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FDA Approves Pfizer's (PFE) Braftovi + Mektovi for Lung Cancer
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Pfizer (PFE - Free Report) announced that the FDA had approved its supplemental new drug applications (sNDAs) seeking label expansion for Braftovi (encorafenib) + Mektovi (binimetinib) in adult patients with BRAF V600E-mutant metastatic non-small cell lung cancer (“NSCLC”).
The approvals were based on data from the ongoing phase II PHAROS study, which evaluated Braftovi plus Mektovi in patients with BRAF V600E-mutant metastatic NSCLC. In the study, PHAROS met its primary endpoint of objective response rate.
Following the label expansion, the Braftovi/Mektovi combination is approved for two indications in the United States. The combination is already approved for treating adult patients with BRAF V600E or V600K mutated metastatic melanoma. Braftovi, in combination with cetuximab, is also approved to treat adult patients with BRAF V600E-mutated metastatic colorectal cancer.
Per management estimates, NSCLC accounts for nearly 80-85% of all lung cancer cases. A BRAF V600E mutation occurs in around 2% of all NSCLC cases. To counter such specific types of cancers, personalized therapies like Braftovi + Mektovi are required, which can address a genetically changed NSCLC indication.
Shares of Pfizer have lost 35.8% so far this year against the industry’s 8.5% growth.
Image Source: Zacks Investment Research
Braftovi and Mektovi were added to Pfizer’s oncology portfolio with the acquisition of Array Biopharma in 2019.
Pfizer has the largest number of new product and indication launches planned for 2023, most of which are expected to occur in the second half of the year. Pfizer is more than halfway to its goal of launching 19 new products or indications in 18 months (all non-COVID indications), which are expected to generate around $20 billion in sales by 2030. Two-thirds of these products have blockbuster potential, according to Pfizer.
Pfizer RSV vaccine, Abrysvo, was approved to help protect older adults, as well as infants (through maternal immunization) in the United States in 2023. In August, the FDA approved Elrexfio, a BCMA-CD3-targeted bispecific antibody for relapsed/refractory multiple myeloma. In June, the FDA approved Litfulo, its JAK3 inhibitor for treating severe alopecia areata and Ngenla, a long-acting once-weekly pediatric growth hormone deficiency treatment. In March, the agency approved the company’s migraine nasal spray, Zavzpret, for use in adults.
These approvals will likely boost the company’s top line, which has been suffering a plunge due to a fall in demand for COVID-19 products.
In the past 60 days, estimates for Allogene Therapeutics’ 2024 earnings per share narrowed from $2.23 to $2.21. Year to date, shares of Allogene Therapeutics have lost 52.9%.
Earnings of Allogene Therapeutics beat estimates in three of the trailing four quarters while meeting the mark on one occasion, witnessing an average earnings surprise of 3.93%. In the last reported quarter, Allogene Therapeutics’ earnings beat estimates by 10.17%.
In the past 60 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 37.4%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 60 days, estimates for Corcept Therapeutics’ 2023 earnings per share increased from 75 cents to 78 cents. During the same period, the earnings estimate per share for 2024 has improved from 81 cents to 83 cents. Year to date, shares of Corcept Therapeutics have risen 36.0%.
Earnings of Corcept Therapeutics beat estimates in two of the trailing four quarters while missing the mark on the other two occasions, witnessing an average earnings surprise of 6.99%. In the last reported quarter, Corcept Therapeutics’ earnings beat estimates by 66.67%.
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FDA Approves Pfizer's (PFE) Braftovi + Mektovi for Lung Cancer
Pfizer (PFE - Free Report) announced that the FDA had approved its supplemental new drug applications (sNDAs) seeking label expansion for Braftovi (encorafenib) + Mektovi (binimetinib) in adult patients with BRAF V600E-mutant metastatic non-small cell lung cancer (“NSCLC”).
The approvals were based on data from the ongoing phase II PHAROS study, which evaluated Braftovi plus Mektovi in patients with BRAF V600E-mutant metastatic NSCLC. In the study, PHAROS met its primary endpoint of objective response rate.
Following the label expansion, the Braftovi/Mektovi combination is approved for two indications in the United States. The combination is already approved for treating adult patients with BRAF V600E or V600K mutated metastatic melanoma. Braftovi, in combination with cetuximab, is also approved to treat adult patients with BRAF V600E-mutated metastatic colorectal cancer.
Per management estimates, NSCLC accounts for nearly 80-85% of all lung cancer cases. A BRAF V600E mutation occurs in around 2% of all NSCLC cases. To counter such specific types of cancers, personalized therapies like Braftovi + Mektovi are required, which can address a genetically changed NSCLC indication.
Shares of Pfizer have lost 35.8% so far this year against the industry’s 8.5% growth.
Image Source: Zacks Investment Research
Braftovi and Mektovi were added to Pfizer’s oncology portfolio with the acquisition of Array Biopharma in 2019.
Pfizer has the largest number of new product and indication launches planned for 2023, most of which are expected to occur in the second half of the year. Pfizer is more than halfway to its goal of launching 19 new products or indications in 18 months (all non-COVID indications), which are expected to generate around $20 billion in sales by 2030. Two-thirds of these products have blockbuster potential, according to Pfizer.
Pfizer RSV vaccine, Abrysvo, was approved to help protect older adults, as well as infants (through maternal immunization) in the United States in 2023. In August, the FDA approved Elrexfio, a BCMA-CD3-targeted bispecific antibody for relapsed/refractory multiple myeloma. In June, the FDA approved Litfulo, its JAK3 inhibitor for treating severe alopecia areata and Ngenla, a long-acting once-weekly pediatric growth hormone deficiency treatment. In March, the agency approved the company’s migraine nasal spray, Zavzpret, for use in adults.
These approvals will likely boost the company’s top line, which has been suffering a plunge due to a fall in demand for COVID-19 products.
Pfizer Inc. Price
Pfizer Inc. price | Pfizer Inc. Quote
Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks are Allogene Therapeutics (ALLO - Free Report) , Annovis Bio (ANVS), and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Allogene Therapeutics’ 2024 earnings per share narrowed from $2.23 to $2.21. Year to date, shares of Allogene Therapeutics have lost 52.9%.
Earnings of Allogene Therapeutics beat estimates in three of the trailing four quarters while meeting the mark on one occasion, witnessing an average earnings surprise of 3.93%. In the last reported quarter, Allogene Therapeutics’ earnings beat estimates by 10.17%.
In the past 60 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 37.4%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 60 days, estimates for Corcept Therapeutics’ 2023 earnings per share increased from 75 cents to 78 cents. During the same period, the earnings estimate per share for 2024 has improved from 81 cents to 83 cents. Year to date, shares of Corcept Therapeutics have risen 36.0%.
Earnings of Corcept Therapeutics beat estimates in two of the trailing four quarters while missing the mark on the other two occasions, witnessing an average earnings surprise of 6.99%. In the last reported quarter, Corcept Therapeutics’ earnings beat estimates by 66.67%.