Shots:
Takeda has reported topline P-III (LATITUDE Atlas) trial data assessing zasocitinib (TAK-279; 30mg, PO, QD) vs deucravacitinib (6mg, QD) in 606 adults with mod. to sev. PsO
Trial showed that zasocitinib was superior to deucravacitinib in the 1EP, with improved PASI 100 response rates at Wk. 16, plus in all key 2EPs, incl. PASI 90…
Shots:
Takeda has terminated its collaboration with Denali for the co-development & commercialization of DNL593, citing strategic considerations unrelated to safety or efficacy
Denali will regain full control of DNL593, a progranulin replacement therapy leveraging its Protein TransportVehicle platform to cross the blood-brain barrier for the treatment of frontotemporal dementia
The ongoing P-I/II study has…
Shots:
Axsome has entered into an asset purchase agreement with Takeda for TAK-063 (balipodect), with an intention to develop it for treating schizophrenia & Tourette syndrome (P-III trial-enabling activities for schizophrenia to begin in 2026)
As per the deal, Axsome gains global rights to develop, manufacture, & commercialize TAK-063, while Takeda receives an upfront payment,…
Shots:
The 2 P-III (Latitude PsO 3001 & PsO 3002) trials assessed zasocitinib in 693 & 1108 adults with mod. to sev. PsO, with plans for NDA submission to FDA & other authorities starting Takeda’s FY’26
PsO 3001 showed 71.4% achieved sPGA 0/1 vs PBO (10.7%) & apremilast (32.1%), with 39.9% reaching sPGA…
Shots:
The US FDA has accepted NDA & granted priority review to rusfertide for the treatment of adults with polycythemia vera (PV), with PDUFA action date of Q3’26
NDA was backed by the 32wk. primary analysis & 52wk. data from the global P-III (VERIFY) trial (n=293) as well as P-II (REVIVE) study & THRIVE LTE…
Shots:
Takeda reported positive data from the global P-III (KEPLER) study evaluating IV ENTYVIO (vedolizumab) in children and adolescents (ages 2–17) with moderate to severe ulcerative colitis (UC) who had inadequate response to conventional therapies and/or TNF antagonists
Nearly half (47.3%) of pts achieved the 1EP of clinical remission at Wk. 54, while 34.7% achieved…
Shots:
The US FDA has accepted NDA & granted priority review to oveporexton (TAK-861) for the treatment of NT1, with PDUFA goal date in Q3’26
NDA was supported by robust clinical data, incl. global P-III (FirstLight & RadiantLight) trials assessing oveporexton in NT1 pts
Oveporexton showed objective and patient-reported improvements in wakefulness, EDS, cataplexy, attention,…
Shots:
Iambic has partnered with Takeda in a multi-year tech & discovery collaboration to utilize Iambic’s AI drug discovery models toward advancing select high-priority small molecule programs in Takeda’s Oncology, & GI & Inflammation therapeutic areas
The collaboration will leverage Iambic’s AI drug discovery suite & wet lab capabilities, with Takeda also gaining access to…
Shots:
The US FDA has received an NDA of rusfertide (SC) for the treatment of adults with polycythemia vera (PV)
NDA was followed by 32wk. primary analysis & 52wk. data from the global P-III (VERIFY) trial (n=293) as well as P-II (REVIVE) study, where VERIFY met its 1EP & all key 2EPs, showing higher response…
Shots:
Takeda has reported data from 2 global P-III trials (NCT06088043 & NCT06108544) assessing zasocitinib (TAK-279) vs apremilast & PBO in 693 & 1108 adult pts, respectively, with mod. to sev. PsO
Trial showed superiority to PBO on co-1EPs (sPGA 0/1 & PASI 75) at Wk. 16, with early PASI 75 responses from Wk. 4, sustained…

