Mirati

Mirati Announces IND Clearance by U.S. FDA Enabling Phase 1 Initiation for First-in-Class Oral KRASG12D Selective Inhibitor, MRTX1133

Retrieved on: 
Thursday, January 19, 2023
Therapy, Doctor of Philosophy, Half-life, Investigational New Drug, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mutation, FDA, SAN, Prevalence, Drug discovery, Drug, Patient, Food, Lung, Pharmaceutical industry, Vaccine, IND, Mirati

SAN DIEGO, Jan. 19, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of MRTX1133, a potential first-in-class oral KRASG12D selective inhibitor for clinical evaluation. KRASG12D mutations impact approximately 180,000 patients in the US and Europe, representing approximately a 2.5-fold increase in prevalence compared to KRASG12C mutations. No targeted oncology treatment options currently exist for these patients.

Key Points: 
  • KRASG12D mutations impact approximately 180,000 patients in the US and Europe, representing approximately a 2.5-fold increase in prevalence compared to KRASG12C mutations.
  • MRTX1133 is a highly potent investigational inhibitor of the KRASG12D driver mutation and demonstrated selective and reversible inhibition of KRASG12D in both its active and inactive states.
  • In addition, MRTX1133 administration resulted in marked tumor response in preclinical KRASG12D mutated pancreatic cancer models as well as lung and colorectal cancer models.
  • The Phase 1/2 clinical trial will launch in early 2023 with plans for multiple expansion cohorts in pancreatic, colorectal, lung and other KRASG12D tumor types.

Cue Biopharma Announces Chief Medical Officer Transition

Retrieved on: 
Monday, January 23, 2023
Endocrinology, Inflammation, Immunology, CMO, Washington University School of Medicine, Mirati, Patient, Translational medicine, SVP, Faculty, George Washington University School of Medicine & Health Sciences, University, Cue, Pfizer, Pharmaceutical industry, Medicine

Matteo Levisetti, M.D., promoted to Chief Medical Officer, effective January 17, 2023

Key Points: 
  • Matteo Levisetti, M.D., promoted to Chief Medical Officer, effective January 17, 2023
    BOSTON, Jan. 23, 2023 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, announced today that Matteo Levisetti, M.D., senior vice president (SVP) of clinical development at Cue Biopharma, has been promoted to Chief Medical Officer (CMO) effective January 17, 2023.
  • “We are very pleased to announce the appointment of Dr. Levisetti as our new chief medical officer,” said Daniel Passeri, chief executive officer of Cue Biopharma.
  • On behalf of Cue Biopharma, we thank him for his invaluable service and tremendous contributions as well as his profound commitment to patients.
  • Dr. Levisetti received his medical degree from the University of Chicago Pritzker School of Medicine and served on the faculty at Washington University School of Medicine prior to his transition to leadership roles in industry.

Orthofix and SeaSpine Announce Completion of Merger of Equals to Create a Leading Global Spine and Orthopedics Company

Retrieved on: 
Wednesday, January 4, 2023
Biotechnology, Practice Management, Surgery, General Health, Health, Medical Devices, Hospitals, Health Technology, Cloud, Mirati, Independent, Executive, III, Multimedia, Surgeon, Elective surgery, Health care, Development, Google Cloud, Spine, Holding company, Management

Of votes cast, 99% of SeaSpine common shares were voted in approval of the merger, and 98% of Orthofix common shares were voted in approval of the merger.

Key Points: 
  • Of votes cast, 99% of SeaSpine common shares were voted in approval of the merger, and 98% of Orthofix common shares were voted in approval of the merger.
  • The combined Orthofix is a leading global spine and orthopedics company with a complementary portfolio of biologics, innovative spinal hardware solutions, market-leading bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system.
  • The Company has approximately 1,600 employees, products distributed in 68 countries world-wide, and a global R&D, commercial and manufacturing footprint.
  • “The completion of this merger catalyzes our ambition to be an industry leader in spine and orthopedics,” said Keith Valentine, President and CEO of Orthofix effective as of the closing.

Mirati Therapeutics Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Friday, January 6, 2023
RSU, Therapy, SAN, Employment, Pharmaceutical industry, Life insurance, Health insurance, Mirati

SAN DIEGO, Jan. 6, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced that the company granted equity awards to 6 new employees with a grant date of January 3, 2023, as equity inducement awards outside of the company's 2022 Equity Incentive Plan (but under the terms of the company's Inducement Plan) and material to the employees' acceptance of employment with the company.

Key Points: 
  • SAN DIEGO, Jan. 6, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, today announced that the company granted equity awards to 6 new employees with a grant date of January 3, 2023, as equity inducement awards outside of the company's 2022 Equity Incentive Plan (but under the terms of the company's Inducement Plan) and material to the employees' acceptance of employment with the company.
  • The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The employees received, in the aggregate, options to purchase 9,010 shares of Mirati's common stock, and in the aggregate 5,780 restricted stock units ("RSUs").
  • The options have an exercise price of $46.65 per share, which is equal to the closing price of Mirati's common stock on January 3, 2023, (the "Grant Date").

Mirati Therapeutics to Present at the 41st Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Thursday, December 22, 2022
Patient, TAM, Webcast, SAN, Judgement, PRMT5, Life, Conference, SOS1, Lung cancer, Therapy, Science, Cancer, MTA, Pharmaceutical industry, Mirati

SAN DIEGO, Dec. 22, 2022 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial-stage targeted oncology company, today announced that the Company will present at the 41st J.P. Morgan Annual Healthcare Conference, on January 9, 2023.

Key Points: 
  • SAN DIEGO, Dec. 22, 2022 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial-stage targeted oncology company, today announced that the Company will present at the 41st J.P. Morgan Annual Healthcare Conference, on January 9, 2023.
  • David Meek , chief executive officer, will make a formal presentation, and answer questions about the Company at 9:00 a.m. P.T.
  • Investors and the general public are invited to listen to a live webcast of the session through the "Investors and Media" section on Mirati.com .
  • This press release contains forward-looking statements regarding the business of Mirati Therapeutics, Inc. ("Mirati").

Zai Lab Partner Mirati Therapeutics Presents Late-Breaking Results Evaluating Concurrent Adagrasib and Pembrolizumab in First-Line Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Monday, December 5, 2022
Squamous cell carcinoma, LFT, ESMO, Colorectal cancer, Coronavirus, Data, Clinical trial, Pancreatic cancer, Health, Incidence, Dana–Farber Cancer Institute, Lung cancer, Degenerative disease, CET, Safety, SCLC, Congress, Cancer, PD-1, Large-cell lung carcinoma, Central nervous system, Doctor of Philosophy, European Society for Medical Oncology, ORR, MD, AST, DCR, Alanine transaminase, Infection, Oncology, Research, ALT, Mutation, Trae tha Truth, Death, COVID-19, World Health Organization, Patient, KRAS, Communications satellite, Pharmaceutical industry, Medical imaging, Mirati, NSCLC

TRAEs led to discontinuation of both adagrasib and pembrolizumab in 2 patients and only pembrolizumab in 2 patients; there were no patients who discontinued only adagrasib due to a TRAE.

Key Points: 
  • TRAEs led to discontinuation of both adagrasib and pembrolizumab in 2 patients and only pembrolizumab in 2 patients; there were no patients who discontinued only adagrasib due to a TRAE.
  • In clinical trials, adagrasib also has shown, central nervous system penetrance and single-agent responses in non-small cell lung cancer (NSCLC), colorectal cancer, pancreatic cancer and other solid tumors with KRASG12C mutations.
  • Mirati company executives will provide an overview of the adagrasib and pembrolizumab combination data presented 2022 ESMO Immuno-Oncology Annual Congress.
  • Lung cancer consists of NSCLC in approximately 85% of cases and small cell lung cancer (SCLC) in approximately 15% of cases.

KRAZATI™ (adagrasib) Now Available from Onco360 for the Treatment of Adult Patients with KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Thursday, December 15, 2022
Pharmaceutical, Health, Oncology, Other Health, Oncology, QT, Mirati, SEER, Diagnosis, Patient, United, Treatment of lung cancer, Diarrhea, NSCLC, FDA, Lung cancer, Fatigue, Hospital, RAS, PharMerica, Appetite, DOR, Large-cell lung carcinoma, Nausea, Vomiting, ORR, National Cancer Institute, Dizziness, Journal of Oncology Pharmacy Practice, Death, Specialty pharmacy, KRAS, Pharmaceutical industry, Epidemiology

Onco360 is honored to partner with Mirati Therapeutics and become a specialty pharmacy provider for KRAZATI patients, said Benito Fernandez, Chief Commercial Officer, Onco360.

Key Points: 
  • Onco360 is honored to partner with Mirati Therapeutics and become a specialty pharmacy provider for KRAZATI patients, said Benito Fernandez, Chief Commercial Officer, Onco360.
  • We are dedicated to supporting the highly specialized needs of patients battling previously treated, advanced NSCLC with KRAS G12C mutations across the United States.
  • When considering all stages and histologic subtypes of lung cancer, five-year overall survival (OS) is only 22.9%.
  • Unfortunately, 56% of lung cancer patients already have metastatic disease upon initial diagnosis.

Verastem Oncology Appoints Rob Gagnon to Board of Directors

Retrieved on: 
Thursday, December 15, 2022
Oncology, Health, Other Health, General Health, Pharmaceutical, Biotechnology, MIT Sloan School of Management, Mirati, RAF, RAMP, Management, FAK, Oncology, Amgen, Harvard Bioscience, NSCLC, Security (finance), Controller, Food, Regenerative medicine, RAS, LLP, Regulation of tobacco by the U.S. Food and Drug Administration, Bentley University, ARAF, Cancer, BRAF, Government, Biogen, Clean Harbors, MEK, MBA, Research, Breakthrough therapy, Patent, CRAF, PricewaterhouseCoopers, Patient, KRAS, Hospital, Pharmaceutical industry, Medical imaging, Verastem Oncology

Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced the appointment of Robert Gagnon to its Board of Directors, effective December 13, 2022.

Key Points: 
  • Verastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced the appointment of Robert Gagnon to its Board of Directors, effective December 13, 2022.
  • I am excited to contribute to Verastem in this new capacity by joining the distinguished and dedicated Board of Directors and contribute to Verastems continued progress.
  • Mr. Gagnon has more than 20 years of financial and commercial experience in heading global finance operations.
  • Verastem Oncology (Nasdaq: VSTM) (Verastem, Inc.) is a development-stage biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with cancer.

Agilent Resolution ctDx FIRST Receives FDA Approval as a Liquid Biopsy Companion Diagnostic Test for Advanced Non-small Cell Lung Cancer

Retrieved on: 
Tuesday, December 13, 2022
Technology, Biotechnology, Health, Other Health, Pharmaceutical, Oncology, Medical Devices, General Health, Hospitals, Genetics, Health Technology, Hardware, Electronic Design Automation, Semiconductor, Knowledge, NGS, Large-cell lung carcinoma, Software, Agilent Technologies, Health, Cancer, NSCLC, Translational medicine, Woman, Oncology, Gene, Systematic review, EGFR, Oncotarget, Diagnosis, NYSE, Lung cancer, American Cancer Society, Circulating tumor DNA, SRL Diagnostics, Neoplasm, Food, Regulation of tobacco by the U.S. Food and Drug Administration, Roswell Park Comprehensive Cancer Center, Mirati, Prevalence, DNA, FIRST, Quality of life, Liquid biopsy, KRAS, Mutation, SNV calling from NGS data, Cdx, American Securities, Plasma, Patient, Meta-analysis, FDA, Blood, ClinicoEconomics and Outcomes Research, News, Biomarker, Pharmaceutical industry, Medical imaging, Uranium, Delays

3,4 ctDx FIRST provides NSCLC patients and their oncologists with a new minimally invasive blood test to help clarify precision treatment options.

Key Points: 
  • 3,4 ctDx FIRST provides NSCLC patients and their oncologists with a new minimally invasive blood test to help clarify precision treatment options.
  • The ctDx FIRST assay uses novel propriety technology to detect genomic alterations in circulating tumor DNA (ctDNA) from plasma.
  • We appreciate the opportunity to partner with companies like Agilent who are committed to creating more opportunities for decision medicine for people living with cancer.
  • The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis.

Mirati Therapeutics Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, December 13, 2022
RSU, Therapy, Judgement, Life, TAM, MTA, Patient, Science, Cancer, Lung cancer, Employment, SOS1, SAN, PRMT5, Pharmaceutical industry, Mirati

The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The options have an exercise price of $91.50 per share, which is equal to the closing price of Mirati's common stock on December 1, 2022, (the "Grant Date").
  • Mirati Therapeutics, Inc. is a clinical-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones.
  • This press release contains forward-looking statements regarding the business of Mirati Therapeutics, Inc. ("Mirati").