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CEO Thomas Schuetz assured that the process performance qualification (PPQ) batches required for a BLA submission are underway and CMC should not be a limiting factor. For CTX-8371, he disclosed the responses occurred at the 0.3 mg/kg and 3.0 mg/kg dose levels but declined to release further clinical data, saving it for a scientific meeting later in the year.

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COO Matthew Ros stated that while not promoted, the company has seen utilization in the wild-type population and reimbursement has not been an issue to date. President and CEO Dan Paterson added that the VS7375 update would be of a similar magnitude to the data presented by their partner Genfleet at ASCO, and that Genfleet itself would provide two additional updates later in the year.

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Chief Medical Officer Tahamtan Ahmadi explained that RINA S's efficacy in tumors with low folate receptor alpha (FRα) expression prompted the expansion. The NSCLC study will initially target EGFR-mutated tumors, which have higher FRα expression, and is supported by encouraging signals from a small existing patient cohort.

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CMO Tahamtan Ahmadi expressed high confidence in approval, citing the breakthrough therapy designation and positive FDA engagement based on the totality of the data. Regarding competition, he stated that once Genmab's data is public, its competitive position will be clear, but declined to preview the results.

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CCO David Lin stated it's too early for paid claims data but noted UroGen provides 'white glove service' to educate offices on the manual J-code process. CEO Liz Barrett and CMO Mark Schoenberg highlighted significant commercial synergies, with the key difference being Zasturi's much larger patient population. Regarding UGN-103, Barrett explained the Utopia trial is designed to replicate ENVISION data to ensure a clean regulatory path, with plans to engage the FDA later in the year.

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CEO Mark Goldsmith confirmed that the RESOLUTE-302 trial is enrolling well, with US enrollment winding down to ensure a global geographic mix for registration, and expects a data readout in 2026. Regarding the first-line PDAC trial, President of R&D Steve Kelsey stated that while safety and tolerability are primary, supplementary efficacy data from first-line patients will be important and will be shared with the trial design later in the year.

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Dr. Wei Lin, Chief Medical Officer, responded with optimism, clarifying that the company is still in the dose optimization phase for the triplet. He stated that observed safety signals, such as rash and QTc prolongation, are consistent with the known monotherapy profiles and are not showing new or enhanced concerns. Dr. Lin assured that more definitive data would be shared before the initiation of a Phase III trial.

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CEO Dr. Mark Goldsmith confirmed that more safety and tolerability data is needed for the daraxonrasib-chemotherapy combination to select the optimal regimen before initiating the planned three-arm trial in 2025. Chief Medical Officer Dr. Wei Lin explained that zoldonrasib, targeting the G12D mutation, is being considered for a separate, stand-alone registrational path and is also being evaluated in a doublet combination with daraxonrasib.

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Dr. Mark Goldsmith, Chairman and CEO, stated that the doublet study includes patients with KRAS-G12C tumors across a mix of solid tumor types and prior treatment backgrounds, with more details to be shared with the data. Regarding the lung cancer trial, he clarified the timing adjustment to Q1 2025 was a practical decision due to the upcoming holidays, which made completing regulatory alignment and trial initiation before year-end unrealistic. He reaffirmed the company's commitment to launching the trial soon.

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CSO Angela Cacace explained that the pan-KRAS program aims for the same potency and differentiation as ARV-806. A key advantage is that as a degrader, it avoids the KRAS upregulation seen as a major resistance mechanism to clinical inhibitors. She also highlighted its potential for superior combinability with immuno-oncology agents like KEYTRUDA because it is not expected to inhibit T-cell receptor activity, a potential advantage over pan-RAF molecules.

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CEO John Houston explained the decision was driven by emerging class data suggesting ER therapies will be restricted to ESR1 mutant patients in the second-line setting, making the planned ITT trial design unsuitable. He stated a belief that vepdegestrant has a best-in-class profile for this population. For commercialization, he described a prudent, data-driven build-out for the 50-50 co-commercialization with Pfizer, with ongoing discussions about the optimal approach.

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CEO John Houston stated that the VERITAC-3 lead-in data would be shared at some point but was a lower-ranking factor in the decision to proceed with atirmociclib, which was based on the totality of evidence. He reiterated the company's policy of not answering any questions related to the VERITAC-2 trial due to the imminent data readout.

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CMO Noah Berkowitz explained that the primary goal of the healthy volunteer study is to understand the drug's PK/PD relationship and confirm CNS penetration by measuring LRRK2 in cerebrospinal fluid (CSF). He stated that success would be the validation of their preclinical modeling in humans, which would de-risk dose selection for future patient trials, but downstream disease biomarkers are not expected to change in healthy volunteers.

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President and Head of R&D Pablo Cagnoni addressed R&D strategy, highlighting an increased focus on novel biology and platforms through collaborations. He also confirmed that asthma remains an important potential indication for povorcitinib, particularly in non-type two asthma, with key data expected by year-end.

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Executive Steven Stein confirmed the HiSCR 75 trend was similar to the HiSCR 50 data. Executive Pablo Cagnoni added that while the KRAS space is competitive, Incyte is optimistic its G12D inhibitor will have a very competitive profile based on progress in both single-agent and combination studies, with data to be shared later in the year.

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Steven Stein, an executive at Incyte, responded that replicating the strong Phase II data, which included a HiSCR 100 response of up to 29%, would establish an extremely favorable and differentiated efficacy profile. He highlighted that demonstrating pain relief would further enhance its competitiveness and noted that strong enrollment in the Phase III studies reflects investigator confidence based on the Phase II results.

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Amy Peterson, EVP & CMO, emphasized that achieving a statistically significant overall survival (OS) benefit in the ITT population against an active comparator is the 'gold standard' and makes the study positive. While the NLM endpoint is still being followed, hitting the ITT endpoint is sufficient for regulatory discussions.

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EVP of Commercial P.J. Haley attributed the strong performance primarily to the base renal cell carcinoma (RCC) business, particularly the frontline CABOMETYX/nivolumab combination, supported by recent 5-year follow-up data. He confirmed there was minimal NET utilization before the late-quarter approval on March 26 and stated that while early prescriber feedback is positive, it is too soon to project the launch trajectory.

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EVP of Commercial P.J. Haley addressed the NET launch, stating the team is 'launch ready' for a market opportunity they estimate at $1 billion. He highlighted the broad applicability of the CABINET data and a significant 80% prescriber overlap with current indications, suggesting a rapid launch trajectory. He also noted a competitive advantage over existing generic therapies.

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EVP of Commercial P.J. Haley attributed the strong CABOMETYX performance to record demand and new patient starts, particularly in first-line RCC. President and CEO Michael Morrissey added that while details of the zanzalintinib RCC trials with Merck are confidential, the partnership with the maker of the only approved HIF-2 inhibitor provides significant momentum.

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Wang Lai, Global Head of R&D, highlighted that the MANGROVE trial evaluates a chemo-free regimen (zanubrutinib + rituximab) against BR, which could be a preferred option for patients. He expressed confidence in BRUKINSA's position against pirtobrutinib, noting pirtobrutinib's frontline trial comparator is not BRUKINSA. Matt Shaulis, GM of North America, added that the company expects to maintain and expand market share, believing continuous BTK therapy will remain the best option in earlier lines.

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Management expressed excitement, stating that early dose-escalation data is already showing signs of translating the drug's superior selectivity and potency into clinical benefits, including less hematological toxicity and better target inhibition. They will use incoming data to decide on initiating a pivotal trial later in the year or early next.

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Lai Wang, Global Head of R&D, highlighted that the MANGROVE trial's chemo-free regimen could be a preferred option. He and Matt Shaulis, GM of North America, expressed confidence in BRUKINSA's position, noting that pirtobrutinib's frontline trial comparator is not BRUKINSA, and they do not expect significant shifts in earlier lines of therapy.

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CEO Michael Metzger stated that anecdotal feedback suggests the vast majority of Q1 Revuforj sales were for on-label KMT2A use. Regarding the EVOLVE-2 trial, he clarified that adding complete remission (CR) as a dual primary endpoint does not impact the overall trial timeline but creates a path for potential accelerated approval. He noted positive progress on the planned studies in the fit population but did not disclose specific FDA feedback.

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CFO Keith Goldan stated that gross-to-net is "very tight" due to the limited distribution model and no foreseen need for rebates. CCO Steven Closter added that the patient assistance program use is in the low single digits. CEO Michael Metzger noted that physicians are successfully getting patients to transplant, with the expectation that many will resume Revuforj as maintenance therapy post-transplant.

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CEO Michael Metzger found the 13-month KMT2A duration encouraging but refrained from speculating on NPM1 outcomes. He highlighted the SAVE trial's combination data, with a 58% CR/CRh rate in heavily pretreated patients, as evidence of Revumenib's distinguished and well-tolerated profile, noting Syndax is furthest advanced in venetoclax/aza combinations.

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Ralph Torbay, Head of Commercial, stated that the 65% penetration reflects significant growth and that the company will continue its expansion into the community setting. Regarding treatment duration, he noted it is already trending beyond clinical trial experience, making it difficult to predict a final plateau. CEO Bahija Jallal added that this extended duration is unusual and highlights KIMMTRAK's impact.

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David Berman, Head of R&D, explained they are focusing on subsets like gene mutation-positive patients and have enriched for PRAME-positive patients in the monotherapy cohort. He noted the upcoming data set will be smaller than prior readouts. Mohammed Dar, an executive, added that combinations with docetaxel and osimertinib are planned for next year.

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David Berman, Head of R&D, described lung cancer as highly heterogeneous and noted they are exploring subsets like those with actionable gene mutations. The initial monotherapy data will be in PRAME-positive patients, but the dataset will be smaller than for melanoma or ovarian. The readout will include both monotherapy and chemotherapy combination data, with future plans for docetaxel and osimertinib combinations.

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CEO Nello Mainolfi highlighted KT-621's excellent preclinical safety profile and selectivity, noting that human genetics also support STAT6 as a clean target. He stated they do not expect safety flags. For future development, he described KT-621 as a broad 'Th2 drug' and said the company will prioritize large indications like AD, asthma, and COPD.

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President and CEO Nello Mainolfi stated that for both studies, the expectation is for KT-621 to perform like dupilumab, which showed clear effects on biomarkers and clinical scores. The key addition from Kymera will be data on the actual level of STAT6 protein degradation. Regarding dosing, he noted that preclinically, KT-621 achieves full degradation rapidly, so a loading dose is not anticipated to be necessary.

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