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Pfizer's (PFE) New Multiple Myeloma Drug Elrexfio Gets FDA Nod
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Pfizer (PFE - Free Report) announced that the FDA has granted accelerated approval to elranatamab, its BCMA-CD3-targeted bispecific antibody for treating relapsed/refractory multiple myeloma (RRMM). It is intended for heavily pre-treated patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Continued approval of the drug will be based on verification of clinical benefit in a confirmatory study.
The drug, to be marketed by the name of Elrexfio, is the first off-the-shelf (ready-to-use) fixed-dose subcutaneous BCMA-CD3-targeted agent to be approved in the United States. It has the option to be dosed every other week in the long term after 24 weeks of weekly treatment.
Pfizer’s stock has declined 31% so far this year against an increase of 7.8% for the industry.
Image Source: Zacks Investment Research
The FDA’s approval of Elrexfio is based on data from the pivotal phase II MagnetisMM-3 study, which evaluated elranatamab in heavily pretreated patients with RRMM who received Elrexfio as their first BCMA-directed therapy. A. The data from the study showed early and deep responses, and a manageable safety profile for elranatamab. In the study, the overall response rate was 58% in patients who received four or more lines of therapy. Out of these patients, 82% maintained the response for at least nine months. The median time to first response was 1.2 months. The approval also includes data from a cohort of the MagnetisMM-3 study in which the overall response rate was 33% among the 63 patients in this cohort who received four or more lines of therapy.
However, Elrexfio’s label comes with a boxed warning for cytokine release syndrome and neurologic toxicity.
The MagnetisMM program continues to study Elrexfio for expanded use in earlier lines of treatment, both as an individual agent as well as a combination therapy across the entire spectrum of myeloma progression, from newly diagnosed multiple myeloma to RRMM. Elranatamab’s marketing authorization application is also under review in the EU.
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' time (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.
The FDA approved Abrysvo, Pfizer’s RSV vaccine for older adults, in May. Zavzpret (zavegepant nasal spray), Pfizer’s CGRP receptor antagonist for the acute treatment of migraine was approved in March 2023.
In June, the FDA approved Litfulo (ritlecitinib), its JAK3 inhibitor for treating severe alopecia areata in adults and adolescents. The FDA also approved Ngenla, a long-acting once-weekly treatment for pediatric growth hormone deficiency in the same month.
Pfizer believes some of its new product launches like Abrysvo RSV vaccine, etrasimod for ulcerative colitis (under review in United States and EU) and its pentavalent meningococcal vaccine (under review in Europe and the United States), coupled with business development activities, including the proposed acquisition of Seagen position Pfizer strongly for operational growth in 2025 and beyond.
Pfizer offered to buy cancer drugmaker Seagen for $229 per share in cash or a total enterprise value of approximately $43 billion in March.
Seagen’s acquisition is expected to strengthen Pfizer’s portfolio of cancer drugs by adding a class of antibody-drug conjugates. Seagen currently markets four cancer drugs — Adcetris, Padcev, Tukysa and Tivdak. The Pfizer/Seagen transaction is expected to be closed in late 2023 or early 2024. The shareholders of Seagen have already approved the deal.
Two large drug stocks worth considering are J&J (JNJ - Free Report) and Novo Nordisk (NVO - Free Report) , both with a Zacks Rank of 2 (Buy).
Estimates for J&J’s 2023 earnings per share have increased from $10.65 to $10.75 over the past 30 days. Estimates for 2024 have jumped from $11.10 per share to $11.29 in the same timeframe. J&J’s stock has declined 2.1% year to date.
J&J beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 5.58%, on average.
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $5.07 to $5.31 over the past 30 days. Estimates for 2024 have jumped from $5.95 per share to $6.18 in the same timeframe. Novo Nordisk’s stock has risen 36.8% year to date.
Novo Nordisk beat earnings expectations in two of the trailing four quarters while missing in one and meeting in one. The company delivered a four-quarter negative earnings surprise of 0.28%, on average.
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Pfizer's (PFE) New Multiple Myeloma Drug Elrexfio Gets FDA Nod
Pfizer (PFE - Free Report) announced that the FDA has granted accelerated approval to elranatamab, its BCMA-CD3-targeted bispecific antibody for treating relapsed/refractory multiple myeloma (RRMM). It is intended for heavily pre-treated patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Continued approval of the drug will be based on verification of clinical benefit in a confirmatory study.
The drug, to be marketed by the name of Elrexfio, is the first off-the-shelf (ready-to-use) fixed-dose subcutaneous BCMA-CD3-targeted agent to be approved in the United States. It has the option to be dosed every other week in the long term after 24 weeks of weekly treatment.
Pfizer’s stock has declined 31% so far this year against an increase of 7.8% for the industry.
Image Source: Zacks Investment Research
The FDA’s approval of Elrexfio is based on data from the pivotal phase II MagnetisMM-3 study, which evaluated elranatamab in heavily pretreated patients with RRMM who received Elrexfio as their first BCMA-directed therapy. A. The data from the study showed early and deep responses, and a manageable safety profile for elranatamab. In the study, the overall response rate was 58% in patients who received four or more lines of therapy. Out of these patients, 82% maintained the response for at least nine months. The median time to first response was 1.2 months. The approval also includes data from a cohort of the MagnetisMM-3 study in which the overall response rate was 33% among the 63 patients in this cohort who received four or more lines of therapy.
However, Elrexfio’s label comes with a boxed warning for cytokine release syndrome and neurologic toxicity.
The MagnetisMM program continues to study Elrexfio for expanded use in earlier lines of treatment, both as an individual agent as well as a combination therapy across the entire spectrum of myeloma progression, from newly diagnosed multiple myeloma to RRMM. Elranatamab’s marketing authorization application is also under review in the EU.
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' time (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.
The FDA approved Abrysvo, Pfizer’s RSV vaccine for older adults, in May. Zavzpret (zavegepant nasal spray), Pfizer’s CGRP receptor antagonist for the acute treatment of migraine was approved in March 2023.
In June, the FDA approved Litfulo (ritlecitinib), its JAK3 inhibitor for treating severe alopecia areata in adults and adolescents. The FDA also approved Ngenla, a long-acting once-weekly treatment for pediatric growth hormone deficiency in the same month.
Pfizer believes some of its new product launches like Abrysvo RSV vaccine, etrasimod for ulcerative colitis (under review in United States and EU) and its pentavalent meningococcal vaccine (under review in Europe and the United States), coupled with business development activities, including the proposed acquisition of Seagen position Pfizer strongly for operational growth in 2025 and beyond.
Pfizer offered to buy cancer drugmaker Seagen for $229 per share in cash or a total enterprise value of approximately $43 billion in March.
Seagen’s acquisition is expected to strengthen Pfizer’s portfolio of cancer drugs by adding a class of antibody-drug conjugates. Seagen currently markets four cancer drugs — Adcetris, Padcev, Tukysa and Tivdak. The Pfizer/Seagen transaction is expected to be closed in late 2023 or early 2024. The shareholders of Seagen have already approved the deal.
Zacks Rank and Stocks to Consider
Pfizer has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Pfizer Inc. Price and Consensus
Pfizer Inc. price-consensus-chart | Pfizer Inc. Quote
Two large drug stocks worth considering are J&J (JNJ - Free Report) and Novo Nordisk (NVO - Free Report) , both with a Zacks Rank of 2 (Buy).
Estimates for J&J’s 2023 earnings per share have increased from $10.65 to $10.75 over the past 30 days. Estimates for 2024 have jumped from $11.10 per share to $11.29 in the same timeframe. J&J’s stock has declined 2.1% year to date.
J&J beat earnings expectations in all the trailing four quarters. The company delivered a four-quarter earnings surprise of 5.58%, on average.
Estimates for Novo Nordisk’s 2023 earnings per share have increased from $5.07 to $5.31 over the past 30 days. Estimates for 2024 have jumped from $5.95 per share to $6.18 in the same timeframe. Novo Nordisk’s stock has risen 36.8% year to date.
Novo Nordisk beat earnings expectations in two of the trailing four quarters while missing in one and meeting in one. The company delivered a four-quarter negative earnings surprise of 0.28%, on average.