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    Anish NikhanjRBC Capital Markets

    Anish Nikhanj's questions to Nuvation Bio Inc (NUVB) leadership

    Anish Nikhanj's questions to Nuvation Bio Inc (NUVB) leadership • Q2 2025

    Question

    Anish Nikhanj from RBC Capital Markets requested a breakdown of the 70 patients on Iptrozy, seeking to differentiate between those from early access programs, free drug programs, and paid commercial prescriptions.

    Answer

    CEO David Hung clarified that none of the 70 patients were from clinical trials. He stated that only six were from the early access program (EAP) and that the majority are commercially paying patients, with a 'relatively small minority' on a free drug program who are expected to convert to paid status in the following month.

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    Anish Nikhanj's questions to Exelixis Inc (EXEL) leadership

    Anish Nikhanj's questions to Exelixis Inc (EXEL) leadership • Q2 2025

    Question

    Anish Nikhanj of RBC Capital Markets asked how Exelixis is balancing zanzalutinib's development between being a life-cycle extension for cabozantinib (in RCC, NET) and expanding into broader, new indications.

    Answer

    CEO Michael Morrissey explained the strategy is to maximize zanzalutinib's impact by pursuing both paths. This includes new combinations in existing areas (like with belzutifan in RCC), head-to-head trials in NET, and expanding into new, large opportunities like earlier-line CRC to build a franchise that will 'eclipse' cabozantinib.

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    Anish Nikhanj's questions to MannKind Corp (MNKD) leadership

    Anish Nikhanj's questions to MannKind Corp (MNKD) leadership • Q1 2025

    Question

    Anish Nikhanj of RBC Capital Markets questioned the rationale behind the upcoming Afrezza adult label update and its potential to increase uptake. He also asked about supply chain risks from the macro backdrop for the company's key products.

    Answer

    Executive Michael Castagna stated the label change aims for a better conversion dose to improve time-in-range, with approval expected in Q4. CFO Christopher Prentiss added that since key products are manufactured in their Connecticut facility, they feel good about managing through the evolving tariff situation, noting key materials are either exempt or manageable.

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    Anish Nikhanj's questions to MannKind Corp (MNKD) leadership • Q4 2024

    Question

    Anish Nikhanj, on behalf of RBC Capital Markets, questioned the anticipated launch trajectory and hurdles for Afrezza in pediatrics and the expected revenue contribution from the Cipla partnership in India.

    Answer

    Executive Michael Castagna identified three critical factors for the pediatric launch: a seamless reimbursement hub, strong institutional selling capabilities, and effective education campaigns. Regarding the Cipla deal, he stated that while the first shipment is expected by year-end, the primary initial benefit will be improved manufacturing efficiency and COGS, with a more significant sales inflection anticipated in 2026.

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    Anish Nikhanj's questions to MannKind Corp (MNKD) leadership • Q3 2024

    Question

    Anish Nikhanj, on behalf of Gregory Renza at RBC Capital Markets, asked about the economic value proposition for MNKD-101 versus competitors and whether MNKD-201 could potentially be used in progressive pulmonary fibrosis (PPF).

    Answer

    Executive Michael Castagna detailed MNKD-101's value proposition, which includes leveraging clofazimine's known efficacy while minimizing systemic side effects and reducing patient burden with a 28-day on, 56-day off dosing schedule. Regarding MNKD-201, he acknowledged the potential for PPF and stated they would hope for indication extrapolation, but the initial focus remains on IPF due to the larger patient population and trial predictability.

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    Anish Nikhanj's questions to Fulcrum Therapeutics Inc (FULC) leadership

    Anish Nikhanj's questions to Fulcrum Therapeutics Inc (FULC) leadership • Q1 2025

    Question

    Anish Nikhanj, on for Gregory Renza at RBC Capital Markets, asked about the potential impact of FDA shifts on pociredir's development, particularly regarding endpoint selection like HbF as a surrogate marker. He also inquired about the company's discovery pipeline and how it plans to differentiate its novel HbF inducers from other mechanisms.

    Answer

    Iain Fraser, Head of Development, responded that the company plans to engage with the FDA in an end-of-Phase I meeting after the 20-milligram cohort data is available to discuss the development path. Regarding the pipeline, he stated that Fulcrum is looking 'broadly and agnostically' at compounds that induce HbF and is closely monitoring other mechanisms entering the clinic, such as WIZ degraders and DNMT1 inhibitors.

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    Anish Nikhanj's questions to Fulcrum Therapeutics Inc (FULC) leadership • Q4 2024

    Question

    Anish Nikhanj from RBC Capital Markets questioned the FDA's receptiveness to using HbF induction as a surrogate for VOC reduction and asked about Fulcrum's pipeline and business development interests outside of hematology.

    Answer

    Executive Iain Fraser confirmed that Fulcrum is actively pursuing discussions with the FDA this year to use HbF as a surrogate endpoint, citing abundant supporting data. CEO Alexander Sapir stated that while the company's focus remains on rare benign hematology, they are conducting preclinical experiments with their PRC2 inhibitors in prostate cancer models, prompted by promising data from other companies, though a move into oncology is not a current strategic goal.

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    Anish Nikhanj's questions to CorMedix Inc (CRMD) leadership

    Anish Nikhanj's questions to CorMedix Inc (CRMD) leadership • Q4 2024

    Question

    Anish Nikhanj, on for Gregory Renza, questioned the trends in Medicare Advantage coverage under TDAPA and the key strategies CorMedix is using to maximize DefenCath uptake to secure a favorable post-TDAPA add-on adjustment.

    Answer

    Executive Joseph Todisco highlighted that Medicare Advantage claims grew from nearly zero at launch to 40% in Q1 2025, a positive trend. He explained that to prepare for the post-TDAPA environment, CorMedix is conducting a real-world evidence study with U.S. Renal Care. The pharmacoeconomic data from this study will be crucial for direct contract negotiations with Medicare Advantage plans to secure sustainable, separate reimbursement.

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    Anish Nikhanj's questions to Pacira Biosciences Inc (PCRX) leadership

    Anish Nikhanj's questions to Pacira Biosciences Inc (PCRX) leadership • Q3 2024

    Question

    Anish Nikhanj, on for Gregory Renza, inquired about the onboarding and ordering process for the new GPO contracts and how the NOPAIN Act's ASP+6% reimbursement can be leveraged to defend EXPAREL against a potential generic.

    Answer

    CEO Frank Lee explained that it is still early for the GPO contracts and the company will work closely with customers to ensure adoption. Regarding generics, he emphasized that multiple patents protect EXPAREL, not just the one in the recent litigation ruling, and that the company continues to innovate. He stated that an at-risk launch is not considered imminent.

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