Takeda Pharm Stock Price, News & Analysis

Takeda (NYSE:TAK) presented groundbreaking Phase 3 clinical trial results for oveporexton (TAK-861), their first-in-class oral orexin receptor agonist for narcolepsy type 1 (NT1), at World Sleep 2025. The FirstLight and RadiantLight studies met all primary and secondary endpoints with statistically significant improvements (p<0.001) across all doses.

Key findings showed that oveporexton significantly improved wakefulness, with 85% of participants achieving normal sleepiness scores and over 80% reduction in cataplexy rates. The drug was generally well-tolerated with no serious treatment-related adverse events. The comprehensive program involved 273 patients across 19 countries, with over 95% of participants continuing into the long-term extension study.

Takeda plans to submit global regulatory applications starting in fiscal year 2025, potentially transforming NT1 treatment by addressing its underlying cause.

Takeda (NYSE:TAK) has received FDA approval for expanded indications of VONVENDI®, their recombinant von Willebrand factor therapy. The expansion includes routine prophylaxis for adults with Type 1 and 2 von Willebrand Disease (VWD) and on-demand and perioperative bleeding management in pediatric VWD patients.

VONVENDI is now the only recombinant VWF replacement therapy approved for both adults and children with VWD, which affects over 3 million people in the U.S. The drug demonstrates a notable half-life of 22.6 hours in adults and 14.3 hours in children, with clinical trials showing that the majority of non-surgical bleeds were treated with just one infusion.

The approval is supported by data from three clinical trials and real-world evidence, marking a significant advancement in VWD treatment standards.

Takeda (NYSE:TAK) reported Q1 FY2025 results showing revenue decline of 3.7% at constant exchange rate (CER) and 8.4% at actual exchange rates (AER), primarily due to VYVANSE® generic erosion. Core operating profit declined 11.9% at CER, while reported operating profit increased 11.0% at AER.

The company achieved significant pipeline milestones, including positive Phase 3 results for oveporexton in narcolepsy type 1, meeting all primary and secondary endpoints. Additionally, Takeda received FDA approval for GAMMAGARD® LIQUID ERC and EC approval for ADCETRIS® in new indications. Despite Q1 impacts, the company maintains its full-year FY2025 outlook announced in May.

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.