 AM
Insider transactionEDGAR1/25/2024, 5:30:00 AM
Insider transactionEDGAR1/25/2024, 5:30:00 AM
Insider transactionEDGAR1/25/2024, 5:30:00 AM
Insider transactionEDGAR1/25/2024, 5:30:00 AM
Insider transactionEDGAR2/7/2024, 5:30:00 AM
Filing 8k materialEDGAR3/5/2024, 5:30:00 AM
Insider transactionEDGAR3/14/2024, 5:30:00 AM
Earnings releaseEDGAR3/14/2024, 5:30:00 AM
Filing 8k materialEDGAR4/3/2024, 5:30:00 AM
Insider transactionEDGAR4/29/2024, 5:30:00 AM
Filing 8k materialEDGAR5/2/2024, 5:30:00 AM
Insider transactionEDGAR5/13/2024, 5:30:00 AM
Filing 8k materialEDGAR5/13/2024, 5:30:00 AM
Earnings releaseEDGAR6/4/2024, 5:30:00 AM
Insider transactionEDGAR6/4/2024, 5:30:00 AM
Insider transactionEDGAR6/12/2024, 5:30:00 AM
Filing 8k materialEDGAR6/14/2024, 5:30:00 AM
Insider transactionEDGAR6/14/2024, 5:30:00 AM
Insider transactionEDGAR6/14/2024, 5:30:00 AM
Insider transactionEDGAR6/14/2024, 5:30:00 AM
Insider transactionEDGAR6/14/2024, 5:30:00 AM
Insider transactionEDGAR6/14/2024, 5:30:00 AM
Insider transactionEDGAR6/14/2024, 5:30:00 AM
Insider transactionEDGAR7/2/2024, 5:30:00 AM
Insider transactionEDGAR7/2/2024, 5:30:00 AM
Insider transactionEDGAR7/2/2024, 5:30:00 AM
Insider transactionEDGAR7/2/2024, 5:30:00 AM
Insider transactionEDGAR7/2/2024, 5:30:00 AM
Insider transactionEDGAR7/2/2024, 5:30:00 AM
Insider transactionEDGAR7/3/2024, 5:30:00 AM
Filing 8k materialEDGAR7/17/2024, 5:30:00 AM
Insider transactionEDGAR7/17/2024, 5:30:00 AM
Insider transactionEDGAR7/17/2024, 5:30:00 AM
Insider transactionEDGAR7/29/2024, 5:30:00 AM
Filing 8k materialEDGAR8/5/2024, 5:30:00 AM
Earnings releaseEDGAR8/5/2024, 5:30:00 AM
Filing 8k materialEDGAR8/5/2024, 5:30:00 AM
Insider transactionEDGAR9/9/2024, 5:30:00 AM
Filing 8k materialEDGAR9/11/2024, 5:30:00 AM
Insider transactionEDGAR9/12/2024, 5:30:00 AM
Filing 8k materialEDGAR9/12/2024, 5:30:00 AM
Insider transactionEDGAR9/17/2024, 5:30:00 AM
Insider transactionEDGAR11/12/2024, 5:30:00 AM
Earnings releaseEDGAR11/12/2024, 5:30:00 AM
Filing 8k materialEDGAR11/18/2024, 5:30:00 AM
Filing 8k materialEDGAR11/19/2024, 5:30:00 AM
Insider transactionEDGAR12/3/2024, 5:30:00 AM
Filing 8k materialEDGAR12/9/2024, 5:30:00 AM
Insider transactionEDGAR12/16/2024, 5:30:00 AM
Insider transactionEDGAR1/6/2025, 5:30:00 AM
Insider transactionEDGAR1/6/2025, 5:30:00 AM
Insider transactionEDGAR1/6/2025, 5:30:00 AM
Insider transactionEDGAR2/3/2025, 5:30:00 AM
Insider transactionEDGAR2/3/2025, 5:30:00 AM
Insider transactionEDGAR2/3/2025, 5:30:00 AM
Insider transactionEDGAR2/3/2025, 5:30:00 AM
Insider transactionEDGAR2/3/2025, 5:30:00 AM
Insider transactionEDGAR2/3/2025, 5:30:00 AM
Insider transactionEDGAR2/3/2025, 5:30:00 AM
Insider transactionEDGAR2/3/2025, 5:30:00 AM
Insider transactionEDGAR2/6/2025, 5:30:00 AM
Filing 8k materialEDGAR2/20/2025, 5:30:00 AM
Filing 8k materialEDGAR2/24/2025, 5:30:00 AM
Filing 8k materialEDGAR2/24/2025, 5:30:00 AM
Insider transactionEDGAR2/25/2025, 5:30:00 AM
Insider transactionEDGAR3/20/2025, 5:30:00 AM
Filing 8k materialEDGAR3/20/2025, 5:30:00 AM
Earnings releaseEDGAR4/2/2025, 5:30:00 AM
Insider transactionEDGAR5/8/2025, 5:30:00 AM
Filing 8k materialEDGAR5/8/2025, 5:30:00 AM
Earnings releaseEDGAR6/12/2025, 5:30:00 AM
Insider transactionEDGAR6/12/2025, 5:30:00 AM
Insider transactionEDGAR6/12/2025, 5:30:00 AM
Insider transactionEDGAR6/12/2025, 5:30:00 AM
Insider transactionEDGAR6/12/2025, 5:30:00 AM
Insider transactionEDGAR6/12/2025, 5:30:00 AM
Insider transactionEDGAR6/16/2025, 5:30:00 AM
Filing 8k materialEDGAR6/16/2025, 5:30:00 AM
Insider transactionEDGAR6/25/2025, 5:30:00 AM
Insider transactionEDGAR6/30/2025, 5:30:00 AM
Insider transactionEDGAR7/3/2025, 5:30:00 AM
Insider transactionEDGAR8/5/2025, 5:30:00 AM
Filing 8k materialEDGAR8/5/2025, 5:30:00 AM
Earnings releaseEDGAR10/2/2025, 5:30:00 AM
Insider transactionEDGAR10/22/2025, 5:30:00 AM
Filing 8k materialEDGAR11/3/2025, 5:30:00 AM
Filing 8k materialEDGAR11/5/2025, 5:30:00 AM
Insider transactionEDGAR11/10/2025, 5:30:00 AM
Earnings releaseEDGAR11/10/2025, 5:30:00 AM
Filing 8k materialEDGAR12/8/2025, 5:30:00 AM
Filing 8k materialEDGAR12/11/2025, 5:30:00 AM
Filing 8k materialEDGAR1/6/2026, 5:30:00 AM
Insider transactionEDGAR1/6/2026, 5:30:00 AM
Insider transactionEDGAR1/9/2026, 5:30:00 AM
Earnings releaseEDGAR1/9/2026, 5:30:00 AM
Filing 8k materialEDGAR1/16/2026, 5:30:00 AM
Insider transactionEDGAR1/16/2026, 5:30:00 AM
Insider transactionEDGAR1/16/2026, 5:30:00 AM
Insider transactionEDGAR1/22/2026, 5:30:00 AM
Filing 8k materialEDGAR2/2/2026, 5:30:00 AM
Insider transactionEDGAR2/2/2026, 5:30:00 AM
Insider transactionEDGAR2/2/2026, 5:30:00 AM
Insider transactionEDGAR2/2/2026, 5:30:00 AM
Insider transactionEDGAR2/2/2026, 5:30:00 AM
Insider transactionEDGAR2/2/2026, 5:30:00 AM
Insider transactionEDGAR2/18/2026, 5:30:00 AM
Insider transactionEDGAR3/17/2026, 5:30:00 AM
Insider transactionEDGAR3/25/2026, 5:30:00 AM
Filing 8k materialEDGAR4/2/2026, 5:30:00 AM
Insider transactionEDGAR4/27/2026, 5:30:00 AM
Filing 8k materialEDGAR5/5/2026, 5:30:00 AM
Insider transactionEDGAR5/5/2026, 5:30:00 AM
Insider transactionEDGAR5/5/2026, 5:30:00 AM
Filing 8k materialEDGAR5/5/2026, 5:30:00 AM
Insider transactionEDGAR5/5/2026, 5:30:00 AM
Insider transactionEDGAR5/5/2026, 5:30:00 AM
Insider transactionEDGAR5/5/2026, 5:30:00 AM
Insider transactionEDGAR5/5/2026, 5:30:00 AM
Insider transactionEDGAR5/5/2026, 5:30:00 AM
Insider transactionEDGAR5/5/2026, 5:30:00 AM
Insider transactionCTGOV9/4/2026, 6:52:06 AM
Trial registeredCTGOV9/4/2026, 6:52:06 AM
Trial registeredCTGOV9/4/2026, 6:52:07 AM
Trial registeredCTGOV9/4/2026, 6:52:07 AM
Trial registeredCTGOV9/4/2026, 6:52:08 AM
Trial registeredCTGOV9/27/2026, 5:07:17 AM
Trial registeredCTGOV9/27/2026, 5:07:18 AM
Trial registeredCTGOV10/16/2026, 5:05:31 AM
Trial enrollment changeCTGOV10/16/2026, 5:05:31 AM
Trial endpoint change| primary_outcomes | [object Object],[object Object],[object Object],[object Object],[object Object],[object Object] | → | [object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object] |
| secondary_outcomes | null | → | [object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object] |
CTGOV10/16/2026, 5:05:31 AM
Indication added| conditions | Chronic Myeloid Leukemia, Chronic Phase,Chronic Myeloid Leukemia | → | Leukemia, Myelogenous, Chronic, BCR-ABL Positive,Chronic Myeloid Leukemia, Chronic Phase,Chronic Myeloid Leukemia |
CTGOV10/16/2026, 5:05:31 AM
Trial eligibility change| eligibility_criteria | Key Inclusion Criteria:
* Male or female participants ≥ 18 years of age at the time of signing the informed consent
* Have an ECOG performance status score of 0 to 2
* Have an established cytopathologically confirmed diagnosis of BCR-ABL1 positive CML in Chronic Phase
* Have received treatment with at least one prior TKI and have treatment failure, suboptimal response, or treatment intolerance
* Prior treatment with asciminib is allowed
* Adequate organ function, as assessed by local laboratory
Key Exclusion Criteria:
* Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of TERN-701
* Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline) | → | Key Inclusion Criteria:
Inclusion Criteria include but are not limited to:
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
* Have an established cytopathologically confirmed diagnosis of breakpoint cluster region::Abelson (BCR-ABL1) positive Chronic Myeloid Leukemia (CML) in Chronic Phase
* Have received treatment with at least one prior tyrosine kinase inhibitor (TKI) and have treatment failure, suboptimal response, or treatment intolerance
* Prior treatment with asciminib is allowed
* Adequate organ function, as assessed by local laboratory
Key Exclusion Criteria:
Exclusion criteria include but are not limited to:
* Systemic antineoplastic therapy (including prior TKIs, interferon-alfa, therapeutic antibodies, chemotherapy) or other experimental therapy 7 days before the first dose of MK-4208/TERN-701
* Have completed previous anticancer therapy without resolution of all associated clinically significant toxicity (to ≤ Grade 2 or baseline) |
CTGOV10/23/2026, 5:05:42 AM
Trial endpoint change| primary_outcomes | [object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object] | → | [object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object] |
| secondary_outcomes | [object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object] | → | [object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object] |
CTGOV10/23/2026, 5:05:42 AM
Trial eligibility change| eligibility_criteria | Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has body weight ≥48 kg (105.6 lbs) and body mass index within the range of 18.5 to 32 kg/m\^2 (inclusive)
* Is in good health
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has history or clinical manifestation of any metabolic, allergic, autoimmune, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, ocular, respiratory, endocrine, or psychiatric disorder, or any condition that would affect drug absorption, distribution, metabolism, or excretion (eg, stomach or intestinal surgery, or gallbladder removal/cholecystectomy). Uncomplicated appendectomy and hernia repair will be allowed.
* Has history of QT prolongation syndrome, unexplained syncope, family history of sudden death, atrial fibrillation, malignant tumor, mental disorder, or any major disease
* Has positive screening test for Hepatitis B surface antigen, anti-Hepatitis C virus antibodies, or anti-Human immunodeficiency virus (HIV) 1 and 2 antibodies
* Has any known history of bleeding, or prothrombin time (TERN-701 + Probe Substrate Cocktail-2 arm only) | → | Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has body weight ≥48 kg (105.6 lbs) and body mass index within the range of 18.5 to 32 kg/m\^2 (inclusive)
* Is in good health
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has history or clinical manifestation of any metabolic, allergic, autoimmune, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, ocular, respiratory, endocrine, or psychiatric disorder, or any condition that would affect drug absorption, distribution, metabolism, or excretion (eg, stomach or intestinal surgery, or gallbladder removal/cholecystectomy). Uncomplicated appendectomy and hernia repair will be allowed.
* Has history of QT prolongation syndrome, unexplained syncope, family history of sudden death, atrial fibrillation, malignant tumor, mental disorder, or any major disease
* Has positive screening test for Hepatitis B surface antigen, anti-Hepatitis C virus antibodies, or anti-Human immunodeficiency virus (HIV) 1 and 2 antibodies
* Has any known history of bleeding, or prothrombin time (Embibatinib + Probe Substrate Cocktail-2 arm only) |