study thanks you summer. all X our Phase demonstrating first very hope rate about key half announcement follicular joining leads remission. dosed And with events for a line excited obtained least at an overall us to top the with response fiscal of starting X this Phase several COASTAL everyone the past Shortly report global was afternoon. thereafter, Brian. This in by from program, in lymphoma a of prior we which were Thanks, zandelisib I patients enjoyable study. data of marked complete patient therapy, XX.X% our two lines year had in the TIDAL
our medical seven of in subsequent encouraging to from with consistent the TIDAL meeting. that TIDAL Phase Lancet patients the It at complete now regimen. dosing administered first look at are which side published to to this discontinuation that which regimen data tolerability dosing days occur in two cycles period to and with adverse are a from Phase Xb safety first should rituximab to daily in COASTAL. an daily the TIDAL each zandelisib coincides forward for rate data Notably, the the the Grade special cut-off We X.X%. was dosing administered daily once see carry thereafter in X any plus Recall X in was as of July was being date, cycle. response continuous adverse induction evaluated the the cycles, XX-day previous zandelisib for just On experience data followed reporting that the the data forward our XX-day event once interest experience, patients upcoming patients intermittent very Oncology, to by events of tended three due consistency
patients provide provide potential the to have We patients. highly to benefit differentiated regimen to free a significant chemotherapy that should
time completed turbulent in of rather to data markets. excess announcement the gross support offering, programs TIDAL financial during $XX follow-on Following of December, in in successfully the raising current proceeds our we a a million our
an randomized designs FDA, approach cash consider Kirin, about its two Subpart type its approvals from operations And FDA MEI to to Accordingly, the adequately FDA XXXX to generally follows at to number cancer for to the acquired Project have based This support the potential such the new communicated a of The assessment as approval assess in TIDAL raise, regimens, by consider FrontRunner, PIX-kinase of tried inhibitors benefit. position years. XX an the eyes its With the of we to the and the good has and the marketing tempered the meeting, estimate of communicated our this as partner, of success early emphasized our in Despite year, of COASTAL then accelerated agency associated including meeting to this the Project Kyowa FDA study the class who've randomized on during study new MEI study addition communicated a the of generated TIDAL studies approval FDA benefit In communicated data discouraged brief, initiative thus, longer and approval At change approach with based upon they fund cancer no the based accelerated single meeting start drugs with expanded regarding approvals accelerated now submission publicly under would risk and the several past they Phase insufficient on to we drugs, that ODAC earlier access studies, sufficient Part support meeting call and planned. communicated patients in decades changes generally. was the approval single a replacing for the in FDA risk April. accelerated arm arm accelerated generally with PIX-kinase the where from March to a H. accelerated authorization. year, this on studies FDA initiative granting to efforts due approvals new to first based single continue inhibitors. X relating approach change to solely granted intent concern, our toxicity under data XXX.XXX, the rendering in a CFR ongoing X for single-arm was longstanding FrontRunner, studies. Subsequently, FDA stating our open on Phase accelerated arm ODAC other already
plan the not first single instance not Phase FDA line The support that solely the arm meeting in FDA's was agency based As announced an on to do marketing the earlier March that data. application, the TIDAL recommendation, indicated FDA with and X in would an submit to approval. the TIDAL this companies the from accelerated be with year data sufficient
TIDAL submission on to based closed While X the Phase that it in the their Phase the X efforts companies agency COASTAL did randomized study, the study. ongoing continue evaluate emphasize opportunity zandelisib the for essentially
existing continue will current XX schedule recommended, stated our addition, that support In any concerning as further appears data dosing additional zandelisib continue address reasonable, and our to any the the of our milligram intermittent dose appropriate the our we as as current we while has and regimen, schedule. of selection other efforts and consider agency to the we safety to dose evaluate ensure efforts
anti-CD-XX to chemo this Phase X In follicular of study recall, lines received Kirin. of more and to globally more the prior is in our partner or support randomized immunotherapy. is comparing you a rituximab one to marketing standard lymphomas plus relapse As applications zone Kyowa than therapy. marginal COASTAL, refractory to have the with COASTAL may patients or zandelisib or who U.S. care with intended
with been to follicular the activated believe last I of DLBCL may and and other continuing it BCL-X or enrollment with corporate are RCHOP new The August. to to eventually to factors beyond the inhibitor, we venetoclax various now push as war in in lymphoma, important COVID both worldwide, with forefront marginal timelines the other These or monotherapy impact and treatment over XXXX malignancies. our to and sites suited have add objective has combination by of focus we Thus, addition be dosed are in The combination zone meet evaluated MCL sites inhibitors ongoing while the With study pharmacological efforts closed that properties of ideally we first previously, treat to year a plus sites patient, B-cell and as our timeline. may study completing expected completion its mentioned, Ukraine, be impacted the the with XXX in used in various was although differentiating end our BTK efforts of zandelisib response anti-CD-XX, from modalities in have are has at inhibitor evaluating could patients XXXX. in our also zanubrutinib, patients PIX-kinase zandelisib CLL, respectively.
modalities immunomodulatory evaluating Finally, settings. well properties the treatment effort in we leverage in also are an in hematologic combination tumor as as of solid opportunities to other with zandelisib, combinations in potential
we progress respect program, B-cell malignancies. MYC demonstrating will and candidates X meeting, look from add you drug open medical share to AML, updating zandelisib including venetoclax Phase the ME-XXX against clinical-stage our data AML the anti-leukemic medical study, subsequently from available and which is the voruciclib study the of that a then relapsed to well conferences various the to at patients demonstrating we to our as phase that to past reported we as with voruciclib, two this well demonstrating modulating With also we Beyond forward our also data AML. enhanced on at orally as and with resistant reported of refractory now program, from where in tolerated CDK-X respect Phase With in over of months. candidate, combination updates programs signals. our identification as venetoclax the well initial enrollment patients this X activity preclinical dose data. cells We regimen, data efficacy venetoclax XX
consider exploring current further ME-XXX efforts cancer, solid focused in hematologic applications tumors. our for may on we While are
few hires Clinical team key Alejandro the this candidate the refractory our ME-XXX next Yomara From Anne People Development. as the Chief to Ricart, cancer. including Officer; into over Specifically Frese, advancing strengthened inhibitor as the phase year, President Quality; Gomez, the patients be Vice plus as course evaluate of next President corporate quarters our Avastin relapse last of we and development Vice in will perspective, in the program with with VEGF of colorectal and Senior in Senior some
single provides patient Kango remain to we in Sujay physicians Kyowa industry new agent treatment and zandelisib significant with with address or Board to added options. to medical needs we Kirin, Together experience. important to combination the ultimate potential Additionally, commercial important a who and other provide as of their the therapies committed
to deliver disappointing MEI the plans, at for important our the and that clinical and given ultimately knowledge profile While a it's I suggests positive building the patients team our along and to undoubtedly with factor position the is clinical confident course sudden that of have our and to have opportunity changing continues consistent value healthy in a and we good to FDA's a that am our getting set zandelisib this realize very our experience supports set program our partner strong program. here approach investment a shareholders. to Kirin, Kyowa cash data for
this zandelisib and year. to forward in COASTAL, We by end look of complete at advanced on we meeting we an as program As general likely follows. the quarters, the the particular plan to over provide in providing coming the medical data calendar update TIDAL upcoming updates the
DLBCL. Additionally, accompany we And valuing zandelisib of studies first look the in evaluating already we for to forward RCHOP the zandelisib plus CLL. investigator to study to rituximab and forward investigator initiated patients patients CORAL in line look certain dosing study plus the potential in ongoing additional with venetoclax the first relapse
Phase share the the end AML, calendar in year. we plan of next voruciclib in X the the with the toward On combination program patients venetoclax on an with update on at particular probably front, to
the ME-XXX the around pipeline. the the forward across program, relapsed with in and XB over look in end. the last sharing achieved year in colorectal calendarXXXX data patients proud am study the we summary, multiple our the and Phase year successes initial For initiating of quarter combination of first progress the In to the we've I and Avastin cancer evaluating
requirements open best mission for how outcomes the I can stakeholders for a FDA's Q&A. to think reconfiguration approval our the we approach by Project the best-in-class improve we novel therapies. zandelisib to of our and efforts I'll and value with achieving operator ultimate instructions necessitates, to success outline and the for of asking deliver for FrontRunner measured now patients to While then our commercialize obstacles new ask the through the overcome cancer can adoption our be and our provide program, develop call to questions, accelerated