Toward no patients molecule quarterly founding we're NrfX the Good X. identify, on novel morning, Ataxia a that of small everyone. the XXXX, therapies. activator thank diseases in develop for treatment of FA. or with mechanisms We has our omaveloxolone, Friedreich's I'll Since omav, and update. developing of Slide you treatment been Reata's approved life-threatening action joining scientific for for our mission for severe start or therapeutics to commercialize few today that with or us have or goal,
patients their mid-XXs neuromuscular in the from mid-XXs. become FA There wheelchairs in FA they approximately the these dependent in is are for then disorder, United on unfortunately, and their no and a typically relentlessly X,XXX pass progressive and disease debilitating patients States. affects walkers which diagnosed patients and approved away therapies
in portion omav Part years of MOXIe We September ago, trial in began initiating X eight over XXXX. of dose-ranging developing the FA the
XXXX. positive Part We Part of from one international largest from October X MOXIe X, Following Part reported the trials of the in X, study in encouraging initiated completed we MOXIe FA. data results
of FDA with with quarter the We pre-NDA the series initiated in leading XXXX. to the a a FDA third interactions meeting of
in and rolling granted completed quarter filing NDA of accepted our NDA FDA this for submission year, our May first of review XXXX, we the and designation. the the During priority
earnings year, mid-cycle the submitted last the FDA our in analysis this FDA call, reported their completed quarter a we to and data response comments. of the third in to additional As in communication meeting and with we
FDA that our to submissions NDA major and The PDUFA extended is to User for or a now XX, Prescription a were data by Drug full the Act these of determined three Fee amendment review provide XXXX. analyses. the and date time new PDUFA The February date months
late-cycle FDA for completed identified the meeting does division's the meeting Next the to a is for the final the slide. The of any NDA. regulatory We decision late-cycle the substantive discuss with review. of the recently objectives meeting The address issues remainder for purpose FDA. not the in
during FDA agenda and data in and we While the from the the NDA formal received stated submissions. not have preliminary continue FDA, included they review our late-cycle to four meeting, that the in minutes the analyses recent
reiterated stated to did risk reviews request requested that issues FDA confirmed identified. no and meeting. they be were requests analyses data been data may The hold information an or The additional no not The to that that FDA that but advisory as are any additional FDA plan management do currently stated related committee outstanding have ongoing. not
pregnancy anticipate that outcomes. a post-marketing trial modulators, CYPXAX interaction approved, indicated are FDA to the evaluation that commitments, of they respect and and With is During QT requiring trial requirements if meeting, the and drug-drug Omav a requirements label stated review ongoing. an post-marketing thorough FDA with
later this we or the in filing the it and Marketing our planned Europe the post-marketing Application amendments NDA to other FDA with may proceeds that and have the during review, commitments stated year. that label the original Authorization that requirements meeting, in noted of to updated be we connection MAA in included
submit committed label and in to comments XXXX. proposed updated be will language the NDA. communicated We FDA early that The to requirements post-marketing the label indicated
making slide. of from our a authorization programs. for received on progress preparation commitment our input pediatric nonclinical time. pediatric investigation Next to the committee the also protocol EMA feedback scientific We plan in positive our follow-up omav the assistance We're advice a marketing opinion and protocol in application Europe. We've received with regarding on for CMC seek additional
there The to EMA impediments MAA feedback no indicated submission. were our planned that
after the completed received nearing completion nonclinical application pre-submission study studies, meeting including our may year. and the approval. of also be end the agreement certain of before MAA. plan recently this to that carcinogenicity submitted submit We data two-year are We We
slide. Next
program our disease. in kidney chronic to with Turning bardoxolone
We FALCON is form a continue hereditary affects ADPKD estimated women cause States. of and population and Disease, both groups. inheritable III with kidney rare all with to an diagnosed Kidney is ADPKD. racial men XXX,XXX patients in Dominant failure leading ADPKD of ethnic of patients in enroll United the the of patients Phase progressive trial that or CKD in Autosomal and our Polycystic ongoing
FDA more in endpoint is that confirmed by The acute eGFR planned which time. reasonable FALCON discontinuation effects on largely pharmacodynamic week suggests weeks trial. the to at should XXX, is XXX the baseline that bardoxolone's that than has be since week eGFR primary change We currently data XXX drug of resolved from the patients after the enrolled eight available
in Bard-treated kidney this eGFR or provide progression in patients delay of the it diabetic than is Phase positive, end-stage If Kyowa a XX% could clinical III greater decline in large our AYAME do, kidney patients observed trial Kirin, of The improvements strategic to disease. in or results time are is evidence with equal failure. that to Japan, fact, in trial sponsoring onset primary disease. trial, kidney to Finally, eGFR collaborator in clinical the endpoint
Dawn top like half four that to over data omav. line guidance and the study call trial. recent of this all an to would has the CKD trial who X,XXX complete Bir the with data three the Colin preparation in Kyowa over then years that, provide FA. diabetic on the of turn will patients efficacy expects data for to in the will in key enrolled over last our AYAME for stage Meyer, and and of Kirin an The collected of second patients in visit with first be overview will three year being provided activities progress available our for XXXX. provide commercial now I With update omav clinical half
And finally, financials Soni update and an on provide our Manmeet will operations.
