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Mirati (MRTX) Gets EU Nod for Krazati in KRAS-Mutated NSCLC
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Mirati Therapeutics, Inc. announced that the European Commission (EC) has granted conditional marketing authorization to Krazati (adagrasib) for the treatment of adult patients with previously-treated KRASG12C-mutated advanced non-small cell lung cancer (NSCLC).
The EC’s conditional marketing nod for Krazati, a KRAS G12C inhibitor, is valid in all 27 EU member states.
The approval by EC was expected as, in November 2023, the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approving Krazati.
The CHMP had initially issued a negative opinion in July 2023, stating that the Krazati marketing authorization application (“MAA”) did not fulfill certain requirements for conditional approval. The committee had claimed that the data supporting the MAA was not comprehensive and there were uncertainties about how well the drug worked.
Shares of Mirati have rallied 38.3% in the past year against the industry’s decline of 11.5%.
Image Source: Zacks Investment Research
Krazati was approved by the FDA for KRASG12C-mutated locally advanced or metastatic NSCLC in December 2022.
Krazati is the only approved product in Mirati’s commercial portfolio currently. The company recorded $36.1 million in Krazati product sales in the first nine months of 2023. Sales were driven by the drug’s differentiated profile.
The drug is also being evaluated in multiple label expansion studies, both as monotherapy and in combination with other drugs, across multiple cancer indications.
Bristol-Myers (BMY - Free Report) offered to acquire Mirati for a total equity value of $5.8 billion in July 2023.
The acquisition is expected to be completed by the first half of 2024. An acquisition by a big pharma giant like Bristol Myers, which has high cash reserves, will allow Mirati to access a larger and well-established commercial supply chain and network distribution.
With this acquisition, BMY is looking to diversify its strong oncology portfolio.
In the past 60 days, estimates for Freeline Therapeutics’ 2024 loss per share have narrowed from 35 cents to 15 cents. In the past year, shares of FRLN have declined 15.7%.
Earnings of Freeline Therapeutics beat estimates in each of the last three quarters. FRLN delivered a four-quarter average earnings surprise of 67.17%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 1.8%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Mirati (MRTX) Gets EU Nod for Krazati in KRAS-Mutated NSCLC
Mirati Therapeutics, Inc. announced that the European Commission (EC) has granted conditional marketing authorization to Krazati (adagrasib) for the treatment of adult patients with previously-treated KRASG12C-mutated advanced non-small cell lung cancer (NSCLC).
The EC’s conditional marketing nod for Krazati, a KRAS G12C inhibitor, is valid in all 27 EU member states.
The approval by EC was expected as, in November 2023, the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approving Krazati.
The CHMP had initially issued a negative opinion in July 2023, stating that the Krazati marketing authorization application (“MAA”) did not fulfill certain requirements for conditional approval. The committee had claimed that the data supporting the MAA was not comprehensive and there were uncertainties about how well the drug worked.
Shares of Mirati have rallied 38.3% in the past year against the industry’s decline of 11.5%.
Krazati was approved by the FDA for KRASG12C-mutated locally advanced or metastatic NSCLC in December 2022.
Krazati is the only approved product in Mirati’s commercial portfolio currently. The company recorded $36.1 million in Krazati product sales in the first nine months of 2023. Sales were driven by the drug’s differentiated profile.
The drug is also being evaluated in multiple label expansion studies, both as monotherapy and in combination with other drugs, across multiple cancer indications.
Bristol-Myers (BMY - Free Report) offered to acquire Mirati for a total equity value of $5.8 billion in July 2023.
The acquisition is expected to be completed by the first half of 2024. An acquisition by a big pharma giant like Bristol Myers, which has high cash reserves, will allow Mirati to access a larger and well-established commercial supply chain and network distribution.
With this acquisition, BMY is looking to diversify its strong oncology portfolio.
Zacks Rank & Stocks to Consider
Mirati currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the healthcare sector are Freeline Therapeutics Holdings plc and Puma Biotechnology, Inc. (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Freeline Therapeutics’ 2024 loss per share have narrowed from 35 cents to 15 cents. In the past year, shares of FRLN have declined 15.7%.
Earnings of Freeline Therapeutics beat estimates in each of the last three quarters. FRLN delivered a four-quarter average earnings surprise of 67.17%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 1.8%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.