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Mirati (MRTX) Q2 Loss Narrower Than Expected, Sales Beat
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Mirati Therapeutics reported a loss of $3.18 per share in second-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of $3.53 and the year-ago quarter’s loss of $3.23.
Mirati reported $5.4 million as collaboration revenues for the second quarter, beating the Zacks Consensus Estimate of $2.2 million in revenues. Management did not record any revenues in the year-ago quarter.
Quarter in Detail
Research and development expenses were down 4.6% from the prior-year quarter’s level to $128.3 million due to a decrease in manufacturing costs following the FDA filing for adagrasib last year.
General and administrative expenses surged 83.1% from the year-ago quarter’s level to $54.2 million due to an increase in commercial readiness costs. The company incurred these costs as management started making preparations for a potential product launch for adagrasib in non-small cell lung cancer (NSCLC), anticipating the FDA’s approval.
Cash, cash equivalents and short-term investments as of Jun 30, 2022, were $1.2 billion compared with $1.3 billion as of Mar 31, 2022.
Pipeline Update
Earlier this February, Mirati announced that the FDA accepted its new drug application (NDA), seeking approval for adagrasib, its KRAS inhibitor drug, for previously-treated KRASG12C-mutated NSCLC. The NDA was filed under the FDA's real-time oncology review pilot program. A decision by the regulatory agency is expected by Dec 14, 2022.
At the earnings call, management suggested that approval on the NDA may be expected prior to the PDUFA date. Also, based on the mid-cycle review with the FDA, management believes that the FDA will not be seeking recommendations from an advisory committee or placing adagrasib under the REMS program. Shares likely rose 5% in after-market trading on Aug 3 following this update.
In the year so far, the stock price of Mirati has plunged 51.1% compared with the industry’s decline of 22.1%.
Image Source: Zacks Investment Research
In May 2022, Mirati filed a marketing authorization application (MAA) in Europe for adagrasib to treat the same indication. Both the NDA and the MAA are based on data from the phase II registration-enabling cohort of the KRYSTAL-1 study.
The KRYSTAL-1 study is evaluating adagrasib in multiple cohorts in combination with other therapies. These include a combination of adagrasib with Merck’s (MRK - Free Report) Keytruda for first-line NSCLC, a combination of adagrasib plus Boehringer Ingelheim’s Gilotrif (afatinib)for advanced NSCLC and adagrasib combined with Bristol-Myers’ (BMY - Free Report) Erbitux for second-line colorectal cancer (CRC).
Preliminary data from the adagrasib plus Merck’s Keytruda cohort demonstrated that the combination achieved a 100% disease control rate, with all seven patients exhibiting tumor regression ranging from 37% to 92% as of Oct 21, 2021.
Mirati is also pursuing a broad combination development program for adagrasib beyond the combinations with Merck’s Keytruda and Bristol-Myers’ Erbitux. These include combinations with SHP2, SOS1 or CDK 4/6 inhibitors.
Another pipeline candidate, sitravatinib, is being evaluated in a pivotal phase III study (SAPPHIRE) combined with Bristol-Myers’ Opdivo for second-line or third-line non-squamous NSCLC. Data from the study is expected in the fourth quarter of 2022. If the outcome turns out to be positive, it could be the basis of regulatory submissions for sitravatinib in the United States and Europe next year.
Mirati submitted an investigational new drug (IND) application with the FDA for its investigational SOS1 inhibitor, MRTX0902. This inhibitor is designed to shift KRAS into an inactivated state, which would significantly increase activity of a KRAS inhibitor like adagrasib. A phase I/II study is expected to start by year-end.
Novavax’s stock has plunged 57.3% this year so far. Novavax’s earnings estimates for 2023 have increased from $10.43 per share to $10.62 per share over the past 30 days.
Novavax missed earnings estimates in each of the last four quarters, delivering a negative earnings surprise of 184.49%, on average. In the last reported quarter, NVAX delivered a negative earnings surprise of 23.12%.
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Mirati (MRTX) Q2 Loss Narrower Than Expected, Sales Beat
Mirati Therapeutics reported a loss of $3.18 per share in second-quarter 2022, narrower than the Zacks Consensus Estimate of a loss of $3.53 and the year-ago quarter’s loss of $3.23.
Mirati reported $5.4 million as collaboration revenues for the second quarter, beating the Zacks Consensus Estimate of $2.2 million in revenues. Management did not record any revenues in the year-ago quarter.
Quarter in Detail
Research and development expenses were down 4.6% from the prior-year quarter’s level to $128.3 million due to a decrease in manufacturing costs following the FDA filing for adagrasib last year.
General and administrative expenses surged 83.1% from the year-ago quarter’s level to $54.2 million due to an increase in commercial readiness costs. The company incurred these costs as management started making preparations for a potential product launch for adagrasib in non-small cell lung cancer (NSCLC), anticipating the FDA’s approval.
Cash, cash equivalents and short-term investments as of Jun 30, 2022, were $1.2 billion compared with $1.3 billion as of Mar 31, 2022.
Pipeline Update
Earlier this February, Mirati announced that the FDA accepted its new drug application (NDA), seeking approval for adagrasib, its KRAS inhibitor drug, for previously-treated KRASG12C-mutated NSCLC. The NDA was filed under the FDA's real-time oncology review pilot program. A decision by the regulatory agency is expected by Dec 14, 2022.
At the earnings call, management suggested that approval on the NDA may be expected prior to the PDUFA date. Also, based on the mid-cycle review with the FDA, management believes that the FDA will not be seeking recommendations from an advisory committee or placing adagrasib under the REMS program. Shares likely rose 5% in after-market trading on Aug 3 following this update.
In the year so far, the stock price of Mirati has plunged 51.1% compared with the industry’s decline of 22.1%.
Image Source: Zacks Investment Research
In May 2022, Mirati filed a marketing authorization application (MAA) in Europe for adagrasib to treat the same indication. Both the NDA and the MAA are based on data from the phase II registration-enabling cohort of the KRYSTAL-1 study.
The KRYSTAL-1 study is evaluating adagrasib in multiple cohorts in combination with other therapies. These include a combination of adagrasib with Merck’s (MRK - Free Report) Keytruda for first-line NSCLC, a combination of adagrasib plus Boehringer Ingelheim’s Gilotrif (afatinib)for advanced NSCLC and adagrasib combined with Bristol-Myers’ (BMY - Free Report) Erbitux for second-line colorectal cancer (CRC).
Preliminary data from the adagrasib plus Merck’s Keytruda cohort demonstrated that the combination achieved a 100% disease control rate, with all seven patients exhibiting tumor regression ranging from 37% to 92% as of Oct 21, 2021.
Mirati is also pursuing a broad combination development program for adagrasib beyond the combinations with Merck’s Keytruda and Bristol-Myers’ Erbitux. These include combinations with SHP2, SOS1 or CDK 4/6 inhibitors.
Another pipeline candidate, sitravatinib, is being evaluated in a pivotal phase III study (SAPPHIRE) combined with Bristol-Myers’ Opdivo for second-line or third-line non-squamous NSCLC. Data from the study is expected in the fourth quarter of 2022. If the outcome turns out to be positive, it could be the basis of regulatory submissions for sitravatinib in the United States and Europe next year.
Mirati submitted an investigational new drug (IND) application with the FDA for its investigational SOS1 inhibitor, MRTX0902. This inhibitor is designed to shift KRAS into an inactivated state, which would significantly increase activity of a KRAS inhibitor like adagrasib. A phase I/II study is expected to start by year-end.
Mirati Therapeutics, Inc. Price
Mirati Therapeutics, Inc. price | Mirati Therapeutics, Inc. Quote
Zacks Rank & Stock to Consider
Mirati currently has a Zacks Rank #4 (Sell).
A better-ranked stock in the biotech sector is Novavax (NVAX - Free Report) , which currently sports a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Novavax’s stock has plunged 57.3% this year so far. Novavax’s earnings estimates for 2023 have increased from $10.43 per share to $10.62 per share over the past 30 days.
Novavax missed earnings estimates in each of the last four quarters, delivering a negative earnings surprise of 184.49%, on average. In the last reported quarter, NVAX delivered a negative earnings surprise of 23.12%.