Thank you, to Nichol. today. And thank us you all time for making join the
to company. commercializing last XXXX, to and and our on into patients value into solid stage First, key focused progress commercial made we OLPRUVA. priorities: Acer quarter close we fourth the During by acquisition we On X announced were deliver Zevra a the call, that transforming
resubmit the to arimoclomol Second, NDA.
to advance rare into of entire happy III. that I'm executed our with the to and like and trial living take prepare all II Third, to Phase the opportunity Phase for recognize complete in diseases. people from extraordinary objectives, would to to on KPXXXX effort we team I report deliver to these idiopathic the hypersomnia
accounting. of be note a to in including important due results, will XXXX and fiscal our or our we call, strategic provide that execute Before cash will believe periods discussing on for company's ability year 'XX details on the warrant later periods to our our have to restated interim LaDuane interim no the the all statements it's priorities. on but will impact financial restatements change more the
quarter on the potential the was propelled revenue Acer of let us rare UCDs, for to a our of commercially up stage Turning becoming can cause commercial bolstering certain with or with completion OLPRUVA. fourth mission, potentially The scale. in and brain a new corporate blood, are including rare the impairments, providing acquisition, team urea assets, death. bringing acquisition harmful of talent Zevra's start damage ammonia which natural group indicated the cycle highlights, diversifying to some available cases, OLPRUVA into complementary company, genetic coma me our and fit disorders disorders, which in the and kind treatment of resulting is of build that the levels a in disease
We And with is powder, formulations is and portable personalized have half there available to and roughly associated take. for easy unmet U.S. is UCD UCDs therapies, needs U.S. most to people in it diagnosed treated. market smell UCD dosage X,XXX approximately been the that the at importantly, estimate as is it formulated in for was million of approximately are with people with We the Despite overcome for the needs patients each that $XXX and requirements, living sodium annually. it which address phenylbutyrate. The OLPRUVA persist. other well estimated of that patient's provides believe challenging suited as to these taste it's
in to mid-November, the have from that are commercial a One, people customer-facing access executing building Since and made Acer team; suffer ensuring progress have establishing completion awareness. ones. X major UCDs we two, OLPRUVA. acquisition significant who and launch priorities, is of strategy of Our on aware benefits of comprised towards of these the the
customer-facing XX have OLPRUVA. end This team the to and decades with are the needs located the January, support in country. excellence launch a built able of of experience of be across of of to As disease of most reach the our team rare to and of we was whom partners, targeted customers approximately centers
medical have to customers. advocates and engaging patient patient market addition we services specialists, sales well access professionals for marketers, with the and science key In as liaisons
We've being launch to built which will several low. initially to launch group currently are if is strategies awareness the approved. initiated that support OLPRUVA, quite build OLPRUVA, arimoclomol, utilized of of professionals While this same of
trial For excellence to drive example, brand to free to we physicians centers working allow with with OLPRUVA. advocacy Quick patient UCDs XX-day groups, gain a which patients community the of and Start, experience patient is and have We're established recognition.
meaningful We're with coverage, growth in than of the also reimbursement We've to a to at access XX% approximately which of broad acquisition now working more patients. payors was XX% seen time lives. for ensure covered market
on to covered monitoring it's net revenue. and the number provide too lives in early key today's patient launch of we're While enrollments, indicators, call, data launch including new
close the prescribers As realign both synergies strategic care within the will its approved, is of that previously centers in established proximity excellence. mentioned, us the high provides majority built. arimoclomol commercial and infrastructure patient we we with fit products for as footprint of same arimoclomol for overlap believe and scale allow the we a If work to
for arimoclomol As C candidate development is NPC. treatment or of drug a reminder, type in Niemann-Pick our the
to treatment support the market as clinical intend foundation people our our to has the as NPC. at an for of well utilize to approved, XX, new this and month, If arimoclomol resubmission NPC expanded and is reimbursement evidence FDA reaffirmed of to we from XXXX, real-world its and discussion access for establish potentially present genetic, committee adviser a aggressive September disease. intent and the rare a meeting. PDUFA decisions date neurologic fatal signed Earlier with access, treatment program data the data
need symptoms, to MPC closely and to early in leaders profile and community. accelerate which opinion diagnosis initiation. and time include and indication, all approved we're of remains work initiatives to presentation continue diagnose. and educate help identify NPC unmet key to difficult of with to this, advocates diagnosis may to supporting clinical evolution will a in time the arimoclomol's the patient drive treatment with which for awareness on diagnosis of the make efforts will psychiatric NPC treatment of and NPC, raise screening.
Together Because an significant the heterogeneous of with Therefore, working neurological the We included guidelines to newborn be these drive
petition access patient the applaud We will advocacy to submitted stakeholders positive provide all united NPC experience. services FDA and to We a that and will arimoclomol's support of a continue to an develop work with the patient in response approval. who to compelling informal community,
have received X,XXX fromo states We nearly signatures support. their XX vouching
program working As maintain continues, and our expanded this access to the as for continue arimoclomol patients Zevra will potential bring possible. tirelessly to as therapy review FDA soon
narcolepsy. turn despite need excessive KPXXXX, Now and I'd as or to developed daytime idiopathic your most sleep and to instances being average a characterized hypersomnia sleep a up for clinical uncontrollable from candidate sleepiness like of difficulty to waking IH. disorder sleep by treatment our longer rare is amounts attention or in chronic IH
symptoms. for steadily or SDX these This KPXXXX, flexible primary As to IH ingredients. you active overcome to was profile recall, dosing unique designed may serdexmethylphenidate allows [indiscernible] pharmacokinetic
concentration they as also it Drug is SDX high The a patients controlled a ensures design substance Enforcement Schedule that when need most. Administration. strength receive X designated
KPXXXX's dosing data of The of safety week, the either most concept were the we once higher our tolerability tolerated was events and and were Earlier mostly daily Phase evaluating nausea adverse pharmacokinetic adverse patients IH. we placebo mild unique severity, and that data in profile, in a insomnia, decreased line including well headache, this proof blind overall XXX reported dose announced II regimen levels common exposure in daily. top Consistent or with QX, study, the milligrams at Due the all of positive in previously study, interim evaluated appetite. anxiety, levels. from control despite events with highest dose twice double KPXXXX to KPXXXX
meaningful and primary baseline from study's data the withdrawal during was Epworth period, X-week or Scale period the These tolerability. titration those. blind EDS open-label showed for II double results Top both from sleepiness as critical safety Phase in by in daytime study which of line produced endpoint two-week Sleepiness improvement assessed the also that change KPXXXX maintained support the the excessive throughout
IH Additionally, severity inertia of study of trial benefit scale, the trial brain the patients the secondary end showed providing II clinical sleep of efficacy the withdrawal design severity and by design. of objectives administered KPXXXX KPXXXX. change the baseline a The end from request results the at the open-label and scale to seek And fulfilled a for scale. successfully potentially the plan period supportive the key on with line pivotal guidance Phase and analog for visual double efficacy at titration. of of FDA are III III Phase initiating endpoints the information to We Phase meeting an trial of end
provide summary, XXXX unmet are U.S., II symptoms IH, with X to upcoming We we're top with remains to pleased address sleep an fall. the the study the results diagnosed the our KPXXXX daytime only need present in to forward treatment And inertia, who significant different approved We therapies and sleepiness action in data FDA this can of people believe conference currently with the including a fourth in Phase the and look XX,XXX that pleased for our in dysfunction. SLEEP cognitive there benefit mechanisms excessive for with progress from quarter. IH. estimated line are With at
XXXX, and ensure enter OLPRUVA patients. successfully we First, of areas to As have access we X focus: for launch
to sleep that -- Second, launch arimoclomol. objectives. continue we positioned to KPXXXX key believe well we of prepare advance are third, to on that believe these in strategic for execute we are to the And deliver potential and disorders.
We
call Now and who on LaDuane, results I'll outlook. financial provide update the over our hand an will to
