you, Caroline. Thank
pipeline. of that milestones disease-associated inhibitor discuss first finally, business For granted and and the in my in certain investigational and I for will drug review In new acquired And development renal accepted with the quarter, activities. HIF-X with cell date. alpha PDUFA remarks today, belzutifan, oncology a recent a Hippel-Lindau carcinoma for regulatory our from I initially our we will von for Peloton key priority then updates broader FDA cover patients September the application treatment clinical
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cancer relapsed States, adult United European KEYNOTE-XXX patients for colorectal Hodgkin the results with classical KEYTRUDA new deficient the repair untreated based pediatric outside from microsatellite Commission approved refractory KEYNOTE-XXX. for and indications Now for or with and previously on instability-high the on or patients based mismatch lymphoma
from evaluating subcutaneous results point this patients earlier that indications. KEYTRUDA presented. the which monotherapy KEYNOTE-XXX, the III development disease-free we EU, interim in with These earlier we following patients an met Annual month, other Phase at regulatory Q cell metastatic for from in of Meeting, with the our This expect types KEYTRUDA in with dosing provides in across several its combination broad another patients an evaluating benefit KEYNOTE-XXX, and the a in already treatment readouts carcinoma dosing melanoma, data recently will of patients survival. primary authorities analysis, cell as this and lines X-week positive with renal announced were in proof KEYTRUDA endpoint program opinion regimens our the for at additional builds formulation it be also We upon received in tumor presented study therapy, adjuvant year of supports where Now for ASCO. X-week carcinoma. shared of a renal schedule approved AACR monotherapy And initial KEYTRUDA CHMP
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metastatic we outcome under yesterday's that We voluntarily the lung Last KEYTRUDA cancer. first-line Drugs trials. KEYTRUDA patients forward for small and review treatment third-line indication announced accelerated review. with We demonstrated the other month, look with approvals efficacy indication in withdraw the cell to and bladder of to an further Committee on for decision discussions committee the the are Advisory pleased positive Oncologic recognition also has of of with advanced cancer safety our clinical of
of a received the We third of with this anticipate we KEYNOTE-XXX. trial As complete KEYTRUDA analysis response discussions from FDA a breast interim with to for cancer forward treatment the announced, and for biologics application the letter further supplemental look patients adjuvant for XXXX, neoadjuvant on FDA. next and from quarter based in the we triple-negative the
to studies On announced hospitalized III turning II/III our the our in Ridgeback partners After focused decided to Phase phase at outpatients we on with we results interim to with Now in both along dose-finding the patients. Biotherapeutics, and populations. of of have from molnupiravir, analysis outpatient data, broader proceed pipeline. higher-risk enrollment Phase
prophylactic study We starting this will a as option postexposure be molnupiravir evaluating a year. later in
the MK-XXXX our In our we Johnson's As translocation have our in COVID-XX development continue on and made development make first-in-class the and pandemic program to for discontinue HIV, advancing nucleoside to efforts previously molnupiravir & producing plan focus to discussed, of transcriptase islatravir, we COVID-XX the at vaccine. Data potentially pharmacokinetic decision reverse meeting for good Johnson both threshold progress subdermal regimens on at supporting target month concentrations the islatravir settings. supports early provide presented the above long-acting the was X the the of the potential Of to for in and in islatravir data last inhibitor. CROI note implant year. treatment in least potential drug dosings PrEP for
have of to HIV long-acting co-develop for and treatment important our upon oral enable address regimens legacy to are pleased to our injectable we effective provide the the We islatravir with unmet build and that with Sciences collaboration innovation in and need and believe Gilead have options co-commercialize creation potential living HIV. of through lenacapavir. Both new remaining people unique properties that
for pneumococcal our VXXX, on VXXX candidates, data later is adult-focused VXXX, by track include vaccine, remains suite first pneumococcal a readout pediatric where a I/II of readout July year-end. associated of from this of also vaccine promising and approval Our a adults year. expected FDA is for filings our and potential the vaccine, which study Phase in
will upcoming potentially gefapixant, announced The a subject patients is Finally, of expected new an PXXX FDA December. This the decision be in for committee chronic meeting. application cough. refractory and inhibitor drug that advisory with unexplained accepted in application first-in-class our adult we
to science. pursue most the development We exciting continue of business areas across
on lead the we autoimmune candidate Phase of year. based Ib/II Our acquisition diseases. study meaningfully differentiated of our Pandion's initiate high Pandion to potential pipeline Therapeutics IL-X plan has candidates expands and be to targeting complements the selectivity, and this internal
the scientists continue This the is make bring life-saving progress to world. pipeline. due the vaccines within and strong to to We medicines passion to our around patients and momentum laboratories commitment research with the to
Now I will turn the call back to Peter.
