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Mirati's (MRTX) Adagrasib Gets Breakthrough Therapy Status

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Mirati Therapeutics, Inc. MRTX announced that adagrasib — an investigational, highly selective, and potent oral small-molecule inhibitor of KRAS G12C — has been granted the Breakthrough Therapy designation (BTD) by the FDA for the treatment of non-small cell lung cancer (NSCLC) patients with KRASG12C mutation following prior systemic therapy.

The designation was supported by preliminary data from the registrational phase I/II study — KRYSTAL-01 — that is evaluating the candidate in advanced NSCLC patients whose disease has progressed following treatment with immunotherapy and/or chemotherapy. The company plans to file a new drug application to the FDA seeking approval for adagrasib in the second half of this year for the treatment of KRAS G12C mutated NSCLC.

Please note that the Breakthrough Therapy designation is granted to medicines being evaluated for serious conditions where early clinical evidence indicates the potential for substantial improvement over available therapy. This designation increases the likelihood of a potential approval of adagrasib.

Last month, the company collaborated with QIAGEN N.V. QGEN to accelerate the development of a tissue-based KRAS companion diagnostic that detects KRAS G12C mutation in NSCLC and colorectal cancer (CRC).

The stock has underperformed the industry so far this year. It has declined 25.2% against the industry’s increase of 0.4%.

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Apart from NSCLC, the company is also developing adagrasib in combination with Merck’s MRK Keytruda (pembrolizumab) or afatinib for treating NSCLC patients. It is also developing a combination of adagrasib and Eli Lilly’s LLY Erbitux (cetuximab) for treating CRC.

The company has another candidate — sitravatinib — in its pipeline. The candidate is being developed in combination with Bristol-Myers’ Opdivo for NSCLC and with Beigene’s anti-PD-1 checkpoint inhibitor candidate, tislelizumab, in a number of advanced solid tumors.

Both adagrasib and sitravatinib are being evaluated in multiple mid- to late-stage studies. Data from these studies will be key catalysts for growth of the company’s shares, going forward.

Mirati Therapeutics, Inc. Price

Mirati Therapeutics, Inc. Price
Mirati Therapeutics, Inc. Price

Mirati Therapeutics, Inc. price | Mirati Therapeutics, Inc. Quote

Zacks Rank

Mirati currently has a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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Merck & Co., Inc. (MRK) : Free Stock Analysis Report

Eli Lilly and Company (LLY) : Free Stock Analysis Report

QIAGEN N.V. (QGEN) : Free Stock Analysis Report

Mirati Therapeutics, Inc. (MRTX) : Free Stock Analysis Report

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