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Bristol Myers' (BMY) Krazati sNDA for CRC Gets Priority Review
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Bristol Myers (BMY - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) for Krazati (adagrasib) in combination with Erbitux (cetuximab) to treat patients with previously treated KRASG12C-mutated locally advanced or metastatic (la/m) colorectal cancer (CRC). The FDA has assigned the Priority Review status to the company’s sNDA for the combination therapy.
A filing designated as a Priority Review reduces the review period by four months. A final decision from the regulatory body is expected on Jun 21, 2024.
Krazati initially received approval in 2022 for treating adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy, under the FDA’s accelerated approval pathway. Continued approval for this indication is contingent upon the success of Bristol Myers’ confirmatory study(s) on Krazati.
The company also received conditional marketing authorization in the EU for Krazati as a targeted treatment option for adult patients with KRASG12C-mutated advanced NSCLC and disease progression after at least one prior systemic therapy.
In the past year, shares of Bristol Myers have plunged 30.1% compared with the industry’s 8.6% decline.
Image Source: Zacks Investment Research
The sNDA submission seeking approval for the Krazati/Erbitux combo therapy to treat the CRC indication is based on positive results from Bristol Myers’ phase I/II KRYSTAL-1 study. The ongoing early to mid-stage study is evaluating Krazati as a monotherapy or in combination with other anticancer therapies in patients with advanced solid tumors harboring a KRASG12C mutation.
The primary endpoint for the registrational phase II cohort of the KRYSTAL-1 study was the objective response rate. The secondary endpointsfor the pooled cohorts included duration of response, progression-free survival, overall survival and safety.
Per the data from the KRYSTAL-1 study, it was observed that Krazati was well tolerated and provided promising clinical activity in pretreated patients with la/m CRC harboring a KRASG12C mutation. Additionally, the drug, in combination with Erbitux, demonstrated a consistent safety profile.
We remind the investors that Krazati was added to Bristol Myers’ oncology portfolio following the $4.8 billion acquisition of Mirati Therapeutics, which was completed in January 2024.
BMY continues to evaluate Krazati as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC and CRC.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 69 cents to 71 cents. Over the past year, shares of PBYI have rallied 68.1%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past year, shares of ADMA have jumped 46.7%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has narrowed from $2.29 to $1.81. In the past year, shares of ACET have plunged 64.6%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.36%.
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Bristol Myers' (BMY) Krazati sNDA for CRC Gets Priority Review
Bristol Myers (BMY - Free Report) announced that the FDA has accepted its supplemental new drug application (sNDA) for Krazati (adagrasib) in combination with Erbitux (cetuximab) to treat patients with previously treated KRASG12C-mutated locally advanced or metastatic (la/m) colorectal cancer (CRC). The FDA has assigned the Priority Review status to the company’s sNDA for the combination therapy.
A filing designated as a Priority Review reduces the review period by four months. A final decision from the regulatory body is expected on Jun 21, 2024.
Krazati initially received approval in 2022 for treating adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy, under the FDA’s accelerated approval pathway. Continued approval for this indication is contingent upon the success of Bristol Myers’ confirmatory study(s) on Krazati.
The company also received conditional marketing authorization in the EU for Krazati as a targeted treatment option for adult patients with KRASG12C-mutated advanced NSCLC and disease progression after at least one prior systemic therapy.
In the past year, shares of Bristol Myers have plunged 30.1% compared with the industry’s 8.6% decline.
Image Source: Zacks Investment Research
The sNDA submission seeking approval for the Krazati/Erbitux combo therapy to treat the CRC indication is based on positive results from Bristol Myers’ phase I/II KRYSTAL-1 study. The ongoing early to mid-stage study is evaluating Krazati as a monotherapy or in combination with other anticancer therapies in patients with advanced solid tumors harboring a KRASG12C mutation.
The primary endpoint for the registrational phase II cohort of the KRYSTAL-1 study was the objective response rate. The secondary endpointsfor the pooled cohorts included duration of response, progression-free survival, overall survival and safety.
Per the data from the KRYSTAL-1 study, it was observed that Krazati was well tolerated and provided promising clinical activity in pretreated patients with la/m CRC harboring a KRASG12C mutation. Additionally, the drug, in combination with Erbitux, demonstrated a consistent safety profile.
We remind the investors that Krazati was added to Bristol Myers’ oncology portfolio following the $4.8 billion acquisition of Mirati Therapeutics, which was completed in January 2024.
BMY continues to evaluate Krazati as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC and CRC.
Bristol Myers Squibb Company Price and Consensus
Bristol Myers Squibb Company price-consensus-chart | Bristol Myers Squibb Company Quote
Zacks Rank and Stocks to Consider
Bristol Myers currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks from the drug/biotech industry are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Adicet Bio, Inc. (ACET - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA & ACET carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 73 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 69 cents to 71 cents. Over the past year, shares of PBYI have rallied 68.1%.
PBYI beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 2 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 22 cents. Over the past year, shares of ADMA have jumped 46.7%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has narrowed from $2.29 to $1.81. In the past year, shares of ACET have plunged 64.6%.
ACET’s earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, delivering an average negative surprise of 8.36%.