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Mirati Therapeutics, Inc. (NASDAQ: MRTX) is a commercial stage biotechnology company focused on pioneering breakthrough therapies to transform the lives of patients with cancer. Specializing in molecularly targeted and immuno-oncology combination therapies, Mirati is at the forefront of cancer treatment innovation. The core of Mirati's mission is to develop drug candidates that target genetic and epigenetic drivers of cancer. The company leverages a strategic approach that includes selecting patients whose tumors depend on specific genetic alterations and employing a highly accomplished leadership team in oncology precision medicine.
Mirati Therapeutics is advancing three primary drug candidates through clinical development for multiple oncology indications. Their flagship product, KRAZATI® (adagrasib), has shown promising results in treating non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation. Adagrasib offers potential best-in-class efficacy, particularly for patients with central nervous system metastases. Notably, the drug has been granted conditional marketing authorization by the UK's MHRA and the European Commission, highlighting its impactful role in current cancer treatment paradigms.
Mirati's innovative pipeline also includes MRTX1719, a PRMT5 inhibitor, and MRTX1133, a selective KRASG12D inhibitor, both of which are designed to address high unmet medical needs. The company recently completed an upsized public offering, extending its cash runway to support upcoming milestones.
In recent developments, Mirati announced that Laurie Stelzer, Chief Financial Officer, will depart the company in September 2023, with Aaron Ondrey stepping in as interim CFO. This transition comes at a pivotal time as Mirati continues to advance its clinical programs and prepare for potential new product launches.
With a relentless focus on patient outcomes, Mirati's vision is to unlock the science behind a life beyond cancer. The company continues to collaborate with global healthcare regulators and partners to ensure broad access to its groundbreaking therapies.
Mirati Therapeutics (NASDAQ: MRTX) announced positive results from the registration-enabling Phase 2 KRYSTAL-1 study of adagrasib, a treatment for non-small cell lung cancer (NSCLC) with the KRASG12C mutation. Initial data showed an objective response rate (ORR) of 43% and a disease control rate (DCR) of 80%. Median overall survival was reported at 12.6 months. Safety data indicated most treatment-related adverse events were Grade 1-2. These findings will be presented at the 2022 ASCO Annual Meeting on June 3, emphasizing adagrasib's efficacy in treating NSCLC.
Mirati Therapeutics, Inc. (NASDAQ: MRTX) announces participation in two healthcare conferences. On June 9 at 10:00 a.m. ET, CEO David Meek will speak at the Jefferies Healthcare Conference. On June 16 at 11:00 a.m. ET, he will also present at the Goldman Sachs 43rd Annual Global Healthcare Conference. Investors can access live webcasts on Mirati's website, with replay available afterward.
Mirati Therapeutics, Inc. (NASDAQ: MRTX) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for adagrasib to treat non-small cell lung cancer (NSCLC) with the KRASG12C mutation in patients previously treated with systemic therapy. This submission follows FDA's acceptance of the adagrasib New Drug Application (NDA) for Accelerated Approval. Data from the Phase 2 KRYSTAL-1 study supports the MAA, and detailed results will be presented at the 2022 ASCO Annual Meeting. Adagrasib also has Breakthrough Therapy Designation in the U.S.
Mirati Therapeutics, Inc. (NASDAQ: MRTX) announced the appointment of Laurie Stelzer as the new Chief Financial Officer, effective May 16, 2022. Laurie brings over 25 years of experience in biopharma finance, previously serving as CFO of Arena Pharmaceuticals. Her role will be crucial as Mirati aims for a U.S. launch of adagrasib for KRASG12C non-small cell lung cancer this year. CEO David Meek expressed confidence in her leadership to help achieve the company's growth objectives.
Mirati Therapeutics (NASDAQ: MRTX) reported its Q1 2022 financial results, showing a net loss of $188.4 million or $3.40 per share, versus $135.7 million or $2.67 per share in Q1 2021. The company ended the quarter with approximately $1.3 billion in cash and equivalents. Key pipeline updates include progress in clinical trials for adagrasib and sitravatinib, with plans for a U.S. commercial launch this year. R&D expenses increased to $131 million reflecting higher employee-related costs and drug development activities.
Mirati Therapeutics (Nasdaq: MRTX) announced exciting new data regarding its investigational KRASG12C inhibitor, adagrasib, at the 2022 ASCO Annual Meeting. The results focus on patients with pre-treated non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation, including those with untreated central nervous system (CNS) metastases. Mirati also revealed that the NDA for adagrasib is under FDA review for Accelerated Approval. An upcoming virtual investor event will be held on June 6, 2022, to discuss these findings in detail.
Mirati Therapeutics (NASDAQ: MRTX) will announce its Q1 2022 financial results and recent updates on May 4, 2022. During a conference call at 4:30 p.m. ET, executives will discuss the financials and company progress. Investors can access the call via a live webcast on Mirati.com or by phone. The company focuses on developing targeted therapies for cancer, including drugs like adagrasib (MRTX849) and sitravatinib. A replay of the call will be available shortly after the event.
Mirati Therapeutics (NASDAQ: MRTX) will participate in the 42nd Annual Cowen Healthcare Conference on March 9, 2022, at 10:30 a.m. P.T.. CEO David Meek will represent the company in a live webcast available on Mirati.com. The company focuses on developing therapies for cancer, with investigational drugs like adagrasib (MRTX849) and sitravatinib. A replay of the session will be accessible post-event. For more details, interested parties can visit Mirati.com.
Mirati Therapeutics (MRTX) reported its fourth quarter and full-year 2021 financial results, highlighting a net loss of $199.6 million or $3.72 per share for Q4 2021, compared to a loss of $101.1 million or $2.08 per share in Q4 2020. For the full year, the net loss was $581.8 million, up from $357.9 million in 2020. The company ended the year with approximately $1.5 billion in cash. Significant advancements include the FDA accepting the NDA for adagrasib, targeting KRASG12C mutated NSCLC with a PDUFA date set for December 14, 2022.
Mirati Therapeutics, Inc. (Nasdaq: MRTX) announced the FDA's acceptance of the New Drug Application (NDA) for adagrasib, a treatment for non-small cell lung cancer (NSCLC) with the KRASG12C mutation. The PDUFA date is set for December 14, 2022. The NDA is reviewed under Accelerated Approval and the FDA's Real-Time Oncology Review program. Adagrasib has received Breakthrough Therapy Designation, emphasizing the need for effective treatments for patients with KRASG12C mutations. Positive data from the Phase 2 KRYSTAL-1 study supports the NDA.
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