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    Colleen Hanley

    Research Analyst at Baird

    Colleen Hanley is an Equity Research Associate at Baird, specializing in equity research and analysis within the financial services sector. She contributes research and support for coverage of publicly traded companies, working closely with senior analysts to deliver actionable investment insights, though specific performance metrics and rankings are not publicly available. Hanley began her career in investment research after completing her academic studies, joining Baird in her early professional years, with no prior roles at other major financial institutions reported. Her credentials include professional registration with relevant securities authorities, and she maintains active participation in equity research functions at Baird.

    Colleen Hanley's questions to Mersana Therapeutics (MRSN) leadership

    Colleen Hanley's questions to Mersana Therapeutics (MRSN) leadership • Q1 2025

    Question

    Colleen Hanley requested more color on the rationale for pursuing a randomized Phase III trial, which management suggested wouldn't take much longer than a single-arm study. She also asked about the work needed to confirm the B7-H4 expression cutoff for patient selection.

    Answer

    An executive, likely CEO Dr. Martin Huber, detailed the advantages of a randomized trial, including broader global regulatory acceptance, avoiding a separate confirmatory trial, and generating robust PFS and OS data quickly. Regarding the B7-H4 biomarker, he explained that work to refine the assay is ongoing in the expansion cohorts. CEO Dr. Martin Huber added that while the exact cutoff score might be tweaked, they anticipate the positive patient population will remain in the 40-50% range, identifying a consistent group of patients.

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    Colleen Hanley's questions to Coherus Oncology (CHRS) leadership

    Colleen Hanley's questions to Coherus Oncology (CHRS) leadership • Q1 2025

    Question

    Colleen Hanley of Robert W. Baird & Co. asked for more details on the Type D meeting with the FDA for CHS-114 and inquired about the company's interest in adding another commercial-stage asset to leverage its sales infrastructure.

    Answer

    Chief Scientific and Development Officer Dr. Theresa Lavallee explained the Type D meeting was focused on Project Optimus for CHS-114, and the FDA found their approach acceptable, a positive development. CEO Dennis Lanfear stated that while they are keen to add another product to the sales bag eventually, the focus for the next year is to fully establish LOQTORZI in the NPC market.

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    Colleen Hanley's questions to Karyopharm Therapeutics (KPTI) leadership

    Colleen Hanley's questions to Karyopharm Therapeutics (KPTI) leadership • Q1 2025

    Question

    Colleen Hanley inquired about the basis for the SENTRY trial's futility analysis, the statistical delta required for the Total Symptom Score (TSS) endpoint to be considered positive, and the reasons for the slight delay in trial enrollment.

    Answer

    Reshma Rangwala, EVP and Chief Medical Officer, explained that the futility analysis was based on unblinded SVR35 and absolute TSS data from the first 61 patients, with thresholds set to ensure no worsening for the combination therapy. She clarified that the study's statistical assumptions include a 4-point delta on TSS for over 80% power. Rangwala also acknowledged that while enrollment remains robust, it has been slightly slower than anticipated in early 2025, leading to the updated June-July completion timeline.

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    Colleen Hanley's questions to Karyopharm Therapeutics (KPTI) leadership • Q4 2024

    Question

    Colleen Hanley of Leerink Partners inquired about the statistical requirements for the Phase III SENTRY trial in myelofibrosis, specifically the necessary reduction in Total Symptom Score (TSS) to achieve statistical significance. She also asked for more details on the FDA discussions that led to modifications in the Phase III endometrial cancer study design and whether the new MMR status requirement would impact enrollment speed.

    Answer

    Chief Medical Officer Reshma Rangwala explained that based on historical data from other trials like MANIFEST, a small point difference in absolute TSS can achieve statistical significance, giving them confidence in the SENTRY trial's design. Regarding the endometrial cancer trial, Dr. Rangwala clarified that the discussions with the FDA were prompted by the evolving standard of care, which now includes checkpoint inhibitors. The FDA recommended focusing on the pMMR population, which benefits less from checkpoints but showed a strong signal with selinexor in the SIENDO subgroup. She confirmed that testing for MMR status is standard practice and will not be an obstacle to enrollment.

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    Colleen Hanley's questions to AGENUS (AGEN) leadership

    Colleen Hanley's questions to AGENUS (AGEN) leadership • Q1 2025

    Question

    Colleen Hanley asked about any interactions with the new FDA leadership, sought more detail on the publication that influenced the FDA's prior decision, questioned Dr. Goldberg on his focus between metastatic and neoadjuvant CRC, and inquired about the data disclosure strategy.

    Answer

    CEO Garo Armen stated they have not yet engaged the 'new FDA' but will present the totality of data at the Type B meeting. He identified the influential publication as a New England Journal of Medicine article, which he argued was partial in its depiction of IO efficacy. Dr. Richard Goldberg, Chief Development Officer, confirmed his focus is on CRC, highlighting the transformative potential in the neoadjuvant setting to help patients avoid toxic therapies. Mr. Armen also noted the acceptable safety profile seen in neoadjuvant studies.

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    Colleen Hanley's questions to OCULAR THERAPEUTIX (OCUL) leadership

    Colleen Hanley's questions to OCULAR THERAPEUTIX (OCUL) leadership • Q4 2024

    Question

    Colleen Hanley asked if the redosing in SOL-1 is solely for FDA safety requirements or if it includes an efficacy component. She also inquired about the reason for changing the SOL-R primary endpoint from 48 weeks to 56 weeks and requested an update on SOL-R recruitment timelines.

    Answer

    President and CEO Dr. Pravin Dugel explained the SOL-1 redosing is primarily for FDA safety requirements but also provides valuable data on 12-month durability, which could support label flexibility, while the primary endpoint at 9 months remains unchanged. He clarified the SOL-R endpoint shifted to 56 weeks after the FDA indicated a preference for an endpoint at 52 weeks or later, a change from the initial 'at risk' proposal of 48 weeks. He noted SOL-R recruitment was strong but it was too early for a specific timeline update.

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    Colleen Hanley's questions to OCULAR THERAPEUTIX (OCUL) leadership • Q2 2024

    Question

    Colleen Hanley asked if Ocular intends to pursue a Special Protocol Assessment (SPA) for the SOL-R study following the positive FDA feedback. She also questioned if any modifications are planned for the SOL-R trial design and sought confirmation on the FDA's view of the high-dose Eylea comparator arm's role.

    Answer

    Dr. Pravin Dugel, President and CEO, explained that the company received a written response to its Type C meeting request and has not yet decided whether to pursue a SPA for SOL-R, as the primary goal is speed to market. He stated that no significant changes to the SOL-R design are anticipated, as the FDA found it acceptable for registration. He reiterated that the comparator arm is for masking purposes only and not for statistical analysis, which is in line with FDA requirements.

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