Pipeline Programs - Setrusumab for Osteogenesis Imperfecta (OI) Phase 3 results were reported around the end of 2025, partnered with Ultragenyx, but neither study achieved the primary endpoint of reduction in AFR compared to placebo or bisphosphonates[8, 11] - Alvelestat for Alpha-1 Antitrypsin Deficiency-associated Lung Disease (AATD-LD) activities are ongoing to support the initiation of Phase 3, following an agreement in principle on the primary endpoints[8] - Vantictumab for osteopetrosis is out-licensed to āshibio, with EU rights retained, and an IND is planned for H2 2026[8] Financial Status - The company has approximately $41 million in cash and cash equivalents as of December 31, 2025, providing a cash runway into mid-2027[8] Setrusumab Clinical Trial Results - In the Orbit study (Setrusumab vs placebo), 19.5% of patients met rescue criteria at 12 months, primarily due to fractures, with a larger number of placebo patients exiting the study[14] - In the Cosmic study (Setrusumab vs bisphosphonates), there was a 59% reduction in vertebral fractures on setrusumab (p=0.081), despite more severe type III/IV patients on setrusumab (65% setrusumab vs 54% IV-BP)[31] - Setrusumab patients in the Orbit study showed improvements in disease severity (PGIS) in peds/teens, as well as improvements in pain/comfort and sports/activity[20] Market Opportunities - Osteogenesis Imperfecta affects approximately 60,000 patients across the US & Europe[9] - Severe Alpha-1 Antitrypsin Deficiency affects an estimated 50,000 patients in North America and 60,000 in Europe[9] - Osteopetrosis has an incidence of 1 in 20,000 in North America and Europe, with onset typically in late childhood[9]

Membership and Growth - Total membership reached 275,300 as of January 1, 2026, reflecting a 30% Compound Annual Growth Rate (CAGR) since inception[16] - The company projects year-end 2026 membership to be in the range of 290,000 to 296,000[16,46] - From 2024 to Q3 2025, peers averaged 1% annual membership growth[36] - As of January 1, 2026, 80% of new members are new to MA, and 20% are MA plan switchers[47] - January 1 net Medicare Advantage enrollment growth in California was +23,800 (+84% YoY)[47] - January 1 net Medicare Advantage enrollment growth Ex-California was +41,500 (+23% YoY)[47] Financial Performance - The company's total revenue has grown from $127 million in 2014 to $3939 million in 2024[16] - The company raised YE adjusted EBITDA guidance from $48M to $94M at the midpoint from initial guidance to current guidance[52] - The company expects consensus adjusted EBITDA of $145M to be within FY 2026 guidance range[52] Quality and Cost Management - 100% of Alignment's members are in plans rated 4 stars or above, compared to 65% for the industry[40] - The company invests ~4% of medical expenses for at-risk members in employed clinical model[21] - The company has achieved superior growth while managing medical costs effectively, differentiating itself from peers who averaged a 1% annual membership growth and an annual increase in MBR of 160bps[36] Market Position - The company has less than 1% national market share and approximately 6% share in existing markets[53] - The MA market is projected to grow further over the next decade, with MA penetration reaching 58% in 2034[54]

Harmony Biosciences FY Conference Summary Company Overview - **Company**: Harmony Biosciences (NasdaqGM:HRMY) - **Event**: 44th JPM Healthcare Conference - **Date**: January 13, 2026 Key Industry Insights - **Core Focus**: Central Nervous System (CNS) disorders, particularly narcolepsy and related conditions - **Product Highlight**: WAKIX, a treatment for narcolepsy, is on track to achieve blockbuster status in 2026 with projected net revenue exceeding $1 billion Core Points and Arguments 1. **Momentum and Growth**: Harmony enters 2026 with significant momentum driven by three key factors: WAKIX performance, a robust late-stage pipeline, and a strong financial profile [2][3] 2. **WAKIX Performance**: WAKIX has shown five years of consecutive growth and profitability, with 2025 net revenue reported at $868 million, exceeding guidance [9][41] 3. **Pipeline Development**: Five phase three programs are advancing towards distinct CNS indications, setting up multiple catalysts for growth in the coming years [2][24] 4. **Pitolisant Franchise Expansion**: The introduction of Pitolisant GR (gastro-resistant formulation) and Pitolisant HD (high-dose formulation) aims to address unmet patient needs and expand the franchise [4][13] 5. **Market Opportunity**: There are approximately 80,000 diagnosed narcolepsy patients in the US, with an additional 90,000 undiagnosed, indicating significant growth potential for WAKIX [10][42] 6. **Commercial Strategy**: Harmony has improved its commercial operations, achieving broad formulary access (80% of lives covered) and enhancing patient support systems [11][27] 7. **Regulatory Milestones**: Anticipated NDA submission for Pitolisant GR in Q2 2026, with a PDUFA date expected in Q1 2027 [30][37] 8. **Financial Health**: Harmony maintains a strong balance sheet with over $770 million in cash, allowing for continued investment in pipeline development and business growth [44][45] Additional Important Insights - **Patient-Centric Approach**: The company emphasizes the importance of addressing patient needs, particularly in narcolepsy and related disorders, through innovative product formulations [4][14] - **Unique Product Profiles**: The differentiated profiles of Pitolisant formulations are expected to enhance clinical utility and market competitiveness [6][39] - **Future Catalysts**: Anticipated data readouts from ongoing trials in 2027 and 2028 for various CNS indications, including Prader-Willi syndrome and epilepsy programs [21][20] - **Business Development Focus**: Harmony is actively seeking strategic opportunities to expand its portfolio in the CNS space, particularly in orphan and rare diseases [44][45] This summary encapsulates the key points discussed during the conference, highlighting Harmony Biosciences' strategic direction, product pipeline, and market opportunities within the CNS industry.

Summary of Natera's Conference Call Company Overview - **Company**: Natera - **Industry**: Life Sciences, Diagnostics, Oncology, Women's Health - **Core Mission**: Transforming disease management globally through proprietary technology that detects small quantities of DNA [2][3] Key Products and Market Position - **Panorama**: A cell-free fetal DNA test for chromosomal abnormalities, leading with over 50% market share [2] - **Prospera**: A test for organ transplant rejection using donor-derived cell-free DNA [2] - **Signatera**: A circulating tumor DNA test for minimal residual disease (MRD) monitoring, achieving record growth with 22,000 clinical MRD tests in Q4 [3][4] Financial Performance - **Q4 2025 Revenue**: $660 million, up 39% year-over-year, driven by strong average selling prices (ASPs) and volume growth [4] - **Free Cash Flow**: Exceeded $100 million for the year [5] - **Unit Sales**: 924,000 units in Q4, with significant growth in oncology and women's health [3][4] Innovations and Future Growth Drivers - **Fetal Focus**: A new 21-gene single-gene NIPT test aimed at severe genetic disorders, filling a gap in clinical care [5][6] - **Signatera Enhancements**: Incorporation of phased variants technology for improved sensitivity, targeting a limit of detection (LOD) down to one part per 10 million [10][11] - **AI Integration**: Development of an augmented MRD score using AI and a foundation model to enhance precision in risk assessment [12][13] Clinical Trials and Partnerships - **Clinical Trials**: Significant investments in clinical trials, particularly in breast cancer, with over $100 million allocated for evidence generation [16][17] - **STELLAR Trial**: A pivotal phase three trial in colorectal cancer, leveraging Signatera for patient enrollment [18][35] - **Partnerships**: Collaborations with NVIDIA for AI initiatives and Ultima Genomics for new product launches [22] Market Dynamics and Competitive Landscape - **Market Share**: Natera holds over 50% market share in women's health and is focused on maintaining and expanding its position through innovation and clinical evidence [25][39] - **Lymphoma Market**: Interest in expanding into lymphoma and hematologic cancers, leveraging Foresight Diagnostics' technology [27][28] Regulatory and Reimbursement Strategies - **Medicare Coverage**: Ongoing efforts to expand Multi-X coverage, with 30% of tests currently not covered under Medicare [21] - **Reimbursement Process**: Coordination with MolDX for new assay coverage, emphasizing the importance of generating data [32] Future Outlook - **2026 Goals**: Plans to complete enrollment for the FIND study in early cancer detection and launch new products incorporating advanced technologies [21][22] - **Operating Margins**: Expectation of growing into profitability as revenue matures, with a focus on maintaining operational efficiency [46][48] Conclusion Natera is positioned for significant growth through innovative product offerings, strategic partnerships, and a strong focus on clinical evidence generation. The company aims to leverage its market leadership in diagnostics to expand into new therapeutic areas while enhancing its existing product lines.

Summary of AnaptysBio Conference Call Company Overview - **Company**: AnaptysBio - **Event**: 44th Annual JPMorgan Healthcare Conference - **CEO**: Dan Faga Key Points Company Separation - AnaptysBio plans to separate into two distinct businesses: BiopharmaCo and Royalty Management Co by Q2 2025 [1][2][34] - The separation aims to align different business strategies and investment philosophies, enhancing shareholder value [44][46] BiopharmaCo Developments - **Clinical Assets**: BiopharmaCo will focus on three clinical assets, primarily driven by AMB033, which is currently in phase 1b trials for Celiac disease and Eosinophilic Esophagitis (EoE) [2][12] - **AMB033**: A CD122 antagonist targeting IL-15 and IL-2 signaling, showing potential in treating Celiac disease and EoE [12][26] - **Market Opportunity**: Celiac disease has over 1 million diagnosed patients in the U.S., with a $5 billion market targeting those non-responsive to a gluten-free diet [16][17] Royalty Management Co Developments - The Royalty Management Co will manage royalties from Jemperli and Imsidolimab, with significant revenue potential from these assets [3][4] - **Jemperli**: Generated over $300 million in revenue in Q3 2025, with a tiered royalty structure starting at 8% and potentially reaching 25% at peak sales [4][5] - **Imsidolimab**: Expected approval in the U.S. later this year, with a 10% flat royalty from sales [6][7] Clinical Trials and Data - **Celiac Disease Trials**: The phase 1b trial will enroll 60 patients, focusing on preventing villus atrophy and healing damaged villi [22][50] - **EoE Trials**: A trial for EoE is set to initiate later this quarter, targeting a growing market currently dominated by Dupixent [25][54] - **Rosnilimab**: A phase 2b trial in rheumatoid arthritis showed positive results, with plans for a phase 3 program pending strategic partnerships or financing [28][29] Financial Position - AnaptysBio has $310 million in cash, sufficient to support ongoing trials and operations for the next couple of years [3][34] - The company anticipates paying down $250 million of its $600 million non-recourse debt by the end of 2025 [5][41] Market Competition and Strategy - Jemperli competes with Keytruda, with GSK focusing on differentiated data in women's cancers [11] - AnaptysBio's strategy includes targeting both IL-15 and IL-2 pathways, which may provide advantages over existing therapies [12][54] Litigation with GSK - Ongoing litigation with GSK regarding Jemperli is not expected to impede the separation of the biopharma business [39][40] - AnaptysBio claims GSK has breached contract terms, with a trial date set for July 2025 [41][43] Future Outlook - AnaptysBio is optimistic about the potential of its clinical assets and the upcoming separation, which is expected to create value for shareholders [46][49] - The company is exploring various financing options to support the advancement of its clinical programs [48][49] Additional Insights - The separation is seen as a strategic move to unlock value by allowing each entity to pursue tailored growth strategies [44][46] - The focus on both Celiac disease and EoE highlights AnaptysBio's commitment to addressing unmet medical needs in immunology [12][54]

Summary of Glaukos Conference Call Company Overview - **Company**: Glaukos - **Industry**: Medical Supplies and Devices, specifically in ophthalmology - **Core Focus**: Innovation in ophthalmic treatments, particularly in minimally invasive glaucoma surgery (MIGS) and procedural pharmaceuticals [4][5] Key Points and Arguments Innovation and Market Leadership - Glaukos has pioneered the global MIGS marketplace and is creating new markets in procedural pharmaceuticals with products like iDose [4][5] - The company has invested approximately $800 million in R&D since 2018, resulting in 12 commercially available products and 13 in various development phases [7] Market Growth and Financial Performance - Achieved over 30% market growth in the past year, with a sustained CAGR of over 20% for the last decade [7] - Reported a record quarter with revenues of $507 million for 2025, projecting a 20% CAGR over the next 10 years [36] Product Development and Pipeline - Focus on changing treatment paradigms for glaucoma and keratoconus, with significant advancements in products like iDose TR and Epioxa [8][28] - iDose TR shows promising results, with 81% of patients off all medications after one year and 70% well-controlled after three years [12][13] - Epioxa is a new treatment for keratoconus, targeting a younger patient demographic and aiming to increase patient access [30][31] Market Dynamics and Challenges - The current treatment paradigm for glaucoma is inefficient, with 90% of patients non-adherent to medication regimens [10] - Glaukos aims to shift clinicians towards interventional approaches that provide continuous treatment [10][11] - The company faces challenges in reimbursement processes for Epioxa, which differ significantly from those for iDose due to the complexity of commercial payers [46][48] Future Vision and Strategy - Glaukos envisions a future where interventional glaucoma procedures could match the volume of cataract surgeries, projecting significant growth in this area by 2035 [27] - Plans to create a new cadre of interventional glaucoma surgeons who will integrate iDose and iStent Infinite into their practices [26][27] - Commitment to building a comprehensive product portfolio that addresses all stages of glaucoma treatment [28] Additional Important Insights - The company is expanding its manufacturing capabilities with new facilities in San Clemente and Huntsville, Alabama [37] - Glaukos is diversifying its operations internationally, now present in 17 countries with over 300 employees [36] - The management emphasizes the importance of educating physicians and patients about the benefits of new therapies to drive adoption [55][56] Conclusion Glaukos is positioned as a leader in ophthalmic innovation, with a strong focus on developing new treatment paradigms for glaucoma and keratoconus. The company is navigating challenges in market access and reimbursement while maintaining a robust growth trajectory and a commitment to expanding its product offerings.

Amneal Pharmaceuticals FY Conference Summary Company Overview - **Company**: Amneal Pharmaceuticals (NasdaqGS:AMRX) - **Industry**: Pharmaceuticals - **Focus**: Affordable medicines, including retail generics, injectables, and biosimilars [2][3] Key Points and Arguments Company History and Mission - Founded in 2002 in Paterson, New Jersey, with a focus on affordable medicine [2] - Currently fills 175 million prescriptions, emphasizing quality and complex dosage forms [3] - Aims to be the number one company in affordable medicines in the U.S. by 2030 [4] Market Position and Strategy - Currently ranked third or fourth in the U.S. generics market, with 98% of revenue from the U.S. [4] - Shifted focus from retail oral solids (25% of revenue) to complex generics and biosimilars due to increased competition [4][10] - Plans to double the business in the affordable medicines category over the next few years [10] Financial Performance - Revenue and EBITDA have doubled over the past six years, with net leverage decreasing from 7.4 to 3.7 [9] - Projected EBITDA for 2026 is expected to exceed $685 million [9] - Anticipates high single-digit growth across various segments, including biosimilars and specialty products [10][42] Product Pipeline and Innovations - Launched three biosimilars, with plans to launch two more (Denosumab presentations) [5] - Crexont, a Parkinson's treatment, has already reached 22,000 patients in its first year, with a market share of 3.2% [11][12] - Focus on developing complex generics, including ophthalmic and inhalation products, with a strong pipeline of 20-30 key products [14][40] Biosimilars Market - Anticipates significant growth in the biosimilars market, with 130 candidates in development [10][20] - Plans to vertically integrate the biosimilars business, aiming to be among the top three players in the market within five years [52] - Collaboration with Pfizer for peptide manufacturing, enhancing global supply capabilities [8][56] Challenges and Opportunities - The generics market is experiencing price erosion of 4-5%, but new product approvals are expected to drive growth [64] - The company is focused on maintaining a disciplined approach to capital deployment, prioritizing biosimilars and branded assets [67] - The competitive landscape for biosimilars is consolidating, with fewer players remaining, which may enhance market opportunities [20] Future Outlook - Expected revenue growth from specialty products and biosimilars, with a focus on affordable innovation [29][67] - Plans to invest more in R&D for biosimilars and specialty products, shifting resources from complex generics [27][29] - Anticipates double-digit EPS growth due to improved operating efficiencies and reduced interest expenses [66] Additional Important Insights - The company has received positive feedback from physicians regarding Crexont, indicating strong market acceptance [35] - AI is being utilized for marketing strategies, significantly increasing the likelihood of prescriptions for Crexont [32] - The company is committed to affordable access to medicines, with Crexont priced at approximately $6,000 per year [36] This summary encapsulates the key points discussed during the Amneal Pharmaceuticals FY Conference, highlighting the company's strategic direction, market positioning, financial performance, and future growth opportunities.

Summary of Merit Medical Systems FY Conference Call Company Overview - **Company Name**: Merit Medical Systems (NasdaqGS: MMSI) - **CEO**: Martha Aronson, appointed on October 3, 2025, succeeding founder Fred Lampropoulos [1][2] - **Market Cap**: Over $5 billion with revenues of $1.5 billion as of 2025 [3][4] - **Employee Count**: Over 7,500 employees globally [3] - **Global Footprint**: Vertically integrated manufacturing in Salt Lake City, Tijuana, Galway, and Singapore [3] Financial Performance - **Revenue Growth**: Total revenue increased at a 10% compounded annual growth rate (CAGR) over the last three years [4] - **Revenue Segmentation**: Approximately 40% of revenue from international customers and 60% from U.S. customers [4] - **Product Segmentation**: Revenue reported in two segments: cardiovascular and endoscopy [4] - **Foundational Products**: Comprise about two-thirds of revenue with a 6% CAGR over the last three years [5] - **Therapeutic Products**: Comprise about one-third of revenue with a 19% CAGR over the last three years [5] Strategic Initiatives - **Mergers and Acquisitions**: Over $1 billion invested in M&A since 2016, crucial for growth [3] - **Continued Growth Initiatives (CGI)**: Targeting a 5%-7% CAGR in revenue, 20%-22% non-GAAP operating margin, and over $400 million in cumulative free cash flow from FY23 to FY26 [15][14] - **Recent Performance**: Preliminary revenue for 2025 projected at $1.5 billion, up 11% [15] Product Development and Innovation - **Cardiac Therapies**: One of the fastest-growing segments with mid-teens growth; includes lead extraction technology from Cook Medical [8] - **Endoscopy Portfolio**: Focus on GERD treatment and tumor localization for breast cancer with the Scout system [9][10] - **Renal Therapies**: Includes dialysis products and the WRAPSODY endoprosthesis for dialysis patients [10][11] Market Position and Competitive Strategy - **Customer Focus**: Emphasis on being a customer-focused organization, leveraging both organic and inorganic growth strategies [29] - **Acquisition Strategy**: Active in pursuing small tuck-in acquisitions to fill strategic gaps, with a disciplined financial approach [36][37] - **Global Market Strategy**: Direct sales combined with distributor partnerships in international markets [12] Challenges and Considerations - **Tariffs Impact**: Anticipated impact of $13-$15 million from tariffs in 2026 [23] - **OEM Business**: Experienced softness due to a slowdown in the coatings business in China [21] - **Reimbursement Issues**: WRAPSODY faced challenges with reimbursement approvals, but the company is pivoting its pricing strategy [30] Leadership Transition - **Board Changes**: Fred Lampropoulos resigned as chairman; F. Ann Millner appointed as new chairman [22] - **Leadership Confidence**: The transition is seen as smooth, with confidence in the internal team's readiness to continue the company's momentum [22] Future Outlook - **Focus on Growth**: Continued emphasis on scaling the business globally while reinforcing existing infrastructure [28] - **Long-term Planning**: Strategy development for 2027-2030 to be informed by current growth platforms [18] - **Investment in R&D**: Plans to prioritize R&D efforts based on customer needs and market opportunities [18][46] This summary encapsulates the key points from the conference call, highlighting Merit Medical's financial performance, strategic initiatives, product development, market positioning, challenges, and future outlook.

Labcorp FY Conference Summary Company Overview - **Company**: Labcorp (NYSE: LH) - **Date of Conference**: January 13, 2026 Key Industry Insights - **Core Therapeutic Areas**: Labcorp is focusing on four core therapeutic areas: oncology, women's health, autoimmune, and neurology, which are expected to grow two to three times faster than the overall diagnostic market [5][6] - **M&A Activity**: In 2025, Labcorp announced 13 new or closed deals, enhancing growth opportunities [5] - **AI Integration**: Significant advancements in artificial intelligence and automation in laboratories, particularly in cytology and microbiology, were highlighted [6][32] Financial Performance - **2025 Performance**: Labcorp reported solid core fundamentals and improved organic growth, with a target of 4.5% organic revenue growth for the full year [13] - **Integration Success**: The integration of Invitae was noted as a remarkable achievement, turning a struggling company into an accretive business by Q3 2025 [7][10] - **Volume Impact from ACA Changes**: An estimated 30 basis points of volume impact on the diagnostic business in 2026 due to ACA subsidy expirations was discussed [20] Growth Drivers - **Increased Testing Utilization**: The aging population and a rise in chronic illnesses are driving increased testing utilization, which is expected to remain higher than pre-COVID levels [14][15] - **Specialty Testing Growth**: Labcorp anticipates growth in specialty testing, particularly in oncology, neurology, and autoimmune diseases, which are expected to drive higher test volumes [22][23] - **Managed Care Relationships**: Strong relationships with managed care organizations are expected to facilitate better pricing negotiations and increased volume [49] Challenges and Risks - **PAMA Legislation**: The potential impact of PAMA on pricing and diagnostics was discussed, with a cautious optimism regarding delays in its implementation [54][58] - **Biopharma Lab Services**: The early development segment is facing challenges due to funding and interest rates, leading to a focus on profitability and divestiture of non-core areas [64][65] Future Outlook - **Capital Deployment Strategy**: Labcorp plans to continue investing in capital expenditures, focusing on technology and infrastructure improvements [43][44] - **Tailwinds for 2026**: Anticipated strong underlying utilization trends, specialty testing growth, and M&A activities are expected to drive growth in 2026 [74] - **AI and Automation**: Continued focus on AI and automation is expected to enhance operational efficiency and reduce costs [73] Additional Insights - **Consumer Health Trends**: Increased consumer focus on health and wellness is seen as an opportunity for Labcorp's OnDemand services, which offer a variety of tests [51][52] - **Companion Diagnostics**: The importance of companion diagnostics in personalized medicine is emphasized as a way to reduce healthcare costs and improve patient outcomes [30][31] This summary encapsulates the key points discussed during the Labcorp FY conference, highlighting the company's strategic focus, financial performance, growth drivers, challenges, and future outlook.

Summary of Stoke Therapeutics FY Conference Call Company Overview - **Company**: Stoke Therapeutics (NasdaqGS:STOK) - **CEO**: Ian Smith, in role since March 2025 - **Focus**: Upregulating protein expression for haplo-insufficient diseases, primarily targeting genetic conditions like Dravet syndrome and Autosomal Dominant Optic Atrophy (ADOA) [2][3] Key Developments - **Lead Medicine**: Zorevunersen, targeting Dravet syndrome by upregulating the SCN1A gene to increase NaV1.1 expression, aiming to reduce seizures and improve neurodevelopment [3][4] - **Clinical Trials**: - Currently in Phase 3 for Dravet syndrome with a target enrollment of 150 patients, approximately 60 patients have been randomized, and another 60 are in the screening phase [5][6] - Enrollment expected to complete by Q2 2026, with potential NDA submission in 2027 or early 2028 [6][20] - **Long-term Data**: Patients have been followed for up to four years, showing durability in seizure reduction (up to 85%) and improvements in neurocognition [7][10][18] Financial Position - **Funding**: Approximately $400 million available, sufficient to fund operations through 2028 [8][9] - **Collaboration**: Partnership with Biogen, which licensed commercial rights to zorevunersen and funds 30% of R&D development [21][22] Market Opportunity - **Patient Population**: Estimated 40,000 patients with Dravet syndrome across key geographies (15-20,000 in the U.S. and Europe) [20][21] - **Commercial Potential**: Anticipated robust demand for a disease-modifying treatment, with market research indicating high clinician willingness to prescribe [41][42] Regulatory Pathway - **Breakthrough Designation**: Zorevunersen has received this designation, allowing for expedited development discussions with the FDA [27][28] - **FDA Interaction**: Productive discussions with the FDA regarding the potential for filing based on Phase 1, 2, and OLE data, although the timeline for filing may not be significantly shortened [28][30] Pipeline and Future Plans - **Next Steps**: - Completion of Phase 3 enrollment and subsequent NDA filing [24][25] - Initiation of clinical trials for ADOA (STK-002) and SYNGAP1, with expectations for early efficacy results by the end of 2026 [50][51] - **Regulatory Strategy**: Focus on demonstrating improvement in vision for ADOA, which could shorten clinical study durations [52][53] Additional Insights - **Data Integrity**: Emphasis on the importance of long-term data and observed outcomes in regulatory discussions to support claims of disease modification [45][46] - **Market Positioning**: Differentiation from existing seizure medications by positioning zorevunersen as a true disease-modifying treatment [48][49] This summary encapsulates the critical points discussed during the Stoke Therapeutics FY Conference Call, highlighting the company's strategic focus, clinical advancements, financial health, and regulatory strategies.