Daratumumab/Hyaluronidase-fihj

Johnson & Johnson has announced that its Darzalex Faspro-based regimen (daratumumab and hyaluronidase, in combination with bortezomib, lenalidomide and dexamethasone (D-VRd)), has received approval from the US FDA to treat adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The approval is based on results from the phase 3 CEPHEUS study, which compared the safety and efficacy of the D-VRd regimen with bortezomib, lenalidomide and dexamethasone (VRd) alone. Almost five years later, the Darzalex Faspro-based regimen showed significantly increased rates of complete response or better at 81.2% vs 61.6% with VRd. The study showed that the safety profile of the Darzalex Faspro-based regimen was favourable, with the most common adverse events including upper respiratory tract infection, sensory neuropathy and musculoskeletal pain. Multiple myeloma is a blood cancer affecting plasma cells. It is the second most common blood cancer globally. Estimates suggest that over 36,000 people will be diagnosed with multiple myeloma in the US, with over 12,000 deaths in 2026. Multiple myeloma has an average five-year survival rate of 59.8% and is currently incurable. Darzalex Faspro received approval from the FDA in May 2020, and is already approved for eleven indications in multiple myeloma. June Lanoue, US president, haematology at Johnson & Johnson, said: “This approval marks the twelfth indication for Darzalex Faspro overall and fifth in newly diagnosed multiple myeloma, underscoring its role as foundational therapy for both newly diagnosed and relapsed/refractory patients. “CEPHEUS demonstrated the efficacy of [D-VRd] as a frontline standard of care. With this approval, patients can receive D-VRd when they are first diagnosed with multiple myeloma, an important milestone as we work to one day deliver a functional cure.”

Halozyme announced the Surf Bio acquisition Wednesday as it raised its 2026 total revenue guidance by 19% at the midpoint.\n Shortly after acquiring Elektrofi to beef up its subcutaneous drug-delivery offerings, Halozyme Therapeutics has struck another deal to purchase Surf Bio.To take over Surf, Halozyme is paying $300 million upfront, subject to customary purchase price adjustments, and up to $100 million in development and regulatory milestones.The buyout was made in late December, and Halozyme announced the deal Wednesday as it raised its 2026 total revenue guidance by 19% at the midpoint to a range between $1.71 billion to $1.81 billion. That’s compared with an estimated $1.385 billion to $1.4 billion for 2025.The increase was driven by higher expectations for royalty revenue from Johnson & Johnson’s Darzalex Faspro, Roche’s Phesgo and argenx’s Vyvgart Hytrulo, Halozyme CFO Nicole LaBrosse said on an investor call Wednesday.With intellectual property protections extending into the mid-2040s, both Elektrofi and Surf could provide long-term, durable royalty revenue opportunities, Halozyme CEO Helen Torley said on the call.“These acquisitions broaden our opportunity to collaborate exclusively and non-exclusively across a full range of leading and emerging targets and mechanisms of action,” Torley said. “We are creating the next wave of major [subcutaneous] innovation following Enhanze, which will last over a very long-term time horizon.” Surf comes with a hyperconcentration technology that allows for the delivery of formulations of monoclonal antibodies and small molecules at high concentrations of up to 500 mg/mL via auto-injector administration at home or in a doctor’s office, according to Halozyme.That draws some similarities to Elektrofi’s Hypercon technology, which also enables delivery concentrations of 400 mg/mL to 500 mg/mL.The two companies’ technologies work differently, Torley explained.Surf achieves high concentrations through a combination of the use of a novel protective excipient that enables stable, dense, low-friction particles and spray drying. It’s a “polymer technology that lowers surface tension during the processing, which results in higher protein stability,” she said.Conversely, Elektrofi’s Hypercon is a microparticle suspension technology that involves a dehydration process to deliver smooth, dense and stable protein microparticles with GRAS (generally recognized as safe) excipients.Partners could select between the two technologies “based on their formulation and their goals,” Torley said.The Elektrofi transaction has closed after passing antitrust review, and the Surf deal isn’t subject to U.S. Federal Trade Commission scrutiny because of the size of the entity, Torley said.For now, Elektrofi\'s tech is more advanced, as Halozyme expects two Hypercon-backed client products to begin phase 1 trials this year, with potential approvals in the 2030-to-2031 timeframe. The Surf technology is expected to enter the clinic by the end of 2027 or early 2028.Halozyme struck the two back-to-back acquisitions as the drug delivery specialist continues to expand the reach of its Enhanze platform of recombinant human hyaluronidase. The company just reached a collaboration with Takeda to develop a new version of the Japanese pharma’s popular inflammatory bowel disease treatment Entyvio. The Takeda pact came after Enhanze was licensed to support Merus’ EGFRxLGR5 bispecific antibody petosemtamab, the centerpiece of Genmab’s $8 billion acquisition of Merus.Halozyme expects six new Enhanze-based products will start human testing this year. During Wednesday’s call, Torley highlighted two “growth trends to watch” related to Enhanze, for which Halozyme is “very busy in conversations with potential partners.”The first is for applying Enhanze to nucleic acids to enable subcutaneous delivery while mitigating the immune reactions typically seen with under-the-skin administrations.And the second is for use with antibody-drug conjugates, where there is an interest in potentially changing the pharmacokinetic profile of a drug to improve its benefit-risk profile, Torley said.“For some disease conditions such as autoimmune, neurology, nephrology and cardiovascular diseases, patients and their physicians are seeking more rapid delivery options, including options that the patient can deliver at home,” the chief executive said. “And this is where Hypercon and the Surf Bio hyperconcentration technology come in.” To hear Torley tell it, Halozyme is not done bringing in additional technologies.“It is our goal to continue to evaluate drug delivery technology opportunities where we can leverage our strong expertise,” she said. “And we will also seek to utilize and deploy our strong cash flow to add growing revenue businesses, adding assets and companies where Halozyme can add to and accelerate the value creation.”“We project that our future acquisitions will add revenue extending into the 2040s and, importantly, could begin to add growing revenue in the nearer term,” Torley said.