joining key our Thank remarks.
This from Medical of progress you, XXXX, and including have with Founder our for for start Chief call Courtney. clinical of Gad, Business Officer, Radioimmunotherapy, our radiotherapy Financial today Officer, and portion Thomas and the Smith; Pretargeted you Bo off morning, will DANYELZA's our Commercial will me or us. and Good highlights prepared by the join technology Q&A Kruse; Chief this our platform. Rajah. Dr. following first thank and Officer, quarter reviewing Officer, Chief financial utilizing us our Chief I SADA Self-Assembly, I performance programs, Sue Vignesh our DisAssembly, clinical of morning, sales operational PRIT the
updates around provide guidance cash Next, the performance, will for resources DANYELZA our ISS Q&A. we of ongoing will financial first Bo provide our of our quarter the Vignesh global will our in Sue and then quarter. our around line then open naxitamab overview full details first trials. clinical XXXX reiterate XXXX sales provide an before
starting with key DANYELZA. with first for quarter highlights begin Let's the XXXX, of
first cancer third infants response the response, quarter or FDA from in and top centers cancer of by demonstrated XXXX, by with most we the for of XX% common high-risk $XX.X in most across a what who for product marrow in relapsed further disease Neuroblastoma refractory We partial or bone stable minor -- sales treatment DANYELZA's reminder, prior the Daniela record common XXXX. million, of a the patients sales record the U.S. the children.
In high-volume of As achieved quarter or the therapies. net penetrating U.S. achieved of up in first DANYELZA approved have vials of we demand neuroblastoma U.S. sold bone in the recorded is
worldwide to We product momentum million expect DANYELZA same continue $XX.X year, throughout in first this the positive in year.
From achieved we decrease standpoint, from of this the the period a quarter of sales X% XXXX. global net a
year of with first by in decrease projections.
We as we total momentum first continue markets confident driven remain partners net the our quarter as purchases product in the to expected, U.S. XXXX of guidance ex compared ahead markets. was internal product in quarter the our XXXX in primarily came and international our the revenue grow to our in full U.S. from While year revenue lower prior
We have this U.S. quarter new in the date, accounts first X activated to with the year. XX across added sites of
commercial U.S. of physician fantastic increasing centers, high-volume DANYELZA. been adoption Our to penetrate team doing a has job continuing of
In addition U.S. to the
and approved updates weeks launches China Our launched partner, just look forward and been footprint partnerships. the in on launched We multiple Mexico to SciClone, through quarters. providing ago. partner our in has ex coming recently by in U.S. our to continues few through a Adium DANYELZA has and been these is Brazil expand further
Our European-named with as Clinical and neuroblastoma relapsed is in patient to program we children the continuing high-risk support needs Europe. WEP with progress refractory of
Hong plan in an we approval and could potentially Argentina to additional year. BLA next receive submit in Asia, in DANYELZA addition, this Kong, for a In year,
as We relapsed Kettering's our forward expansion of particular, Phase Gap]. indication continue ISS look patients II In trials trial we to we support from its Sloan naxitamab our [Audio ongoing Memorial strategy. among see multicenter investigating to readout progress with in osteosarcoma naxitamab in
for Now PRIT is I first And our of is which lung PRIT cancer, small tumors, and clinical our the of X of dose Part of cell days intervals lutetium safety dosing. DOTA; GDX-SADA, DOTA programs. lutetium to determines B the the efficacy you our initial SADA which parts, progress finding malignant evaluates melanoma. has study see evaluating GDX-SADA in of This Phase and dose explores let can program GDX-SADA, sarcomas X including protein GDX-positive to SADA X and repeat signs safety treatment escalation, here.
Part and single-arm, and Phase I between the is and using dose dose in the tolerability. testing Part optimal clinical of the A solid Phase safety molecule its C I me payload; the shift that multicenter
in currently very are pleased Part and progressing. how is are trial We A the with
patients We have X, dosing advanced X and now through Cohort X X. and Cohorts are in
results to is are timing to that ultimate It SPECT/CT have that patients instances can XX We important of not activity date, on date a and currently adverse SADA full safety of X We to concept development the sites.
Recall in trials dosed serious demonstrated that trial still A proof and is we the the sites scans and ongoing. been profile radionuclide. The success the plan the encouraged have seen is no have experienced there remain dose-limiting tumors. by total no program. very To is of treatment-related determining the we've we have evaluation and of protein data -- far. to bind patients additional the the optimal any both trial. the trials or the have this note seen indicative these find the to Part and GDX-SADA of so investigating events.
Based adding of administer and toxicities, in not necessarily PK date, continue open We or we of believe to early what have complete,
Part at the full to A of complete of expect data by present A look this from in Cohort X I Phase a 'XX and Part year set component the XXXX. We of study to end meeting late medical forward or
CDXX the program treatment which in and first PRIT B will SADA circulating we of lymphoma in second is first be program T plan study tumors. focusing SADA to SADA, This lymphoma. Our cell our non-Hodgkin's on the
comparable first the planned our trial, a Phase Phase recruitment which here. of to you sites this X contracts. and second activate the quarter GDX-SADA on follow design see of closing Our in I I year the of patients follows expect We're track to the can to
of Meeting and Kruse. We oncology. both Society opportunity in excited and potentially our Molecular across bit, updates the incredibly of platform Annual look a which shift occur I potentially beyond clinical acknowledge on cancers indications PRIT even the the providing Annual treatment We further SNMMI to including SADA programs SADA and Meeting, progress by Imaging, want Bo the variety ASCO paradigm our PRIT a forward are of or gears at throughout to the June.
Shifting year, Medicine Nuclear moment to and a take to
a the years resignation has the ensured of Bo our CFO as Y-mAbs for tenure. throughout embarks member As leadership financial dedication CFO I you and is XX partnership. been a next journey. new March, a and soon in the likely his he's role operational strong to as of as us Y-mAbs served in best we thank position valued for supports announced that saw his He has search and in wish nearly Y-mAbs. in out on career of We want Bo's as transitions his his of him all and has to strategic he team both Bo CFO.
impact We agreement of future a not to March statements. entered our financial endeavors. this wish in did into Additionally, Officer, material separation with Lisby. our Chief Steen in year, Lisby luck we result with good Dr. separation a Scientific The agreement
focused at improve we confident Y-mAbs, Our a through team Officer the the of ongoing on on and provide demonstrates of currently quarter therapies advancement search that our to day. Sue the continued every to color one incredibly our team for our Smith over commitment members with novel platform.
I'm Chief further We and on XXXX. I'm DANYELZA in the development.
I entire to really will for Scientific place of of to every execute on mission have patient and focus sales each our global advance our as now lives strategy pass here patients new novel first is radiopharmaceutical to proud call clinical on remain our
