Yahoo Finance Amgen's (AMGN) Blincyto Gets FDA Nod for Consolidation Treatment
Amgen AMGN announced that the FDA has granted approval to its leukemia drug, Blincyto, for consolidation treatment, regardless of measurable residual disease (MRD) status.
Blincyto, a first-in-class Bispecific T-cell Engager (BiTE) therapy, is now approved for the treatment of adult and pediatric patients one month and older with Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (B-ALL) in the consolidation phase, regardless of MRD status. ALL is a fast-growing type of blood cancer that develops in the bone marrow.
Consolidation treatment is given to cancer patients after their cancer has disappeared following initial treatment. This therapy is given to kill any cancer cells that may be left in the body. The risk of B-ALL recurrence after initial treatment is relatively high, which makes the approval for consolidation treatment important.
The approval for consolidation treatment was based on data from the phase III E1910 study. Data from the study showed that Blincyto added to multiphase consolidation chemotherapy reduced the risk of death by 58%, showing superior overall survival versus chemotherapy alone.
So far this year, Amgen’s stock has risen 3.7% against the industry‘s 6.4% decline.
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The approval for consolidation treatment marks the third indication for Blincyto. It is already approved for treating CD19-positive B-ALL in adult and pediatric patients one month and older with MRD greater than or equal to 0.1% in first or second complete remission and those with relapsed or refractory disease.
Blincyto is a key contributor to Amgen’s top line and generated sales of $861 million in 2023, rising 48% year over year.
Amgen’s other BiTE therapy, which was recently approved in May, was Imdelltra (tarlatamab) for treating pre-treated advanced small cell lung cancer (ES-SCLC).
Zacks Rank & Stocks to Consider
Amgen currently carries a Zacks Rank #3 (Hold).
Amgen Inc. Price and Consensus
Amgen Inc. price-consensus-chart | Amgen Inc. Quote
Some better-ranked stocks from the drug/biotech industry are Ligand Pharmaceuticals LGND, Twist Bioscience TWST and Annovis Bio ANVS, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, the Zacks Consensus Estimate for Ligand’s 2024 earnings per share has increased from $4.56 to $4.71. During the same time frame, the consensus estimate for Ligand’s 2025 earnings per share has increased from $5.20 to $5.90. Year to date, shares of LGND have risen 12.1%.
Ligand beat estimates in each of the trailing four quarters, delivering an average surprise of 56.02%.
In the past 60 days, estimates for Twist Biosciences’ loss per share have narrowed from $3.17 to $3.08 for 2024 and from $2.81 to $2.64 for 2025. Year to date, shares of TWST have climbed 35.2%.
Twist Biosciences beat estimates in each of the trailing four quarters, delivering an average surprise of 9.36%.
In the past 60 days, the Zacks Consensus Estimate for Annovis’ loss per share has narrowed from $3.35 to $2.46 for 2024 and from $2.82 to $1.95 for 2025. Year to date, shares of ANVS have plunged 68.7%.
ANVS beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average negative earnings surprise of 1.39%.
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Amgen Inc. (AMGN) : Free Stock Analysis Report
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