{"success":true,"data":{"pressRelease":{"id":"115106","rtpr_id":"nGNXc2Ynp5","ticker":"ACIU","exchange":"NASDAQ","all_tickers":["ACIU"],"title":"AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD)","author":"Globe Newswire","published_at":"2026-08-11T11:00:00.370Z","article_body":"AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active\nImmunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD)\n* Ongoing Phase 2 VacSYn study to expand to sites in USA with Investigational\nNew Drug (IND) clearance\n* Recent positive interim results showed safety and immunogenicity with early\nsignals of activity\n* Full week-100 results from Part 1 of VacSYn trial expected in H2 2026\nLausanne, Switzerland, August 11, 2026 – AC Immune SA (NASDAQ: ACIU), a\nclinical-stage biopharmaceutical company developing targeted therapeutics for\nneurodegenerative diseases, today announced that it has received Fast Track\ndesignation and clearance of its Investigational New Drug (IND) application\nfrom the U.S. Food and Drug Administration (FDA) for its wholly owned\nanti-alpha-synuclein (a-syn) active immunotherapy candidate, ACI-7104, for the\ntreatment of early-stage Parkinson’s disease (PD).\n\nACI-7104 is designed to induce a-syn-specific antibodies, preferentially\nrecognizing aggregated a-syn species that are toxic to neurons. The candidate\nis currently being investigated in the VacSYn Phase 2 trial, an adaptive,\nbiomarker-based study in patients with early-stage Parkinson’s disease, with\nfinal Part 1 week-100 results on track to be announced in H2.\n\nMartin Zügel, interim CEO of AC Immune SA, commented: “Fast Track\ndesignation and IND clearance from the FDA are important achievements for\nACI-7104, one of our wholly-owned programs, given its potential to address the\nsignificant unmet need in Parkinson’s. We look forward to working closely\nwith the FDA as we advance ACI-7104 through its ongoing clinical development\ntowards potentially delivering a much-needed treatment option for patients.”\n\nFDA Fast Track designation reflects the early interim Phase 2 data\ndemonstrating safety, tolerability and immunogenicity, and providing first\nsignals that targeting underlying a-syn pathology with an active immunotherapy\ncould potentially impact PD. The interim results, reported for Part 1 of the\nstudy at 76 weeks, successfully demonstrated ACI-7104 was safe and well\ntolerated, with no clinically relevant safety issues being reported. Targets\nwere also met for immunogenicity with a 100% responder rate. AC Immune\nrecently announced a $4 million research grant from the Vijay and Marie\nGoradia Charitable Foundation to support the extension of Part 1 of the VacSYn\ntrial, enabling the assessment of long-term safety and efficacy of ACI-7104\nfor an additional two years.\n\nGünther Staffler, Executive Vice President, Development at AC Immune SA,\ncommented: “ACI-7104 represents a promising active immunotherapy designed\nto target pathological a-syn for the treatment of prodromal and early PD. The\nFDA’s decision signifies the growing importance of the program including the\npositive interim Phase 2 findings. This is a key regulatory milestone for the\nprogram, and we look forward to delivering the full results from Part 1 of the\nVacSYn trial in the coming months.”\n\nAbout ACI-7104\n\nACI-7104 is an optimized formulation of AC Immune’s anti-a-syn predecessor\nactive immunotherapy which generated an antibody response against pathological\noligomeric a-syn to inhibit spreading and downstream neurodegeneration in\nearly Parkinson’s disease. The accumulation of alpha-synuclein protein\naggregates has been shown to cause inflammatory stress in cells and\ncontributes to the degeneration of neurons in the brain, linking it to the\ndevelopment of neurodegenerative diseases such as Parkinson’s Disease.\n\nAbout AC Immune SA \n\nAC Immune (NASDAQ: ACIU) is a clinical stage biopharmaceutical company\ndeveloping a pipeline of products, including both active immunotherapies and\nsmall molecules, targeting key misfolded proteins and pathways for the\ntreatment of multiple neurodegenerative diseases. The company has a growing\nfocus on its wholly owned proprietary clinical-stage programs, including:\nACI-7104, an active immunotherapy targeting α-synuclein (α-syn) in\nParkinson's disease; and ACI-19764, a small molecule inhibitor of the NLRP3\ninflammasome. In addition, an early-stage small molecule development program\ntargeting intracellular a-syn is advancing towards the clinic.\n\nACIU has a strong track record of securing strategic partnerships with leading\nglobal pharmaceutical companies, resulting in substantial non-dilutive funding\nand >$4.5 billion in potential milestone payments. ACIU’s pharma-partnered\nprograms, all in Alzheimer’s disease, include: a collaboration on ACI-24, an\nactive immunotherapy targeting Abeta; a collaboration on ACI-35 targeting\nphospho-Tau; and a collaboration developing brain-penetrant small molecule\ndrugs targeting intracellular pathologic Tau.\n\nAll trademarks used or mentioned in this release are protected by law. The\ninformation on our website and any other websites referenced herein is\nexpressly not incorporated by reference into, and does not constitute a part\nof, this press release.\n\nFor further information, please contact:\n\n SVP, Investor Relations & Corporate Communications  Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com                        \n International Media  Optimum Strategic Communications Nick Bastin, Joshua Evans, Aoife Minihan, Ben Cowe Phone: +44 (0) 20 4566 8543 Email: acimmune@optimumcomms.com    \n\nForward looking statements\n\nThis press release contains statements that constitute “forward-looking\nstatements” within the meaning of Section 27A of the Securities Act of 1933\nand Section 21E of the Securities Exchange Act of 1934. Forward-looking\nstatements are statements other than historical fact and may include\nstatements that address future operating, financial or business performance or\nAC Immune’s strategies or expectations. In some cases, you can identify\nthese statements by forward-looking words such as “may,” “might,”\n“will,” “should,” “expects,” “plans,” “anticipates,”\n“believes,” “estimates,” “predicts,” “projects,”\n“potential,” “outlook” or “continue,” and other comparable\nterminology. Forward-looking statements are based on management’s current\nexpectations and beliefs and involve significant risks and uncertainties that\ncould cause actual results, developments and business decisions to differ\nmaterially from those contemplated by these statements. These risks and\nuncertainties include those described under the captions “Item 3. Key\nInformation – Risk Factors” and “Item 5. Operating and Financial Review\nand Prospects” in AC Immune’s Annual Report on Form 20-F and other filings\nwith the Securities and Exchange Commission. These include: the impact of\nCovid-19 on our business, suppliers, patients and employees and any other\nimpact of Covid-19. Forward-looking statements speak only as of the date they\nare made, and AC Immune does not undertake any obligation to update them in\nlight of new information, future developments or otherwise, except as may be\nrequired under applicable law. All forward-looking statements are qualified in\ntheir entirety by this cautionary statement.\n\nAttachment\n*     20260810__ACIU ACI-7104 IND+FastTrack PR_final\n(https://ml-eu.globenewswire.com/Resource/Download/b63f43a4-04aa-41c4-830e-4b9dd4009005)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/0065cdfd-b9fc-4994-8aca-731c1d031b51)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXc2Ynp5","title":"AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active Immunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD)","author":"Globe Newswire","ticker":"ACIU","created":"2026-08-11T11:00:00.370Z","tickers":["ACIU"],"exchange":"NASDAQ","article_body":"AC Immune Receives FDA Fast Track Designation for Anti-Alpha-synuclein Active\nImmunotherapy, ACI-7104, to Treat Early Parkinson’s Disease (PD)\n* Ongoing Phase 2 VacSYn study to expand to sites in USA with Investigational\nNew Drug (IND) clearance\n* Recent positive interim results showed safety and immunogenicity with early\nsignals of activity\n* Full week-100 results from Part 1 of VacSYn trial expected in H2 2026\nLausanne, Switzerland, August 11, 2026 – AC Immune SA (NASDAQ: ACIU), a\nclinical-stage biopharmaceutical company developing targeted therapeutics for\nneurodegenerative diseases, today announced that it has received Fast Track\ndesignation and clearance of its Investigational New Drug (IND) application\nfrom the U.S. Food and Drug Administration (FDA) for its wholly owned\nanti-alpha-synuclein (a-syn) active immunotherapy candidate, ACI-7104, for the\ntreatment of early-stage Parkinson’s disease (PD).\n\nACI-7104 is designed to induce a-syn-specific antibodies, preferentially\nrecognizing aggregated a-syn species that are toxic to neurons. The candidate\nis currently being investigated in the VacSYn Phase 2 trial, an adaptive,\nbiomarker-based study in patients with early-stage Parkinson’s disease, with\nfinal Part 1 week-100 results on track to be announced in H2.\n\nMartin Zügel, interim CEO of AC Immune SA, commented: “Fast Track\ndesignation and IND clearance from the FDA are important achievements for\nACI-7104, one of our wholly-owned programs, given its potential to address the\nsignificant unmet need in Parkinson’s. We look forward to working closely\nwith the FDA as we advance ACI-7104 through its ongoing clinical development\ntowards potentially delivering a much-needed treatment option for patients.”\n\nFDA Fast Track designation reflects the early interim Phase 2 data\ndemonstrating safety, tolerability and immunogenicity, and providing first\nsignals that targeting underlying a-syn pathology with an active immunotherapy\ncould potentially impact PD. The interim results, reported for Part 1 of the\nstudy at 76 weeks, successfully demonstrated ACI-7104 was safe and well\ntolerated, with no clinically relevant safety issues being reported. Targets\nwere also met for immunogenicity with a 100% responder rate. AC Immune\nrecently announced a $4 million research grant from the Vijay and Marie\nGoradia Charitable Foundation to support the extension of Part 1 of the VacSYn\ntrial, enabling the assessment of long-term safety and efficacy of ACI-7104\nfor an additional two years.\n\nGünther Staffler, Executive Vice President, Development at AC Immune SA,\ncommented: “ACI-7104 represents a promising active immunotherapy designed\nto target pathological a-syn for the treatment of prodromal and early PD. The\nFDA’s decision signifies the growing importance of the program including the\npositive interim Phase 2 findings. This is a key regulatory milestone for the\nprogram, and we look forward to delivering the full results from Part 1 of the\nVacSYn trial in the coming months.”\n\nAbout ACI-7104\n\nACI-7104 is an optimized formulation of AC Immune’s anti-a-syn predecessor\nactive immunotherapy which generated an antibody response against pathological\noligomeric a-syn to inhibit spreading and downstream neurodegeneration in\nearly Parkinson’s disease. The accumulation of alpha-synuclein protein\naggregates has been shown to cause inflammatory stress in cells and\ncontributes to the degeneration of neurons in the brain, linking it to the\ndevelopment of neurodegenerative diseases such as Parkinson’s Disease.\n\nAbout AC Immune SA \n\nAC Immune (NASDAQ: ACIU) is a clinical stage biopharmaceutical company\ndeveloping a pipeline of products, including both active immunotherapies and\nsmall molecules, targeting key misfolded proteins and pathways for the\ntreatment of multiple neurodegenerative diseases. The company has a growing\nfocus on its wholly owned proprietary clinical-stage programs, including:\nACI-7104, an active immunotherapy targeting α-synuclein (α-syn) in\nParkinson's disease; and ACI-19764, a small molecule inhibitor of the NLRP3\ninflammasome. In addition, an early-stage small molecule development program\ntargeting intracellular a-syn is advancing towards the clinic.\n\nACIU has a strong track record of securing strategic partnerships with leading\nglobal pharmaceutical companies, resulting in substantial non-dilutive funding\nand >$4.5 billion in potential milestone payments. ACIU’s pharma-partnered\nprograms, all in Alzheimer’s disease, include: a collaboration on ACI-24, an\nactive immunotherapy targeting Abeta; a collaboration on ACI-35 targeting\nphospho-Tau; and a collaboration developing brain-penetrant small molecule\ndrugs targeting intracellular pathologic Tau.\n\nAll trademarks used or mentioned in this release are protected by law. The\ninformation on our website and any other websites referenced herein is\nexpressly not incorporated by reference into, and does not constitute a part\nof, this press release.\n\nFor further information, please contact:\n\n SVP, Investor Relations & Corporate Communications  Gary Waanders, Ph.D., MBA AC Immune Phone: +41 21 345 91 91 Email: gary.waanders@acimmune.com                        \n International Media  Optimum Strategic Communications Nick Bastin, Joshua Evans, Aoife Minihan, Ben Cowe Phone: +44 (0) 20 4566 8543 Email: acimmune@optimumcomms.com    \n\nForward looking statements\n\nThis press release contains statements that constitute “forward-looking\nstatements” within the meaning of Section 27A of the Securities Act of 1933\nand Section 21E of the Securities Exchange Act of 1934. Forward-looking\nstatements are statements other than historical fact and may include\nstatements that address future operating, financial or business performance or\nAC Immune’s strategies or expectations. In some cases, you can identify\nthese statements by forward-looking words such as “may,” “might,”\n“will,” “should,” “expects,” “plans,” “anticipates,”\n“believes,” “estimates,” “predicts,” “projects,”\n“potential,” “outlook” or “continue,” and other comparable\nterminology. Forward-looking statements are based on management’s current\nexpectations and beliefs and involve significant risks and uncertainties that\ncould cause actual results, developments and business decisions to differ\nmaterially from those contemplated by these statements. These risks and\nuncertainties include those described under the captions “Item 3. Key\nInformation – Risk Factors” and “Item 5. Operating and Financial Review\nand Prospects” in AC Immune’s Annual Report on Form 20-F and other filings\nwith the Securities and Exchange Commission. These include: the impact of\nCovid-19 on our business, suppliers, patients and employees and any other\nimpact of Covid-19. Forward-looking statements speak only as of the date they\nare made, and AC Immune does not undertake any obligation to update them in\nlight of new information, future developments or otherwise, except as may be\nrequired under applicable law. All forward-looking statements are qualified in\ntheir entirety by this cautionary statement.\n\nAttachment\n*     20260810__ACIU ACI-7104 IND+FastTrack PR_final\n(https://ml-eu.globenewswire.com/Resource/Download/b63f43a4-04aa-41c4-830e-4b9dd4009005)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/0065cdfd-b9fc-4994-8aca-731c1d031b51)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-08-11T11:00:00.421054721Z","server_sent_at_ms":1786446000421},"received_at":"2026-08-11T11:00:00.665Z","source_url":"https://www.globenewswire.com/news-release/2026/08/11/3342526/0/en/ac-immune-receives-fda-fast-track-designation-for-anti-alpha-synuclein-active-immunotherapy-aci-7104-to-treat-early-parkinson-s-disease-pd.html"},"analysis":{"id":"104099","press_release_id":"115106","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"AC Immune secured FDA Fast Track designation and IND clearance for ACI-7104, an active immunotherapy targeting alpha-synuclein for early-stage Parkinson's disease.\n\nThe designation is supported by interim Phase 2 data from the VacSYn trial, which demonstrated safety, tolerability, and a 100% immunogenicity responder rate at 76 weeks.\n\nFull week-100 results from Part 1 of the study are expected in the second half of 2026, supported by a recently awarded $4 million research grant.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Fast Track status accelerates Parkinson's candidate ACI-7104 following positive Phase 2 interim data."},"keyFigures":{"drugName":"ACI-7104","phaseOfTrial":"Phase 2","customDimensions":{"grant_amount":"$4 million","immunogenicity_responder_rate":"100%"}},"quotedText":"Fast Track designation and IND clearance from the FDA are important achievements for ACI-7104, one of our wholly-owned programs, given its potential to address the significant unmet need in Parkinson’s.","namedEntities":{"people":[{"name":"Martin Zügel","role":"Interim CEO"},{"name":"Günther Staffler","role":"Executive Vice President, Development"}],"products":["ACI-7104"],"companies":[{"name":"AC Immune SA","ticker":"ACIU"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"Vijay and Marie Goradia Charitable Foundation","relationship":"grant provider"}],"dollarAmounts":[{"amount":"$4 million","context":"research grant to extend Part 1 of the VacSYn trial"},{"amount":">$4.5 billion","context":"potential milestone payments across ACIU's pharma-partnered programs"}]},"materialImpact":{"score":4,"reasoning":"FDA Fast Track designation is a significant de-risking event that accelerates the development path for ACI-7104. The designation was granted based on positive interim Phase 2 data showing safety and high immunogenicity, marking a key milestone for the company's wholly-owned Parkinson's program."},"tickerRelevance":{"others":[],"primary":"ACIU"},"globalImportance":35,"audienceRelevance":40,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"small-mid-cap","eventGravity":"regulatory_acceleration","sectorWeight":"biotech_catalyst"}},"event_type":"regulatory","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":4,"narrative":"AC Immune secured FDA Fast Track designation and IND clearance for ACI-7104, an active immunotherapy targeting alpha-synuclein for early-stage Parkinson's disease.\n\nThe designation is supported by interim Phase 2 data from the VacSYn trial, which demonstrated safety, tolerability, and a 100% immunogenicity responder rate at 76 weeks.\n\nFull week-100 results from Part 1 of the study are expected in the second half of 2026, supported by a recently awarded $4 million research grant.","key_figures":{"drugName":"ACI-7104","phaseOfTrial":"Phase 2","customDimensions":{"grant_amount":"$4 million","immunogenicity_responder_rate":"100%"}},"named_entities":{"people":[{"name":"Martin Zügel","role":"Interim CEO"},{"name":"Günther Staffler","role":"Executive Vice President, Development"}],"products":["ACI-7104"],"companies":[{"name":"AC Immune SA","ticker":"ACIU"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"Vijay and Marie Goradia Charitable Foundation","relationship":"grant provider"}],"dollarAmounts":[{"amount":"$4 million","context":"research grant to extend Part 1 of the VacSYn trial"},{"amount":">$4.5 billion","context":"potential milestone payments across ACIU's pharma-partnered programs"}]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-11T11:29:57.514Z","global_importance":35,"audience_relevance":40,"importance_components":{"tickerTier":"small-mid-cap","eventGravity":"regulatory_acceleration","sectorWeight":"biotech_catalyst"}},"durationMs":201781,"modelName":"glm-4.7"}}