to Quarter and Call. Second Thomas, you, again Thank XXXX Y-mAbs welcome Therapeutics Earnings
We are morning very pleased that you with to spend have chosen this us.
we COVID-XX to continue on closely the saying me Let of business. impact monitor our by start that
number have activities. to measures the disruption We of steps potential employees, safety to supply and and our also mitigate of trials planning implemented to our continue and our of chain a protect while taking health commercial clinical
data the on ongoing While changed we have have critical our seen business patient enrollment, guidance trial our XXXX and date, we patients trials. for are site of cancer continuity anticipated of pleased we need and not our ability in with to some clinical clinical support near-term readouts. impact To key the initiation our
keep as will you updated We appropriate forward. going
we second lead omburtamab, to continued and work product market. advance candidates, quarter, that During to two naxitamab the towards ensure hard the have our
will BLA year. is to as relapsed/refractory of able we confident year, now in at you XXX for BLA safety we suitable November a this called bone XX-XXX, we year. data which and on is naxitamab, will results The in to we bone the this completed based agency For high-risk pivotal The plan. a and that neuroblastoma And present studies naxitamab patients March still have BLA expect submission dialogues and the stick later venue treatment with efficacy from recall, marrow. with and this of PDUFA for are the be of this had the XX received to and number date the
year of survival the the to in we two aiming ones that the for progression-free in a from post-marketing are terms In addition filing. XXX, Study were the planned commitments, and for patients
refractory for trials trials Barcelona naxitamab, neuroblastoma In as addition and in patients. BLA the at ongoing neuroblastoma first-line we MSK for chemo-combination to well have for as
we XXXX, and of frontline treatments. chemo-combination remainder multicenter both the with in II naxitamab expect trial Phase for international an to initiate During
later This had February of metastases with our our treatment February than we're rolling after BLA had neuroblastoma. the in before to We our started our for this second activities. lead the have pre-BLA we COVID-XX BLA. week the with back FDA omburtamab, the pre-BLA and We originally CNS/leptomeningeal anticipated to weeks the by BLA Now patients from completed meeting, compound. to me lead agency pleased let but and very few a June submission plans for earlier year, jump affect the initiated in confirmed is meeting the the in this the
very However, we naxitamab in-house only another BLA to months the and work we coordinate of to continue BLA, submission have keep submissions filing progress. pleased completion and four the the our after competence the to on are the of will you posted of
XX confirm commitment patients We XX% significantly three better a are post-marketing hoping reported the survival XXX a year from to survival historically. Study overall to from than be showing overall
That's later pivotal metastases CNS/leptomeningeal preliminary October. present the study from this in in from year. XXX We will data at neuroblastoma SIOP
U.S. This In a we plan our the Europe making program, in in marketing a are step forward progress good for potentially Europe the omburtamab six XXXX. months. market and in to development application the we efforts to next vital is within addition authorization to omburtamab in to submit bring
diffuse multicenter discussed, omburtamab to for for pontine as in previously II Phase developing DIPT we're known also we As DIPT, are patients I open MSK, Phase planning intrinsic a in glioma, study a at and study XXXX.
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to patients we indications very to of hope the studies, For XXX-iodine omburtamab. the with clinic these see second-generation our iodinated pleased utilize prior omburtamab treating very soon. experience the I'm entering both
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place. in largely is team commercial Our
Commercial many more of Phil our Herman, you we his and hired building know, As team Chief since. years ago, two have we ever been than Officer,
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to well commercialization and continue PDUFA later positioned With FDA late approval we to November in we year. move to the that believe naxitamab are this XXXX, date
well For XXXX. the technology omburtamab, focus pipeline, for product positioned next-in-line and believe indications bispecific we antibody FDA we by increase we and as approval our the our including of the potential plan constructs omburtamab and that to generated commercialization the the omburtamab. the and on naxitamab beginning candidates earlier-stage lutetium-label well Concurrently, SADA for in the are programs, in as
Now the let me to remarks invite Bo financials. second his on share quarter
