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CEO Sean Nolan and President & Head of R&D Sukumar Nagendran both responded. Nolan emphasized Taysha's data-driven approach, which establishes a new paradigm by focusing on objective, functional milestone gains that impact daily living. He also highlighted the favorable safety profile attributed to CMC quality and intrathecal delivery. Nagendran added that their comprehensive natural history data clearly shows that gaining skills post-intervention is a strong signal of efficacy, underscoring their commitment to delivering a clinically meaningful and safe therapy.

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CEO Nello Mainolfi confirmed that the upcoming data release will include results for pruritus NRS, alongside EASI scores. He acknowledged that itch is a critical factor for patient quality of life and stated the data would be available for all patients enrolled in the study.

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President & CEO Jan Møller Mikkelsen explained that there is no formal medical definition to classify hypoparathyroidism by severity, making it impossible to provide such a split. He noted that the commercial strategy targeted high-volume prescribers and that international guidelines suggest approximately 95% of all patients are candidates for PTH replacement therapy, comparing the situation to insulin for type 1 diabetes.

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President and CEO Jan Mikkelsen provided a method to estimate the revenue split, suggesting ex-U.S. growth was steady at around €4-5 million sequentially. By subtracting this from the total quarterly growth, he implied the U.S. launch contributed approximately €26 million in Q1. Earlier commentary indicated the insurance approval process typically takes four to eight weeks.

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Jan Mikkelsen, President and CEO, stated that Ascendis has the complete data package required for submission to both the FDA and European agencies, with no missing data to be generated. He emphasized the strength of the data in addressing comorbidities beyond linear growth, positioning it as a comprehensive treatment for achondroplasia.

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President and CEO Jan Mikkelsen stated that SKYTROFA is realizing its best-in-class potential and performing well against competitors, including other long-acting products. He noted that even where competitors have preferred formulary positions, SKYTROFA's differentiated profile drives adoption. He also highlighted that a major supplier of daily growth hormone saw a significant revenue decline, indicating a broader market reset that benefits SKYTROFA.

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Chief Business Officer Eric Pauwels confirmed that PTC will report on prescriptions, patient start forms, and the number of commercial patients on a quarterly basis, along with color on provider and payer dynamics. He announced that PTC has already received prescriptions and patient start forms in the U.S. and has patients on commercial therapy in Europe. The initial patient types align with expectations, including those poorly controlled on or having failed existing therapies, patients seeking better control, and treatment-naive patients.

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CEO Dr. Matthew Klein stated the FDA communicated at the mid-cycle meeting that an AdCom was not needed, likely due to the agency's familiarity with the disease and endpoints. CBO Eric Pauwels added that physician feedback indicates a high unmet need, especially in pediatrics, and they expect rapid uptake due to vatiquinone's efficacy and strong safety profile.

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CEO Dr. Matthew Klein differentiated PTC518 as the only oral, highly selective therapy with full brain biodistribution. CBO Eric Pauwels described a potential U.S. Translarna launch as 'plug-and-play,' leveraging their existing DMD commercial infrastructure, Emflaza patient database, and clinical trial participants for rapid patient identification and uptake.

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EVP, Head of R&D, Elizabeth Thompson, confirmed the company still anticipates the Lewy Body study will start in Q3 2025. She expressed that existing NUPLAZID data in Lewy Body is supportive, despite small patient numbers. A positive result in the ADP study would provide further confidence by demonstrating the activity of the ACP204 molecule specifically, reinforcing the potential for success in Lewy Body Dementia.

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CEO Catherine Owen Adams explained that the European launch will be strategically phased, starting with Germany, which allows for free pricing initially. She emphasized that key learnings from the U.S. launch, especially regarding patient and family engagement on titration, will be applied. The company is building a specialized European team and developing value dossiers for country-by-country reimbursement negotiations.

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EVP of R&D Elizabeth Thompson emphasized that while hyperphagia is the primary endpoint, secondary measures like defined responder levels and caregiver assessments are important for context. Both she and CEO Catherine Owen Adams noted that the complexity of Prader-Willi syndrome allows for multiple therapeutic approaches, and Acadia is confident in its distinct mechanism of action.

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CEO Catherine Owen Adams explained that the European launch process is similar to the U.S. but can be simpler post-approval due to single-payer healthcare systems, which streamline patient access. She outlined the timeline: an MAA submission is planned for early next year, followed by an approximate one-year review, after which reimbursement negotiations will begin with national HTA bodies, starting with Germany. She expressed confidence in the team being built in Europe to manage a successful launch.

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CEO John Houston explained that the original 50/50 co-commercialization deal with Pfizer is no longer sensible for a second-line monotherapy indication alone. Arvinas is not building out a salesforce and is in active negotiations with Pfizer to either revise the deal for Pfizer to lead the launch or for Arvinas to regain the asset. If the asset is returned, Arvinas would immediately seek a new partner to commercialize it, aiming to avoid any gap between approval and launch.

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CEO John Houston highlighted a significant opportunity, noting a targeted launch to ~6,000 oncologists could be highly effective. CFO Andrew Saik confirmed a milestone is due on first approval but not its amount, and none are specific to the KAT6 combo. Houston reiterated that the first-line trial is not proceeding at this time, with funds being reallocated to other pipeline assets.

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Chief Medical Officer Noah Berkowitz suggested that an improvement in median PFS of over 5-6 months would be needed to be viewed as a substantial advance. Chief Scientific Officer Angela Cacace highlighted that their KRAS degrader is significantly more potent than competitors, binds both active and inactive KRAS states, and has a distinct mechanism that could overcome resistance, a point reinforced by Dr. Berkowitz who noted potency could be key to avoiding toxicity issues seen with other agents.

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CSO Angela Cacace estimated that about one-third of idiopathic Parkinson's patients have elevated LRRK2 and noted a partnership with the Michael J. Fox Foundation to understand how to use biomarkers for stratification. CMO Noah Berkowitz added that the current healthy volunteer study is in all-comers, and the data will inform the patient selection strategy for future trials.

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Emil Kakkis, Founder, President & CEO, responded that the treatment effect size could be consistent, with variation merely extending the time to statistical separation. He argued that any fracture reduction in the 40-60% range is a substantial benefit. He emphasized that, similar to Crysvita, the key driver for adoption will be the drug's impact on functional ability and overall patient health, not just the primary endpoint percentage.

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CEO and President Emil Kakkis clarified that the next step after the second interim is the final analysis, not a third interim. He expressed high confidence that the study would succeed at one of these two points, noting the final analysis has a much easier p-value threshold of 0.04. He identified patient variability as the main risk in rare disease trials but stated that the study's large size (159 patients) and the drug's profound effect on bone mineral density provide a strong basis for success.

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CEO Emil Kakkis expressed high confidence that the trial will succeed this year, either at the second interim analysis or the final readout. He noted the second interim has a greater chance of success than the first due to a stringent 0.01 p-value threshold and patients having at least 12 months of treatment, allowing for better separation between study groups.

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CEO Emil Kakkis clarified that missing the first interim analysis would not affect the ultimate efficacy determination, as it relates to the speed of event separation, not the drug's power. He emphasized that shortening the timeline by even a few months through an interim success has a substantial positive impact on the program's net present value (NPV), justifying the aggressive approach.

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Pravin Dugel, Executive Chairman, President & CEO, confirmed the company plans to submit its NDA after receiving positive 56-week data from the SOLAR trial. He noted that leveraging the 505(b)(2) pathway, available because the drug is already approved for other indications, could shorten the FDA review timeline by approximately two months. He added that details on the commercial strategy would be provided at the upcoming Investor Day.

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President and CEO Dr. Pravin Dugel explained that the changes create a more efficient, complementary trial program. He stated that the FDA's approval for redosing in SOL-1, combined with excellent patient retention, allowed for the streamlined design. This enhances SOL-1's ability to capture durability data at both 9 and 12 months and increases safety data. This efficiency was then applied to SOL-R, permitting a size reduction from 825 to 555 patients without compromising statistical integrity, ultimately aiming for a faster path to market with a superior label.

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President and CEO Dr. Pravin Dugel confirmed that many sites overlap by design to ensure a seamless transition and maintain recruitment momentum between the SOL-1 and SOL-R trials. He stated that there is no slowdown and that Ocular is continuing to activate new sites for the larger SOL-R study to execute as quickly as possible.

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Dr. Pravin Dugel, President and CEO, confirmed the company received written validation from the FDA that both SOL-1 and SOL-R are acceptable as registration-enabling studies. He noted that SOL-R is designed to accelerate SOL-1 recruitment, which is already in an 'exponential phase.' Regarding dosing, Dr. Dugel explained that the combined data from both trials is intended to provide physicians with the flexibility to personalize treatment, allowing for dosing as frequently as every 6 months or extending it to 9, 10, or even 12 months depending on the patient.

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David Meeker, Chairman, President & CEO, described the study as exploratory with a 'legitimate fifty-fifty' chance of success. He explained that while there is high conviction in the MC4R pathway's role, the disease is challenging. He noted the goal is to report on 10 to 20 patients by the end of the year to have a meaningful basis for assessment.

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David Meeker, Chairman, CEO, and President, explained that early in a launch, every incremental patient data point, like the upcoming 24-patient French HO data, is valuable for building confidence. Jennifer Chien, Head of North America, noted that Q1 sees the biggest seasonal impact from insurance changes, and while Q4 can have some specialty pharmacy ordering variability, significant seasonality is not expected in other quarters.

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CEO David Meeker responded that physicians are focused on having an effective therapy where none exists, not a specific weight loss percentage. CFO Hunter Smith added that the recent ATM provides flexibility, so they do not have to raise post-data, but they haven't ruled out future raises to fund pipeline success.

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Chairman, CEO and President David Meeker explained that the H1 2025 timeline is based on the last patient's 60-week follow-up and subsequent data cleanup, making it difficult to refine the guidance further publicly. He confirmed there is physician interest in combination therapies, noting that adding a GLP-1 could provide incremental benefit for patients and that anything improving patient outcomes is a positive.

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President and CEO Dr. Reshma Kewalramani confirmed the plan to launch POVY with an auto-injector. She justified prioritizing gMG due to high unmet need, POVY's mechanism targeting the underlying cause, promising class data, an efficient regulatory path, and the drug's best-in-class engineering.

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CCO Duncan McKechnie stated that JOURNAVX is being used broadly across surgical and non-surgical settings (e.g., joint replacements, ankle sprains) by a wide range of physicians. He confirmed that the company has consistently guided that prescription volume would ramp in the first half of the year, with revenue accelerating in the second half as payer coverage is secured.

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COO Stuart Arbuckle confirmed that Vertex expects patients to switch from TRIKAFTA to ALYFTREK due to its favorable profile but did not provide guidance on the rate of switching. CEO Reshma Kewalramani detailed the Type 1 Diabetes program, VX-880, noting the initial target population is about 60,000 patients and that the company aims to complete enrollment in the pivotal study this year.

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CEO Dr. Reshma Kewalramani stated there is no read-through from LSR to the DPN program, which is already in Phase III. Regarding the competitor, she was not surprised, explaining that achieving high specificity for NaV1.8 is a major challenge that Vertex has overcome with its molecule.

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President & CCO Charlie Gayer stated that with approximately 11,000 diagnosed patients, there is still significant room for growth. He noted a strong influx of 69 new prescribers in Q2. Both Gayer and CEO Jon Stonehouse asserted that patients who do well on Orlodeyo are 'extremely sticky' and unlikely to switch, as they do not see a superior profile among potential future oral therapies compared to the convenience and efficacy of once-daily Orlodeyo.

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Chief R&D Officer Dr. Helen Thackray stated that initial patient data is expected this year, noting that even a small number of patients could validate the mechanism. Positive data would involve suppressing KLK5 activity and observing subsequent skin healing. She suggested the regulatory path could be a single, short pivotal trial. CEO Jon Stonehouse added that the ultimate goal is a "functional cure," and a larger treatment effect could accelerate the development timeline.

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Chief R&D Officer Dr. Helen Thackray outlined a progressive data release for the Netherton program, starting with skin penetration, followed by markers of activity, and then longer-term skin recovery. CEO Jon Stonehouse emphasized the goal is a 'functional cure.' CFO Anthony Doyle indicated that while OpEx will increase in 2025 to support clinical trials, revenue growth will significantly outpace this spending, leading to continued margin accretion.

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Chief Strategy Officer Ryan Richardson acknowledged lower vaccination rates but emphasized the substantial high-risk population and the franchise's overall value. CFO Ramón Zapata added that combination vaccines are expected to complement, not replace, standalone COVID-19 vaccines, citing sustained demand from specific patient groups like the immunocompromised.

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Chief Strategy Officer Ryan Richardson estimated the second-line endometrial cancer market at approximately 10,000 patients in the U.S. and Europe. He clarified that BNT323 is currently manufactured in China via a CDMO, with plans to diversify the supply chain. Both Richardson and CFO Jens Holstein stated they do not anticipate a significant financial impact from currently announced tariffs but are actively monitoring the situation.

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CEO Ugur Sahin expressed confidence that BNT323's results would meet registration requirements, given its breakthrough therapy designation. CSO Ryan Richardson added that observed response rates of around 50% are significantly higher than the standard of care. The question regarding commercial launch preparations was not fully addressed.

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Chief Medical Officer Dr. Özlem Türeci stated that in 2025, the company expects to share efficacy and safety data from its single-arm trial in second-line endometrial cancer across different HER2 positivity populations. Dr. Türeci defined a positive outcome as a strong clinical activity profile and a favorable safety profile, noting the company is already seeing this across various HER2 expression levels.

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CFO Jeff Poulton confirmed the expectation for a modest and gradual reduction in net price, forecasting a mid-single-digit decline for the full year 2025 compared to 2024. CCO Tolga Tanguler added that payer dynamics are favorable, with most patients receiving first-line access and paying minimal out-of-pocket costs.

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Chief Commercial Officer Tolga Tanguler responded that the launch is seeing a "good broad uptick" from both cardiologists familiar with AMVUTTRA and those new to the drug. He highlighted that a key early success was getting AMVUTTRA onto the formulary of over half of the key health systems within just four weeks of approval, which he sees as a significant enabler for future growth.

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Chief Commercial Officer Tolga Tanguler explained that while Alnylam is excited about the launch, the formulary uptake will make it a "second half story." He noted that existing value-based agreements will be extended, but the formulary process takes time, so meaningful uptake is expected in the second half of the year.

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Chief Commercial Officer Tolga Tanguler acknowledged the question's relevance and stated that the company would provide additional color and context on launch metrics, such as script-to-dispense timelines, closer to the actual launch date.

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COO Karen Massey stated that argenx welcomes innovation as it expands the overall market. She emphasized that Vyvgart's high bar for efficacy (MSE rate), safety profile, and formulation options position it to remain the leading and fastest-growing biologic. Massey confirmed that discontinuation rates for both MG and CIDP are in line with expectations for a chronic therapy, noting that patients who achieve MSE are motivated to stay on treatment.

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Chief Operating Officer Karen Massey responded that argenx is still in the early stages of the gMG launch curve, with about 60% of new patients coming from oral therapies, indicating a move into earlier treatment lines. She confirmed that VYVGART maintains the #1 market share among biologics in gMG and that discontinuation rates have remained consistent and strong, with no significant shifts observed.

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Chief Operating Officer Karen Massey stated that she does not see significant pent-up demand, but expects the PFS to open up the prescriber and patient base, driving consistent growth rather than a large, immediate switch event. Chief Financial Officer Karl Gubitz added that pricing will be responsible and aim for broad patient access, with specific details to be provided at launch.

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COO Karen Massey stated that despite increased competition, VYVGART's market share among biologics has continued to grow quarter-over-quarter. She noted that the majority of this growth comes from VYVGART Hytrulo, with new patients switching directly from oral medications, indicating no significant negative impact from competitors due to VYVGART's strong value proposition.

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CFO Matt Abernethy explained that the guidance adjustment is driven entirely by a change in pricing assumptions, not volume. He noted that Neurocrine successfully accelerated key payer contracts from 2026 into 2025, which shifted the full-year pricing expectation from 'flattish' to a 'negative 5% price decline.' Abernethy reiterated that volume growth remains robust, with record new patient starts and total prescriptions.

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Chief Commercial Officer Eric Benevich stated that while Neurocrine does not provide exact market share data, INGREZZA continues to hold the majority of both new and total prescriptions in TD. Regarding CRENESSITY, he explained that uptake is trending towards more pediatric and adolescent patients than adults, which aligns with the company's pre-launch expectations.

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Chief Commercial Officer Eric Benevich acknowledged that Q1 is typically challenging due to prescription reauthorizations and gross-to-net pressures. Chief Financial Officer Matthew Abernethy clarified that while full-year 2025 net revenue per script is expected to be similar to 2024, there is a sequential gross-to-net headwind of about 3% from Q4 into Q1. He also noted potential for ordering pattern noise due to the calendar setup.

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CFO Matt Abernethy clarified that the guidance implies sequential growth of $10 million to $20 million, which is consistent with historical Q4 trends. He attributed the moderation to the time it takes for the new sales force expansion to become fully productive and a typical sequential increase in the gross-to-net discount in the fourth quarter.

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President and Head of R&D Pablo Cagnoni explained that the drug's mechanism is identical in both diseases, increasing the probability of success in MF. He noted the data release was shifted to later in the year to include combination data with ruxolitinib. For MF, he stated they expect to see improvements in spleen volume, symptoms, and potentially hemoglobin.

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Pablo Cagnoni, an executive at Incyte, confirmed that a substantive data update for the monoclonal antibody will be presented in 2025. The update will include dose escalation data, results in both ET and myelofibrosis, and information on clinical endpoints and variant allele fraction burden.

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Christiana Stamoulis, CFO, explained that the Opzelura guidance of $630M-$670M reflects 24-32% growth driven by demand in AD/vitiligo, the pediatric AD launch, and EU contribution, with the range accounting for variables in patient adherence. Pablo Cagnoni, President, Head of R&D, added that for povorcitinib, a competitive profile would involve replicating the overall Phase II results, including strong effects on HiSCR levels and pain, coupled with a clean safety profile.

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Steven Stein, an executive, differentiated the two by patient population: ruxolitinib cream targets the mild-to-moderate HS population (100k-150k patients) with limited abscesses and no draining tunnels, while oral povorcitinib targets the moderate-to-severe population with more extensive disease. He noted that determining tube usage and treatment duration would require data from the Phase III studies but anticipated it would likely be long-term therapy.

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Executive David Acheson stated that Apellis uses a highly accurate site-of-care dataset covering 50% of the market, contrasting it with less accurate claims data. Executive Timothy Sullivan explained that the company is holding off on guidance due to recent market dynamics, including a competitor's CRL and co-pay funding issues, as well as the upcoming EMPAVELI launch. Executive Caroline Baumal added that GA market adoption will likely be a steady growth process, similar to the early wet AMD market.

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EVP of Commercial David Acheson stated that Q1 net revenue is expected to be lower than Q4 due to temporary factors like sample usage, but noted that underlying injection demand is growing. Regarding the competitor's label, Mr. Acheson and CMO Dr. Caroline Baumal highlighted SYFOVRE's differentiated profile, including its proven efficacy with every-other-month dosing, as a key competitive advantage.

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CFO Timothy Sullivan responded that providing 2025 guidance is currently under consideration. He explained that the company wants to first observe the impact of its new commercial initiatives and allow market dynamics to settle before committing to a formal sales forecast. The immediate focus remains on solidifying SYFOVRE's market leadership.

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President and CEO Douglas Ingram responded that it was a mix of all three factors, with longer cycle times having the largest mechanical effect on the forecast. He clarified the situation is not worsening and that the company is assuming a steady state for planning purposes, though this may be conservative. He noted the Q2 softness was expected as delays from the late Q1 safety event flowed into the new quarter, but "green shoots" like new start forms are appearing.

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CEO Douglas Ingram reiterated strong confidence in the full-year guidance of $2.9 billion to $3.1 billion, with over two-thirds from ELEVIDYS. He confirmed expectations for sequential quarter-over-quarter growth throughout 2025, attributing the ramp-up pace to the natural cadence of the patient journey, which includes administrative steps, contracts, and infusion scheduling.

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President and CEO Doug Ingram confirmed that the company remains comfortable with its prior guidance, which was based on the original Q3 forecast. He also reiterated confidence in the 2025 guidance of approximately $3 billion in revenue and the long-term peak sales forecast of $5 billion or more across its four approved therapies.

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CEO Douglas Ingram responded that there is no fundamental bottleneck, explaining that the 3-to-5-month timeline is a normal process for complex gene therapies, which includes antibody testing. He emphasized that demand, start forms, and payer interactions are all strong, and the company is performing brilliantly. He noted that Q3 will see moderate growth, with a significant ramp in Q4 and into 2025, consistent with prior successful Duchenne therapy launches.

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President and CEO Bradley Campbell clarified the 'onetime' issue was the unexpectedly large size of the annual VPAG rebate, not the rebate itself. He stated Pombiliti/Opfolda's positioning is based on its strong data, leading to favorable reimbursement. Chief Business Officer Sebastien Martel added that while the deal expands their U.S. presence in rare kidney disease, their strategy remains focused on adjacencies like neuromuscular and rare cardiology.

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President and CEO Bradley Campbell confirmed two remaining litigants but expressed high confidence in the company's IP position, noting he would not expect a settlement date later than the January 2037 agreement with Teva. He also highlighted that Galafold's patient discontinuation rate has progressively decreased, contributing to sustained growth.

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President and CEO Bradley Campbell explained that both markets are progressing well but have distinct dynamics. The U.S., as the largest single market, will see strong, consistent new patient growth. Europe's growth will be driven by the phased addition of new countries. Campbell noted that in Europe, they see switches from both Myozyme and Nexviazyme plus naive patients, while the U.S. launch primarily involves switches from existing therapies.

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COO Brandon Smith clarified that the patient numbers represent those already diagnosed and treated, making them identifiable through established channels. He cautioned that while the long-term opportunity is significant, initial commercial uptake will take time to build awareness and secure contracts. President and CEO Gene G. Kinney added that the current focus remains on the Mayo Stage IV population studied in the trial.

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