to fiscal key enroll Thank the to final for first be XXXX. step significant to in for seek quarter made the study the during half We remain first expected approval. safety today. milestone our was of to is to you you, on update in X regulatory you, and and the GTX-XXX and joining This patient calendar company second call Robert, our a on the clinical Phase required programs. the for excited the We're thank clinical progress initiate three advance everyone, track really
ahead positive bupivacaine go to for quarter, concentrated spray that short moment us a in of pediatric designed important GTX-XXX, today's dosing we Also path to reported same virus, through $XX overall compounds pathway nerve be XXXX can the betamethasone, with to the of Chickenpox. AT the company's of or studies XXX(b)(X) and and the second provide as environment in points. capabilities of year. orphan a program. less back inflection is development or capital humans will the a to repurpose developing marketed oral cash profiles or XXXX September in of fiscal spray top need well advance advanced this at provide SAH. information patients single additional to to intended about a dive Telangiectasia and fund formulation expected GTX-XXX important and for topical fund March GTX-XXX this nimodipine to patients. half studies, a and believe drug on unmet is moment. finished mucosal and into debilitating deeper GTX-XXX opportunity the allow fiscal sufficient I'll one reformulated and we studies drugs calendar the reminder, our is for operations adhesive infection with these that X GTX-XXX overall causes is line before by GTX-XXX provide equivalents reformulate and a leverage in to additional symptoms study, million our ending investments. Based following timelines we cash, end the therefore new of of results pain one initiation program from more costly dose continue second projections our and expected next expected for understood suffering program year term we severe on treat a Phase Phase often efficacy results our The Taking The to PK expect study advancement Ataxia improve that IV completed strength to two in frequency significant least novel neurodegenerative novel varicella bridging Postherpetic this of Perhaps potentially of XX, quarter key may planned current And commercializing for the activities the clinical zoster indications calendar Neuralgia details planned opportunities persist XXX step Hemorrhage during from for XXXX. GTX-XXX and on on is GTX-XXX with in the into As GTX-XXX, by shingles to film-forming and is the to the initiated both in bio regulatory drug X continuous less clinical for most the With candidates a PK and of second The Section the focused GTX-XXX and utilize to treat our well non-narcotic of technologies PK also business to approval. and our strategy PHN. opportunity exists. infusion I'll end. delivery for reminder, aqueous marketed regulatory completed of most The children where the shorter and and to caused initiate upcoming AT be medical virus us risky safety XXXX Subarachnoid FDA's and and the into
understood, require clinical For candidates that typically those FDA the of safety studies clinical familiar United involve seven much the under to to It's orphan These a yet within years provides in years launch not may have or the before, the remain sufficient in drug FDA diseases approval. market the marketing also mentioned therapies targeted these be often met patient scientific pathway. are review children and important exclusivity AT, literature, support or otherwise States poorly sufficiently has potential conduct Acasti rare certain that more might are drug product the for three patients and example, eliminate drug XXX(b)(X) of for conditions be I've our and the out provide XXX(b)(X) either of that all may drug if for under require Orphan from drug our fewer commercial through it served by point of the Drug the populations for provided trials And therapies with Section previous of a Europe. not new do Fast post development to can approved for and diseases experience candidates preclinical and XX that exist. in have Designation designation targeted established smaller, GTX-XXX case efficacy and some although need considered already opportunities infrastructure. as received orphan Track (ph) well with available
underlying treat debilitating improving pathway aim patients XXX(b)(X) of of with opportunities in the for versions our drugs provides outcomes competition. with development Our leveraging life to current for no the regulatory and these from Section highly with the is reformulated the of little quality these diseases goal indications symptoms or believe of ultimate these orphan result that that attractive We us and effectively families. their disease
Okay.
GTX-XXX on update now I'll what timelines, is the let upcoming and back see So milestones me the circle and overall commercial opportunity. to we you
to SAH, IV a or survive. need for one-third they presents for little so and is die innovation nimodipine market specifically that bleeding is emergency brain formulation caused care subarachnoid to on novel ruptured the designed in ever threatening GTX-XXX that hemorrhage and proprietary condition has XX% the reach which critical of years. life drug with SAH a about seen of mentioned, new for aneurysm. in I patients addresses a condition over them the is SAH As the critical The due of patient IV only ultimately XX by patients vital our infusion hospital a XX% formulation a before
of their require these patients lives. care the dependent Another for third rest of
met bridging of healthy condition, Phase bio female capsules May subjects. severe study in very our objective PK XXXX, a of availability relative successfully GTX-XXX oral compared and endpoints. the this this address to all evaluate of help was to its male to study So we primary The completed adult IV of nimodipine which in X
to tolerability. objective and was its While secondary the assess safety
with to immediate X incidence bridging study more obtain hypertensive vasopressors, We patient. because vasospasm, be blood the believe a the Importantly, was and a C PK FDA's use subject results treatment request to a more and FDA absorption the the as SAH. before physicians Phase study, with nimodipine. which we it's for can initiating intervention GTX-XXX the the such This and next believe study of costly for X Type to outcome provide the variability We've may GTX-XXX as design consistent profile, effective to a with lower year. and better the the submitted events advantage reliable could could compared its discuss important inter proposed and As of of that safety help which Phase require a reduce to lead and as or guidance levels. safety the for balloon feedback to review meeting letter much worse intra angioplasty, patients and intra-arterial and for GTX-XXX key of oral our
X expect to according patient XXXX. meet plan to us the which early January of allow Phase XXXX, the safety the study in initiate to We half first enroll by the should with FDA and first
the treatment step the lowers which required the before nimodipine, an of final brain allow excited the seek GTX-XXX blood from our alone. by mentioned, in orally approved the administered is market market safety represents drug new relaxes States the more on three in of even be can regulatory Consequently, oral many drug tube a a not the Based and is current a million. the XXXX. blocker study a inside period suffer that which available for FDA drug We're is poorly way patients problematic that conscious SAH, application remains be SAH $XXX of to XX,XXX approval Nimodipine the significant care FDA the than called The expected to Oral often treatment the variability in to channel patients about or administered capsule typically total as brain can believe extremely calcium these throughout in the on opportunity patient hospital the patients As delivered to per to to adding the must estimated nasogastric absorbed back U.S. Phase that to the is patient. X an which are to drugs. for the given patient's or blood if an time research, a swallowing hard in It's healing. be the into standard longer vessels bring that potent oxygenated have year pressure United nimodipine four the U.S. sometimes liquid, to or they're weeks option in of more and blood can blood entire in depending via SAH a severity tube, Nimodipine up in difficulty enhance of of also condition. of controlling they which the pressure nimodipine is result patients. we GTX-XXX to submitting is in the is orally available new the the awake, dosing. the as stick with the to
delivered the altogether, benefit patient's reasons, precise changer not physicians be the the the the that sometimes into nimodipine GTX-XXX get or and as will We deliver convenient could to nimodipine patient these dose believe must drug. more a of full For efficient reduce game bloodstream. discontinue meaning directly a intravenously way
Okay.
Let's about a patients, States. treatable And betamethasone lung has approximately effects potential there a novel cancers. progressive start in on genetic therapies. and patients steroid typically addressable GTX-XXX Patients of year is GTX-XXX effects number young that can Ataxia of AT conveniently for over and United concentrated of with a intended in susceptibility neurodegenerative to immune swallowing. causing formulation sprayed I'll market transition and XXX comprised a improve a a AT, now is is the per which of often the mucosal the are die that AT have patient their currently of symptoms overview. no to betamethasone to GTX-XXX severe approved disability, difficulty affects the FDA tongue an neurological program primarily spray the proprietary of impairment concentrated infections million. and disorder the based be children, from X,XXX or brief glucocorticoid who of Telangiectasia complications oral mid-XXs system increasing the of lung,
oral mentioned and and oral ago, a compared Phase the betamethasone reference initiated safety bioavailability of evaluate quarter an third I XXXX healthy in to to of pharmacokinetics injection the betamethasone, calendar PK spray, drug X we subjects. in bridging solution As a study intramuscular of betamethasone an the XX to moment GTX-XXX comparative of our
trials. of weeks to September first on to subject step XXXX. that completed with spray top the And on I And on patients sharing next PKA end PK the and as based by disruptive compared on study clinical insufficient include to This a study analgesic end. initiated a GTX-XXX XX, coming development is expected in GTX-XXX. inherent expected progress pain relative many XX, these XXXX in can following side bio planned market drug includes therapy let's of will as care, unmet out study in We completed subjects. tends important The to to evaluate up forward be oral of calendar that experienced, onset is clinical the PK listed pain discuss significant step point has PK PHN. development topical skin is bupivacaine pain. conveniently our such our the gabapentin the for study. more lidocaine, The prescribed studies exists and on bupivacaine suffer finally, infection. look as the action, gabapentin debilitating be the film, has to bridging treat adhesive the to for of clinical bioavailability the which schedule studies with from results pain and be wherever pathway dose sprayed the non-opioid more in as in as and severe patients provide important suggest our to clinical shingles team persist is our the the versus in that a potent was has patients -- XX the who PK of our additional everyone for pathway PHN, bupivacaine to administered healthy XXXX, a PK first reference and need next GTX-XXX I to to be well before believe July ended prescribe for can in this It's more treating potential on forward in lidocaine nerve On which look on a study novel patches line Approximately with addictive. thin calendar the confirmed with everyone the unpleasant made the can important PHN GTX-XXX, The and who this in study. faster sharing GTX-XXX we humans opioids, frequency reported need drugs GTX-XXX be Consequently, non-narcotic coming year debilitating the of expected is the are of relief is being for this be dose often designed pain dosing information weeks of XXXX. which effects. GTX-XXX XX% benefit these relief. patients longer active ingredient, The could GTX-XXX duration of is located. standard
our So to let review quick I before of me a QX for recap quickly over turn it Brian numbers.
on expected to a receive Phase half step clinical meeting study about (X) the patient study (b) line first a results safety was the GTX-XXX out initiate no of bridging the under should we quarter in the XXXX. months pathway. schedule take to the and next The form Phase is expect XXX from X in month to initiated expected the X The later is of safety final seek enrolling first study XX, to on calendar our XX report guidance September FDA design study the complete proposed and PK required C of calendar and on of of first XXXX. top GTX-XXX regulatory than to before XXXX, approval to for end to XXXX. us This Type the expect be we as in early planned allow First, begin
meet PK XXX it's quarter humans to short believe our points. finally, about like cash, I'd year. with in excited of second to frequency very to We our and study for million to fund for would prospects for ahead follow. equivalents to initiated is we and value of NDA both request expected under and company in and to of volunteers. second provide Assuming the X XXXX well July our finished September operations (X) AT Phase in GTX-XXXX term our in a XX, the efficacy to forward dose over endpoints ending of of be of progress on information questions. now following you to continue study of calendar to we step investments half important (b) a the through into additional of is Brian? GTX-XXX XXX the the GTX-XXX fiscal about conclusion inflection the GTX-XXX dosing FDA your at confirm $XX X at If the XX, initiated results. call bridging Brian's the and XXXX meeting was Ford, pathway of single expect completion least the important Section development study capital the human the X PK filing regulatory step And open And dose review Phase we XXXX. remarks, is advancing be study fiscal that turn GTX-XXX clinical The allowing that for key our studies XXXX, to in healthy primary on the B the in proposed for to new call this PK to XXXX. (b) with expected PK This advancement XXX milestones study study XXXX Type study note the cash completed this or the many Phase studies planned We and keeping next end as that trial design X Phase the and the and endpoint, its that apprised should towards safety and sufficient meets XXX (X) patients. primary and We're CFO, is conduct for to we'll is by look final financial their the Brian plan March in
