Daratumumab/Hyaluronidase-fihj

DARZALEX Faspro® is co-formulated with Halozyme's ENHANZE® drug delivery technology SAN DIEGO, Nov. 7, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson received U.S. Food and Drug Administration (FDA) approval of a new indication for DARZALEX Faspro® (daratumumab and hyaluronidase-fihj) co-formulated with ENHANZE®, as single agent treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). DARZALEX Faspro® is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma. "DARZALEX Faspro is the first approved treatment in the U.S. for adult patients with high risk smoldering multiple myeloma," said Dr. Helen Torley, President and CEO of Halozyme. "The approval expands the indications for DARZALEX Faspro with ENHANZE, further solidifying its role as a cornerstone therapy across all stages of multiple myeloma." Smoldering multiple myeloma (SMM) is an asymptomatic malignancy that is genomically the same as active multiple myeloma and where these abnormal cells can be detected in the bone marrow.1,2,3 In 2025, it is estimated that more than 36,000 people will be diagnosed with multiple myeloma in the U.S., and approximately 15 percent of those are classified as smoldering.4,5 An estimated 50 percent of patients diagnosed with HR-SMM are likely to progress to active disease within two years of diagnosis.5 Currently, the standard of care for HR-SMM is active monitoring to track signs of biochemical progression and/or end-organ damage. Recent evidence suggests that people at high-risk of progressing to active multiple myeloma could benefit from earlier therapeutic intervention.5 The FDA approval is based on findings from the AQUILA study (NCT03301220), which evaluated the efficacy and safety of DARZALEX Faspro® compared to active monitoring (or "Watch and Wait") in the largest Phase 3 trial in patients with HR-SMM. For more information on the study and its findings, please view Johnson & Johnson's press release issued on November 6, 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 Bui VP, Investor Relations and Corporate Communications 609-333-7668 [email protected] Sydney Charlton Teneo 917-972-8407 [email protected] 1 American Cancer Society. What is Multiple Myeloma? Accessed June 2025. Available at: 2 Oben, B, Froyen, G, Maclachlan, K.H, et al. Whole-genome sequencing reveals progressive versus stable myeloma precursor conditions as two distinct entities. Nat Commun 2021;12(1861). doi:10.1038/s41467-021-22140-0 3 Maura, F, Bergsagel PL. Targeting the Tumor and the Immune System in Smoldering Multiple Myeloma. N Engl J Med. 2025;392:1858-1860. doi: 10.1056/NEJMe2504273 4 American Cancer Society. Myeloma Cancer Statistics. Accessed June 2025. Available at: 5 M.A. Dimopoulos, et al. Phase 3 Randomized Study of Daratumumab Monotherapy Versus Active Monitoring in Patients With High-risk Smoldering Multiple Myeloma: Primary Results of the AQUILA Study. Presented at the December 2024 ASH Annual Meeting & Exposition. Abstract JJD-78127. SOURCE Halozyme Therapeutics, Inc. 21% more press release views with Request a Demo

iStock, Sundry Photography Darzalex Faspro’s approval for smoldering multiple myeloma could allow for earlier intervention and reduce the risk of progression to active disease. The FDA has signed off on Johnson & Johnson’s oncology blockbuster Darzalex Faspro for smoldering multiple myeloma, marking the first approved therapy for the indication. The approval indicates Darzalex Faspro for high-risk adult patients, who according to J&J, are more likely to progress to active disease within two years of being diagnosed. The expansion of Darzalex Faspro enables “earlier intervention and disease interception,” the pharma said on Thursday. The approval is backed by data from the Phase III AQUILA study , which enrolled nearly 400 patients and compared Darzalex Faspro intervention to active monitoring, also known as the watch and wait approach to surveillance. Results presented in December last year showed that the drug was able to significantly delay disease progression to active multiple myeloma, resulting in an overall 51% benefit versus active monitoring. This effect was more pronounced in those who were classified as high-risk, with Darzalex Faspro’s benefit reaching 64%. Treatment also improved overall survival by 48%. In May this year, the FDA’s Oncologic Drugs Advisory Committee voted 6–2 in favor of approving Darzalex Faspro for high-risk smoldering multiple myeloma. Administered under the skin, Darzalex Faspro is a monoclonal antibody designed to bind the CD38 protein, which is found on certain subsets of cells involved in the pathology of multiple myeloma. This mechanism of action allows Darzalex Faspro to block the growth of cancer cells and trigger their death. The drug is also approved for various types of multiple myeloma and light chain amyloidosis. Since first winning the FDA’s blessing in 2020, Darzalex Faspro has become one of J&J’s most valuable franchises. Last year, the product brought in more than $11.6 billion worldwide, accounting for more than half of the pharma’s cancer earnings. In the third quarter of this year, Darzalex Faspro emerged as J&J’s top-selling drug, hitting more than $3.6 billion in sales —nearly a 20% year-on-year growth. Darzalex Faspro’s label expansion on Thursday is the second bit of news for the multiple myeloma space in recent weeks. Late last month, the FDA allowed the comeback of GSK’s antibody-drug conjugate Blenrep, clearing its use for third-line multiple myeloma. That approval came despite an overwhelmingly negative adcomm vote in July. “The efficacy data were strong but the toxicity data were also very strong,” Neil Vasan, expert panelist and assistant professor at the Columbia University Medical Center, said during the committee meeting. Vasan voted against Blenrep’s approval.