Welcome to our dedicated page for Takeda Pharm news (Ticker: TAK), a resource for investors and traders seeking the latest updates and insights on Takeda Pharm stock.
Takeda Pharmaceutical Company Limited reports news as a Japan-based, R&D-driven biopharmaceutical company whose American depositary shares trade under TAK. Its updates center on medicines and pipeline programs in gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines, including ENTYVIO, GAMMAGARD LIQUID ERC, HYQVIA, TAK-881, zasocitinib, rusfertide and oveporexton.
Recurring developments include pivotal clinical trial data, U.S. FDA regulatory actions involving new drug applications, prescription product availability, collaboration updates, and financial reports. Takeda also reports on launch preparation, generic competition affecting established products, operating-cost discipline, foreign-exchange effects, corporate transformation initiatives and governance matters tied to its global pharmaceutical business.
Takeda (NYSE:TAK) reported new secondary endpoint data from two pivotal Phase 3 LATITUDE PsO 3001 and 3002 studies of its oral TYK2 inhibitor zasocitinib (TAK-279) in adults with moderate-to-severe plaque psoriasis. At week 16, around 70% of patients in prior topline results achieved sPGA 0/1 and PASI 75 responses emerged by week 4 and continued to rise through week 24.
According to Takeda, the new analysis shows high, consistent skin-clearance rates at hard-to-treat, high-impact sites. For scalp psoriasis, 77% and 74% of zasocitinib-treated patients achieved ssPGA 0/1 versus 7% and 13% on placebo and 42% and 30% on apremilast. For palmoplantar disease, 71% and 69% achieved hfPGA 0/1 versus 22% and 10% on placebo and 44% and 43% on apremilast. Zasocitinib also produced statistically significant NAPSI improvements versus placebo at week 16, with responses sustained to week 24 and no new safety signals; common adverse events included upper respiratory tract infection, nasopharyngitis and acne. Takeda plans to begin New Drug Application submissions for plaque psoriasis this fiscal year and is studying zasocitinib in additional immune-mediated diseases.
Takeda (NYSE:TAK) and the Government of Indonesia announced a multi-year collaboration to strengthen Indonesia’s plasma ecosystem and expand access to plasma-derived medicinal products (PDMPs). The Ministry of Health granted Takeda a plasma fractionation license, marking a key step in building local biopharmaceutical manufacturing and health resilience.
Takeda will invest up to USD 30 million over two years to pilot plasma donation centers that could later scale into a national network, following international quality standards. In parallel, Takeda will assess the feasibility of a plasma-derived therapy manufacturing facility in Indonesia. The first plasma donation center, integrated into Takeda’s BioLife network, is expected to open in 2027, with collected plasma fractionated through Takeda’s global network while prioritizing Indonesia’s domestic PDMP needs.
Takeda (NYSE:TAK) completed its 18‑month CEO transition on June 24, 2026, appointing Julie Kim as Representative Director, President and CEO following shareholder election to the Board.
The company also refreshed its Board, Audit, Nomination and Compensation committees, maintaining a majority of external directors to support transparency and governance.
Takeda (NYSE:TAK) reported new Phase 3 data for oveporexton (TAK-861) in narcolepsy type 1 at SLEEP 2026. The oral OX2R-selective agonist improved daily functioning, cognition and nighttime sleep versus placebo, with significant Functional Impacts of Narcolepsy Instrument (FINI) gains and shifts in REM sleep patterns toward healthy controls.
Takeda (NYSE:TAK) reported positive topline Phase 3 results for once-daily oral zasocitinib (TAK-279) in moderate-to-severe plaque psoriasis. In the LATITUDE Atlas head-to-head study, zasocitinib showed statistical superiority to deucravacitinib on PASI 100 at week 16 and all key secondary endpoints.
More than 35% of zasocitinib-treated patients achieved PASI 100 at week 16, over 2.5 times the deucravacitinib response rate. Safety was generally consistent with prior studies, with no new safety signals. Takeda plans to present full data and is on track to submit a New Drug Application for plaque psoriasis starting this fiscal year.
Takeda (NYSE:TAK) announced that the U.S. FDA has accepted for review a supplemental Biologics License Application for intravenous ENTYVIO (vedolizumab) to treat moderately to severely active pediatric ulcerative colitis and Crohn's disease in patients aged 2 years and older.
The FDA set a PDUFA goal date in Q1 2027. The filing is supported by two Phase 3 pediatric trials (KEPLER in UC and WEBB in Crohn's). A parallel marketing authorization application has been submitted to the European Medicines Agency, with additional global filings planned.
Summary not available.
Takeda (NYSE:TAK) reported positive topline results from the pivotal Phase 2/3 TAK-881-3001 trial in primary immunodeficiency disease (PID).
The study met its primary endpoint showing PK comparability to HYQVIA with a geometric mean ratio of 99.67% (90% CI: 95.10%–104.46%) for AUC0-tau,ss. TAK-881 maintained protective IgG levels, showed comparable infection rates and safety, and delivered required doses at about half the infusion volume with shorter infusion duration. Takeda plans regulatory submissions in fiscal year 2026 and will continue safety evaluation in an ongoing extension study.
Takeda (NYSE:TAK) reported Phase 3 results showing once-daily oral zasocitinib (TAK-279) produced rapid, durable skin clearance in moderate-to-severe plaque psoriasis. At week 16, sPGA 0/1 rates were 71.4% and 69.2% versus placebo (10.7% and 12.6%) and apremilast (32.1% and 29.7%).
PASI90 rates reached 61.3% and 51.9% at week 16; PASI100 reached 33.4% and 25.2%. Responses increased through week 24, and >90% of responders at week 40 maintained response at week 60. Safety was consistent with Phase 2b; no new safety signals. Takeda plans NDA submissions beginning fiscal 2026.
Takeda (NYSE:TAK) and Protagonist announced the FDA accepted the NDA for rusfertide and granted Priority Review with a PDUFA target action date in the third quarter of this calendar year. Rusfertide is a first-in-class hepcidin mimetic for adults with polycythemia vera.
The NDA was based on Phase 3 VERIFY primary and 52-week results plus four-year Phase 2 REVIVE/THRIVE data showing improved hematocrit control, reduced phlebotomy needs, higher clinical response rates versus standard of care, and generally tolerable safety.