Takeda Pharm - TAK STOCK NEWS

Takeda announced the U.S. FDA's acceptance of its Biologics License Application (BLA) resubmission for the investigational subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC). This resubmission addresses FDA feedback from a 2019 Complete Response Letter (CRL). The resubmission includes additional data on the SC administration of Entyvio, which is currently available in intravenous form. Takeda expects a decision by the end of 2023. The pivotal VISIBLE 1 trial, assessing the SC formulation, involved 216 adult patients and demonstrated a primary endpoint of clinical remission at week 52. The SC formulation aims to offer patients an alternative to IV infusion, enhancing treatment options.

Takeda has received FDA approval for HYQVIA (Immune Globulin Infusion 10% with Recombinant Human Hyaluronidase), enabling treatment of primary immunodeficiency (PI) in children aged 2 to 16. This supplement expands its market presence, as HYQVIA was initially authorized in 2014 for adults. The approval is based on a Phase 3 study demonstrating effective infection protection, showing a mean rate of acute serious bacterial infections (aSBIs) at 0.04 per year, significantly lower than the predefined target. The drug offers a less frequent treatment option (once a month) that can be administered at home after training. Takeda's commitment to plasma-derived therapies is reinforced through this expanded indication, catering to the specific needs of pediatric patients and their families.

Arrowhead Pharmaceuticals (NASDAQ: ARWR) announced the dosing of the first patient in Takeda’s Phase 3 REDWOOD study for fazirsiran (TAK-999/ARO-AAT), targeting alpha-1 antitrypsin deficiency-associated liver disease (AATD-LD). This event unlocks a $40 million milestone payment from Takeda to Arrowhead. Fazirsiran, an investigational RNA interference therapy, aims to reduce the production of the harmful Z-AAT protein. The study, involving 160 patients, evaluates the drug's efficacy and safety. Fazirsiran has previously received Breakthrough and Orphan Drug Designations from the FDA.

Takeda has announced an investment of $19.5 million in FY2022, granting funds to 21 new U.S. non-profit organizations, bringing its total CSR investment to nearly $40 million. The funds aim to improve equity in health, education, and environment in under-resourced communities. Launched in FY2021, the 'Takeda Cares' program seeks sustainable change by addressing social disparities. The newly funded organizations include food banks, health equity programs, and educational initiatives across major U.S. cities such as Greater Boston, San Diego, and Atlanta. Detailed insights are available in the recently published 'Takeda Cares for Communities Report.'

Takeda announced positive results from the Phase 4 EARNEST study of vedolizumab for chronic pouchitis in the New England Journal of Medicine. The study showed that 31% of participants receiving vedolizumab achieved remission at Week 14, compared to 10% on placebo. This superiority continued with 35% remission at Week 34 versus 18% on placebo. The study confirms vedolizumab's efficacy in treating this condition, with no new safety signals reported. The commitment to alleviating chronic inflammatory gastrointestinal conditions is underscored by Takeda's focus on advancing treatment options for affected patients.

Takeda (TSE:4502/NYSE:TAK) announced plans to propose Miki Tsusaka as a new independent external director at the 147th Ordinary Meeting of Shareholders on June 28, 2023. This follows the retirement announcement of Masato Iwasaki, who has served for nearly 40 years, significantly contributing to Takeda's transformation as a global biopharmaceutical leader. Tsusaka brings strong expertise from her role as President of Microsoft Japan and her previous experience at Boston Consulting Group. Takeda emphasizes its commitment to board diversity, aiming to strengthen governance and pursue its vision as a leading digital biopharmaceutical company.

BioLife Plasma Services, part of Takeda, has opened its 200^th plasma donation center in the U.S. with new locations in West Springfield, Massachusetts and Pearland, Texas. This expansion is crucial for addressing the increasing demand for life-saving plasma therapies for rare conditions. Each new center generates an estimated $4-5 million in local community contributions and creates around 70 jobs. BioLife emphasizes inclusivity in the donation process and operates over 50 bilingual centers across the U.S., enhancing accessibility for diverse communities.

Takeda's TAK-279, an allosteric TYK2 inhibitor, showed promising results in a Phase 2b clinical trial for moderate-to-severe plaque psoriasis, presented on March 18, 2023, at the AAD Annual Meeting. Involving 259 patients, the trial demonstrated significant efficacy with patients on TAK-279 achieving PASI 75 (44%-67%), PASI 90 (21%-46%), and PASI 100 (10%-33%) compared to placebo (6%, 0%, 0%, respectively; p<0.001). Notably, the 2mg dose did not show significant benefits. Nimbus Therapeutics highlighted the unmet need addressed by TAK-279, steering towards further development in immune-mediated diseases.

Takeda has announced promising results from its Phase 2b trial for TAK-279, a selective oral TYK2 inhibitor, showing significant effectiveness in treating moderate-to-severe plaque psoriasis. Patients receiving dosages of 5mg, 15mg, and 30mg achieved Psoriasis Area and Severity Index (PASI) scores of 75, 90, and 100, substantially higher than the placebo. A Phase 3 study is set to commence in FY2023, along with further evaluations in other immune-mediated diseases such as systemic lupus erythematosus and inflammatory bowel disease. The trial involved 259 patients, with mild to moderate adverse events noted.