BCR-ABL

Terns Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates

Retrieved on: 
Thursday, March 14, 2024
Pharmacokinetics, Patient, Administration, Research and development, Weight loss, Obesity, BCR-ABL, CML, GIPR, Safety, Pharmaceutical industry

FOSTER CITY, Calif., March 14, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided corporate updates.

Key Points: 
  • Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026.
  • Research and Development (R&D) Expenses: R&D expenses were $17.5 million and $63.5 million for the quarter and year ended December 31, 2023, respectively, as compared with $10.7 million and $39.6 million for the quarter and year ended December 31, 2022, respectively.
  • General and Administrative (G&A) Expenses: G&A expenses were $6.6 million and $39.1 million for the quarter and year ended December 31, 2023, respectively, as compared with $6.2 million and $22.4 million for the quarter and year ended December 31, 2022, respectively.
  • Net Loss: Net loss was $21.0 million and $90.2 million for the quarter and year ended December 31, 2023, respectively, as compared with $15.8 million and $60.3 million for the quarter and year ended December 31, 2022, respectively.

BIO-TECHNE RECEIVES EUROPEAN IVDR CERTIFICATION FOR DIAGNOSTIC TEST TO MONITOR CHRONIC MYELOID LEUKEMIA

Retrieved on: 
Friday, March 22, 2024
Certification, Acute leukemia, Kit, BCR-ABL, Patient, CML, Class, Bio-Techne, Sale, Cancer, IVDR, Diagnosis, Workflow, ABL1, Safety, Liquid biopsy, TKI, Physician, IVDD, Medical device

MINNEAPOLIS, March 22, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Asuragen, part of Bio-Techne's Molecular Diagnostics Division, has completed the Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX® qPCR BCR-ABL IS Kit. Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR.

Key Points: 
  • Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR.
  • The QuantideX qPCR BCR-ABL IS Kit gives labs a robust and reliable tool for monitoring chronic myeloid leukemia (CML) patients.
  • The highly sensitive qPCR-based in vitro diagnostic test quantifies BCR-ABL1 and ABL1 transcripts in blood samples from patients with CML to determine their response to tyrosine kinase inhibitor (TKI) therapy.
  • CML patients must undergo regular monitoring to ensure that they continue to receive the most appropriate treatment for their cancer.

Terns Pharmaceuticals Announces Orphan Drug Designation Granted to TERN-701 for the Treatment of Chronic Myeloid Leukemia

Retrieved on: 
Monday, March 11, 2024
BCR-ABL, MD, Obesity, FDA, Food, Acute leukemia, Safety, Leukemia, CML, TKI, Pharmaceutical industry

FOSTER CITY, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TERN-701 for the treatment of chronic myeloid leukemia (CML).

Key Points: 
  • FOSTER CITY, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TERN-701 for the treatment of chronic myeloid leukemia (CML).
  • “CML is a serious leukemia that requires chronic, life-long treatment,” said Emil Kuriakose, MD, chief medical officer of Terns.
  • Orphan drug designation for TERN-701 underscores the FDA’s recognition of the unmet need for people living with CML and Terns’ commitment to developing new treatment options.”
    FDA Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States.
  • Orphan drug status provides benefits to drug developers, including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity.

Global Registrational Phase III Study of Olverembatinib (HQP1351) Cleared by FDA

Retrieved on: 
Wednesday, February 14, 2024
CHB, BCR-ABL, FDA, Food, Hepatitis, Safety, Bone marrow, NCCN, Patient, Notifiable disease, National Comprehensive Cancer Network, Mutation, CML, TKI, Cancer, Pharmaceutical industry

Under protocol HQP1351CG301, titled "A Global Multicenter, Open-Label, Randomized, Phase III Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic-Phase Chronic Myeloid Leukemia (POLARIS-2)," the study is designed to assess the efficacy and safety of olverembatinib in the treatment of patients with CML-CP with or without the T315I mutation.

Key Points: 
  • Under protocol HQP1351CG301, titled "A Global Multicenter, Open-Label, Randomized, Phase III Registrational Study of Olverembatinib (HQP1351) in Patients with Chronic-Phase Chronic Myeloid Leukemia (POLARIS-2)," the study is designed to assess the efficacy and safety of olverembatinib in the treatment of patients with CML-CP with or without the T315I mutation.
  • The US FDA's clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted.
  • Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma.
  • *Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland.

Terns Pharmaceuticals Reports Third Quarter 2023 Financial Results and Corporate Updates

Retrieved on: 
Tuesday, November 14, 2023
JD, THR, Research, Safety, Chemistry, Acute leukemia, IND, PD, FXR, Clinical trial, SAD, Overweight, Fatty liver disease, Administration, Patient, DSM-IV codes, Tern, Week, Part, FDA, Obesity, Pharmacokinetics, BCR, Bangladesh Technical Education Board, Houston Methodist Hospital, Investigational New Drug, Non-alcoholic fatty liver disease, BCR-ABL, MD, CML, R, Research and development, NASH, DUET, Pharmaceutical industry, Medical imaging, Cryptocurrency

FOSTER CITY, Calif., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, obesity and non-alcoholic steatohepatitis (NASH), today reported financial results for the quarter ended September 30, 2023 and provided corporate updates.

Key Points: 
  • Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026.
  • Research and Development (R&D) Expenses: R&D expenses were $14.8 million for the quarter ended September 30, 2023, as compared with $12.2 million for the quarter ended September 30, 2022.
  • General and Administrative (G&A) Expenses: G&A expenses were $18.4 million for the quarter ended September 30, 2023, as compared with $5.1 million for the quarter ended September 30, 2022.
  • Net Loss: Net loss was $29.8 million for the quarter ended September 30, 2023, as compared with $16.8 million for the quarter ended September 30, 2022.

Ascentage Pharma Hosts Ceremony Marking the Launch of Olverembatinib in Newly Approved Indication and the Dispatch of First Batch for the New Indication

Retrieved on: 
Friday, November 24, 2023
NDA, Bone marrow, Priority review, Safety, National Medical Products Administration, BAT, Leukemia, EFS, New Drug Application, NMPA, TKI, CDE, Patient, BTD, Imatinib, Trust, Nilotinib, Therapy, BCR-ABL, CML, Death, Survival, NRDL, Government, Mutation, HIV disease progression rates, Pharmaceutical industry

Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT).

Key Points: 
  • Patients were randomized to either receive olverembatinib or into the control group to receive the current best available treatment (BAT).
  • Olverembatinib is a global best-in-class novel drug developed by Ascentage Pharma with support from the National Major New Drug Discovery and Manufacturing Program in China.
  • Ascentage Pharma and Innovent are mutually committed to the commercialization of olverembatinib in the China market.
  • Nilotinib vs imatinib in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase: ENESTnd 3-year follow-up.

ASURAGEN TO PRESENT NOVEL CLINICAL TESTING DATA AT AMP 2023 CONFERENCE

Retrieved on: 
Thursday, November 2, 2023
SMN2, Medical Affairs Bureau, Real-time, IVD, AMP, Bio-Techne, Doctor of Philosophy, RUO, FMR1, ESR1, SMN1, Cystic fibrosis, Frequency, Workflow, Diagnosis, BCR-ABL, Patient, Neoplasm, Targeted molecular therapy for neuroblastoma, Pharmaceutical industry, Medical imaging

MINNEAPOLIS , Nov. 2, 2023 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ:TECH) today announced that Asuragen, a Bio-Techne brand, will present new data on clinical laboratory testing solutions related to cystic fibrosis variant detection, cancer monitoring, resolving conventionally inaccessible, disease-causing genes, and more at the upcoming meeting of the Association for Molecular Pathology (AMP), to be held November 14-18 in Salt Lake City, Utah. Attendees can learn about Asuragen's new products and innovations through a series of corporate workshops and poster presentations.

Key Points: 
  • Attendees can learn about Asuragen's new products and innovations through a series of corporate workshops and poster presentations.
  • "We look forward to sharing new data that reinforces our commitment to more equitable healthcare, comprehensive genetic coverage, and novel approaches to cancer monitoring and management."
  • In addition, Dr. Jordan Laser, Senior Director, Clinical and Medical Affairs for Bio-Techne's Diagnostics and Genomics Segment, will be recognized at the conference with the AMP Meritorious Service Award for his work to promote AMP as a member of the association.
  • AmplideX® to the Rescue: One easy-to-implement test workflow enabling repeat expansion resolution, copy number assessment, and highly multiplexed variant detection.

Terns Pharmaceuticals Announces Global Phase 1 Clinical Trial Design of TERN-701 for the Treatment of Chronic Myeloid Leukemia

Retrieved on: 
Monday, October 16, 2023
Incidence, Food, Pharmacokinetics, Obesity, BCR-ABL, MD, CML, PK, Safety, Fatty liver disease, NASH, FDA, Food and Drug Administration, Acute leukemia, Drug discovery, History, Part, Dasatinib, Infrared spectroscopy correlation table, Patient, TKI, Pharmaceutical industry

FOSTER CITY, Calif., Oct. 16, 2023 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, non-alcoholic steatohepatitis (NASH) and obesity, today announced the U.S. Food and Drug Administration’s (FDA’s) clearance of the Company’s Investigational New Drug application and the design of the CARDINAL Trial, Terns’ global Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of TERN-701 in participants with chronic myeloid leukemia (CML). TERN-701 is the Company’s proprietary, allosteric BCR-ABL tyrosine kinase inhibitor (TKI), designed to target the BCR-ABL myristoyl pocket.

Key Points: 
  • We are particularly pleased with our Phase 1 trial design for TERN-701 as it will recruit chronic CML patients who experienced treatment failure on at least one prior second-generation TKI.
  • We are well-positioned to report initial data from this global Phase 1 trial in the second half of 2024,” continued Dr. Kuriakose.
  • The CARDINAL Trial is a global, multicenter, open-label, two-part Phase 1 clinical trial to evaluate the safety, PK, and efficacy of TERN-701 in participants with previously treated CML.
  • More information about the TERN-701 global Phase 1 (CARDINAL Trial) trial may be found on clinicaltrials.gov when available.

Terns Pharmaceuticals Reports Second Quarter 2023 Financial Results and Corporate Updates

Retrieved on: 
Tuesday, August 8, 2023
FXR, Obesity, NASH, CML, Week, Cohort, GIPR, American Society of Clinical Oncology, Clinical trial, BCR-ABL, Research, Acute leukemia, THR, ASCO, DSM-IV codes, Administration, Team Impulse, DUET, American Diabetes Association, Fatty liver disease, Research and development, R, BMI, FDA, ADA, Society, Pharmaceutical industry, Cryptocurrency, Tern

FOSTER CITY, Calif., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology, non-alcoholic steatohepatitis (NASH) and obesity, today reported financial results for the quarter ended June 30, 2023 and corporate updates.

Key Points: 
  • Based on its current operating plan, Terns expects these funds will be sufficient to support its planned operating expenses into 2026.
  • Research and Development (R&D) Expenses: R&D expenses were $14.2 million for the quarter ended June 30, 2023, as compared with $8.7 million for the quarter ended June 30, 2022.
  • General and Administrative (G&A) Expenses: G&A expenses were $7.0 million for the quarter ended June 30, 2023, as compared with $5.4 million for the quarter ended June 30, 2022.
  • Net Loss: Net loss was $17.9 million for the quarter ended June 30, 2023, as compared with $13.9 million for the quarter ended June 30, 2022.

Precipio Launches Its Much-Anticipated Quantitative BCR-ABL 2.0 Panel

Retrieved on: 
Tuesday, August 8, 2023
Reflex, Laboratory, Workflow, CML, EMR, BCR, Mutation, BCR-ABL, Cell, Electronic health record, Point mutation, Patient, Cell division, LIS, Diagnosis, Health, ABL1, Economics, Chronic myelogenous leukemia, Medical device, HAVEN

NEW HAVEN, Conn., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO) , announces the launch of its new quantitative BCR-ABL 2.0 panel, with features making it the most innovative panel of its kind on the market.

Key Points: 
  • NEW HAVEN, Conn., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Specialty cancer diagnostics company Precipio, Inc. (NASDAQ: PRPO) , announces the launch of its new quantitative BCR-ABL 2.0 panel, with features making it the most innovative panel of its kind on the market.
  • For more information on this new panel please visit us at https://tinyurl.com/QBCR-ABL1 .
  • The following features make this product the most advanced BCR-ABL panel on the market, besting competition in terms of robust coverage, workflow ease, accuracy, and cost:
    1.
  • Precipio’s HemeScreen BCR-ABL 2.0 assay is the only panel on the market that provides quantitative coverage of four clinically relevant2,3 breakpoints – p.190, p.210, p.203 and p.230.