FDA Approval for KRAZATI (ADAGRASIB) issued to MIRATI THERAPEUTICS, INC

12/12/22 4:56:01 PM ET

$MRTX

Biotechnology: Pharmaceutical Preparations

Health Care

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New Drug Application (NDA): 216340
Company: MIRATI THERAPEUTICS, INC

Products on NDA 216340

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KRAZATI (ADAGRASIB)	ADAGRASIB	200mg	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216340

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/12/2022	ORIG-1	Approval	Efficacy	STANDARD		Label is not available on this site.

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Recent Analyst Ratings for
$MRTX

Date	Price Target	Rating	Analyst
8/10/2023	$51.00 → $48.00	Neutral → Buy	Citigroup
8/9/2023	$45.00	Neutral → Buy	B. Riley Securities
8/9/2023	$45.00	Overweight	Piper Sandler
7/27/2023		Sector Underperform	Scotiabank
5/25/2023		Perform → Outperform	Oppenheimer
12/14/2022		Hold	Needham
12/9/2022	$121.00 → $53.00	Buy → Neutral	Citigroup
12/8/2022	$110.00 → $59.00	Outperform → Market Perform	BMO Capital Markets

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Mirati Therapeutics Appoints Industry Veteran Carol Gallagher, Pharm.D. as New Independent Director
SAN DIEGO, June 23, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.® (NASDAQ:MRTX), a commercial stage biotechnology company, today announced its Board of Directors has appointed a new independent director, Dr. Carol Gallagher. "I am pleased to welcome Dr. Gallagher to our Board during this pivotal time for the company," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "Carol brings a tremendous amount of biopharmaceutical and leadership experience, and her insights will be significant as we continue to advance our mission to positively impact the lives of people living with cancer." Dr. Gallagher has over 30 years of strategic, commercial, business development and drug dev
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Mirati Therapeutics Appoints Alan Sandler, M.D., as Executive Vice President and Chief Medical Officer, Shares Update to Executive Leadership Team
Charles M. Baum, M.D., Ph.D., President, Founder and head of R&D to retire 2Q 2023 following over a decade of Mirati leadership, driving corporate transformation SAN DIEGO, Nov. 8, 2022 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ:MRTX), a clinical-stage targeted oncology company, today announced the appointment of Alan Sandler, M.D., to the position of executive vice president and chief medical officer. In his role, Dr. Sandler will provide leadership and direction over clinical development and operations, regulatory affairs, drug safety and asset development strategy and report to David Meek, chief executive officer. As part of the transition, Dr. James Christensen, executive vice pr
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ImmunOs Therapeutics Announces Appointment of Joseph Leveque, MD, to its Board of Directors
- Seasoned immuno-oncology executive brings significant medical and biopharma expertise Schlieren (Zurich Area), Switzerland, and Gaithersburg, MD, USA – October 4, 2022 – ImmunOs Therapeutics AG, a biopharmaceutical company leveraging its HLA-based technology platform to develop first-in-class therapeutics for the treatment of cancer and autoimmune diseases, today announced that Joseph Leveque, MD, has been appointed to the Company´s Board of Directors. Dr. Leveque has over a decade of experience in the development of immuno-oncology therapeutics. He is currently President, Chief Medical Officer, and a Board Member of Medikine. Prior to Medikine, he was Executive Vice President a
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Mirati Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Updates
Shares plans to initiate Phase 3 combination study evaluating adagrasib with pembrolizumab in first line non-small cell lung cancer in patients with TPS ≥ 50% Announces compelling initial clinical data for MRTX1719 in MTAP-deleted cancers demonstrating favorable safety profile and early signs of strong clinical activity David Meek to depart Company, Charles M. Baum, M.D., Ph.D., President and Founder, to assume role of interim CEO during search for permanent CEO Company will announce financial results for the second quarter 2023 along with recent corporate updates during a conference call at 5:30 p.m. ET / 2:30 p.m. PT SAN DIEGO, Aug. 8, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.® (NASD
8/8/23 4:01:00 PM ET
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Mirati Therapeutics® to Report Second Quarter 2023 Financial Results and Recent Corporate Updates on August 8, 2023
SAN DIEGO, July 25, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ:MRTX), a commercial stage biotechnology company, will announce financial results for the second quarter 2023 along with recent corporate updates on August 8, 2023. During a conference call at 4:30 p.m. ET / 1:30 p.m. PT on August 8, company executives will provide company updates and review financial results. Investors and the general public are invited to listen to a live webcast of the call at the "Investors and Media" section on Mirati.com or by dialing the U.S. toll free +1 773-305-6853 or international +1 888-394-8218, confirmation code: 6674271. A replay of the call will be available approximately 2 hours after
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Mirati Therapeutics Reports First Quarter 2023 Financial Results and Recent Corporate Updates
SAN DIEGO, May 9, 2023 /PRNewswire/ -- Mirati Therapeutics, Inc.® (NASDAQ:MRTX), a commercial stage biotechnology company, today announced financial results for the first quarter 2023 along with recent pipeline and corporate updates. "Today we are pleased to share the significant progress made during the first quarter of 2023, highlighted by our first full quarter of sales for KRAZATI®, which we believe is the best-in-class KRASG12C inhibitor. This is just the beginning of our journey with KRAZATI®, as we continue to advance our broad development plan in lung cancer and across other indications and lines of therapy," said David Meek, chief executive officer, Mirati Therapeutics, Inc. "In add
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European Commission Approves KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation
SAN DIEGO and ZUG, Switzerland, Jan. 10, 2024 /PRNewswire/ -- Mirati Therapeutics, Inc.® (NASDAQ:MRTX), a commercial stage biotechnology company, today announced that the European Commission (EC) granted conditional marketing authorization for KRAZATI® (adagrasib) as a targeted treatment option for adult patients with KRASG12C -mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy. KRAZATI has demonstrated a positive benefit-risk profile based on the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, evaluating KRAZATI 600 mg administered orally twice daily in 116 patients with KRASG12C-mutated advanced NSCLC who previ
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Kura Oncology and Mirati Therapeutics Enter into Clinical Collaboration and Supply Agreement to Evaluate KO-2806 and Adagrasib in KRASᴳ¹²ᶜ-Mutated NSCLC
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Bristol Myers Squibb Strengthens and Diversifies Oncology Portfolio With Acquisition of Mirati Therapeutics
Bristol Myers Squibb to Acquire Mirati for $58.00 Per Share, Representing $4.8 Billion Equity Value and Up to $5.8 Billion Including the Contingent Value Right Acquisition Brings KRAZATI® (adagrasib), a Best-in-Class KRASG12C Inhibitor Approved by the U.S. FDA for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harboring a KRASG12C Mutation and Who Have Received at Least One Prior Systemic Treatment KRAZATI is in Clinical Development in Combination with a PD-1 Inhibitor as a First-Line Therapy for Patients with Non-Small Cell Lung Cancer Harboring a KRASG12C Mutation as well as in Other Indications Mirati's Promising Pipeline Includes a Potent Selective PRMT5/MTA Inh
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FDA Approval for KRAZATI (ADAGRASIB) issued to MIRATI THERAPEUTICS, INC

Products on NDA 216340

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216340

Original Approvals or Tentative Approvals

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Recent Analyst Ratings for $MRTX

$MRTX FDA approvals

Live FDA approvals issued by the Food and Drug Administration and FDA breaking news

FDA Approval for KRAZATI issued to MIRATI THERAPEUTICS, INC

FDA Approval for KRAZATI (ADAGRASIB) issued to MIRATI THERAPEUTICS, INC

FDA Approval for KRAZATI (ADAGRASIB) issued to MIRATI THERAPEUTICS, INC

$MRTX Analyst Ratings

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Mirati Therapeutics upgraded by Citigroup with a new price target

Mirati Therapeutics upgraded by B. Riley Securities with a new price target

Piper Sandler resumed coverage on Mirati Therapeutics with a new price target

$MRTX Leadership Updates

Live Leadership Updates

Mirati Therapeutics Appoints Industry Veteran Carol Gallagher, Pharm.D. as New Independent Director

Mirati Therapeutics Appoints Alan Sandler, M.D., as Executive Vice President and Chief Medical Officer, Shares Update to Executive Leadership Team

ImmunOs Therapeutics Announces Appointment of Joseph Leveque, MD, to its Board of Directors

$MRTX Financials

Live finance-specific insights

Mirati Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Updates

Mirati Therapeutics® to Report Second Quarter 2023 Financial Results and Recent Corporate Updates on August 8, 2023

Mirati Therapeutics Reports First Quarter 2023 Financial Results and Recent Corporate Updates

$MRTX Press Releases

Fastest customizable press release news feed in the world

European Commission Approves KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation

Kura Oncology and Mirati Therapeutics Enter into Clinical Collaboration and Supply Agreement to Evaluate KO-2806 and Adagrasib in KRASᴳ¹²ᶜ-Mutated NSCLC

Bristol Myers Squibb Strengthens and Diversifies Oncology Portfolio With Acquisition of Mirati Therapeutics

$MRTX SEC Filings

SEC Form 15-12G filed by Mirati Therapeutics Inc.

SEC Form EFFECT filed by Mirati Therapeutics Inc.

SEC Form EFFECT filed by Mirati Therapeutics Inc.

$MRTX Large Ownership Changes

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SEC Form SC 13G filed by Mirati Therapeutics Inc.

SEC Form SC 13G/A filed by Mirati Therapeutics Inc. (Amendment)

SEC Form SC 13G/A filed by Mirati Therapeutics Inc. (Amendment)

Boxer Capital, Llc returned 6,859,544 shares to the company (SEC Form 4)

Cherrington Julie M returned 11,252 shares to the company, closing all direct ownership in the company (SEC Form 4)

Sharp Shalini returned 16,222 shares to the company, closing all direct ownership in the company (SEC Form 4)

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