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SAN DIEGO - The European Commission has approved DARZALEX Faspro (daratumumab) as monotherapy for adult patients with high-risk smouldering multiple myeloma (SMM), Halozyme Therapeutics, Inc. (NASDAQ:HALO), a $7.2 billion market cap company with impressive 25.7% revenue growth over the last twelve months, announced Wednesday.
The approval marks a shift from the current "watch and wait" standard of care for SMM patients, allowing for therapeutic intervention before the disease progresses to multiple myeloma.
DARZALEX Faspro is co-formulated with Halozyme’s ENHANZE drug delivery technology, which facilitates subcutaneous administration of the treatment. The company maintains strong operational efficiency with a 76.2% gross profit margin and has achieved a perfect Piotroski Score of 9, according to InvestingPro data.
The EC approval is based on data from the Phase 3 AQUILA study that evaluated the efficacy and safety of fixed-duration monotherapy daratumumab SC compared with active monitoring in patients with high-risk SMM.
Smouldering multiple myeloma is an asymptomatic intermediate disease state where abnormal cells can be detected in the bone marrow. Previously, even high-risk patients were only offered therapeutic intervention when the disease progressed.
"This approval reinforces DARZALEX Faspro with ENHANZE as a foundational treatment across all stages of multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme, according to the press release statement. InvestingPro analysis suggests the stock is currently undervalued, with 8 additional exclusive tips available for subscribers.
Janssen-Cilag International NV, a Johnson & Johnson company, received the approval for the new indication of the treatment that has already been used in other stages of multiple myeloma.
In other recent news, Halozyme Therapeutics has reported significant developments. The company announced that argenx received European Commission approval for VYVGART with ENHANZE technology, enhancing treatment options for chronic inflammatory demyelinating polyneuropathy. Additionally, the European Commission approved Bristol-Myers Squibb’s Opdivo, utilizing Halozyme’s ENHANZE technology, for multiple adult solid tumors. Halozyme has also been added to the Russell 1000 Index, reflecting its standing among large U.S. securities by market capitalization.
Analysts have weighed in on Halozyme’s prospects. Goldman Sachs resumed coverage with a Neutral rating, noting uncertainty over how Medicare and Medicaid Services will handle drug pricing negotiations involving Halozyme’s Enhanze technology. Meanwhile, TD Cowen maintained a Buy rating, suggesting the stock is undervalued despite potential revenue impacts from the Inflation Reduction Act. H.C. Wainwright also upheld a Buy rating, with confidence bolstered by recent regulatory approvals in Europe. These developments highlight ongoing interest and analysis in Halozyme’s market position.
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