joining XX for Zone Sean. the And as you, here milestones, Lymphoma today, Marginal readout, from nice at that you, of data build many year-end. first Thank UNITY-CLL TG And NDA with including fruition. around Phase thank so filing TG, hard study. we MS creation finally, which NDA toward morning. Zone filing we within important we see commercial of all work to approximately thank are MBLE and It's many heading to and our now ultimate And to And all at final NDA our prepare exciting times initiate us start you associated as months value this filing, our Jenna. Marginal by it's data see X team, years
notably, believe some we briefly we year Most this the announced accelerated anticipating registration approval, submit an are now have for end. umbralisib of major of around the our me FDA accomplishments. initiation to following with and NDA path a Let submission confirmation review meeting year's we now we that forward
feedback We US from the in cohort also Lymphoma many oral leaders as Zone have opinion present interim from positive positive in receiving key the and well ICML at opportunity results Marginal the as that to abroad. presentations ASCO
who discontinued ICML -- ICML the from prior BTK a prior XX study to from toxicity umbralisib PIXK due At of meeting, to CLO also presented intolerant in inhibitor. that we are a patients agent to is data single our at inhibitor delta say or they
patients to patients, what the were significantly delta XX% event, inability adverse only treatment. that tolerated due a was BTK for We of an deltas, below in or already other an continue to well reported umbralisib pleased on those PIXK been very discontinuing demonstrated prior patients report who PIXK is to especially has which in with
for the Additionally, study, meeting reported an on progression of survival we patients free months. estimated XX.X
relapsed recall to UNITY-CLL months for the XX free progression plus survival trial, been approximately with of have XX umbralisib YouTube of combination of ublituximab refractory in that patients those For who you may the you targeting we're CLL. following
perform So, it's single encouraging to level. that umbralisib agent see at around
overall UX CLL. rate In patients we an and with refractory in saw response CLL At with XX%. relapsed combination refractory patients, ICML we our the presented patients PD-X Richter's also from the with data And of inhibitor, transformation. relapsed
overall alone the the of for any introduction BTK to and XX% And upon PD-X rate patients amongst an CLL six to a responded prior four refractory response to inhibitor was patient of that notably, patients. triple BTK fifth UX responded refractory refractory therapy BTK
BTK refractory without patient with disease mutations Patients or BTK population. represented challenging with
So, see those working UX patients. in encouraging it to is
gives or in patients, a a aggressive including challenging particularly us to therapy, which Three refractory CLL is in further also Richter's patients treat. type CLL, our of approved. transformed UX failures, eight It nothing another Richter’s of population relapsed is trial. very again activity the confidence to in patient responded Carty the triple UNITY-CLL In disease of currently
showing three a trials, be a XX.X bit well the the of nice forms weeks, follow-up in MS two median XX of Phase of than which little data tolerability is follow-up On continued tolerated, the ultimate continue see through the to the the so longer that drug of patients of point. ublituximab just Ublituximab duration long-term to with weeks time MS, we've trial in from MSI, with presented relapsing phase
some Now, quickly from let pivotal me ongoing our provide updates trials.
Let's an start overall UNITY-NHL our single and by patients with single agent the confirmed with Lymphoma rate, the study review arm where primary treated from study, umbralisib, is Zone cohort as were independent endpoint committee. response Marginal XX for this
rate overall the that response XX% for targeted interim medical the a its three major previously first We've response to study patients of overall data presented XX% XX% oral announced meetings we enrolled, showing XX% primary rate. presentations XX on a and during all endpoint XX patients at met
initiation designation in from with drug and FDA approval received in zone we for forward confirmed the recently earlier lymphoma. breakthrough orphan submit path our Additionally, have zone accelerated rolling treatment of around margins refractory designation met or the for umbralisib alluded as anticipate submission umbralisib of therapy to FDA the year in to We on the NDA margin a with relapse and patients Most end. June, lymphoma. we
exciting and bring closer us with patients zone closer move as It we to umbralisib lymphoma. for is to marginal extremely
alone, each we to form The approved. approximately in the if in And This population. patients second estimated sizable and are our represents XX of in XXXX teams year cases awareness umbralisib, approximately currently adoption new was of building relapsing commercial broaden lymphomas with and a each largest an ensure medical with need treatment. patient year of U.S. the
update refractory a lymphocytic is randomized treatment UNITY-CLL provide both me trial, our let of study on patients chronic Next, with naive leukemia. quick to relapse UX in a which and
for this free progression to be and endpoint survival. has primary The continues trial
have said study this it's to trial, we've year next early previously, predict challenging year. into hope or results from event But timing. end driven the around As we is an to accurately this as
to successful study. review to of extremely safety remain safety extremely for needs this We optimistic the issues about study noted. been the outcome. and modification prospects is from We it date regularly trial DSMB requiring the have note no to And that this think important
concerns. encouraging part This PIXK delta's in first to are CLL us. no to approved there due in highly is safety Since currently large line
our let's MS Next, program. review
this XX-week well our final long-term trial, as extension. open trial's presented label data data follow-up now We have MS X from Phase as from
from Phase of rate well X with in weeks. Gd-enhancing tolerated. ublituximab Data X.XX, that was follow extension as was from Highlights by legends to the it final XX.X MRI. measured the as of Again, relapse set label annualized open data well continues XXX% include, show immediate as up reduction
We highly in ublituximab our a Phase belief X over and of can therapies. efficacy, are believe fully that comparable deliver to convenience program MS better the supportive safety, class Phase price comparable that best X includes anti-CD-XX profile results and our ultimate enrolled
year anticipated to in billion approved in XXXX And $X the Ublituximab second is full anti-CD-XX only revenues following launch. is and its only for MS. generate in approximately
As patients significant before, large to and we this we've value one MS. provide mentioned is which with market, believe in a can we
compounds And which mention pipeline, progress I the three expansion Phase in finally, dose development early briefly and continues X our cohorts. wanted to to now
the bispecific activity, and we anti-CD-XX this early escalation to later from more inhibitor a studies discussed our previously expansion with early CD-XX to for cohorts next have dose data identify that novel begin Dose antibody continues our year. We these present with can BTK year. hope hope
conference the session With will provide begin some to remarks. I over return operator that, turn I'd the which to concluding following and call like the Q&A
