The U.S. Food and Drug Administration approved the combination of TECVAYLI® (teclistamab‑cqyv) with DARZALEX FASPRO® (daratumumab and hyaluronidase‑fihj) for adults with relapsed or refractory multiple myeloma on March 05 2026, following an announcement on March 06 2026.
The approval was based on Phase 3 MajesTEC‑3 data, which showed an 83 % reduction in the risk of disease progression or death compared with standard regimens and a three‑year progression‑free survival rate of 83 %.
Halozyme Therapeutics’ ENHANZE® platform, which enables subcutaneous delivery of DARZALEX FASPRO®, is now validated in a new indication. The company reported record total revenue of $1.397 billion in 2025, a 38 % year‑over‑year increase, and royalty revenue of $868 million, a 52 % rise. For Q4 2025, total revenue was $451.8 million and royalties were $258 million. Halozyme reiterated its 2026 guidance, projecting total revenue of $1.71 billion to $1.81 billion and royalty revenue of $1.13 billion to $1.17 billion.
"The newly approved TECVAYLI plus DARZALEX FASPRO treatment regimen, in which both drugs are administered subcutaneously, offers patients with relapsed or refractory multiple myeloma a new, effective treatment option that can be administered across all treatment settings. DARZALEX FASPRO, incorporating the ENHANZE technology, continues to set new standards in multiple myeloma treatment and outcomes," said Dr. Helen Torley, President and CEO of Halozyme.
"2025 was a pivotal year for Halozyme as we delivered record total revenue of $1.4 billion, which was the result of continued growth in our ENHANZE business. In addition, we expanded our drug delivery technology portfolio with two acquisitions," added Dr. Torley.
The approval expands the addressable market for ENHANZE‑enabled products, strengthens Halozyme’s royalty revenue stream, and reinforces the company’s strategy of positioning its technology as a key enabler for subcutaneous delivery across multiple therapeutic areas.
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