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James Bradner, EVP of R&D, stated that the regulatory strategy has not yet been disclosed. He noted that the strategy will integrate data from both the positive FORTITUDE-101 study and the FORTITUDE-102 study, which is expected to read out in H2 2025 or H1 2026.

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James Bradner, EVP of R&D, stated they are hopeful the FORTITUDE-101 study will demonstrate a meaningful improvement in overall survival. Murdo Gordon, EVP of Global Commercial Operations, outlined the market as the fifth most common cancer globally, with an initial addressable U.S. population of about 7,000 patients and a significant opportunity in Asia, highlighting the drug's combinability with standard chemotherapy.

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James Bradner, EVP of R&D, described the VESALIUS study as a large and valuable dataset that will yield significant insights. Murdo Gordon, EVP of Global Commercial Operations, added that there are substantial commercial synergies in applying their LDL-lowering leadership to Lp(a) with olpasiran, while acknowledging the unique market dynamics for an Lp(a)-targeting therapy.

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EVP of R&D James Bradner emphasized that subcutaneous BLINCYTO is a 'major priority,' citing impressive efficacy data from earlier studies. He stated that the program is progressing and that there is 'nothing to read into the timing' of the study initiation.

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Chief Medical & Scientific Officer Dr. Kumar Budur, introduced by President & CEO Dr. Jeffrey Dayno, confirmed the Q3 data readout is on track. Dr. Budur stated that success is defined by achieving a statistically significant outcome on the primary endpoint of social avoidance in patients with complete methylation. He expressed high confidence, noting the study is designed to replicate the strong, statistically significant findings from the prior Phase II/III CONNECT study.

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CEO Bill Sibold stated that business development remains a key strategy and that the market will move toward combinations with ResDiffera as the foundational therapy. CMO David Soergel added that the scientific rationale is strong, as 5% weight loss enhances ResDiffera's efficacy. He confirmed the chosen molecule has a de-risked structure and favorable properties. Sibold noted a fixed-dose combo is ideal but not essential.

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CEO William Sibold reported positive feedback on the DTC campaign, which aims to educate patients and spur action. On business development, he stated the focus is on extending MASH leadership by acquiring assets with compelling new mechanisms or those that could be combined with Rezdiffra, emphasizing a financially disciplined approach across all stages of development.

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CEO William Sibold declined to comment on event rates in the ongoing trial. Regarding the ESSENCE trial, he stated they will wait for the full data, as top-line results can be misleading without details on dosing and discontinuation handling. He reiterated confidence in Rezdiffra's strong market position and product profile regardless of competitive data readouts.

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President & CEO Marcio Souza and Chief Scientific Officer Steven Petrou both suggested the data points towards disease modification. Petrou explained that the sustained reduction in seizures indicates a reversal of the "seizures beget seizures" process by resetting the brain's excitability level. Regarding DEE, Souza stated that while theoretically possible, the company's strategy is to focus vormatrogene on adult epilepsy and advance raletirgene, which is better suited, for DEE conditions like SCN2A and SCN8A.

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CEO Robert Barrow noted that Phase 2 data showed no loss of separation at twelve weeks, suggesting durability could extend further. Chief Medical Officer Dr. Daniel Karlin explained that real-world dosing would likely be variable based on individual patient response patterns rather than a prespecified interval, with some patients potentially achieving long-term remission from a single dose.

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CEO Robert Barrow noted that Phase 2 data suggested durability could last beyond 12 weeks. CMO Dr. Daniel Karlin added that they don't anticipate a pre-specified dosing interval. Instead, treatment patterns will be variable, ranging from a single dose providing long-term remission to potential redosing every few months or annually, depending on individual patient response.

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Priya Singhal, EVP & Head of Development, highlighted the upcoming PDUFA date and noted subcu offers convenience and a safety advantage with fewer infusion reactions. Alisha Alaimo, President & Head of North America, added that physicians and patients value the flexibility. She expects the choice will be patient-driven, particularly benefiting those in rural areas, with physicians offering all available options.

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Priya Singhal, EVP & Head of Development, highlighted the upcoming PDUFA date and noted subcu Leqembi offers convenience, optionality, and a safety advantage. Alisha Alaimo, President & Head of North America, added that physicians will offer patients the choice between IV and subcu formulations, with the latter being particularly beneficial for patients in rural areas. She confirmed that even the IV maintenance option is being well-received.

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CEO Christopher Viehbacher declined to provide individual product forecasts but framed the figure as a measure of the pipeline's potential magnitude. He highlighted BIIB080 in Alzheimer's and the lupus franchise as significant opportunities, clarifying that the $14 billion is a cumulative peak sales estimate at the high end of a $9 billion to $14 billion range, contingent on clinical success.

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CMO Sanjay Keswani stated he was drawn to Neurocrine's transformational stage, evolving into a multi-modality company. He highlighted the high quality of the late-phase psychiatry portfolio with its validated targets and expressed excitement for the early-phase pipeline, which includes large molecules like bispecifics, ADCs, and peptides with transformational potential.

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Chief Medical Officer Dr. Eiry Roberts confirmed the JOURNEY study data is expected around mid-2025 and will provide key learnings on efficacy and patient subgroups to guide future development. She noted that a competitor's recent trial failure highlights the difficulty of research in this area but does not diminish their confidence in their own NBI-'568 muscarinic program for acute psychosis.

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CEO Kyle Gano affirmed a strong commitment to epilepsy, highlighting a number of preclinical programs. He stated that while the company will not pursue another T-type calcium channel blocker, it is looking forward to bringing a mixed NAV1.2/1.6 inhibitor into the clinic next year, pending completion of preclinical studies.

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CEO Brett Monia stated that the company's priority remains its wholly-owned pipeline, focusing on cardiology and neurology, but they will continue to partner assets outside these core areas, as exemplified by the recent sapaglutizine deal. Regarding ex-U.S. expansion, he said the immediate focus is on executing U.S. launches successfully, and while internal discussions are happening, it is not yet time to build out an international commercial presence.

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Chief Global Product Strategy Officer Kyle Jenne confirmed a significant prescriber overlap (cardiologists, endocrinologists) and noted the TRYNGOLZA launch is building the foundation for sHTG. CEO Brett Monia explained that while the sHTG studies are not formally powered for the secondary AP endpoint, they are combining data from the CORE and CORE2 studies and extending the observation period to maximize the potential to see a signal. He stressed the primary endpoint is triglyceride reduction, a key driver for physician adoption.

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Chief Global Product Strategy Officer Kyle Jenne reported a very successful early launch, noting that "several hundred" of the addressable patients are currently identified. While declining to provide specific metrics, he highlighted encouraging trends, including a broad prescriber base of endocrinologists and cardiologists, rapid prescription fulfillment times, and positive feedback on the Ionis Every Step patient support program.

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CEO Brett Monia stated they are nearing alignment with EU regulators for the Angelman trial and that it's too early to comment on ex-U.S. commercial plans. EVP of Research Eric Swayze explained that Down syndrome was a logical starting point for the APP ASO because patients have an extra APP gene, causing amyloid accumulation. Chief Clinical Development Officer Eugene Schneider added that sporadic Alzheimer's is a potential future indication.

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CEO Bill Meury stated that myeloproliferative neoplasms (MPNs) in hematology are the company's number one priority, citing an "asymmetrical advantage" and the transformative potential of assets like the mutant CalR antibody, 989. He described immunology as having a credible path to building a large product with povorcitinib in specific skin conditions. For broader oncology, he emphasized a disciplined approach to finding the right products in defensible markets.

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Executive Pablo Cagnoni described the upcoming ASCO data as an incremental update to the comprehensive ESMO presentation. He confirmed that the pivotal trial in platinum-resistant ovarian cancer is being implemented, the companion diagnostic is advancing well, and a required combination study with bevacizumab is underway.

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Herve Hoppenot, CEO, outlined that ruxolitinib XR is expected to be submitted to the FDA by year-end 2025, with a commercial launch anticipated in 2026. The goal is to switch as many patients as possible before the 2029 generic entry. He added that a decision on a fixed-dose combination with the BET inhibitor is pending further data on the frontline combination's profile and the evolution of the broader MPN portfolio.

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Herve Hoppenot, CEO, highlighted the near-term launches of Niktimvo, tafasitamab, and retifanlimab, which could collectively add around $800 million in revenue by 2029. He pointed to povorcitinib and the CDK2 inhibitor as the next wave of larger opportunities. He stated that the current pipeline is strong, so the BD focus is on early-stage technology or potentially late-stage commercial products, rather than assets that would require significant near-term R&D spending.

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President & CEO Brian Lian confirmed that patient dosing is underway in the VANQUISH studies and that enthusiasm is high, but it is too early to project enrollment timelines. He clarified that the maintenance study will not be a randomized withdrawal design; instead, patients will be titrated to a high dose and then transitioned to various monthly or daily oral maintenance doses.

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Brian Lian, President and CEO, confirmed that the Phase III program for VK2735 will include a study in obese patients with type 2 diabetes, which will assess both weight change and glycemic control. Regarding M&A, he acknowledged the high level of interest in the obesity space and Viking's attractive portfolio but declined to comment on specific business development discussions.

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CEO Brian Lian confirmed the long-term goal is label inclusion for a monthly dose. The initial study will assess weight maintenance by titrating patients to a high dose and then switching to a monthly cadence. Regarding the transition to an oral formulation, he indicated this would ideally be studied by first conducting a PK exploratory study, followed by a longer-term maintenance trial.

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Executive Brian Lian indicated a comfortable tolerability profile, as the review committee never recommended halting dose escalation. He stated that discussions on synthetic manufacturing routes are in progress. He estimated the value of the VK2735 franchise is split approximately 80% for the subcutaneous formulation and 20% for the oral version, viewing the injectable as the anchor product.

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CCO Michael Sumner explained that while the FDA recognizes surgery reduction as the key benefit, it is too early to predict the exact label terminology. CEO Jacqueline Shea stated that the placebo-controlled confirmatory trial is designed to meet European and U.K. regulatory requirements for future submissions. Regarding the dMAb platform, Shea noted that specific target indications are not yet disclosed but highlighted the technology's broad potential for antibodies and protein replacement therapies.

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CEO Dr. Jacqueline Shea confirmed the device issue is resolved and outlined a timeline to complete validation testing in the first half of 2025, begin a rolling BLA submission mid-year, and complete it within 3-4 months. Dr. Shea and Chief Medical Officer Dr. Michael Sumner affirmed that the confirmatory trial must be initiated before the BLA submission, noting significant progress has already been made on site activation to demonstrate commitment to the FDA.

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Chief Medical Officer Dr. Mike Sumner stated that compelling, placebo-controlled data would be required for approval in the EU and UK, and the current trial is designed to provide this data. He noted that outreach to Japan and China has not yet occurred. Both Dr. Sumner and CEO Dr. Jacqueline Shea confirmed that feedback from clinicians and Key Opinion Leaders (KOLs) on the new immunology data has been very positive, as it clearly illustrates the mechanism of action and builds confidence in the clinical results.

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Executive Jonathan Zalevsky explained the top-line data will feature the primary endpoint (EASI score change) and key secondary endpoints like EASI-75, EASI-90, vIGA, and itch scores. He confirmed that Nektar plans to continue with precise, weight-based dosing in Phase III, likely administered via an auto-injector with weight bands.

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CEO Howard Robin and CRDO Dr. Jonathan Zalevsky responded. Dr. Zalevsky indicated the top-line release will cover the 16-week induction data, with full results reserved for a medical meeting. He stated that replicating Phase Ib efficacy is the primary way to impact the first-line setting, but REZPEG's novel, durable mechanism offers another path. For NKTR-255, they reiterated Merck's guidance for a potential PFS readout in mid-2025, as the analysis is event-driven.

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CSO Chris Twitty confirmed that in the DIO model, Nimacimab showed significant fat mass reduction with lean mass preservation, an effect that was even greater in combination with tirzepatide. Tu Diep, a commercial executive, stated that both monotherapy and combination therapy represent large, multi-billion dollar opportunities of relatively equal size. CEO Punit Dhillon noted that while a fixed-dose combination is a future possibility, the immediate priority is demonstrating monotherapy efficacy.

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CSO Christopher Twitty stated the upcoming preclinical data will be more robust, including biomarker work on key mechanisms and differentiation, and will begin to explore combination approaches. President and CEO Punit Dhillon and COO Tu Diep commented that recent industry deals validate the market's interest in alternative mechanisms beyond GLP-1s. They noted that KOLs are increasingly seeking tolerable and convenient options, positioning nimacimab favorably.

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Punit Dhillon, President and CEO, stated that KOLs appreciated the new data distinguishing peripheral from central CB1 inhibition, especially following recent data from monlunabant. He noted the preclinical results showed significant dose-dependent weight loss, improved glucose metabolism, and lean mass preservation. Regarding commercial strategy, Dhillon positioned nimacimab as a complementary alternative to GLP-1s, targeting metabolism rather than just appetite. He sees a significant opportunity for a monotherapy in the overweight and Class 1 obesity populations where extreme weight loss isn't always necessary.

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Chief Medical Officer David Lebwohl stated that the baseline characteristics, including the proportion of patients with variant disease (10-15%) and Class III patients (10-15%), are similar to other recent Phase III studies in the field. This suggests that the event rate should evolve similarly, though he noted more patients are on baseline tafamidis.

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CEO John Leonard stated that the company's primary focus is on a successful U.S. launch. He confirmed they are evaluating various options for ex-U.S. commercialization, and a partnership is one of the possibilities being considered, though no decision has been made yet.

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CEO John Leonard confirmed a substantial ex-U.S. commercial opportunity exists. He stated that Intellia's current plan is to be positioned to launch the drug themselves but that they continuously evaluate potential partnerships that could extend their reach. Any such plans would be shared as the strategy evolves.

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The company is winding down its own spending on luvelta and seeks a partner to assume full development responsibility and expenses. For STRO-006, differentiation comes from a proprietary antibody targeting a specific integrin beta-6 confirmation and the use of a unique DAR8 exatecan payload, which they believe is competitive and potentially superior to competitor approaches.

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Executive Jane Chung confirmed Sutro is winding down luvelta-related expenses and is seeking a partner to take over and lead future development. CSO Dr. Hans-Peter Gerber detailed that STRO-006 is differentiated by its selective antibody that binds to a specific tumor confirmation of integrin beta-6 without interfering with target biology, and by its use of an exatecan payload, a combination he believes is unique for this target.

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CSO Dr. Todd Carter confirmed the target knockdown is in the 50-73% range. CEO Dr. Al Sandrock identified the cerebral cortex as the key target region. He stated that while the program is intended for partnership, Voyager would prioritize Alzheimer's disease first due to the well-established natural history and validated biomarkers like tau PET, a point echoed by CMO Dr. Toby Ferguson.

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CEO Dr. Alfred Sandrock viewed the bepranemab data as a positive sign that an antibody can affect tau biology in the human brain, reinforcing potential read-through given VY7523's comparable performance in preclinical models. Chief Scientific Officer Dr. Todd Carter added that detailed PK/PD data from UCB would be important to see. Dr. Sandrock stated that both the antibody and gene therapy are high priorities. He sees a potential role for combination with anti-amyloid therapies for patients who show a partial response, but noted monotherapy data is needed first.

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CSO Dr. Todd Carter explained that liver detargeting is an empirical observation, possibly related to capsid charge modifications, and is a key selection criterion. CEO Dr. Al Sandrock stated that for the ALPL platform, Voyager is currently experimenting with its ability to transport various macromolecules, including therapeutic antibodies, enzymes, and oligonucleotides like ASOs and siRNAs, across the blood-brain barrier.

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Executive Todd Carter explained that ALPL is expressed robustly from birth and its expression may even increase slightly with age, suggesting consistent or better delivery in older populations. Executive Alfred Sandrock added that while much of the follow-on development work will be done internally, Voyager is always open to collaborations that can enhance its discovery and development efforts.

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CSO Dr. Paul Moore outlined the necessary IND-enabling activities, including tox studies and materials manufacturing, maintaining a guidance of H2 2026. Chair and CEO Kenneth Galbraith added they always look to accelerate high-impact programs. Regarding multi-payload ADCs, Dr. Moore confirmed it's an area of investigation, but development would depend on a strong therapeutic rationale for a specific target.

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CEO Dr. Mark Goldsmith stated it was too early to comment on specific adjuvant trial design details like dosing duration. Regarding NSCLC, he confirmed strong interest in moving into earlier lines of therapy, such as adjuvant settings, but noted the strategy is less developed than for PDAC. He highlighted the recent initiation of the second/third-line NSCLC trial as a key first step.

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Dr. Mark Goldsmith, Chairman and CEO, explained that since Tango Therapeutics is sponsoring the studies, Revolution Medicines could not provide additional details beyond what Tango has disclosed. He noted the scientific rationale is strong, as preclinical results were encouraging for suppressing two distinct oncogenic signaling pathways in patients with both a RAS mutation and MTAP deletion.

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President and CEO Gene G. Kinney noted the trial's focus on Mayo Stage IV patients, where daratumumab has not shown an early survival benefit. Chief Development Officer Chad Swanson confirmed that baseline characteristics are similar to the VITAL trial's Stage IV population, approximately 80% of subjects are on daratumumab, and success is defined by achieving a p-value of 0.1 or less per the FDA SPA agreement.

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President and CEO Gene G. Kinney noted the trial's focus on Mayo Stage IV patients, where daratumumab has not shown an early survival benefit. Chief Development Officer Chad Swanson confirmed that baseline characteristics are similar to the VITAL trial's Stage IV cohort, approximately 80% of patients are on daratumumab, and success is defined by the FDA SPA agreement's p-value of ≤ 0.10.

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CEO Gene G. Kinney noted the focus on Mayo Stage IV patients and reiterated that daratumumab has not shown an impact on early mortality. Chief Development Officer Chad Swanson confirmed that baseline characteristics are similar to the VITAL trial's Stage IV cohort, with about 80% of AFFIRM-AL participants on daratumumab, and that success is defined by a p-value of 0.1 or less per the FDA agreement.

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The study is a double-blind, placebo-controlled trial for 6 months, after which patients can enter an open-label extension where enrollment has been strong. Placebo patients will receive the drug for the first time, and others will continue for up to 12 months of treatment. The company will capture safety, tolerability, PK, and pharmacodynamic data during this period.

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CEO Catherine Owen Adams shared that she was attracted to Acadia by the combination of three factors: a strong commercial base with NUPLAZID and Daybue where she could add value, an exciting pipeline with two late-stage assets, and a strong financial position with a solid board and investors. She stated that six weeks into the role, she is even more motivated and believes the company will go from 'strength to strength.'

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CFO Jens Holstein stated it was too early for future guidance but noted the company is comfortable with its current R&D spending levels and will invest wisely in high-potential assets like BNT327 while controlling costs. Chief Strategy Officer Ryan Richardson added that the current R&D level already supports 10 ongoing Phase II or III trials, demonstrating significant scale in the mid- and late-stage pipeline.

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President and CEO Michael Morrissey explained that with the ANDA litigation overhang removed, it is the right time to focus stakeholders on the company's future. The goal is to highlight the forward momentum with CABOMETYX, the high-potential zanzalintinib program, and the pipeline as Exelixis builds a multi-franchise business.

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CEO Barry Greene explained that while OB/GYNs are the primary point of care, telehealth is crucial for women who are diagnosed later or need immediate psychiatric access. Chief Business Officer Chris Benecchi added that telehealth platforms like Talkiatry are a much-needed resource that expands the opportunity for women to engage with healthcare professionals.

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CEO Barry Greene reiterated that the primary focus and the upcoming sales force expansion are aimed at OB/GYNs, who are the key point of interception for PPD. CBO Chris Benecchi added that ACOG guidelines provide a significant tailwind for screening and diagnosis. He also noted that personal and non-personal promotion efforts are in place to reach psychiatrists and PCPs for patients on different care journeys.

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Dr. Tara Kieffer, Chief Product Strategy Officer, explained that the primary goal is to achieve best-in-disease efficacy, similar to what has been seen with KIT-targeting monoclonal antibodies, but with the convenience and safety of a potent, selective, once-daily oral drug. She noted that beyond CSU, the company is interested in other mast cell-driven diseases such as chronic inducible urticaria, eosinophilic esophagitis (EOE), and prurigo nodularis (PN).

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The company aims for their oral KIT inhibitor to match or exceed the best-in-disease efficacy seen with anti-KIT monoclonal antibodies, but with the convenience of an oral, once-daily dose and a good safety profile. Key differentiators will be potency, selectivity, and a tunable dosing regimen. For additional indications, they are interested in other mast cell-driven diseases such as chronic inducible urticaria, eosinophilic esophagitis (EOE), prurigo nodularis (PN), and potentially asthma.

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The company plans to include vaccinated patients in future RSV trials as breakthrough infections will occur. For CSU, they are targeting best-in-class efficacy similar to what's been seen with antibody KIT inhibitors, potentially exceeding BTK inhibitors. They believe the known side effects of KIT inhibitors are manageable and not a limitation.

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The company hopes to see strong viral load and symptom reduction in the EDP-323 study, comparable to the high bar set by EDP-938. Differentiation will come later, but having two mechanisms offers flexibility. They declined to comment on specific nonvirology areas until early 2024.

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The company stated that SHINE baseline characteristics are not yet available. Top-line results will be shared via press release, with a full data set at the AAIC meeting. They reported positive investigator enthusiasm and progress in site activation for the START study.

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The company is on track to establish in vivo preclinical proof of concept for one undisclosed indication this year, with more details on the timing and forum to be shared later. The chosen editing tool is their proprietary AsCas12a enzyme, and the delivery method is focused on non-viral nanoparticles.

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