Takeda Pharm Stock Price, News & Analysis

Takeda (NYSE:TAK) has received FDA 510(k) clearance for its HyHub™ and HyHub™ Duo devices, designed to simplify the administration of HYQVIA®, an immunoglobulin therapy. These innovative devices reduce the preparation steps by up to 50% for HYQVIA infusions and enable needle-free transfer from vials in home or clinical settings.

The devices, developed with patient and caregiver input, are specifically designed for patients 17 years and older using HYQVIA, which treats primary immunodeficiency (PI) and chronic inflammatory demyelinating polyneuropathy (CIDP). Takeda plans to make these devices available in the U.S. during the second half of fiscal year 2025 at no additional cost to patients. The company has also submitted a CE Mark application for European approval.

Takeda (NYSE:TAK) announced breakthrough results from two Phase 3 studies of oveporexton (TAK-861) for narcolepsy type 1 (NT1) treatment. The FirstLight and RadiantLight trials demonstrated statistically significant improvements across all primary and secondary endpoints with p-values <0.001 at all doses.

The studies showed clinically meaningful improvements in wakefulness, excessive daytime sleepiness, cataplexy, attention, and quality of life, with most participants reaching near-normal ranges. Oveporexton was generally well-tolerated, with no serious treatment-related adverse events reported. Common side effects included insomnia and urinary issues.

Takeda plans to submit regulatory applications globally in fiscal year 2025, aiming to bring this first-in-class oral orexin receptor 2 agonist to market as quickly as possible.

Takeda (NYSE:TAK) has received FDA approval for GAMMAGARD LIQUID ERC, a groundbreaking immunoglobulin therapy for primary immunodeficiency patients aged two and older. This therapy stands out as the only ready-to-use liquid immunoglobulin treatment with low IgA content (≤2 µg/mL in a 10% solution).

The company plans to begin U.S. commercialization in 2026, followed by European Union launch in 2027 under the brand name DEQSIGA®. The product offers dual administration flexibility, being suitable for both intravenous and subcutaneous use, eliminating the need for reconstitution.

In a significant portfolio shift, Takeda announced the planned discontinuation of GAMMAGARD S/D, their first-generation low IgA product, by December 2027. The company will maintain inventory until depletion or expiration, citing manufacturing process limitations in meeting future patient needs.

[ "First and only ready-to-use liquid immunoglobulin therapy with low IgA content approved by FDA", "Dual administration flexibility (intravenous or subcutaneous use)", "Eliminates need for reconstitution, reducing administration burden", "Uses state-of-the-art manufacturing process", "Maintains lowest IgA content among ready-to-use liquid immunoglobulin therapies" ]

The European Commission has approved ADCETRIS (brentuximab vedotin) in combination with ECADD chemotherapy for treating adult patients with newly diagnosed Stage IIb/III/IV Hodgkin lymphoma. The approval is based on the Phase 3 HD21 trial results, where the ADCETRIS-based combination (BrECADD) showed significantly better safety and non-inferior progression-free survival compared to the standard eBEACOPP treatment. This marks ADCETRIS's second approval for frontline Hodgkin lymphoma treatment in the EU, adding to its six previously approved indications. ADCETRIS is an antibody-drug conjugate targeting CD30, a key marker of Hodgkin lymphoma. The treatment demonstrates greater curative potential while reducing treatment-related morbidity, potentially establishing a new standard of care for advanced-stage Hodgkin lymphoma patients.

Protagonist and Takeda announced positive Phase 3 VERIFY study results for rusfertide in treating polycythemia vera (PV), to be presented at ASCO. The study met its primary endpoint with 76.9% of patients on rusfertide plus standard care achieving clinical response vs 32.9% in placebo group. Key findings include a reduction in required phlebotomies (0.5 vs 1.8 per patient) and improved hematocrit control (62.6% vs 14.4% maintaining levels below 45%). The drug showed significant improvements in patient-reported outcomes including fatigue and symptom burden. Rusfertide was well-tolerated with no serious drug-related adverse events, and has received FDA Orphan Drug and Fast Track designations. The treatment represents a potential first-in-class therapy for PV, a condition characterized by red blood cell overproduction that can lead to serious thrombotic events.

Takeda (NYSE:TAK) has opened applications for its 2026 Innovators in Science Award, a prestigious global recognition program for emerging biomedical researchers. The award focuses on three key areas: gastrointestinal and inflammatory diseases, neuroscience, and oncology. Three category winners will each receive $75,000, while one grand prize winner will receive an additional $175,000, totaling $250,000. The program includes a 12-month career development initiative administered by Nature, offering training in grant writing, research communication, and lab management. Springer Nature will independently manage the award process. Applications are open until September 16, 2025, with winners to be announced at a gala in Boston on April 9, 2026.

The New England Journal of Medicine has published Phase 2b trial results for Takeda's (TAK) oveporexton (TAK-861), an oral orexin receptor 2 agonist for narcolepsy type 1 (NT1). The trial, involving 112 adults, demonstrated significant improvements in wakefulness and reduction in symptoms across all tested doses. Key findings include:

The drug achieved its primary endpoint with substantial increases in mean sleep latency, reaching levels similar to healthy individuals. Secondary endpoints showed significant reductions in excessive daytime sleepiness and weekly cataplexy rates. Quality of life measures also showed marked improvements across multiple symptom domains.

The treatment was generally well-tolerated, with most common side effects being insomnia (43%), increased urinary urgency (30%), and frequency (29%). Notably, 95% of participants continued into the long-term extension study. Takeda expects Phase 3 trial results in 2025, positioning oveporexton as a potential first-in-class therapeutic option for NT1.

Takeda (TAK) reported strong FY2024 financial results with core revenue growth of 7.4% (AER) and 2.8% (CER), driven by Growth & Launch Products momentum. Core Operating Profit increased by 4.9% at CER, supported by efficiency program cost savings. The company's core operating profit margin improved to 25.4%, up from 24.7%. Operating cash flow surged by 47.6% to ¥1,057.2 billion, while adjusted free cash flow jumped 171.3% to ¥769.0 billion. For FY2025, Takeda forecasts broadly flat revenue and core profit, reflecting VYVANSE generic impact offset by continued efficiency savings. The company announced a dividend increase from ¥196 to ¥200 per share. Notably, Takeda's pipeline includes up to six new molecular entities in Phase 3 development, with three Phase 3 data readouts recently completed or anticipated in FY2025.