Halozyme and Johnson & Johnson's Combination Therapy Approved
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Should l Buy HALO?
Source: NASDAQ.COM
- FDA Approval: Halozyme Therapeutics announced that Johnson & Johnson's Tecvayli in combination with Darzalex Faspro has received FDA approval for adults with relapsed or refractory multiple myeloma who have had at least one prior therapy, marking a significant advancement in treatment options.
- Clinical Trial Success: The approval is based on positive results from the MajesTEC-3 study, which demonstrated that the combination significantly improved progression-free and overall survival, reducing the risk of disease progression or death by 83% compared to standard treatments after a median follow-up of three years.
- Market Reaction: Despite the approval of the new therapy, Halozyme's stock closed down 3.8% at $67.36 on Thursday, reflecting a cautious market sentiment regarding the company's future performance, which may impact investor confidence.
- Strategic Implications: This approval not only strengthens Halozyme's market position in multiple myeloma treatment but also showcases the potential of its ENHANZE drug delivery technology through collaboration with Johnson & Johnson, potentially laying the groundwork for future product development and market expansion.
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Analyst Views on HALO
Wall Street analysts forecast HALO stock price to rise
5 Analyst Rating
3 Buy
1 Hold
1 Sell
Moderate Buy
Current: 68.140
Low
56.00
Averages
78.50
High
90.00
Current: 68.140
Low
56.00
Averages
78.50
High
90.00
About HALO
Halozyme Therapeutics, Inc. is a biopharmaceutical company advancing solutions to improve patient experiences and outcomes for emerging and established therapies. The Company's commercially-validated solution, ENHANZE drug delivery technology with the proprietary enzyme rHuPH20, is used to facilitate the subcutaneous delivery of injected drugs and fluids, with a focus on improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. The Company licenses its technology to biopharmaceutical companies to collaboratively develop products that combine ENHANZE with its partners’ proprietary compounds. It also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies. The Company has two commercial proprietary products, Hylenex and XYOSTED. It also has a proprietary ultra-high concentration microparticle formulation technology for biologics, branded Hypercon.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Halozyme and Johnson & Johnson's Combination Therapy Approved
- FDA Approval: Halozyme Therapeutics announced that Johnson & Johnson's Tecvayli in combination with Darzalex Faspro has received FDA approval for adults with relapsed or refractory multiple myeloma who have had at least one prior therapy, marking a significant advancement in treatment options.
- Clinical Trial Success: The approval is based on positive results from the MajesTEC-3 study, which demonstrated that the combination significantly improved progression-free and overall survival, reducing the risk of disease progression or death by 83% compared to standard treatments after a median follow-up of three years.
- Market Reaction: Despite the approval of the new therapy, Halozyme's stock closed down 3.8% at $67.36 on Thursday, reflecting a cautious market sentiment regarding the company's future performance, which may impact investor confidence.
- Strategic Implications: This approval not only strengthens Halozyme's market position in multiple myeloma treatment but also showcases the potential of its ENHANZE drug delivery technology through collaboration with Johnson & Johnson, potentially laying the groundwork for future product development and market expansion.
See More
FDA Approves Halozyme and Johnson & Johnson's TECVAYLI for Multiple Myeloma
- FDA Approval: Johnson & Johnson's TECVAYLI® in combination with DARZALEX FASPRO® has received FDA approval for treating adults with relapsed or refractory multiple myeloma who have had at least one prior therapy, marking a significant advancement in treatment options.
- Clinical Trial Success: Based on data from the MajesTEC-3 study, the combination therapy demonstrated an 83% progression-free survival rate after a median follow-up of three years, significantly reducing the risk of disease progression or death by 83% compared to standard treatments, providing patients with a more effective option.
- Innovative Treatment Method: Both TECVAYLI and DARZALEX FASPRO are administered subcutaneously, simplifying the treatment process and enhancing patient convenience, aligning with modern healthcare's focus on patient experience.
- Broad Market Potential: This approval not only elevates Halozyme's position in the biopharmaceutical sector but may also drive further applications of its ENHANZE® technology, enhancing the company's competitiveness in the global market.
See More
FDA Approves Halozyme and Johnson & Johnson's TECVAYLI for Multiple Myeloma Treatment
- FDA Approval: Johnson & Johnson's TECVAYLI in combination with DARZALEX FASPRO has received FDA approval for treating adults with relapsed or refractory multiple myeloma who have had at least one prior therapy, marking a significant advancement in treatment options.
- Significant Clinical Results: Based on data from the MajesTEC-3 study, the combination therapy demonstrated an 83% progression-free survival rate after a median follow-up of three years, with an 83% reduction in the risk of disease progression or death compared to standard treatments, highlighting its clinical superiority.
- Innovative Administration: Both TECVAYLI and DARZALEX FASPRO are administered subcutaneously, offering a more convenient delivery method that aims to enhance patient experience and improve adherence to treatment, aligning with modern healthcare trends towards patient-friendly solutions.
- Broad Market Potential: This approval not only strengthens Halozyme's position in the biopharmaceutical sector but also may drive further applications of its ENHANZE technology, potentially attracting more pharmaceutical partnerships and expanding market share.
See More
FDA Approves Johnson & Johnson's Tecvayli for Multiple Myeloma Treatment
- FDA Approval: The U.S. Food and Drug Administration (FDA) approved Johnson & Johnson's antibody therapy Tecvayli (teclistamab) in combination with Darzalex Faspro for adults with relapsed or refractory multiple myeloma, marking a significant advancement in blood cancer treatment.
- Rapid Approval Process: This approval was achieved in just 55 days after J&J received a national priority voucher in December, demonstrating the FDA's commitment to expediting the review of experimental therapies aligned with U.S. national interests, thereby enhancing J&J's competitive edge in biopharmaceuticals.
- Innovative Technology Application: Darzalex Faspro, developed using Halozyme's Enhanze drug delivery technology, when combined with Tecvayli, may offer a more effective treatment option for multiple myeloma patients, potentially improving their quality of life.
- Broad Market Prospects: This approval not only opens new market opportunities for Johnson & Johnson but may also encourage other biopharmaceutical companies to accelerate the development of similar therapies, further driving innovation and growth in the multiple myeloma sector.
See More
Halozyme Announces Upcoming Investor Conference Presentations
- Investor Conference Schedule: Halozyme Therapeutics is set to participate in the TD Cowen 46th Annual Healthcare Conference on March 3, 2026, in Boston, where CEO Dr. Helen Torley will engage in a fireside chat and one-on-one meetings, enhancing the company's interaction with investors.
- Multiple Conference Appearances: Following this, Halozyme will also attend the Leerink Partners Global Healthcare Conference on March 10 and the Citizens Life Sciences Conference on March 11, showcasing its innovations in the biopharmaceutical sector and further elevating its visibility among investors.
- Showcasing Technological Innovations: With its ENHANZE® drug delivery technology at the forefront, Halozyme has launched ten commercial products globally, impacting over one million patients, which highlights its potential in improving patient experiences and outcomes, likely attracting more investor interest.
- Future Growth Potential: The company is also developing Hypercon™ and Surf Bio hyperconcentration technologies, aimed at expanding the applications of drug delivery technologies, enhancing patient convenience and adherence, which could provide new momentum for future market growth.
See More
Halozyme Reports Q4 2026 Earnings Miss, Stock Drops
- Disappointing Earnings: Halozyme reported a non-GAAP EPS of -$0.24 for Q4 2026, a significant drop from $1.26 in the same period last year, indicating a notable decline in profitability that could undermine investor confidence.
- 2026 EPS Guidance: The company reiterated its 2026 non-GAAP EPS guidance range of $7.75-$8.25, with a midpoint of $8.00, which is below the consensus estimate of $8.15, suggesting potential pressure on future earnings expectations.
- Revenue Outlook: Halozyme anticipates 2026 revenue between $1.71B and $1.81B, with a midpoint of $1.76B, slightly below the consensus of $1.77B, reflecting a cautious market sentiment regarding its growth potential.
- Deteriorating Cash Position: As of the end of 2025, Halozyme's cash, cash equivalents, and marketable securities totaled $145.4M, a sharp decline from $596.1M at the end of 2024, indicating challenges in cash management that may impact future investment capabilities.
See More
Halozyme and Johnson & Johnson's Combination Therapy Approved
- FDA Approval: Halozyme Therapeutics announced that Johnson & Johnson's Tecvayli in combination with Darzalex Faspro has received FDA approval for adults with relapsed or refractory multiple myeloma who have had at least one prior therapy, marking a significant advancement in treatment options.
- Clinical Trial Success: The approval is based on positive results from the MajesTEC-3 study, which demonstrated that the combination significantly improved progression-free and overall survival, reducing the risk of disease progression or death by 83% compared to standard treatments after a median follow-up of three years.
- Market Reaction: Despite the approval of the new therapy, Halozyme's stock closed down 3.8% at $67.36 on Thursday, reflecting a cautious market sentiment regarding the company's future performance, which may impact investor confidence.
- Strategic Implications: This approval not only strengthens Halozyme's market position in multiple myeloma treatment but also showcases the potential of its ENHANZE drug delivery technology through collaboration with Johnson & Johnson, potentially laying the groundwork for future product development and market expansion.
See More
FDA Approves Halozyme and Johnson & Johnson's TECVAYLI for Multiple Myeloma
- FDA Approval: Johnson & Johnson's TECVAYLI® in combination with DARZALEX FASPRO® has received FDA approval for treating adults with relapsed or refractory multiple myeloma who have had at least one prior therapy, marking a significant advancement in treatment options.
- Clinical Trial Success: Based on data from the MajesTEC-3 study, the combination therapy demonstrated an 83% progression-free survival rate after a median follow-up of three years, significantly reducing the risk of disease progression or death by 83% compared to standard treatments, providing patients with a more effective option.
- Innovative Treatment Method: Both TECVAYLI and DARZALEX FASPRO are administered subcutaneously, simplifying the treatment process and enhancing patient convenience, aligning with modern healthcare's focus on patient experience.
- Broad Market Potential: This approval not only elevates Halozyme's position in the biopharmaceutical sector but may also drive further applications of its ENHANZE® technology, enhancing the company's competitiveness in the global market.
See More
FDA Approves Halozyme and Johnson & Johnson's TECVAYLI for Multiple Myeloma Treatment
- FDA Approval: Johnson & Johnson's TECVAYLI in combination with DARZALEX FASPRO has received FDA approval for treating adults with relapsed or refractory multiple myeloma who have had at least one prior therapy, marking a significant advancement in treatment options.
- Significant Clinical Results: Based on data from the MajesTEC-3 study, the combination therapy demonstrated an 83% progression-free survival rate after a median follow-up of three years, with an 83% reduction in the risk of disease progression or death compared to standard treatments, highlighting its clinical superiority.
- Innovative Administration: Both TECVAYLI and DARZALEX FASPRO are administered subcutaneously, offering a more convenient delivery method that aims to enhance patient experience and improve adherence to treatment, aligning with modern healthcare trends towards patient-friendly solutions.
- Broad Market Potential: This approval not only strengthens Halozyme's position in the biopharmaceutical sector but also may drive further applications of its ENHANZE technology, potentially attracting more pharmaceutical partnerships and expanding market share.
See More
FDA Approves Johnson & Johnson's Tecvayli for Multiple Myeloma Treatment
- FDA Approval: The U.S. Food and Drug Administration (FDA) approved Johnson & Johnson's antibody therapy Tecvayli (teclistamab) in combination with Darzalex Faspro for adults with relapsed or refractory multiple myeloma, marking a significant advancement in blood cancer treatment.
- Rapid Approval Process: This approval was achieved in just 55 days after J&J received a national priority voucher in December, demonstrating the FDA's commitment to expediting the review of experimental therapies aligned with U.S. national interests, thereby enhancing J&J's competitive edge in biopharmaceuticals.
- Innovative Technology Application: Darzalex Faspro, developed using Halozyme's Enhanze drug delivery technology, when combined with Tecvayli, may offer a more effective treatment option for multiple myeloma patients, potentially improving their quality of life.
- Broad Market Prospects: This approval not only opens new market opportunities for Johnson & Johnson but may also encourage other biopharmaceutical companies to accelerate the development of similar therapies, further driving innovation and growth in the multiple myeloma sector.
See More
Halozyme Announces Upcoming Investor Conference Presentations
- Investor Conference Schedule: Halozyme Therapeutics is set to participate in the TD Cowen 46th Annual Healthcare Conference on March 3, 2026, in Boston, where CEO Dr. Helen Torley will engage in a fireside chat and one-on-one meetings, enhancing the company's interaction with investors.
- Multiple Conference Appearances: Following this, Halozyme will also attend the Leerink Partners Global Healthcare Conference on March 10 and the Citizens Life Sciences Conference on March 11, showcasing its innovations in the biopharmaceutical sector and further elevating its visibility among investors.
- Showcasing Technological Innovations: With its ENHANZE® drug delivery technology at the forefront, Halozyme has launched ten commercial products globally, impacting over one million patients, which highlights its potential in improving patient experiences and outcomes, likely attracting more investor interest.
- Future Growth Potential: The company is also developing Hypercon™ and Surf Bio hyperconcentration technologies, aimed at expanding the applications of drug delivery technologies, enhancing patient convenience and adherence, which could provide new momentum for future market growth.
See More
Halozyme Reports Q4 2026 Earnings Miss, Stock Drops
- Disappointing Earnings: Halozyme reported a non-GAAP EPS of -$0.24 for Q4 2026, a significant drop from $1.26 in the same period last year, indicating a notable decline in profitability that could undermine investor confidence.
- 2026 EPS Guidance: The company reiterated its 2026 non-GAAP EPS guidance range of $7.75-$8.25, with a midpoint of $8.00, which is below the consensus estimate of $8.15, suggesting potential pressure on future earnings expectations.
- Revenue Outlook: Halozyme anticipates 2026 revenue between $1.71B and $1.81B, with a midpoint of $1.76B, slightly below the consensus of $1.77B, reflecting a cautious market sentiment regarding its growth potential.
- Deteriorating Cash Position: As of the end of 2025, Halozyme's cash, cash equivalents, and marketable securities totaled $145.4M, a sharp decline from $596.1M at the end of 2024, indicating challenges in cash management that may impact future investment capabilities.
See More
