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OSAKA/CAMBRIDGE - Takeda (TSE:4502/NYSE:TAK), a pharmaceutical giant with a market capitalization of $46 billion and a "GOOD" financial health rating according to InvestingPro, announced Monday that the U.S. Food and Drug Administration has granted 510(k) clearance for HyHub and HyHub Duo, devices designed to simplify the administration of HYQVIA, an immunoglobulin therapy.
The devices, intended for patients 17 years and older, allow HYQVIA to be transferred from vials without using needles in home or clinical settings. According to the company, which maintains a robust gross profit margin of 65.7% and achieved 7.45% revenue growth in the last twelve months, they reduce the number of steps required to prepare infusions by up to half compared to traditional methods using a pooling bag.
HYQVIA is a combination therapy approved for primary immunodeficiency in patients two years and older and as maintenance therapy for chronic inflammatory demyelinating polyneuropathy in adults in the United States.
"We designed HyHub and HyHub Duo, Takeda’s first customized devices for use with a plasma-derived therapy, with input from patients and caregivers," said Kristina Allikmets, senior vice president and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit, in a press release statement.
The devices will be available at no additional cost to patients, with U.S. availability expected in the second half of fiscal year 2025. Takeda has also submitted a CE Mark application for the European Union market and is evaluating availability in other regions. With annual revenue exceeding $30.5 billion, Takeda appears well-positioned to support this expansion. InvestingPro analysis suggests the stock is currently trading below its Fair Value, presenting a potential opportunity for investors ahead of its upcoming earnings report on July 30.
The HyHub devices serve as docking stations for HYQVIA’s dual vial units, which include immunoglobulin and hyaluronidase components. They also reduce the ancillary supplies needed for infusion preparation and come with a carrier bag for mobility.
Jorey Berry, president and CEO of the Immune Deficiency Foundation, noted in the press release that "innovative devices that can help simplify the administration process of their immunoglobulin treatment can be especially meaningful" for those requiring lifelong treatment.
In other recent news, Takeda Pharmaceutical Company Limited has received approval from the European Commission for its therapy, ADCETRIS® (brentuximab vedotin), in combination with a chemotherapy regimen for adult patients with advanced Hodgkin lymphoma. The approval is grounded on the Phase 3 HD21 trial results, which demonstrated that the combination, known as BrECADD, is safer and as effective as the current standard of care in Europe. This development marks the second approval for an ADCETRIS-based regimen, expanding treatment options for patients with Hodgkin lymphoma. Additionally, Takeda has reported progress in its Phase 2b clinical trial for oveporexton (TAK-861), a drug aimed at treating narcolepsy type 1. The trial showed significant improvements in wakefulness and symptom reduction compared to a placebo. Oveporexton has also been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration. Takeda anticipates results from the Phase 3 trial in 2025, with hopes that oveporexton will become a first-in-class treatment option. These developments underscore Takeda’s ongoing efforts in oncology and sleep medicine innovation.
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