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Bristol Myers (BMY) Gets FDA Nod for Label Expansion of Augtyro
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Bristol Myers Squibb (BMY - Free Report) announced that the FDA has approved a label expansion of its lung cancer drug Augtyro (repotrectinib).
The regulatory body granted accelerated approval to Augtyro for the treatment of adult and pediatric patients aged 12 years and above with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
The accelerated approval is based on positive results from the phase I/II TRIDENT-1 study, which evaluated Augtyro in adult patients with NTRK-positive solid tumors. The TRIDENT-1 trial included both TKI-naïve (n=40) and TKI-pretreated (n=48) patients with NTRK-positive locally advanced/metastatic solid tumors collectively representing 15 different types of cancer.
The latest approval was granted under accelerated approval based on the overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Per BMY, there was no FDA-approved treatment option for NTRK-positive cancers that were studied in both TKI-naïve and TKI-pretreated patients across solid tumors. The FDA approval of repotrectinib has broadened the BMY oncology portfolio, adding a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumors for both TKI-naïve and TKI-pretreated patients.
Please note that the drug was granted full approval in the United States for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in November 2023.
The acquisition of Turning Point Therapeutics in 2022 added repotrectinib to BMY’s portfolio.
However, Augtyro is associated with certain warnings and precautions of the central nervous system effects, interstitial lung disease/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, hyperuricemia, skeletal fractures and embryo-fetal toxicity.
Bristol Myers is currently in the transition mode as it shifts its mature product portfolio, which is facing generic competition, to new drugs.
Shares of the company have lost 20.4% year to date compared with the industry's decline of 5.6%.
Image Source: Zacks Investment Research
The approval of additional new drugs should enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as blockbuster oncology drugs Revlimid and Eliquis face generic competition.
Bristol Myers’ immuno-oncology drug Opdivo is already approved for NSCLC.
In January 2024, BMY acquired oncology-focused company Mirati Therapeutics for a total equity value of $5.8 billion.
The acquisition added Mirati’s lung cancer drug Krazati (adagrasib) to BMY’s strong oncology portfolio. The FDA approved the drug in December 2022 for the treatment of adult patients with KRAS-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.
Zacks Rank and Stocks to Consider
BMY currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Ligand Pharmaceuticals , ALX Oncology Holdings (ALXO - Free Report) and Minerva Neurosciences, Inc. (NERV - Free Report) . While LGND sports a Zacks Rank #1 (Strong Buy) at present, ALXO and NERV carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share (EPS) has increased 16 cents to $4.71. During the same time frame, the consensus estimate for 2025 EPS has increased 70 cents to $5.90. Year to date, shares of LGND have risen 12.5%.
Ligand beat on earnings in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 60 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73.
ALX Oncology beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.83%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimate for 2025 has narrowed from $4.54 to $3.60 during the same time frame.
NERV’s earnings beat estimates in one of the trailing four quarters and missed the same in the other three, the average negative surprise being 54.43%.
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Bristol Myers (BMY) Gets FDA Nod for Label Expansion of Augtyro
Bristol Myers Squibb (BMY - Free Report) announced that the FDA has approved a label expansion of its lung cancer drug Augtyro (repotrectinib).
The regulatory body granted accelerated approval to Augtyro for the treatment of adult and pediatric patients aged 12 years and above with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.
The accelerated approval is based on positive results from the phase I/II TRIDENT-1 study, which evaluated Augtyro in adult patients with NTRK-positive solid tumors. The TRIDENT-1 trial included both TKI-naïve (n=40) and TKI-pretreated (n=48) patients with NTRK-positive locally advanced/metastatic solid tumors collectively representing 15 different types of cancer.
The latest approval was granted under accelerated approval based on the overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Per BMY, there was no FDA-approved treatment option for NTRK-positive cancers that were studied in both TKI-naïve and TKI-pretreated patients across solid tumors. The FDA approval of repotrectinib has broadened the BMY oncology portfolio, adding a next-generation TKI that can be used across a broad range of NTRK fusion-positive solid tumors for both TKI-naïve and TKI-pretreated patients.
Please note that the drug was granted full approval in the United States for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in November 2023.
The acquisition of Turning Point Therapeutics in 2022 added repotrectinib to BMY’s portfolio.
However, Augtyro is associated with certain warnings and precautions of the central nervous system effects, interstitial lung disease/pneumonitis, hepatotoxicity, myalgia with creatine phosphokinase elevation, hyperuricemia, skeletal fractures and embryo-fetal toxicity.
Bristol Myers is currently in the transition mode as it shifts its mature product portfolio, which is facing generic competition, to new drugs.
Shares of the company have lost 20.4% year to date compared with the industry's decline of 5.6%.
Image Source: Zacks Investment Research
The approval of additional new drugs should enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as blockbuster oncology drugs Revlimid and Eliquis face generic competition.
Bristol Myers’ immuno-oncology drug Opdivo is already approved for NSCLC.
In January 2024, BMY acquired oncology-focused company Mirati Therapeutics for a total equity value of $5.8 billion.
The acquisition added Mirati’s lung cancer drug Krazati (adagrasib) to BMY’s strong oncology portfolio. The FDA approved the drug in December 2022 for the treatment of adult patients with KRAS-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy.
Zacks Rank and Stocks to Consider
BMY currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Ligand Pharmaceuticals , ALX Oncology Holdings (ALXO - Free Report) and Minerva Neurosciences, Inc. (NERV - Free Report) . While LGND sports a Zacks Rank #1 (Strong Buy) at present, ALXO and NERV carry a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share (EPS) has increased 16 cents to $4.71. During the same time frame, the consensus estimate for 2025 EPS has increased 70 cents to $5.90. Year to date, shares of LGND have risen 12.5%.
Ligand beat on earnings in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 60 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has narrowed from $3.33 to $2.89. During the same period, the consensus estimate for 2025 loss per share has narrowed from $2.85 to $2.73.
ALX Oncology beat on earnings in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 8.83%.
In the past 60 days, estimates for Minerva Neurosciences’ 2024 loss per share have narrowed from $3.57 to $1.89. Loss per share estimate for 2025 has narrowed from $4.54 to $3.60 during the same time frame.
NERV’s earnings beat estimates in one of the trailing four quarters and missed the same in the other three, the average negative surprise being 54.43%.