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Chairman, President & CEO Alan Auerbach stated the data would likely be a corporate update around November. He detailed that for small cell lung cancer, the bar is a Progression-Free Survival (PFS) and Overall Survival (OS) benefit comparable to a prior combination study. For breast cancer, a significant PFS benefit over endocrine therapy alone is required. Auerbach emphasized that regardless of the outcome, the company is committed to maintaining profitability and would be highly selective with any potential in-licensing, ensuring it would not jeopardize their positive net income status.

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CEO Mark Goldsmith stated that the chemotherapy dosing being studied is well within standard practice and that the 2026 data readout refers to the first analysis, which could be either an interim or final analysis as it is event-driven. He noted that the first analysis cannot be skipped and the company is optimistic about delivering a report in 2026 based on robust enrollment.

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Dr. Mark Goldsmith, CEO, directed the question on follow-up to previously released December data. Dr. Stephen Kelsey, President of R&D, explained that the non-G12C program is operationally ready, while the G12C program is gated by dose optimization of the RAS(ON) doublet for the first-line setting. Both executives clarified that achieving mature PFS data is not a gating factor, as the high response rates observed in lung cancer are considered a reasonable correlate for PFS.

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Chief Medical Officer Dr. Wei Lin indicated the goal is to include the broadest possible patient population in the adjuvant trial, potentially an 'all-comer' approach for RAS-mutant PDAC. CEO Dr. Mark Goldsmith addressed the strategic question by emphasizing the urgency to serve patients and the competitive need to 'create the bar' rather than chase others. He described the situation as an 'embarrassment of riches' that necessitates swift, real-time decision-making.

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Dr. Mark Goldsmith, Chairman and CEO, responded that while the steps to start trials are similar, practical realities like enrollment can cause timelines to diverge and are difficult to predict a year in advance. Regarding combinations, he stated the Tango collaboration is not a one-off and they expect more, but internal priorities remain combinations of RMC-6236 with other RAS(ON) inhibitors, pembrolizumab, and chemotherapy.

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COO Keith Woods noted that payers already cover two concurrent SMA therapies for some patients, setting a precedent. President of R&D Akshay Vaishnaw confirmed the new indication is the first of many, stating the company sees "enormous opportunity" for its myostatin platform and will add more indications "in quick succession."

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CEO David Hallal focused on the persistent unmet need, noting that even treated patients can experience motor function loss. COO Keith Woods added that while patient identification is an advantage, the launch dynamic will differ from prior SMA launches because patients are already on therapy and have less frequent physician visits, suggesting a steady, consistent launch.

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Executive Jay Backstrom responded that they were not surprised by the FDA's approach but noted the guidance now asks sponsors to assess lean mass loss, reinforcing the importance of their strategy. He highlighted that the FDA guidance invites discussion on body composition, which he sees as 'foreshadowing.' He reiterated that a clear path for approval would be to show additional benefit on endpoints like HbA1c or functional measures.

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CMO Dr. Sarah Gheuens noted the review is ongoing and the final label will be known at the PDUFA date, but at a minimum, the label will be updated for the thalassemia indication and dose. CFO Cecilia Jones stated that some additional growth in SG&A is expected for launch-related expenses post-approval.

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President and Head of R&D Pablo Cagnoni confirmed they 'absolutely have to have single agent activity in MF' for the CALR program. Regarding G12D, CEO Bill Meury stated the hurdle is high and the position must be defensible. Pablo Cagnoni added that their G12D inhibitor's potential for better combinability could be a key differentiator, particularly in pancreatic cancer.

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Executive Pablo Cagnoni confirmed that next steps for Klar will be discussed with the data release. Regarding povorcitinib in HS, he explained that it is difficult to prospectively identify patient responders but noted that the company has a clear view of where the drug will fit into the treatment paradigm initially.

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Pablo Cagnoni, President, Head of R&D, confirmed that antibiotic use is treated identically in Phase III as it was in Phase II, where starting systemic antibiotics for a flare is considered a non-response. Christiana Stamoulis, CFO, stated that while the global Opzelura guidance includes increased contribution from Europe (Germany, France, Italy, Spain), the company will not be providing a regional breakdown.

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An unnamed executive reiterated that the 25 mg cohort was a separate study initiated early to be ready for Phase III as soon as possible. Regarding the efficacy bar, he stated that since all trial patients are refractory to antihistamines, demonstrating efficacy over placebo combined with an expected excellent safety profile would be sufficient for INCB00262 to become a first option after antihistamines for some patients.

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Cintia Piccina explained that the 21 year-to-date apheresed patients include some who were already invoiced in March and April, with the majority to be invoiced shortly. CEO Adrian Rawcliffe declined to provide quarterly apheresis guidance but expressed strong confidence in the full-year revenue forecast of $35 million to $45 million, based on current momentum.

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CEO Adrian Rawcliffe explained that the process from initial testing to treatment could take 3-4 months, with the first significant revenues expected in 2025 as the initial 15 double-positive patients progress. He clarified that the decision to halt the uza-cel trial was based on capital allocation and portfolio prioritization, favoring the high-return sarcoma franchise and early-stage assets like PRAME and CD70, rather than being driven by specific data from the trial.

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CEO Adrian Rawcliffe deferred to Cintia Piccina, an executive leading commercial efforts. Piccina confirmed significant enthusiasm from treatment centers and awareness of patients beginning the biomarker testing process. She noted that the majority of new interest and potential referrals are coming from other sarcoma centers of excellence across the U.S.

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An executive, Rick Winningham, stated that ampreloxetine's IP resides in Ireland and its API is manufactured in Taiwan, emphasizing the company has flexibility to adapt. Chief Business Officer Rhonda Farnum addressed the YUPELRI question, highlighting the close partnership with Viatris at a local level, the sharing of best practices from successful territories, and the critical role of the transition of care voucher program in ensuring patients move smoothly to maintenance therapy.

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CMO Jared Gollob confirmed prior-treated patients could enroll if they had responded previously. CEO Nello Mainolfi expressed high confidence the two Phase IIb studies would be sufficient for broader Phase III dose selection. He stated Kymera's internal bar is to be 'dupi-like' and they do not expect a lesser effect.

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CEO Nello Mainolfi explained that the primary endpoint is STAT6 protein degradation, the most direct biomarker, noting that downstream markers like IgE and TARC are variable in healthy volunteers but should be in line with precedents. CFO Bruce Jacobs confirmed that savings from the oncology shift will be meaningfully reinvested into the immunology pipeline, maintaining the company's cash runway guidance into mid-2027.

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President and CEO Nello Mainolfi, CMO Jared Gollob, and Senior Director of Immunology Veronica Campbell all contributed. Nello Mainolfi stated that preclinically, over 80% degradation provides a best-in-class profile and that superiority is a key goal in lupus due to high unmet need. Jared Gollob added that over 90% knockdown is achievable and safe in NHP models. Veronica Campbell emphasized that they expect superior efficacy by targeting multiple disease biologies simultaneously.

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Mark Erlander, an executive at Cardiff Oncology, confirmed that CRDF-004 enrollment is on track for an initial data readout later in the year, aided by their partnership with Pfizer Ignite and a lack of competing trials. Regarding the pancreatic cancer trial, Erlander explained that onvansertib has already been successfully combined with three of the four agents in NALIRIFOX, shows good tolerability, and the remaining agent (oxaliplatin) lacks overlapping toxicities, making it a confident choice to pair with a superior efficacy regimen.

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Mark Erlander, an executive at Cardiff Oncology, clarified that the updated Q3/Q4 2024 timeline for the initial data readout is based on the actual pace of enrollment now that the trial is active, rather than site activation delays. He expressed high confidence in meeting this timeline by leveraging the resources of their partner, Pfizer Ignite. Erlander also noted that since the CRDF-004 trial is a dose confirmation study under the FDA's Project Optimus, the primary goal is to identify the optimal dose as quickly as possible to advance to a registrational trial.

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The company confirmed no inventory stocking occurred. The guidance reflects various factors including seasonality, but year-over-year growth remains substantial. To raise the peak sales forecast, the company will continue to monitor key dynamics like the broadening of patient eligibility and growth in the diagnosed population, and will update the forecast when it is meaningful to do so.

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The company clarified that the five patients not yet evaluable for efficacy are all still on study awaiting their first scan. It is too early to determine if efficacy correlates with prior PARP inhibitor use. For the MIRV combo trial, they expect to enroll up to 70 patients across high, medium, and low folate expression levels and are working with ImmunoGen to establish response benchmarks for each subgroup.

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