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    Divya Rao • TD Cowen

    Divya Rao's questions to Agios Pharmaceuticals Inc (AGIO) leadership

    Divya Rao's questions to Agios Pharmaceuticals Inc (AGIO) leadership •

    Question

    Divya Rao of TD Cowen asked about the planned timing and design for pediatric trials in thalassemia and questioned what constitutes the bar for success for the Phase IIb study of tebapivat in MDS, given the initial 5mg dose showed a modest signal.

    Answer

    CMO Dr. Sarah Gheuens indicated the pediatric thalassemia trial approach would be similar to the one in PK deficiency, with timing to be detailed later. For tebapivat in MDS, she explained the Phase IIb is testing higher doses (10, 15, 20mg) and the primary endpoint is transfusion independence for at least 8 consecutive weeks, a clinically meaningful bar set after advisory feedback.

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    Divya Rao's questions to Agios Pharmaceuticals Inc (AGIO) leadership • Q1 2025

    Question

    Divya Rao of TD Cowen inquired about the FDA review process for PYRUKYND, asking if communication frequency had changed amid agency reshuffling and if there is a firm deadline for the FDA to announce a potential advisory committee meeting.

    Answer

    CMO Dr. Sarah Gheuens responded that communication with the FDA remains normal and consistent, with a standard back-and-forth process. She clarified that while the FDA can always request an advisory committee during a review, the agency has informed Agios that none is planned at this time. CEO Brian Goff added that the strength of the Phase III data in a high-unmet-need area likely contributes to the smooth progression of the review.

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    Divya Rao's questions to Agios Pharmaceuticals Inc (AGIO) leadership • Q4 2024

    Question

    Divya Rao from TD Cowen asked about any modifications to the sickle cell disease trial protocol following the liver toxicity disclosure and questioned the long-term development path for tevapivat in sickle cell, including whether it is intended for pivotal development.

    Answer

    Chief Medical Officer Dr. Sarah Gheuens clarified that liver enzyme monitoring was already standard in the trial's core period, and the open-label extension was simply aligned to that frequency. Regarding tevapivat, Chief Financial Officer Cecilia Jones stated that Agios aims to build a sickle cell franchise with both PYRUKYND and tevapivat, with final positioning to be determined by clinical data and the competitive landscape. CEO Brian Goff added that more trial design details would be shared mid-year.

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    Divya Rao's questions to Vertex Pharmaceuticals Inc (VRTX) leadership

    Divya Rao's questions to Vertex Pharmaceuticals Inc (VRTX) leadership • Q2 2025

    Question

    Divya Rao of Cowen and Company asked about the process for patients obtaining free Gernavix samples and requested a breakdown of Gernavix prescriptions between retail and hospital settings, as well as the types of physicians prescribing it.

    Answer

    EVP and CCO Duncan McKechnie clarified that physicians provide free samples directly to patients, so they do not appear in retail data. He stated that approximately 65% of prescriptions are retail, with the remainder in hospitals. Prescribers are broad, including general, plastic, and orthopedic surgeons, dentists, and anesthesiologists.

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    Divya Rao's questions to Apellis Pharmaceuticals Inc (APLS) leadership

    Divya Rao's questions to Apellis Pharmaceuticals Inc (APLS) leadership • Q2 2025

    Question

    Divya Rao from TD Cowen inquired if the competitor's label expansion has impacted Cyfovri prescribing patterns and asked what specific launch metrics can be expected for Empaveli in C3G and IC-MPGN.

    Answer

    CEO Dr. Cedric Francois noted the competitor's label update highlighted its limitations. For the Empaveli launch, EVP David Acheson stated that Apellis will initially report on the transition of EAP patients, new start forms, and REMS enrollments, with plans to report patients on product over time.

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