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CCO Christopher Sarchi projected a broad and rapid adoption, initially focused on ~350 key hospital accounts. CEO Sushil Patel added that while FDA approval is sufficient, they will submit the IGNYTE publication to NCCN to solidify RP1's position. Sarchi also detailed a proactive strategy for immediate submission to drug compendia to ensure rapid integration into electronic medical record (EMR) systems upon launch.

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Richard Miller, an executive, explained that the Phase II design is not finalized but will include at least two active dose groups, with 200mg BID being one. He mentioned that doses up to 600mg BID were tested in lymphoma trials without reaching a maximum tolerated dose, providing a safety cushion. Regarding partnerships, Miller stated that while Corvus is engaged in discussions, the company is not dependent on a partner and will 'blast ahead' on its own, using the recent warrant exercise proceeds to fund the extension cohort and advance into Phase II.

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Executive Richard Miller stated that 28-day data will be reported in December, with full follow-up for the first cohort. He anticipates efficacy may improve with higher doses, drawing parallels to lymphoma studies, but emphasized the trial's goal is to determine the optimal dose for atopic dermatitis, which may not require the same target saturation as lymphoma.

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President and CEO Dr. Paul Bolno benchmarked success against GLP-1 therapies, which show around 4% weight loss at 3 months and 7% at 6 months. However, he emphasized a key differentiator: up to 40% of GLP-1-induced weight loss is muscle mass. Dr. Bolno stated that a 'grand slam' for WVE-007 would be achieving a similar magnitude of total weight loss that is composed entirely of fat, preserving muscle, which would align with their preclinical findings and represent a healthier weight loss profile.

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President and CEO Paul Bolno explained that the goal for WVE-006 is to restore patients to a heterozygous phenotype, which is known from human data to be protective for lung and liver function. He emphasized that tracking M-protein is the best way to measure this correction. Regarding the DMD program, he confirmed the upcoming update will provide details on the next steps for the program, including accelerated registration and study design.

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CEO John Jacobs stated that Novavax has not publicly detailed the post-marketing commitment but sees a clear path to approval and does not anticipate an impact on the upcoming season's strain selection. Head of R&D Dr. Ruxandra Draghia-Akli clarified the mid-year CIC data is a non-pivotal study focused on generating immunogenicity and safety data to inform the design of a future registrational trial with a partner.

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President and CEO John Jacobs affirmed the strength of the Sanofi partnership and the vaccine's position as a differentiated option. Ruxandra Draghia-Akli, Head of R&D, explained that the upcoming Phase III cohort data will provide additional immunogenicity and safety results, which would be attractive to a potential partner for optimizing future trial design.

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Chief Medical Officer Dr. Robert Walker stated that while the trial will start 'as soon as possible,' a specific date is not yet set, pending logistical planning. He confirmed the serious adverse event was deemed unrelated to the vaccine, so no significant new safety protocols are expected. CEO John Jacobs reiterated that they expect to start in the 'near-term.' President and COO John Trizzino noted that current market share is approximately 3%, and Dr. Walker later clarified that IQVIA data shows about 500,000 doses administered.

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Krish Krishnan, Chairman and CEO, stated that while current compliance is high, it is expected to normalize towards 50% long-term as the patient mix evolves. Jennifer McDonough, SVP of Patient Access, confirmed patients are successfully pausing and restarting therapy based on individual needs. Regarding the EU, Krish Krishnan noted the German launch is set for Q3, and while patient identification is easier, the launch trajectory will become clearer after the first quarter.

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CEO Michael Weiss stated that the company is leaning toward including two dosing regimens, every other month and quarterly, in the pivotal trial. He indicated that PK data would likely be presented later in the year, as the company continues to collect more data leading into the trial.

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CEO Michael Weiss described non-MS indications as a lower near-term priority, with more clarity expected in 2025 as the company evaluates options. For azer-cel, he hopes to start the Phase 1 study by late 2024 or early 2025, but cautioned that any data updates would likely not occur until the second half of 2025 due to the anticipated slow enrollment of such trials.

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CEO Troy Wilson confirmed the data cut-off for the ASCO abstract and presentation is identical. He explained that an approval in the relapsed/refractory setting should not negatively affect frontline trial enrollment, as it is a distinct patient population for which no menin inhibitor is approved.

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CEO Dr. Troy Wilson stated that pivotal combination studies for 7+3 and ven/aza are planned to start by mid-2025, following engagement with health authorities early in the year. For the monotherapy, he reiterated that top-line results are expected in early 2025, with an NDA submission a few months later, targeting a potential approval in the second half of 2025.

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President and COO Michael Benkowitz reiterated expectations for continued double-digit revenue growth from the existing portfolio. He emphasized that significant growth opportunities remain, as only about 40% of PAH patients are on a prostacyclin. He also highlighted the potential of the TETON data to open the large IPF market and continued expansion in PH-ILD as key future growth drivers.

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Michael Benkowitz, President and Chief Operating Officer, reiterated the company's expectation for continued double-digit revenue growth into the mid-decade. He noted that this outlook for the foundational business remains unchanged despite recent contracting efforts and anticipates a significant growth inflection upon potential approvals for ralinepag and Tyvaso in IPF.

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Executive Michael Benkowitz expressed continued confidence in Remodulin's durability, stating it remains a go-to drug for PAH. He acknowledged that while less invasive options are tried first, PAH is a progressive disease, and most patients will eventually need parental therapy. He anticipates continued strong performance, though some variability may occur as the 'expedite' protocol with Orenitram gains traction.

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Chief Commercial Officer Ross Moat confirmed that first-recurrence patients constitute about 15% of users, showing physicians are using the label's full breadth. Chief Financial Officer Mark Ragosa clarified that Q4 2024 R&D was elevated by a one-time charge and that the Q1 2025 level is a more representative baseline, noting future spending will be variable due to upcoming clinical trials.

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Chief Commercial Officer Ross Moat explained that while the primary focus remains on the larger market of patients with two or more recurrences, the 15% of prescriptions from the first-recurrence segment is encouraging and reflects growing awareness of the drug's broad label. Regarding growth, he highlighted the strong 8.5% sequential growth in Q3 and the resulting guidance increase, but did not provide a specific forward-looking growth rate, emphasizing the large opportunity still ahead.

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Brian Lian, President and CEO, stated that full details of the Phase III trials will be released upon initiation but confirmed they will adhere to regulatory guidance, including a total of at least 4,500 participants across two studies. For the amylin program, he mentioned that extensive work has led to a promising weekly, long-acting candidate that they hope to advance into the clinic by year-end.

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Brian Lian, an executive, confirmed that dosing up to 100mg was completed but deferred sharing detailed results until the upcoming ObesityWeek poster presentation. On manufacturing, he assured that Viking has sufficient supply for current development plans and is actively working with global suppliers to secure long-term agreements for a potential blockbuster-scale launch.

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CEO Grant Pickering and EVP & COO Jim Wassil clarified that the data readout timing is standard for antibody response accumulation and that significant safety data will be available. They confirmed using a 15-percentage-point differential for non-inferiority in the smaller Phase II study is a standard predictor for meeting the 10-point hurdle in Phase III. Pickering added that while the primary series focuses on seroconversion, the provided IgG antibody comparisons will offer a strong indication of performance for the booster dose, where they expect to show higher immune responses.

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Interim CEO Neal Walker confirmed the hypothesis of a synergistic effect, which the proof-of-concept study aims to validate with pharmacodynamic markers. Chief Scientific Officer Joseph Monahan added that preclinical models showed ATI-2138 had a boosted anti-inflammatory effect compared to the more JAK3-selective ritlecitinib. Monahan explained the 10mg BID dose was chosen based on preclinical models and its ability to achieve high inhibition of both pathways, with the flexibility to dose higher. Walker noted the efficacy goal is to outperform existing JAK inhibitors.

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