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Mirati (MRTX) KRAS Candidate MRTX1133 to Enter Clinical Stage
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Mirati Therapeutics, Inc. reported that the FDA has cleared its investigational new drug (IND) application, which will allow it to initiate phase I studies on its potential first-in-class oral KRASG12D selective inhibitor, MRTX1133. A targeted oncology treatment for patients with KRAS G12D mutations does not exist currently. The prevalence of the mutations has increased by approximately 2.5-fold in patients across the United States and Europe. This represents a clear unmet medical need.
In the past year, shares of MRTX have plunged 63.7% compared with the industry’s decline of 8.6%.
Image Source: Zacks Investment Research
MRTX1133 is an investigational, highly potent, selective, and reversible small molecule inhibitor of KRASG12D. This candidate has been optimized by Mirati to obtain near-complete target inhibition. With the FDA clearance of its IND in place, MIrati is scheduled to launch a phase I/II study in early 2023, evaluating the candidate’s impact on pancreatic, colorectal, lung and other KRASG12D tumor types.
Mirati reported that, in preclinical studies, treatment with MRTX1133 resulted in positive tumor response in pre-clinical KRASG12D mutated pancreatic cancer models as well as lung and colorectal cancer (CRC) models.
MRTX1133 is Mirati’s third KRAS inhibitor to enter clinical development. Its first KRAS drug, Krazati (adagrasib), a KRAS G12C inhibitor, was approved by the FDA to treat adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in December 2022.
In the market for KRAS inhibitors, another big player providing serious competition to MRTX is Amgen, Inc. (AMGN - Free Report) . Amgen’s Lumakras (sotorasib) was approved for advanced NSCLC in the United States in May 2021 and in the EU in January 2022. It is now launched in more than 45 countries. Lumakras is off to an excellent start while its label expansion studies, which have the potential to significantly expand the currently addressable patient population, are progressing rapidly.
In the domain of KRAS-mutated solid tumor lung cancer, Biomea Fusion (BMEA - Free Report) recently announced the successful dosing of the first patient in the phase I/Ib study of BMF-219. This study will evaluate BMF-219 as a monotherapy in patients with unresectable, locally advanced, or metastatic NSCLC, CRC, and pancreatic ductal adenocarcinoma, with any (pan) KRAS mutation.
Zacks Rank and Stock to Consider
Mirati Therapeutics currently has a Zacks Rank #4 (Sell).
In the past 60 days, the estimate for Celularity’s 2022 loss per share has narrowed from 44 cents to 34 cents. During the same period, the loss per share estimate for 2023 has narrowed from 97 cents to 86 cents. In the past year, shares of Celularity have plunged 75.4%.
CELU delivered an average earnings surprise of 51.01% in the trailing four quarters, beating estimates in three out of the last four quarters.
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Mirati (MRTX) KRAS Candidate MRTX1133 to Enter Clinical Stage
Mirati Therapeutics, Inc. reported that the FDA has cleared its investigational new drug (IND) application, which will allow it to initiate phase I studies on its potential first-in-class oral KRASG12D selective inhibitor, MRTX1133. A targeted oncology treatment for patients with KRAS G12D mutations does not exist currently. The prevalence of the mutations has increased by approximately 2.5-fold in patients across the United States and Europe. This represents a clear unmet medical need.
In the past year, shares of MRTX have plunged 63.7% compared with the industry’s decline of 8.6%.
Image Source: Zacks Investment Research
MRTX1133 is an investigational, highly potent, selective, and reversible small molecule inhibitor of KRASG12D. This candidate has been optimized by Mirati to obtain near-complete target inhibition. With the FDA clearance of its IND in place, MIrati is scheduled to launch a phase I/II study in early 2023, evaluating the candidate’s impact on pancreatic, colorectal, lung and other KRASG12D tumor types.
Mirati reported that, in preclinical studies, treatment with MRTX1133 resulted in positive tumor response in pre-clinical KRASG12D mutated pancreatic cancer models as well as lung and colorectal cancer (CRC) models.
MRTX1133 is Mirati’s third KRAS inhibitor to enter clinical development. Its first KRAS drug, Krazati (adagrasib), a KRAS G12C inhibitor, was approved by the FDA to treat adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) in December 2022.
In the market for KRAS inhibitors, another big player providing serious competition to MRTX is Amgen, Inc. (AMGN - Free Report) . Amgen’s Lumakras (sotorasib) was approved for advanced NSCLC in the United States in May 2021 and in the EU in January 2022. It is now launched in more than 45 countries. Lumakras is off to an excellent start while its label expansion studies, which have the potential to significantly expand the currently addressable patient population, are progressing rapidly.
In the domain of KRAS-mutated solid tumor lung cancer, Biomea Fusion (BMEA - Free Report) recently announced the successful dosing of the first patient in the phase I/Ib study of BMF-219. This study will evaluate BMF-219 as a monotherapy in patients with unresectable, locally advanced, or metastatic NSCLC, CRC, and pancreatic ductal adenocarcinoma, with any (pan) KRAS mutation.
Zacks Rank and Stock to Consider
Mirati Therapeutics currently has a Zacks Rank #4 (Sell).
A better-ranked stock in the same industry is Celularity, Inc. (CELU - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, the estimate for Celularity’s 2022 loss per share has narrowed from 44 cents to 34 cents. During the same period, the loss per share estimate for 2023 has narrowed from 97 cents to 86 cents. In the past year, shares of Celularity have plunged 75.4%.
CELU delivered an average earnings surprise of 51.01% in the trailing four quarters, beating estimates in three out of the last four quarters.