for broad setting. where the the will include of opportunity clinical the TIBSOVO our next steps and expanding outside strategy I relapsed refractory with moving AML start development to our US AML Jackie. Thanks, frontline
and XXXX. we at AML of mutant As for end Jackie mentioned, MAA or IDHX relapsed submitted TIBSOVO the application refractory
one CLARITY validated from questions review the during the on Our have and day With application quarter. Medicines we review XX been underway. for the the listed the timelines validation agency by has now process is and European second Agency the expect procedure this
addition access our to have goal is I In IDHX refractory relapsed to mutant AML ensure all TIBSOVO. patients an AML, to with
an pursuing we one So Today, other three treatments. standard into in and outline comorbidities strategy for therapy that setting the frontline factors, age, patients I will for diagnosed newly based are intensive therapy, ambitious development any segmented on categories, you. of non-eligible are AML clinical and non-intensive
today Our the the to goal receive patients is both labeled not approved therapy. setting therapy do for to first indications in and and achieve TIBSOVO intensive who be active non-intensive treatment
above At in where combination begin in encouraging X CRI is rate we CRP a a standard XX% last and with year care combination as CR, chemotherapy therapy, Let's data TIBSOVO reported demonstrated intensive IDHIFA where TIBSOVO arm. X+X known with our Phase X+X. study ASH we of the of plus from
who and non-intensive the stage expect Phase often agents patients therapy tolerate or hypomethylating minimal patients Co-operative Group's disease to CR for elimination Additionally was setting, we achieved aggressive such randomized by able in TIBSOVO. a residual CRI, run chemotherapy This also AMSG are quarter. observed the suggesting sets a to with and of responses of In CRP HOVON X durable the deep azacitidine. which the subset not initiate and this study receive as agent
the now we patients could achieving mutant TIBSOVO’s mechanism of the response revealed of with % rate a in deep longer where of CR, XX with IDH demonstrated a exploration a molecular CRI, study and we've these no preclinical the azacitidine CRP combination significant Phase detect X clone. Our rational portion
We profile the XX of the addition, remained CR, is IDH patients forward place of Munich. is months. XXth International up expected duration as Phase patients follow with consistent all safety In profiles in up to impressive at X CRP the look CRI taking of Leukemias data sharing Symposium cut-off this The on Acute month data with to longer with as or agent. azacitidine treatment and later as the of study each and on combination the on these known the
to mirrors and enroll on multitude In trial in with we AGILE therapies enrollment that and market, with believe of focus appropriate. adding we've targeting multiple of and he X will as the seen future patients expected TIBSOVO AML both new targeted agents Phase in XXXX. treatment entering on therapy actionable combining settings as non-targeted complete cancers a a experienced Our non-intensive continues myeloma. intensive the mutations other This such what azacitidine
a supporting approved and other TIBSOVO XOSPATA. with medicines Venclexta recently broad that strategy we're such, As combines such ISG
not reviewing timelines to the of newly the patients any for Phase AML on we TIBSOVO is month. process have for Finally, approval are standard expect X who eligible sNDA our clarity and treatment, diagnosed on this later the based the in FDA data more
oncology progress of FDAs Within patient to the solid this reminder, real be time our the also setting. tumor pilot would significant is new targeted made therapy As the program, this population. we've important frontline first in in be and review approved portfolio, part IDH a submission
previously and treated TIBSOVO CLARITY is X fully mutant Phase trial enrolled. now Our evaluating IDHX cholangiocarcinoma
TIBSOVO a XXXX. has the from therapy a positive to at first to this a line complete year we'll report top in NDA to supplemental by expect first the we half the be in of meeting cholangiocarcinoma year present clinical in approved end a potential trial more and half the the file the of assuming targeted the to medical second are prepared We and result. update of data study plan
study ASCO have annual June, of we approximately Data of glioma, perioperative uptake taking and drug been have tumor TIBSOVO as forward IDHX for AG-XXX molecule mutation. low reduction XX% vorasidenib, meeting and include known place this in patients indication, to which the also levels of the of in we on the in presentation Turning brain will tissue. as in at data vorasidenib where announced that January in 'window' the relative go grade Chicago submitted an selected from XHG
and chemotherapy in glioma As to vorasidenib wait suitable watch a need radiation a grade utilize reminder, the for to approach. are who for our patients two delay goal treatment is and
the We effects include are and pivotal driven tumor survival design the will event growth such working as with imaging. progression regulators in on which using process on volumetric free trial endpoints of
advanced alignment, by of this to the field. move potential that Assuming get is disease and approved end program the our we in now to this has genetic the activator, most initiate I'll mitapivat, PKR be medicine plan trial our year. first to rare our we
PKR is potential the have XXXX benefit. opportunity of to our in patients mitapivat activator broadly goal the who to Our to expand
ACTIVATE-T patients Our lifelong approved in transfusions significant disease receive who year. initiated complete initial focus end the burden a mitapivat in with by anemia is and thalassemia year. of ACTIVATE in mitapivat has studies deficiency, do pivotal on transfuse regular adults this achieve to no pyruvate of half and in of to in not The hope characterized we proof-of-concept which and track kinase treatment this options. with been second currently and enrollment indication by December study of the the regularly patients are We the in
patient population. deficiency We PK an be advancing XX this of in an mitapivat appropriate of pediatric also next generation in January, the which preclinical with range working strategy important and PKR also In plan with in development design is development through IND of to to PKR we'll regulators we this activator mutations. to molecule clinical anticipate a the unveiled currently next for development goal wider a addressing months. pursue XX submitting We
clinical advancing addition two AG-XXX, we're stage development our inhibitor oncology In inhibitor. for programs, stage untapped AG-XXX, programs, tumors DHODH our of our MATXA to and later early deleted
For AG-XXX trial quarter. we multiple study end the and forward the AG-XXX phase basket to expansion the agent single year select of the types. One and will expansion phase across dose by last a selective in of study initiated we trial dose second tumor a Phase the at go escalation begin arm the X expect the of dose
focus In X may Deletion. on Phase the XXXX, AG-XXX of suggest the our with half to XX AG-XXX assess Xrd will the strategies the annual translational Research combination arm the an clinically XXXX program for tumor. with from solid for of Association presentation a efficacy This in actionable first data the some of of expansion finding second AG-XXX oral will clinical Cancer further been dose other data ongoing enhance we solid combination through at expect taking which study. American tumors accepted of the meeting from has care that the present in Preclinical portion standard March April The Atlanta. in MTAP place presentation escalation
first Turning We the to the IND the turn at to FDA Steve. end the to over With AG-XXX, our XXXX half the the I'll to are on Phase during of year. DHODH of development enter X call and in submitted that, track inhibitor. lymphoma
