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    Daniil Gataulin

    Senior Research Analyst at Chardan

    Daniil Gataulin, PhD, is a Senior Research Analyst at Chardan, specializing in biotech and life sciences coverage. He covers approximately 20 companies, including notable names such as Ocugen (OCGN) and Adverum Biotechnologies (ADVM), and has generated standout calls with returns up to 124% on individual ratings, though his overall success rate on TipRanks stands at 26%. Gataulin began his equity research career at Raymond James in 2019 before moving to Chardan in July 2021, where he advanced rapidly to his current senior role. He holds a PhD from the University of Chicago and is recognized for his analytical insight into emerging biotech equities.

    Daniil Gataulin's questions to REGENXBIO (RGNX) leadership

    Daniil Gataulin's questions to REGENXBIO (RGNX) leadership • Q2 2025

    Question

    Daniil Gataulin inquired if Regenxbio is considering an earlier FDA meeting for RGX-202 due to industry uncertainty and asked about the supply strategy for the SCS Microinjector, given that partner Clearside is restructuring.

    Answer

    President & CEO Curran Simpson expressed confidence in the microinjector supply, citing significant inventory and contractual provisions. Regarding the FDA, he stated that while they are considering it, there is no urgency for an earlier meeting for RGX-202. He noted they are in constant contact with review teams and are not detecting any shifts in expectations, and that recent events in DMD underscore the urgency for new therapies.

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    Daniil Gataulin's questions to REGENXBIO (RGNX) leadership • Q3 2024

    Question

    Daniil Gataulin of Chardan requested details on the newly authorized RGX-202 clinical trial in Canada and asked about plans for a bilateral (fellow eye) study for the suprachoroidal RGX-314 program.

    Answer

    Dr. Steve Pakola, CMO, confirmed the expansion into Canada and stated that data from Canadian sites will be relevant for the pivotal submission. For RGX-314, he said it is a logical next step to evaluate bilateral treatment with the suprachoroidal delivery method, and they are confident in doing so due to its compartmentalized delivery and favorable safety profile seen in single-eye studies.

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    Daniil Gataulin's questions to EyePoint Pharmaceuticals (EYPT) leadership

    Daniil Gataulin's questions to EyePoint Pharmaceuticals (EYPT) leadership • Q2 2025

    Question

    Daniil Gataulin asked about the geographic split of patients between the U.S. and ex-U.S. in the LUCHIA trial and the level of awareness and interest in DuraVu outside the United States.

    Answer

    CEO Dr. Jay Duker estimated the LUCHIA trial enrollment was approximately 80% U.S. and 20% ex-U.S., attributing the split to the very rapid enrollment pace in the U.S. He described the interest from ex-U.S. physicians and patients as 'really, really great,' given the high value placed on durable therapies in healthcare systems where frequent injections can be challenging.

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    Daniil Gataulin's questions to EyePoint Pharmaceuticals (EYPT) leadership • Q2 2025

    Question

    Daniil Gataulin of Chardan Capital Markets inquired about the fraction of U.S. versus ex-U.S. patients in the LUCHIA trial and the level of awareness and interest in DuraVu outside the United States.

    Answer

    CEO Jay Duker estimated the LUCHIA trial enrollment was approximately 80% U.S. and 20% ex-U.S., attributing the split to the rapid pace of enrollment in the U.S. before international sites were fully activated. He described the interest from ex-U.S. patients and practitioners as 'really, really great,' noting the significant need for durable therapies in countries where frequent injections pose a challenge.

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    Daniil Gataulin's questions to Ocugen (OCGN) leadership

    Daniil Gataulin's questions to Ocugen (OCGN) leadership • Q2 2025

    Question

    Daniil Gataulin from Chardan Capital Markets inquired about the OCU200 Phase 1 trial, asking about patient and physician interest and the timeline for initial data. He also sought details on the regulatory approval path for OCU400 in Korea and other Asian markets, and asked about the company's recent interactions with the FDA, particularly any impact from the recent leadership change at CBER.

    Answer

    Chief Medical Officer Dr. Huma Qamar reported that OCU200 is dosing in Cohort 3 with data expected late this year, noting good investigator interest due to its potential for non-responders to existing therapies. CEO Shankar Musunuri explained that the regulatory path in Korea and other markets will likely leverage the U.S. FDA approval, avoiding the need for additional local trials. He also stated that interactions with the FDA remain positive and prompt, with no negative impact observed on their programs following the leadership change at CBER.

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    Daniil Gataulin's questions to Ocugen (OCGN) leadership • Q1 2025

    Question

    Stephen, on behalf of Daniil Gataulin, asked whether patients treated in Europe are required for an OCU400 filing in the region, or if data from the U.S. and Canada would be sufficient.

    Answer

    Chief Medical Officer Dr. Huma Qamar stated that no additional trials or patients from Europe are necessary for the MAA filing. She explained that the current trial in the U.S. and Canada is sufficient for European approval, as it provides adequate representation of global mutations for the gene-agnostic therapy.

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    Daniil Gataulin's questions to Ocugen (OCGN) leadership • Q4 2024

    Question

    Daniil Gataulin from Chardan questioned the manufacturing strategy for OCU410ST, asking if a commercial-grade product would be used in the pivotal study, and inquired about the geographic distribution of trial sites.

    Answer

    CEO Dr. Shankar Musunuri confirmed that a commercial-scale product, the same used in Phase I, will be used for the Phase II/III trial for OCU410ST, a strategy agreed upon with the FDA. He also stated that the company is confident it can recruit the 51-patient trial entirely within the U.S.

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    Daniil Gataulin's questions to Ocugen (OCGN) leadership • Q3 2024

    Question

    Daniil Gataulin from Chardan inquired about Ocugen's strategy to capitalize on the lack of approved geographic atrophy treatments in Europe and any related regulatory interactions. He also asked about the potential for modifying the OCU410ST Phase II trial to serve as a pivotal study for registration.

    Answer

    Dr. Shankar Musunuri, CEO, responded that Ocugen plans to engage with EU regulators in the coming quarters for its geographic atrophy program, focusing on the functional endpoints they prioritize. Regarding the Stargardt program (OCU410ST), he confirmed they are exploring the possibility of converting the Phase II trial into a pivotal study. The company will pause to discuss this pathway with the FDA, citing new guidance for orphan disease gene therapies.

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    Daniil Gataulin's questions to Clearside Biomedical (CLSD) leadership

    Daniil Gataulin's questions to Clearside Biomedical (CLSD) leadership • Q4 2024

    Question

    Daniil Gataulin asked for an elaboration on the trial's redosing criteria, which rely on OCT biomarkers, how these criteria interact with the separate rescue criteria, and what role physician discretion plays in the redosing decision.

    Answer

    Dr. Victor Chong, Chief Medical Officer, distinguished between proactive 'redosing' based on specific OCT biomarkers like intraretinal fluid, and 'rescue' for significant disease progression. He explained that the protocol uses AI tools for consistent biomarker assessment to determine the dosing interval. He believes these tighter, protocol-driven redosing criteria will minimize the need for physician-discretionary rescue, thereby reducing regulatory risk, similar to the experience in recent competitor trials.

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    Daniil Gataulin's questions to COGNITION THERAPEUTICS (CGTX) leadership

    Daniil Gataulin's questions to COGNITION THERAPEUTICS (CGTX) leadership • Q4 2024

    Question

    Daniil Gataulin asked if Cognition Therapeutics is exploring any biomarkers for its Dementia with Lewy Bodies (DLB) program to increase the probability of success, and also inquired about the planned dosing for the pivotal studies in both AD and DLB.

    Answer

    Executive Anthony Caggiano explained that the company currently has no definitive biomarker enrichment strategy for DLB, as the SHIMMER trial showed a robust response across all patient subgroups. Regarding dosing, he stated that a final dose has not been selected but will likely be below 300mg, as the 100mg and 300mg doses produced nearly identical responses. The final dose selection will be part of the end-of-Phase II meeting discussions with the FDA.

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    Daniil Gataulin's questions to COGNITION THERAPEUTICS (CGTX) leadership • Q4 2024

    Question

    Inquired about the potential use of biomarkers to enrich the DLB program for pivotal studies and asked for clarification on the planned dosing for both the AD and DLB pivotal trials.

    Answer

    The company currently has no definitive biomarker enrichment strategy for the DLB program because a robust response was observed across all patient subgroups. The exact dose for pivotal studies has not been selected but will likely be below 300mg, as lower doses showed a nearly identical robust response. The final dose will be determined as part of the end-of-Phase II meeting with the FDA.

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    Daniil Gataulin's questions to COGNITION THERAPEUTICS (CGTX) leadership • Q2 2024

    Question

    Asked about the key learnings from the SHINE trial beyond trial size/duration, the impact of recent Alzheimer's drug approvals on trial enrollment, and the expected percentage of participants on concurrent therapies in the START trial.

    Answer

    Key learnings from SHINE include the consistent efficacy trend and the favorable profile of the 100mg dose. Recent drug approvals have generally boosted recruitment by increasing public awareness. The START trial is designed to stratify patients on concurrent therapies to properly evaluate combination use, though the exact percentage is still unknown.

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    Daniil Gataulin's questions to Outlook Therapeutics (OTLK) leadership

    Daniil Gataulin's questions to Outlook Therapeutics (OTLK) leadership • Q3 2024

    Question

    Daniil Gataulin asked how off-label bevacizumab use dynamics might change in the EU and U.K. post-approval and what key items are on the checklist for the European commercial launch planned for the first half of 2025.

    Answer

    Executive C. Trenary explained that off-label use varies by market, but he believes their approved product will compete effectively based on superior quality, clinical data, and GMP standards. For the launch checklist, he highlighted ongoing market access work with HTA groups in Germany and the U.K., physician education through symposia, and the final step of deploying a sales force and MSLs, either directly or with a partner.

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    Daniil Gataulin's questions to Outlook Therapeutics (OTLK) leadership • Q2 2024

    Question

    Asked about the timing of the FDA Type C/D meetings for CMC issues, whether a separate communication would be issued upon resolution, and the initial product formulation (vial vs. prefilled syringe).

    Answer

    The Type C and D meetings are scheduled for Q2 and Q3 of the year, and no specific updates will be provided as they are technical working meetings. The process is reportedly going well. The product will initially launch in vials, with the prefilled syringe project ongoing; an application for the syringe will follow the main product's FDA approval.

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    Daniil Gataulin's questions to Outlook Therapeutics (OTLK) leadership • Q2 2024

    Question

    Daniil Gataulin asked about the timing of the Type C and D meetings for CMC questions, whether a separate communication would follow, the initial product formulation, and the status of the prefilled syringe program.

    Answer

    Executive C. Trenary confirmed the Type C and D meetings are scheduled for Q2 and Q3 2024 but stated no specific updates would be provided on these technical discussions. He affirmed the initial product supply will be in vials. He also noted that the prefilled syringe program (NORSE SEVEN) is progressing, but an application for the syringe will only be submitted after securing the initial FDA approval for the vial formulation.

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    Daniil Gataulin's questions to Kodiak Sciences (KOD) leadership

    Daniil Gataulin's questions to Kodiak Sciences (KOD) leadership • Q4 2023

    Question

    Asked about the timeline for the second pivotal study for KSI-501 and the potential consequences if tarcocimab does not succeed in the DAYBREAK study.

    Answer

    The company has not disclosed a plan or timeline for the second KSI-501 pivotal study. A failure for tarcocimab in DAYBREAK would negatively impact its potential for approval and use in wet AMD, but the company views it as an educated and optimistic gamble.

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