{"success":true,"data":{"pressRelease":{"id":"105854","rtpr_id":"nGNE2KZfwq","ticker":"OCS","exchange":"NASDAQ","all_tickers":["OCS","CR5"],"title":"REG-Oculis Announces Positive FDA Pre-IND Feedback Supporting Privosegtor Development Strategy for Treatment of Acute Multiple Sclerosis Relapses","author":"Globe Newswire","published_at":"2026-08-03T08:00:00.167Z","article_body":"ZUG, Switzerland, Aug. 03, 2026 (GLOBE NEWSWIRE) --\n* The FDA Division of Neurology provided positive feedback supporting a\nregulatory pathway for Privosegtor in acute multiple sclerosis (MS) relapses,\naddressing a significant unmet medical need\n* The FDA confirmed that existing Privosegtor data can be cross-referenced for\na new Investigational New Drug (IND) application in acute MS relapses, planned\nfor submission in the fourth quarter of 2026\n* Privosegtor, a novel neuroprotective candidate, continues to advance across\ncore neuro-ophthalmology indications, including optic neuropathies and acute\nMS relapses, and is transforming Oculis as an emerging leader in\nneuro-ophthalmology \n* Oculis will host a virtual R&D Day in the fourth quarter of 2026 to provide\nfurther updates on its clinical pipeline\nOculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis” or the\n“Company”), a global biopharmaceutical company focused on breakthrough\ninnovations to address significant unmet medical needs in neuro-ophthalmology\nand ophthalmology, today announced positive U.S. Food and Drug Administration\n(FDA) pre-IND feedback regarding Privosegtor’s clinical development plan in\nacute multiple sclerosis (MS) relapses.\n\nPrivosegtor is a novel peptoid small-molecule candidate with potential\nneuroprotective properties.  In the previously completed Phase 2 ACUITY\nstudy, Privosegtor showed a clear neuroprotective effect in optic neuritis,\nimproving visual function, preserving retinal ganglion cell (RGC) layer\nintegrity, and reducing neurofilament levels, a biomarker of axonal injury.\nOptic neuritis is frequently observed during new onsets of MS or as a typical\nrelapse and serves as a well-established pathophysiological model that is\ngeneralizable to potentially all other acute MS relapses. The ACUITY study\nevaluated a broad population of patients with optic neuritis (ON), including\nthose with and without MS. The ACUITY study provided confidence to investigate\nPrivosegtor in the ongoing PIONEER global registrational program for optic\nneuritis. Expanding into acute MS relapses is a natural evolution for the\nPrivosegtor program as the Company looks to leverage positive learnings from\nthe ACUITY study and to address additional relapse types.\n\nOculis requested pre-IND feedback from the FDA to guide its development plans\nwith Privosegtor for a potential new indication in acute MS relapses. The FDA\nDivision of Neurology provided guidance that Oculis could cross-reference data\nfrom the open IND and that no additional preclinical studies are required for\nan IND submission in acute MS relapses. The constructive FDA feedback also\nsupported the proposed clinical development strategy and regulatory pathway,\nwhich will include MS patients with both optic neuritis and other relapses,\nsuch as ambulatory relapses, in future trials. It also supported a primary\nendpoint as early as 3 months, with the same 3mg/kg dose administered daily\nfor 5 days as in PIONEER-1. Oculis anticipates an IND submission for the\ntreatment of acute MS relapses in the fourth quarter of 2026.\n\nRiad Sherif, M.D., Chief Executive Officer of Oculis, remarked: “Our recent\npositive engagement with the FDA supports a regulatory pathway for Privosegtor\nin acute MS relapses, an area of high unmet need with no currently approved\nneuroprotective options. Building on positive Phase 2 ACUITY data in optic\nneuritis, a frequent type of MS relapse, we believe Privosegtor has the\npotential to mitigate neuroaxonal damage and improve recovery following acute\nrelapse events. This milestone significantly advances our strategy to build a\nleading neuro-ophthalmology pipeline, and we look forward to sharing further\ndetails on PIONEER and this new program at our upcoming R&D event later this\nyear.”\n\nProfessor Amit Bar-Or, M.D., Chief, Multiple Sclerosis Division, Department of\nNeurology, Perelman School of Medicine, University of Pennsylvania, added:\n“I am very encouraged at the prospect of a novel neuroprotective agent such\nas Privosegtor entering clinical development in acute MS relapses. While\nimmunomodulators are increasingly deployed in practice to reduce the frequency\nof relapses in MS patients, recovery from an acute event is very rarely\ncomplete. The neurodegeneration that occurs during these acute attacks\npersists after the relapse, leading to an accumulation of disabilities.\nPrivosegtor, as a CNS-penetrant neuroprotective agent, could potentially\nenhance recovery following relapses and improve long-term outcomes for people\nwith MS.”\n\nOculis management plans to host an R&D Day in the fourth quarter of 2026 to\nreview additional details on the pivotal development program for Privosegtor\nin acute MS relapses and provide a comprehensive update on the PIONEER program\nin optic neuropathies.\n\nMS is a chronic immune-mediated disease affecting approximately 2.8 million\npeople worldwide, including around 850,000 in the U.S. alone.(1-3) There are\ntwo main types of MS: relapsing-remitting MS (RRMS) and progressive MS. While\nprogressive MS remains a significant unmet medical need, RRMS is the most\ncommon type, representing ~85% of patients at initial diagnosis.(2) It is\ncurrently managed using immunomodulators or disease-modifying therapies (DMTs)\nthat reduce the rate of relapses and therefore related relapse-associated\nworsening (RAW). However, relapses still persist for many patients, with an\nestimated 170,000 MS relapses occurring each year in the U.S.(4)\n\nDuring an acute relapse, neurologists commonly use a short course of high-dose\ncorticosteroids to reduce inflammation and shorten the episode, as is also\nstandard of care in optic neuritis. However, corticosteroids do not influence\nthe long-term disability, and recovery from relapses is often incomplete, such\nas in optic neuritis. The tissue damage that occurs during these relapses can\ncontribute to neuroaxonal loss and the accumulation of functional disability\nover time, underscoring the need for therapies that protect neurons and axons\nduring relapses. There are currently no neuroprotective therapies approved for\nMS relapses, and there remains an urgent unmet medical need for treatments\nthat can prevent central nervous system damage.\n\nOur recent advancements create a robust clinical development roadmap\nopportunity for Privosegtor built on two distinct pillars:\n* Immediate Registrational Path: advancing optic neuritis as our primary\nregistrational indication through PIONEER-1, supported by ACUITY Phase 2\nfindings across functional, anatomical and biomarker measures and conducted\nunder a Special Protocol Assessment (SPA) with the FDA; and\n* First Expansion Wave: expanding into acute MS relapses as a natural\nextension of the optic neuritis program, leveraging the clinical and\npathophysiological relevance of optic neuritis as a common MS relapse type and\nthe FDA’s constructive feedback on the proposed development pathway.\n-ENDS-\n\nAbout Privosegtor\n\nPrivosegtor, a novel peptoid small-molecule candidate that crosses the\nblood-brain and retinal barriers, has the potential to become the first\nneuroprotective therapy for optic neuritis (ON) and other neuro-ophthalmic and\nneurological diseases. Positive results from the ACUITY Phase 2 trial showed\nPrivosegtor’s neuroprotective potential, as evidenced by improvements in\nvisual function, corroborated by anatomical preservation of the retina,\nincluding GCIPL and RNFL layers, and reduced neurofilament levels in the blood\nafter an acute episode of optic neuritis. Consistent results were observed in\nanimal models of glaucoma, optic neuritis, and multiple sclerosis (MS), where\nPrivosegtor preserved retinal ganglion cells and was associated with\nimprovements in mobility (clinical function disability) in the MS model.\n\nPrivosegtor has received Breakthrough Therapy designation from the U.S. Food\nand Drug Administration (FDA) and Priority Medicines (PRIME) designation from\nthe European Medicines Agency (EMA) as well as Orphan Drug designation from\nboth the FDA and the EMA for ON. Privosegtor is currently being evaluated in\nOculis’ PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy\nEvaluation Research) program, which includes two registrational trials in ON\nand one registrational trial in non-arteritic anterior ischemic optic\nneuropathy (NAION). Building on the ACUITY Phase 2 dataset in optic neuritis\nand constructive FDA pre-IND feedback, Oculis is also planning an IND\nsubmission for Privosegtor for the treatment of acute MS relapses.\n\nPrivosegtor is an investigational drug and has not received regulatory\napproval for commercial use in any country.\n\nAbout Oculis\n\nOculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused\non breakthrough innovations to address significant unmet medical needs in\nneuro-ophthalmology and ophthalmology. Oculis’ highly differentiated\nlate-stage clinical pipeline focuses on two core product candidates.\nPrivosegtor is a breakthrough neuroprotective candidate in the PIONEER\nprogram, which consists of studies intended to support registration plans for\ntreatment of optic neuropathies, including optic neuritis (ON) and\nnon-arteritic anterior ischemic optic neuropathy (NAION). Privosegtor also has\npotential to be developed for additional indications in other neuro-ophthalmic\nand neurological diseases. Licaminlimab is a novel, topical anti-TNFα in a\nregistrational trial, and is being developed with a genotype-based approach\nfor treating patients with dry eye disease (DED). Headquartered in Switzerland\nwith operations in the U.S., Iceland and Switzerland, Oculis is led by an\nexperienced management team with a successful track record and supported by\nleading international healthcare investors.\n\n            \nFor more information, please visit: www.oculis.com \n\nOculis Contact\nMs. Sylvia Cheung, CFO\nsylvia.cheung@oculis.com\n\nInvestor Relations \nLifeSci Advisors\nCorey Davis, Ph.D.\ncdavis@lifesciadvisors.com\n\nMedia Relations\nICR Healthcare\nAmber Fennell / David Daley / Sean Leous\noculis@icrhealthcare.com\n\nCautionary Statement Regarding Forward Looking Statements\n\nThis press release contains forward-looking statements and information. For\nexample, statements regarding the potential benefits of the Company’s\nproduct candidates, including the potential of Privosegtor to become the first\nneuroprotective therapy for ON and other neuro-ophthalmic and neurological\nindications including acute MS relapses, the initiation, timing, progress and\nresults of current and future clinical trials, including the planned IND\nsubmission for Privosegtor in acute MS relapses; the development of a pivotal\nclinical program for an acute MS relapse indication, including the clinical\ndevelopment strategy, trial design and expected endpoints, as well as the\npotential for Privosegtor’s results in ON to be predictive of outcomes in\nacute MS relapses; Oculis’ research and development programs, regulatory and\nbusiness strategy; Oculis’ future development plans; statements about market\nopportunity and the ability of Oculis’ product candidates to address those\nmarkets; and the timing or likelihood of regulatory interactions, filings and\napprovals, are forward-looking. All forward-looking statements are based on\nestimates and assumptions that, while considered reasonable by Oculis and its\nmanagement, are inherently uncertain and are inherently subject to risks,\nvariability, and contingencies, many of which are beyond Oculis’ control.\nThese forward-looking statements are provided for illustrative purposes only\nand are not intended to serve as, and must not be relied on by an investor as,\na guarantee, assurance, prediction or definitive statement of a fact or\nprobability. Actual events and circumstances are difficult or impossible to\npredict and will differ from assumptions. All forward-looking statements are\nsubject to risks, uncertainties and other factors that may cause actual\nresults to differ materially from those that we expected and/or those\nexpressed or implied by such forward-looking statements. Forward-looking\nstatements are subject to numerous conditions, many of which are beyond the\ncontrol of Oculis, including those set forth in the Risk Factors section of\nOculis’ annual report on Form 20-F and any other documents filed with the\nU.S. Securities and Exchange Commission (SEC). Copies of these documents are\navailable on the SEC’s website, www.sec.gov. Oculis undertakes no obligation\nto update these statements for revisions or changes after the date of this\nrelease, except as required by law.\n\nReferences:\n1. MS National Society\n2. Wallin et al., 2019, The prevalence of MS in the United States: A\npopulation-based estimate using health claims data - PubMed\n(https://pubmed.ncbi.nlm.nih.gov/30770430/)\n3. McGinley et al., 2021, Diagnosis and Treatment of Multiple Sclerosis: A\nReview - PubMed (https://pubmed.ncbi.nlm.nih.gov/33620411/)\n4. Multiple sources on relapse rate (ARR) including: Ocrelizumab versus\nfingolimod after natalizumab cessation in multiple sclerosis: an observational\nstudy - PubMed (https://pubmed.ncbi.nlm.nih.gov/34982200/)","article_body_html":"","raw_payload":{"data":{"id":"nGNE2KZfwq","title":"REG-Oculis Announces Positive FDA Pre-IND Feedback Supporting Privosegtor Development Strategy for Treatment of Acute Multiple Sclerosis Relapses","author":"Globe Newswire","ticker":"OCS","created":"2026-08-03T08:00:00.167Z","tickers":["OCS","CR5"],"exchange":"NASDAQ","article_body":"ZUG, Switzerland, Aug. 03, 2026 (GLOBE NEWSWIRE) --\n* The FDA Division of Neurology provided positive feedback supporting a\nregulatory pathway for Privosegtor in acute multiple sclerosis (MS) relapses,\naddressing a significant unmet medical need\n* The FDA confirmed that existing Privosegtor data can be cross-referenced for\na new Investigational New Drug (IND) application in acute MS relapses, planned\nfor submission in the fourth quarter of 2026\n* Privosegtor, a novel neuroprotective candidate, continues to advance across\ncore neuro-ophthalmology indications, including optic neuropathies and acute\nMS relapses, and is transforming Oculis as an emerging leader in\nneuro-ophthalmology \n* Oculis will host a virtual R&D Day in the fourth quarter of 2026 to provide\nfurther updates on its clinical pipeline\nOculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis” or the\n“Company”), a global biopharmaceutical company focused on breakthrough\ninnovations to address significant unmet medical needs in neuro-ophthalmology\nand ophthalmology, today announced positive U.S. Food and Drug Administration\n(FDA) pre-IND feedback regarding Privosegtor’s clinical development plan in\nacute multiple sclerosis (MS) relapses.\n\nPrivosegtor is a novel peptoid small-molecule candidate with potential\nneuroprotective properties.  In the previously completed Phase 2 ACUITY\nstudy, Privosegtor showed a clear neuroprotective effect in optic neuritis,\nimproving visual function, preserving retinal ganglion cell (RGC) layer\nintegrity, and reducing neurofilament levels, a biomarker of axonal injury.\nOptic neuritis is frequently observed during new onsets of MS or as a typical\nrelapse and serves as a well-established pathophysiological model that is\ngeneralizable to potentially all other acute MS relapses. The ACUITY study\nevaluated a broad population of patients with optic neuritis (ON), including\nthose with and without MS. The ACUITY study provided confidence to investigate\nPrivosegtor in the ongoing PIONEER global registrational program for optic\nneuritis. Expanding into acute MS relapses is a natural evolution for the\nPrivosegtor program as the Company looks to leverage positive learnings from\nthe ACUITY study and to address additional relapse types.\n\nOculis requested pre-IND feedback from the FDA to guide its development plans\nwith Privosegtor for a potential new indication in acute MS relapses. The FDA\nDivision of Neurology provided guidance that Oculis could cross-reference data\nfrom the open IND and that no additional preclinical studies are required for\nan IND submission in acute MS relapses. The constructive FDA feedback also\nsupported the proposed clinical development strategy and regulatory pathway,\nwhich will include MS patients with both optic neuritis and other relapses,\nsuch as ambulatory relapses, in future trials. It also supported a primary\nendpoint as early as 3 months, with the same 3mg/kg dose administered daily\nfor 5 days as in PIONEER-1. Oculis anticipates an IND submission for the\ntreatment of acute MS relapses in the fourth quarter of 2026.\n\nRiad Sherif, M.D., Chief Executive Officer of Oculis, remarked: “Our recent\npositive engagement with the FDA supports a regulatory pathway for Privosegtor\nin acute MS relapses, an area of high unmet need with no currently approved\nneuroprotective options. Building on positive Phase 2 ACUITY data in optic\nneuritis, a frequent type of MS relapse, we believe Privosegtor has the\npotential to mitigate neuroaxonal damage and improve recovery following acute\nrelapse events. This milestone significantly advances our strategy to build a\nleading neuro-ophthalmology pipeline, and we look forward to sharing further\ndetails on PIONEER and this new program at our upcoming R&D event later this\nyear.”\n\nProfessor Amit Bar-Or, M.D., Chief, Multiple Sclerosis Division, Department of\nNeurology, Perelman School of Medicine, University of Pennsylvania, added:\n“I am very encouraged at the prospect of a novel neuroprotective agent such\nas Privosegtor entering clinical development in acute MS relapses. While\nimmunomodulators are increasingly deployed in practice to reduce the frequency\nof relapses in MS patients, recovery from an acute event is very rarely\ncomplete. The neurodegeneration that occurs during these acute attacks\npersists after the relapse, leading to an accumulation of disabilities.\nPrivosegtor, as a CNS-penetrant neuroprotective agent, could potentially\nenhance recovery following relapses and improve long-term outcomes for people\nwith MS.”\n\nOculis management plans to host an R&D Day in the fourth quarter of 2026 to\nreview additional details on the pivotal development program for Privosegtor\nin acute MS relapses and provide a comprehensive update on the PIONEER program\nin optic neuropathies.\n\nMS is a chronic immune-mediated disease affecting approximately 2.8 million\npeople worldwide, including around 850,000 in the U.S. alone.(1-3) There are\ntwo main types of MS: relapsing-remitting MS (RRMS) and progressive MS. While\nprogressive MS remains a significant unmet medical need, RRMS is the most\ncommon type, representing ~85% of patients at initial diagnosis.(2) It is\ncurrently managed using immunomodulators or disease-modifying therapies (DMTs)\nthat reduce the rate of relapses and therefore related relapse-associated\nworsening (RAW). However, relapses still persist for many patients, with an\nestimated 170,000 MS relapses occurring each year in the U.S.(4)\n\nDuring an acute relapse, neurologists commonly use a short course of high-dose\ncorticosteroids to reduce inflammation and shorten the episode, as is also\nstandard of care in optic neuritis. However, corticosteroids do not influence\nthe long-term disability, and recovery from relapses is often incomplete, such\nas in optic neuritis. The tissue damage that occurs during these relapses can\ncontribute to neuroaxonal loss and the accumulation of functional disability\nover time, underscoring the need for therapies that protect neurons and axons\nduring relapses. There are currently no neuroprotective therapies approved for\nMS relapses, and there remains an urgent unmet medical need for treatments\nthat can prevent central nervous system damage.\n\nOur recent advancements create a robust clinical development roadmap\nopportunity for Privosegtor built on two distinct pillars:\n* Immediate Registrational Path: advancing optic neuritis as our primary\nregistrational indication through PIONEER-1, supported by ACUITY Phase 2\nfindings across functional, anatomical and biomarker measures and conducted\nunder a Special Protocol Assessment (SPA) with the FDA; and\n* First Expansion Wave: expanding into acute MS relapses as a natural\nextension of the optic neuritis program, leveraging the clinical and\npathophysiological relevance of optic neuritis as a common MS relapse type and\nthe FDA’s constructive feedback on the proposed development pathway.\n-ENDS-\n\nAbout Privosegtor\n\nPrivosegtor, a novel peptoid small-molecule candidate that crosses the\nblood-brain and retinal barriers, has the potential to become the first\nneuroprotective therapy for optic neuritis (ON) and other neuro-ophthalmic and\nneurological diseases. Positive results from the ACUITY Phase 2 trial showed\nPrivosegtor’s neuroprotective potential, as evidenced by improvements in\nvisual function, corroborated by anatomical preservation of the retina,\nincluding GCIPL and RNFL layers, and reduced neurofilament levels in the blood\nafter an acute episode of optic neuritis. Consistent results were observed in\nanimal models of glaucoma, optic neuritis, and multiple sclerosis (MS), where\nPrivosegtor preserved retinal ganglion cells and was associated with\nimprovements in mobility (clinical function disability) in the MS model.\n\nPrivosegtor has received Breakthrough Therapy designation from the U.S. Food\nand Drug Administration (FDA) and Priority Medicines (PRIME) designation from\nthe European Medicines Agency (EMA) as well as Orphan Drug designation from\nboth the FDA and the EMA for ON. Privosegtor is currently being evaluated in\nOculis’ PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy\nEvaluation Research) program, which includes two registrational trials in ON\nand one registrational trial in non-arteritic anterior ischemic optic\nneuropathy (NAION). Building on the ACUITY Phase 2 dataset in optic neuritis\nand constructive FDA pre-IND feedback, Oculis is also planning an IND\nsubmission for Privosegtor for the treatment of acute MS relapses.\n\nPrivosegtor is an investigational drug and has not received regulatory\napproval for commercial use in any country.\n\nAbout Oculis\n\nOculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused\non breakthrough innovations to address significant unmet medical needs in\nneuro-ophthalmology and ophthalmology. Oculis’ highly differentiated\nlate-stage clinical pipeline focuses on two core product candidates.\nPrivosegtor is a breakthrough neuroprotective candidate in the PIONEER\nprogram, which consists of studies intended to support registration plans for\ntreatment of optic neuropathies, including optic neuritis (ON) and\nnon-arteritic anterior ischemic optic neuropathy (NAION). Privosegtor also has\npotential to be developed for additional indications in other neuro-ophthalmic\nand neurological diseases. Licaminlimab is a novel, topical anti-TNFα in a\nregistrational trial, and is being developed with a genotype-based approach\nfor treating patients with dry eye disease (DED). Headquartered in Switzerland\nwith operations in the U.S., Iceland and Switzerland, Oculis is led by an\nexperienced management team with a successful track record and supported by\nleading international healthcare investors.\n\n            \nFor more information, please visit: www.oculis.com \n\nOculis Contact\nMs. Sylvia Cheung, CFO\nsylvia.cheung@oculis.com\n\nInvestor Relations \nLifeSci Advisors\nCorey Davis, Ph.D.\ncdavis@lifesciadvisors.com\n\nMedia Relations\nICR Healthcare\nAmber Fennell / David Daley / Sean Leous\noculis@icrhealthcare.com\n\nCautionary Statement Regarding Forward Looking Statements\n\nThis press release contains forward-looking statements and information. For\nexample, statements regarding the potential benefits of the Company’s\nproduct candidates, including the potential of Privosegtor to become the first\nneuroprotective therapy for ON and other neuro-ophthalmic and neurological\nindications including acute MS relapses, the initiation, timing, progress and\nresults of current and future clinical trials, including the planned IND\nsubmission for Privosegtor in acute MS relapses; the development of a pivotal\nclinical program for an acute MS relapse indication, including the clinical\ndevelopment strategy, trial design and expected endpoints, as well as the\npotential for Privosegtor’s results in ON to be predictive of outcomes in\nacute MS relapses; Oculis’ research and development programs, regulatory and\nbusiness strategy; Oculis’ future development plans; statements about market\nopportunity and the ability of Oculis’ product candidates to address those\nmarkets; and the timing or likelihood of regulatory interactions, filings and\napprovals, are forward-looking. All forward-looking statements are based on\nestimates and assumptions that, while considered reasonable by Oculis and its\nmanagement, are inherently uncertain and are inherently subject to risks,\nvariability, and contingencies, many of which are beyond Oculis’ control.\nThese forward-looking statements are provided for illustrative purposes only\nand are not intended to serve as, and must not be relied on by an investor as,\na guarantee, assurance, prediction or definitive statement of a fact or\nprobability. Actual events and circumstances are difficult or impossible to\npredict and will differ from assumptions. All forward-looking statements are\nsubject to risks, uncertainties and other factors that may cause actual\nresults to differ materially from those that we expected and/or those\nexpressed or implied by such forward-looking statements. Forward-looking\nstatements are subject to numerous conditions, many of which are beyond the\ncontrol of Oculis, including those set forth in the Risk Factors section of\nOculis’ annual report on Form 20-F and any other documents filed with the\nU.S. Securities and Exchange Commission (SEC). Copies of these documents are\navailable on the SEC’s website, www.sec.gov. Oculis undertakes no obligation\nto update these statements for revisions or changes after the date of this\nrelease, except as required by law.\n\nReferences:\n1. MS National Society\n2. Wallin et al., 2019, The prevalence of MS in the United States: A\npopulation-based estimate using health claims data - PubMed\n(https://pubmed.ncbi.nlm.nih.gov/30770430/)\n3. McGinley et al., 2021, Diagnosis and Treatment of Multiple Sclerosis: A\nReview - PubMed (https://pubmed.ncbi.nlm.nih.gov/33620411/)\n4. Multiple sources on relapse rate (ARR) including: Ocrelizumab versus\nfingolimod after natalizumab cessation in multiple sclerosis: an observational\nstudy - PubMed (https://pubmed.ncbi.nlm.nih.gov/34982200/)"},"type":"article","timestamp":"2026-08-03T08:00:00.299108467Z","server_sent_at_ms":1785744000299},"received_at":"2026-08-03T08:00:00.395Z","source_url":null},"analysis":{"id":"94865","press_release_id":"105854","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"Oculis received positive pre-IND feedback from the FDA for Privosegtor, supporting a regulatory pathway for the treatment of acute multiple sclerosis relapses.\n\nThe agency confirmed that existing data can be cross-referenced for a new IND submission, which is now planned for the fourth quarter of 2026 without the need for additional preclinical studies.\n\nThe proposed clinical strategy includes a primary endpoint as early as 3 months using the same 3mg/kg dose regimen currently in the PIONEER program.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"FDA clears Privosegtor for MS relapse expansion without new preclinical work; IND filing set for Q4."},"keyFigures":{"drugName":"Privosegtor","phaseOfTrial":"Phase 2","customDimensions":{"dose":"3mg/kg","primary_endpoint":"3 months","planned_ind_submission":"fourth quarter of 2026","orphan_drug_designation":true,"breakthrough_therapy_designation":true}},"quotedText":"Our recent positive engagement with the FDA supports a regulatory pathway for Privosegtor in acute MS relapses, an area of high unmet need with no currently approved neuroprotective options.","namedEntities":{"people":[{"name":"Riad Sherif","role":"Chief Executive Officer"},{"name":"Professor Amit Bar-Or","role":"Chief, Multiple Sclerosis Division, Perelman School of Medicine"},{"name":"Sylvia Cheung","role":"CFO"}],"products":["Privosegtor","Licaminlimab"],"companies":[{"name":"Oculis Holding AG","ticker":"OCS"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"European Medicines Agency","relationship":"regulator"},{"name":"LifeSci Advisors","relationship":"investor relations"},{"name":"ICR Healthcare","relationship":"media relations"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Positive FDA pre-IND feedback significantly de-risks the expansion strategy for Privosegtor into acute MS relapses by confirming the existing data package is sufficient and waiving new preclinical studies."},"tickerRelevance":{"others":[],"primary":"OCS"},"globalImportance":35,"audienceRelevance":40,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"clinical_stage_biotech","eventGravity":"FDA_pre_IND_clearance","sectorWeight":"biotech"}},"event_type":"regulatory","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":3,"narrative":"Oculis received positive pre-IND feedback from the FDA for Privosegtor, supporting a regulatory pathway for the treatment of acute multiple sclerosis relapses.\n\nThe agency confirmed that existing data can be cross-referenced for a new IND submission, which is now planned for the fourth quarter of 2026 without the need for additional preclinical studies.\n\nThe proposed clinical strategy includes a primary endpoint as early as 3 months using the same 3mg/kg dose regimen currently in the PIONEER program.","key_figures":{"drugName":"Privosegtor","phaseOfTrial":"Phase 2","customDimensions":{"dose":"3mg/kg","primary_endpoint":"3 months","planned_ind_submission":"fourth quarter of 2026","orphan_drug_designation":true,"breakthrough_therapy_designation":true}},"named_entities":{"people":[{"name":"Riad Sherif","role":"Chief Executive Officer"},{"name":"Professor Amit Bar-Or","role":"Chief, Multiple Sclerosis Division, Perelman School of Medicine"},{"name":"Sylvia Cheung","role":"CFO"}],"products":["Privosegtor","Licaminlimab"],"companies":[{"name":"Oculis Holding AG","ticker":"OCS"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"European Medicines Agency","relationship":"regulator"},{"name":"LifeSci Advisors","relationship":"investor relations"},{"name":"ICR Healthcare","relationship":"media relations"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-03T08:01:58.970Z","global_importance":35,"audience_relevance":40,"importance_components":{"tickerTier":"clinical_stage_biotech","eventGravity":"FDA_pre_IND_clearance","sectorWeight":"biotech"}},"durationMs":118555,"modelName":"glm-4.7"}}