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President & CEO Brian Lian explained that placebo retention will be encouraged through diet and exercise counseling, regular clinician visits, and, importantly, eligibility for an open-label extension with active treatment after the trial. For the amylin program, he stated that based on internal models, their compounds are competitive on appetite and body weight reduction, and they look forward to human data.

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Brian Lian, President and CEO, acknowledged that a formal food effect study has not yet been conducted but will be, and an effect is expected. Regarding supply chain, he reported that suppliers have not raised any concerns about the availability of starting materials, suggesting supply should be adequate as they scale up.

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Guowei Fang, President of R&D, provided details on the survey, noting it was 86% community-based and geographically diverse. Alan Bash, President of CARVYKTI, stated the updated EU label is expected to drive earlier-line use and clarified that the 30-day median turnaround time is a relevant metric for physicians due to bridging therapy schedules. He did not provide a specific outpatient breakdown by disease stage but noted a correlation with earlier-line use.

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Executive Alan Bash acknowledged that Europe is still a supply-constrained environment and that the company is working to keep up with growing demand. He noted the Ghent facility is now delivering at full capacity and the Tech Lane facility will have commercial approval by the end of 2025. Executive Jessie Yeung stated that R&D spending remains disciplined and flattish, and while spending for BCMA may remain similar for now, a decline could be seen in 2027.

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CEO Ying Huang attributed the rapid approval to high-quality operations and clarified that the EMA does not regulate capacity like the FDA, so stepwise increases are not needed in Europe. He reiterated the goal of 10,000+ doses/year capacity by late 2025. SVP Steven Gavel outlined the frontline strategy, which involves expanding their commercial reach into the community setting and engaging patient advocacy groups, building on the current second-line launch model.

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CEO Liz Barrett confirmed the FDA review team remains the same as it was for JELMYTO. She also verified that the 18-month data has already been shared with the FDA and is incorporated into all discussions. Regarding marketing, she stated that while broad-based DTC is not planned initially, they will have robust patient engagement programs to ensure patients are part of the treatment discussion.

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CEO Michael Metzger acknowledged that the KMT2A market could be larger than the 2,000 patients currently estimated, though it's too early to confirm. He affirmed the expectation that post-transplant maintenance use will be reimbursed. He also confirmed the sNDA for NPM1 was submitted with the 77-patient efficacy evaluable data set presented at ASH.

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CSO Dr. Anjali Ganguli cited sorafenib and gilteritinib as precedents for securing NCCN listing based on Phase II data. President and Head of R&D Dr. Neil Gallagher stated that revumenib has been well-tolerated at both doses tested in combinations, giving them choices, and that they are currently combining it at full dose, with more data to be reported later in the year.

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CEO Michael Metzger stated there are no plans to update the KMT2A data again before approval and that the Hovan trial timeline is not yet defined. He affirmed his belief that Royalty Pharma's valuation considered all potential indications, including GVHD and IPF, leading to a deal that reflects a robust forecast.

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CEO Troy Wilson expressed confidence but noted they must wait for formal FDA notification on priority review. He added that an ODAC meeting is unlikely due to the palliative setting and the drug's strong safety profile. Executive Mollie Leoni clarified the Phase 3 trials have 'dual primary' endpoints, meaning the trial can succeed on either the accelerated approval endpoint (MRD-negative CR) or the survival-based endpoint (EFS/OS) independently.

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CEO Troy Wilson clarified that the data packages are contemporaneous and the core results will be consistent. He and CMO Dr. Mollie Leoni explained the FDA's willingness to consider the MRD endpoint is based on collaborative work with the IMPACT Consortium and is not unprecedented. Mr. Wilson noted that guidance on the EFS endpoint timing will be provided later in the year.

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CEO Dr. Troy Wilson explained the diabetes candidate will prioritize an even higher safety and tolerability profile suitable for a less sick patient population. He also highlighted ziftomenib's durable epigenetic effects as a key feature. SVP of Finance and Accounting, Tom Doyle, confirmed that the company's cash runway guidance into 2027 includes the planned early clinical work for this next-generation program.

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