Latest news with #HelenTorley
Yahoo
10 hours ago
- Business
- Yahoo
Janssen's Darzalex new indication gains EC approval for SMM
The European Commission (EC) has approved the Johnson & Johnson company Janssen-Cilag International's new indication for Darzalex Faspro (daratumumab) subcutaneous (SC) formulation to treat adults with smouldering multiple myeloma (SMM) at high-risk of developing MM. Daratumumab is co-formulated with Halozyme's drug delivery technology, Enhanze. The EC approval is based on outcomes from the Phase III AQUILA study, which assessed the safety and efficacy of fixed-duration daratumumab SC administration against active monitoring in patients with high-risk SMM. The primary endpoint of the study is progression-free survival, while secondary endpoints encompass overall response rate, time to progression and overall survival. Patients included in the study had been diagnosed with SMM within the previous five years. Those with prior exposure to either approved or investigational treatments for SMM or multiple myeloma were excluded from participation. Halozyme president and CEO Dr Helen Torley stated: "This approval reinforces DARZALEX Faspro with ENHANZE as a foundational treatment across all stages of multiple myeloma. "We are pleased that the new treatment paradigm addresses the critical needs of people living with this complex blood disease." Halozyme's Enhanze drug delivery technology, featuring the enzyme rHuPH20, enables rapid SC delivery of drugs and fluids, enhancing patient experience and reducing treatment burden. It has been licensed to companies including Takeda, Roche, Pfizer, AbbVie and Acumen Pharmaceuticals. Johnson & Johnson innovative medicine multiple myeloma disease area leader and vice-president Jordan Schecter stated: 'Until now, there have been no approved treatment options for patients diagnosed with high-risk smouldering multiple myeloma. 'We can now offer physicians and patients the option to treat with daratumumab earlier, significantly delaying progression and the need for more intensive, continuous therapy, as well as extending overall survival.' "Janssen's Darzalex new indication gains EC approval for SMM" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Malaysian Reserve
a day ago
- Business
- Malaysian Reserve
European Commission Approved DARZALEX Faspro® for Adult Patients with Smouldering Multiple Myeloma
DARZALEX Faspro® is co-formulated with Halozyme's ENHANZE® drug delivery technology Approval represents critical advancement in early intervention for multiple myeloma SAN DIEGO, July 23, 2025 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Janssen-Cilag International NV, a Johnson & Johnson company, received European Commission (EC) approval of a new indication for DARZALEX Faspro® (daratumumab) co-formulated with ENHANZE®, as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma. '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. 'We are pleased that the new treatment paradigm addresses the critical needs of people living with this complex blood disease.' SMM is an asymptomatic intermediate disease state of multiple myeloma where abnormal cells can be detected in the bone marrow. The current standard of care for SMM, even in high-risk cases, is active monitoring (or 'Watch and Wait') to track for signs of biochemical progression and/or end-organ damage. This means therapeutic intervention is only offered when the disease progresses. The EC approval is supported by data from the Phase 3 AQUILA study (NCT03301220), evaluating the efficacy and safety of fixed-duration monotherapy daratumumab SC compared with active monitoring in those with high-risk SMM. For more information on the study and its findings, please view Johnson & Johnson's press release issued on July 23, 2025. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and broadening the treatment options for the indications referred to in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words 'expect,' 'believe,' 'enable,' 'may,' 'will,' 'could,' 'intends,' 'estimate,' 'anticipate,' 'plan,' 'predict,' 'probable,' 'potential,' 'possible,' 'should,' 'continue,' and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram BuiVP, Investor Relations and Corporate Communications609-333-7668tbui@ Sydney
Malaysian Reserve
01-07-2025
- Business
- Malaysian Reserve
Halozyme Therapeutics Added to Russell 1000® Index
SAN DIEGO, June 30, 2025 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that it has been added to the U.S. large-cap Russell 1000® Index, effective after market close on June 27th, as part of the 2025 FTSE Russell indexes annual reconstitution. The Russell 1000® Index includes approximately 1,000 of the largest U.S. securities based on market capitalization and is widely used by investors as a benchmark for the performance of large-cap stocks. 'Joining the Russell 1000 Index is an important milestone that reflects our leadership in rapid large-volume subcutaneous drug delivery and our track record of durable top-and-bottom line growth,' said Dr. Helen Torley, President and CEO of Halozyme. 'The inclusion will help to expand our visibility among the investment community as we continue to execute our strategy and deliver sustainable growth and profitability well into the future.' The Russell 1000® is managed by FTSE Russell, a global leader in index and analytics. Membership in the Russell 1000® Index, which remains in place for one year, is based on membership in the broad-market Russell 3000® Index. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the future execution of Halozyme's strategy and delivery of future sustainable growth and profitability, the durability of Halozyme's top and bottom line growth, the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words 'expect,' 'believe,' 'enable,' 'may,' 'will,' 'could,' 'intends,' 'estimate,' 'anticipate,' 'plan,' 'predict,' 'probable,' 'potential,' 'possible,' 'should,' 'continue,' and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results in the execution of Halozyme's strategy and unexpected future financial results and top and bottom line growth,. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram BuiVP, Investor Relations and Corporate Communications609-333-7668tbui@ Sydney
Yahoo
30-06-2025
- Business
- Yahoo
Halozyme Therapeutics Added to Russell 1000® Index
SAN DIEGO, June 30, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that it has been added to the U.S. large-cap Russell 1000® Index, effective after market close on June 27th, as part of the 2025 FTSE Russell indexes annual reconstitution. The Russell 1000® Index includes approximately 1,000 of the largest U.S. securities based on market capitalization and is widely used by investors as a benchmark for the performance of large-cap stocks. "Joining the Russell 1000 Index is an important milestone that reflects our leadership in rapid large-volume subcutaneous drug delivery and our track record of durable top-and-bottom line growth," said Dr. Helen Torley, President and CEO of Halozyme. "The inclusion will help to expand our visibility among the investment community as we continue to execute our strategy and deliver sustainable growth and profitability well into the future." The Russell 1000® is managed by FTSE Russell, a global leader in index and analytics. Membership in the Russell 1000® Index, which remains in place for one year, is based on membership in the broad-market Russell 3000® Index. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the future execution of Halozyme's strategy and delivery of future sustainable growth and profitability, the durability of Halozyme's top and bottom line growth, the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results in the execution of Halozyme's strategy and unexpected future financial results and top and bottom line growth,. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram BuiVP, Investor Relations and Corporate Communications609-333-7668tbui@ Sydney View original content to download multimedia: SOURCE Halozyme Therapeutics, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Malaysian Reserve
21-06-2025
- Business
- Malaysian Reserve
Halozyme Announces argenx Received European Commission Approval for VYVGART® Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
SC injection of VYVGART® is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional SAN DIEGO, June 20, 2025 /PRNewswire/ — Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that argenx received European Commission (EC) approval of VYVGART® 1000mg (efgartigimod alfa) developed with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins. VYVGART is the first and only targeted IgG Fc-antibody fragment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and the first novel mechanism of action for CIDP treatment in more than 30 years. 'We are pleased to announce the European Commission approval of the subcutaneous injection of VYVGART, which is co-formulated with our ENHANZE drug delivery technology for use in CIDP patients. This marks another milestone in our partnership with argenx and the expansion of access to Europe is another catalyst supporting our growth,' said Dr. Helen Torley, president and chief executive officer of Halozyme. The EC decision is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. For more information on the study and its findings, please view argenx's press release issued on June 20, 2025. The approval by the EC is valid in all 27 European Union (EU) Member States, as well as Iceland, Norway and Liechtenstein. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and broadening the treatment options for the indication referred to in this press release. Forward-looking statements may also include statements regarding potential growth catalysts and opportunities driven by the product development and commercialization efforts of Halozyme's ENHANZE® partners. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words 'expect,' 'believe,' 'enable,' 'may,' 'will,' 'could,' 'intends,' 'estimate,' 'anticipate,' 'plan,' 'predict,' 'probable,' 'potential,' 'possible,' 'should,' 'continue,' and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning unexpected results or delays in the timing of the Halozyme's expected growth catalysts or in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram BuiVP, Investor Relations and Corporate Communications609-333-7668tbui@ Sydney CharltonTeneo 917-972-8407
