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Pfizer's (PFE) Multiple Myeloma Drug Elrexfio Gets Nod in EU
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Pfizer Inc. (PFE - Free Report) announced that the European Commission (EC) has granted conditional marketing authorization to its BCMA-CD3-targeted bispecific antibody, Elrexfio (elranatamab), for treating relapsed/refractory multiple myeloma (RRMM).
The EC has approved Elrexfio for heavily pre-treated patients who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and experienced disease progression on the last therapy.
The EC’s nod was based on data from cohort A of the phase II MagnetisMM-3 study, which showed that treatment with Elrexfio led to meaningful responses in the above-mentioned patient population.
The approval by the EC was expected as in October the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended conditional marketing authorization for Elrexfio.
Shares of Pfizer have declined 43.8% so far this year against the industry’s increase of 4.3%.
Image Source: Zacks Investment Research
Elrexfio is an off-the-shelf (ready-to-use) fixed-dose subcutaneous BCMA-CD3-targeted immunotherapy, which offers deep and durable responses, with a manageable tolerability profile with a convenient dosing.
The FDA had granted accelerated approval to Elrexfio for treating RRMM in August.
However, in the United States, 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.
In the past 60 days, estimates for Journey Medical’s 2023 loss per share have narrowed from $1.28 to 16 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 41 cents to 35 cents. Year to date, shares of DERM have surged 203.1%.
Earnings of Journey Medical beat estimates in one of the last four quarters while missing the same on the remaining three occasions. DERM delivered a four-quarter earnings surprise of 118.25%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year to date, shares of TRDA have risen by 5.3%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. Year to date, shares of PBYI have lost 2.4%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Pfizer's (PFE) Multiple Myeloma Drug Elrexfio Gets Nod in EU
Pfizer Inc. (PFE - Free Report) announced that the European Commission (EC) has granted conditional marketing authorization to its BCMA-CD3-targeted bispecific antibody, Elrexfio (elranatamab), for treating relapsed/refractory multiple myeloma (RRMM).
The EC has approved Elrexfio for heavily pre-treated patients who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and experienced disease progression on the last therapy.
The EC’s nod was based on data from cohort A of the phase II MagnetisMM-3 study, which showed that treatment with Elrexfio led to meaningful responses in the above-mentioned patient population.
The approval by the EC was expected as in October the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended conditional marketing authorization for Elrexfio.
Shares of Pfizer have declined 43.8% so far this year against the industry’s increase of 4.3%.
Elrexfio is an off-the-shelf (ready-to-use) fixed-dose subcutaneous BCMA-CD3-targeted immunotherapy, which offers deep and durable responses, with a manageable tolerability profile with a convenient dosing.
The FDA had granted accelerated approval to Elrexfio for treating RRMM in August.
However, in the United States, 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.
Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Journey Medical Corporation (DERM - Free Report) , Entrada Therapeutics, Inc. (TRDA - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Journey Medical’s 2023 loss per share have narrowed from $1.28 to 16 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 41 cents to 35 cents. Year to date, shares of DERM have surged 203.1%.
Earnings of Journey Medical beat estimates in one of the last four quarters while missing the same on the remaining three occasions. DERM delivered a four-quarter earnings surprise of 118.25%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year to date, shares of TRDA have risen by 5.3%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. Year to date, shares of PBYI have lost 2.4%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.