{"success":true,"data":{"pressRelease":{"id":"18885","rtpr_id":"nGNX4fy73s","ticker":"CLNN","exchange":"NASDAQ","all_tickers":["CLNN"],"title":"After Successful FDA Meeting, Clene Filing Accelerated Approval NDA for ALS","author":"Globe Newswire","published_at":"2026-05-04T12:00:01.110Z","article_body":"* FDA stated that the “proposed data may be capable of supporting the\nsubmission and review of an [NDA] under the accelerated approval pathway”\nfor CNM-Au8 based on neurofilament light (NfL) biomarker data\n* FDA acknowledged NfL could potentially serve as a reasonably likely\nsurrogate endpoint\n* Clene expects to submit an NDA for CNM-Au8 to the FDA in the third quarter\nof 2026\n* CNM-Au8 represents a potential first-in-class therapeutic approach for ALS,\na disease area with significant unmet medical need\nSALT LAKE CITY, May 04, 2026 (GLOBE NEWSWIRE) --  Clene Inc. (Nasdaq: CLNN)\n(along with its subsidiaries, “Clene”) and its wholly owned subsidiary\nClene Nanomedicine Inc., a late clinical-stage biopharmaceutical company\nfocused on revolutionizing the treatment of neurodegenerative diseases,\nincluding amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS),\ntoday announced receipt of final meeting minutes following its recent Type C\nmeeting with the U.S. Food and Drug Administration (FDA).\n\nDuring the meeting and confirmed in the final meeting minutes, the FDA stated\nthat Clene’s “proposed data may be capable of supporting the submission\nand review of an [New Drug Application (NDA)] under the accelerated approval\npathway for the treatment of ALS.” The FDA reminded the Company that the\nsubmission should demonstrate the effectiveness of an effect of CNM-Au8 on NfL\nand show that the magnitude of change in NfL is reasonably likely to predict\nclinical benefits in patients with ALS. Clene intends to submit its NDA in the\nthird quarter of 2026, which will remain a matter of FDA review.\n\nThe Agency also noted that “NfL could potentially serve as a reasonably\nlikely surrogate endpoint to support (an) accelerated approval.” This\nsubmission would occur under the Subpart H accelerated approval pathway (21\nCFR 314.510) in ALS. The Agency has also requested that the Company provide\nadditional information in its NDA, including to support a connection between\nthe reported magnitude of reduction in NfL and clinical benefit, which Clene\nhas prepared and will include in the submission.\n\nClene’s journey with the FDA has been constructive. Today, we express our\ngreat appreciation for the FDA’s clear display of regulatory flexibility and\nits recent communications of a willingness to consider receipt of an NDA\nsubmission. That the Agency has now agreed to review our extensive data\ndossier is a critical moment in our company’s history.\n\n“We are encouraged by the FDA’s careful evaluation of the benefits and\nrisks associated with Clene’s ALS drug candidate, CNM-Au8, including the\nbiomarker data the Company provided. The filing of an NDA submission\nrepresents an important milestone for CNM-Au8 and for the ALS community,”\nsaid Rob Etherington, President and CEO of Clene. “We are committed to\nworking with the Agency on this filing and are conducting the Phase 3\nconfirmatory study for CNM-Au8, which we intend to commence in the first\nquarter of 2027.”\n\n\"People living with ALS cannot afford to wait,\" said Sandra Abrevaya, I AM ALS\nCo-Founder and Board Member.   \"Flexible, science-driven regulatory\napproaches such as this can play a critical role in accelerating access to new\ntherapies for a fast-progressing, fatal disease. We’re grateful for the\nAgency’s recognition of the urgency and unmet need in ALS.”\n\nThe planned NDA submission will be supported by NfL biomarker and clinical\ndata from the Phase 2 HEALEY ALS Platform Trial and its open-label extension,\nas well as the Phase 2 RESCUE-ALS Trial, and the NIH-sponsored Expanded Access\nProtocol for CNM-Au8. Supporting data include reductions in plasma NfL\nassociated with longer survival in the open-label extension and additional\nclinical outcomes. CNM-Au8 has previously received Orphan Drug Designation\nfrom the FDA for the treatment of ALS.\n\nAbout Clene\nClene Inc. (Nasdaq: CLNN), along with its subsidiaries, “Clene” and its\nwholly owned subsidiary Clene Nanomedicine, Inc., is a late clinical-stage\nbiopharmaceutical company focused on improving mitochondrial health and\nprotecting neuronal function to treat neurodegenerative diseases, including\namyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis.\nCNM-Au8(®) is an investigational first-in-class therapy that improves\ncentral nervous system cells’ survival and function via a mechanism that\ntargets mitochondrial function and the NAD pathway while reducing oxidative\nstress. CNM-Au8(®) is a federally registered trademark of Clene\nNanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and\nmanufacturing operations in Maryland. For more information, please\nvisit www.clene.com or follow us on X\n(https://www.globenewswire.com/Tracker?data=UnAAud0W7MxkoAYsRQ1VaBn8I-emWW80Lf377NhZapY-pySrIcWB49HmL7Qhqqyl9K3x45ul6N8Cowz7ptsnqv7JXIUKWyAdll3tvH2pjXO5doxFLdpq2PTNKSvhFzVwo_6RQq1zcvoNZIAzeI6xy0AMZRgWJM1aFx_qdoa1QikSyjFLd2EN9D6aQFLmTQ7VfQdX7fYa47-aqphhSQDi1Dng2s5DpuQ5WYxrgLokkhTZKjCBaUWo3__W2ENIsV0PyuX0Ob3q4dMlxyL-CB58sFGdwx3xBSLC8etTwCtWIZicBQtGkrAdn4IRCZOIq7fYpj_-ESb2Mzc8wGas8NMFSM8mvFyagT4fC8b_3W1xzibLeQ2iUThDXXAaJ79aOf6f3W7ztjrVohHesunuWaQNHASDBWNb0tBttdsoE0OmRpwtHF9j_1kYhzkMZteUywZDUxb9ZKrYUq1VqzIy1UjBP7n8jPSFJNFUsZE86bJlrUX1WismwuJGaR1uPdk7NARZieOHwC8ekGHs1XS5MPxRDBEAo4ogJIMxewheb_owPlZkY0nArmTMpoBYiqUaW2FhF-B_-vGEY6jMoBfH2S7vZucbL-XIn65kiEsD7JF72uk=) (formerly Twitter\n(https://www.globenewswire.com/Tracker?data=ha4I-OMl0vOQvXpczf1IaaSt6jdDdZEFBUlChV_qU20g_eFPBGEC8mM4T4zIsB9NKgPxTIDP7C5QYSch7a6VxF0zN3SGzcCpPWuDEk3hH-taqlSe-I_cqnEbDuvhX5s9SiUO6nlP9S87fqdW_a2HNs5za-j5587mndHF30uPhd3awb15dbpjWKSsDys5RQ_hYpcgmgiTwjJ0yJtFm9F7fwX3P_Av-XcQPkSW5F6gDo92rp-8j4IWciR1MLTVjmw2VxcaFzW3No_UJG7tlQHqTUHAQ2CsgRHBGsN8gwKjdi_69-Oe_jynPNFJWWK4xMTUKcqTj5pMy8rolliXUEh5d3dzF2J-JQtr-WTxpOpp-VSlN27XhWvtiIEfnAaBWKmYbdMeIOXvWdd5lZ7rYg-fANAUjTPoNtJpQ4vnA1YK2FSnetPxHuJ14hkcGnqDD3-CbTqIfTYn0xup8bthpAx8lg5SsVoocIoCaklNnKox9eEoLbvEO4_-iC-mqwFO-LcuZAewrLQOu61xUE2eN728f_LNadphySMFOxnI9k1zGwCe6Pe5Ju_6TS8xxoRFvc0P2xx3eHkfXYBRGiJeuG1iHtQP2Ib6JzeuSabuCICPvR-fv6QGd_pj0FlRBrG7Ml7f_Bg9N2v0XbOkSYyveXyBTnz5v9DVJFkPN6nqtcQAXjI=))\nand LinkedIn\n(https://www.globenewswire.com/Tracker?data=eKAZv58AUQIQljfWD_vhVXY8JQoJSKi4-VeX0w3TSkJgalwZp0gtWNdFXss3KWmhxyf4sMNeJ8FAdmGC4UYDgZkUs39oqcC3kRp_tU88T3DqlU6i5iGNhzkcHHhjaVAl4hCSHN8lZQm_P9aGOOsGnvMiOE6JBjDrwQMQXix2zCOz4IJPo39NAHKUFzbY4pvoZNUEbN8iC7Rzy9coKPHrpRj-x3V6mPWX03NYIGtffpsqQHdHzOnLqWLRIcvLE3qRSgO7ttqHI98caJsxLYwHWzbq8YXn7SuSQPPoLDJKzVsEJWqDvqhEz7LZyZjRSm3r3yif9V_iRS6gBn-BXF5jteGk9gbXxDZnbE10QGB3d_7tZAs7o34tNLnoSZ_VWmJ7pUwbMOkswnoCyRlilftv2SNPRuoT7vyA1oO3EPr0YkwQDK9mhvNHdL3YldDk-NMiGBUkx9AIlkbPFJX6c2Pasn0Jh3IheBPr7JfHHCOLG8VnU8l6mrEj4N0-Arqldf5jb_ACaXTtZp8hRDVo_JofSYZPyoHGEuXraHdjXIhJnQyaFt8Kh-0XfQndqQKIrHyEHNJT4fkKr6UF4LYK9rzMXLI2b0gC47aT5IdkXKe2qom9PtV8h6F63Oe-PDJy7KdIaVz42UoXKuq32BmNXVQdkN7SNKD2EmPuWpd-yfGAvXCr9CHedmBIdZTnZbY-ls5dkpuallX4ttB0E7XtOiuLVkgadvatMeoH-8tvdCfeY_ofs6jpTFUB74HEpgsvVpkB).\n\nAbout CNM-Au8(®)\nCNM-Au8 is an oral suspension of gold nanocrystals developed to restore\nneuronal health and function by increasing energy production and utilization.\nThe catalytically active nanocrystals of CNM-Au8 drive critical cellular\nenergy producing reactions that enable neuroprotection and remyelination by\nincreasing neuronal and glial resilience to disease-relevant stressors.\nCNM-Au8(®) is a federally registered trademark of Clene Nanomedicine, Inc.\n\nForward-Looking Statements\n\nThis press release contains “forward-looking statements” within the\nmeaning of Section 21E of the Securities Exchange Act of 1934, as amended, and\nSection 27A of the Securities Act of 1933, as amended, which are intended to\nbe covered by the “safe harbor” provisions created by those laws.\nClene’s forward-looking statements include, but are not limited to,\nstatements regarding the timing of the Company’s NDA submission, that the\nbiomarker findings support an NDA submission, and the timing of the initiation\nof the Phase 3 trial. In addition, any statements that refer to projections,\nforecasts or other characterizations of future events or circumstances,\nincluding any underlying assumptions, are forward-looking statements. The\nwords “anticipate,” “believe,” “contemplate,” “continue,”\n“estimate,” “expect,” “intends,” “may,” “might,”\n“plan,” “possible,” “potential,” “predict,” “project,”\n“should,” “will,” “would,” and similar expressions may identify\nforward-looking statements, but the absence of these words does not mean that\na statement is not forward-looking. These forward-looking statements represent\nour views as of the date of this press release and involve a number of\njudgments, risks and uncertainties. We anticipate that subsequent events and\ndevelopments will cause our views to change. We undertake no obligation to\nupdate forward-looking statements to reflect events or circumstances after the\ndate they were made, whether as a result of new information, future events or\notherwise, except as may be required under applicable securities laws.\nAccordingly, forward-looking statements should not be relied upon as\nrepresenting our views as of any subsequent date. As a result of a number of\nknown and unknown risks and uncertainties, our actual results or performance\nmay be materially different from those expressed or implied by these\nforward-looking statements. Some factors that could cause actual results to\ndiffer include general market conditions, whether clinical trials demonstrate\nthe efficacy and safety of our drug candidates to the satisfaction of\nregulatory authorities, or do not otherwise produce positive results which may\ncause us to incur additional costs or experience delays in completing, or\nultimately be unable to complete the development and commercialization of our\ndrug candidates; the clinical results for our drug candidates, which may not\nsupport further development or marketing approval; actions of regulatory\nagencies, which may affect the initiation, timing and progress of clinical\ntrials and marketing approval; our ability to achieve commercial success for\nour drug candidates, if approved; our limited operating history and our\nability to obtain additional funding for operations and to complete the\ndevelopment and commercialization of our drug candidates; and other risks and\nuncertainties set forth in “Risk Factors” in our most recent Annual Report\non Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition,\nstatements that “we believe” and similar statements reflect our beliefs\nand opinions on the relevant subject. These statements are based upon\ninformation available to us as of the date of this press release, and while we\nbelieve such information forms a reasonable basis for such statements, such\ninformation may be limited or incomplete, and our statements should not be\nread to indicate that we have conducted an exhaustive inquiry into, or review\nof, all potentially available relevant information. These statements are\ninherently uncertain and you are cautioned not to rely unduly upon these\nstatements. All information in this press release is as of the date of this\npress release. The information contained in any website referenced herein is\nnot, and shall not be deemed to be, part of or incorporated into this press\nrelease.\n\nInvestor Contact: Kevin Gardner, LifeSci\nAdvisors; kgardner@lifesciadvisors.com; 617-283-2856\n\nMedia Contact: Caroline Wagner, Forbes Tate\nPartners; CWagner@forbes-tate.com; (267) 294-6563 \n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/e9de96a4-582e-4975-8e43-6f3e6259c075)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX4fy73s","title":"After Successful FDA Meeting, Clene Filing Accelerated Approval NDA for ALS","author":"Globe Newswire","ticker":"CLNN","created":"2026-05-04T12:00:01.110Z","tickers":["CLNN"],"exchange":"NASDAQ","article_body":"* FDA stated that the “proposed data may be capable of supporting the\nsubmission and review of an [NDA] under the accelerated approval pathway”\nfor CNM-Au8 based on neurofilament light (NfL) biomarker data\n* FDA acknowledged NfL could potentially serve as a reasonably likely\nsurrogate endpoint\n* Clene expects to submit an NDA for CNM-Au8 to the FDA in the third quarter\nof 2026\n* CNM-Au8 represents a potential first-in-class therapeutic approach for ALS,\na disease area with significant unmet medical need\nSALT LAKE CITY, May 04, 2026 (GLOBE NEWSWIRE) --  Clene Inc. (Nasdaq: CLNN)\n(along with its subsidiaries, “Clene”) and its wholly owned subsidiary\nClene Nanomedicine Inc., a late clinical-stage biopharmaceutical company\nfocused on revolutionizing the treatment of neurodegenerative diseases,\nincluding amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS),\ntoday announced receipt of final meeting minutes following its recent Type C\nmeeting with the U.S. Food and Drug Administration (FDA).\n\nDuring the meeting and confirmed in the final meeting minutes, the FDA stated\nthat Clene’s “proposed data may be capable of supporting the submission\nand review of an [New Drug Application (NDA)] under the accelerated approval\npathway for the treatment of ALS.” The FDA reminded the Company that the\nsubmission should demonstrate the effectiveness of an effect of CNM-Au8 on NfL\nand show that the magnitude of change in NfL is reasonably likely to predict\nclinical benefits in patients with ALS. Clene intends to submit its NDA in the\nthird quarter of 2026, which will remain a matter of FDA review.\n\nThe Agency also noted that “NfL could potentially serve as a reasonably\nlikely surrogate endpoint to support (an) accelerated approval.” This\nsubmission would occur under the Subpart H accelerated approval pathway (21\nCFR 314.510) in ALS. The Agency has also requested that the Company provide\nadditional information in its NDA, including to support a connection between\nthe reported magnitude of reduction in NfL and clinical benefit, which Clene\nhas prepared and will include in the submission.\n\nClene’s journey with the FDA has been constructive. Today, we express our\ngreat appreciation for the FDA’s clear display of regulatory flexibility and\nits recent communications of a willingness to consider receipt of an NDA\nsubmission. That the Agency has now agreed to review our extensive data\ndossier is a critical moment in our company’s history.\n\n“We are encouraged by the FDA’s careful evaluation of the benefits and\nrisks associated with Clene’s ALS drug candidate, CNM-Au8, including the\nbiomarker data the Company provided. The filing of an NDA submission\nrepresents an important milestone for CNM-Au8 and for the ALS community,”\nsaid Rob Etherington, President and CEO of Clene. “We are committed to\nworking with the Agency on this filing and are conducting the Phase 3\nconfirmatory study for CNM-Au8, which we intend to commence in the first\nquarter of 2027.”\n\n\"People living with ALS cannot afford to wait,\" said Sandra Abrevaya, I AM ALS\nCo-Founder and Board Member.   \"Flexible, science-driven regulatory\napproaches such as this can play a critical role in accelerating access to new\ntherapies for a fast-progressing, fatal disease. We’re grateful for the\nAgency’s recognition of the urgency and unmet need in ALS.”\n\nThe planned NDA submission will be supported by NfL biomarker and clinical\ndata from the Phase 2 HEALEY ALS Platform Trial and its open-label extension,\nas well as the Phase 2 RESCUE-ALS Trial, and the NIH-sponsored Expanded Access\nProtocol for CNM-Au8. Supporting data include reductions in plasma NfL\nassociated with longer survival in the open-label extension and additional\nclinical outcomes. CNM-Au8 has previously received Orphan Drug Designation\nfrom the FDA for the treatment of ALS.\n\nAbout Clene\nClene Inc. (Nasdaq: CLNN), along with its subsidiaries, “Clene” and its\nwholly owned subsidiary Clene Nanomedicine, Inc., is a late clinical-stage\nbiopharmaceutical company focused on improving mitochondrial health and\nprotecting neuronal function to treat neurodegenerative diseases, including\namyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis.\nCNM-Au8(®) is an investigational first-in-class therapy that improves\ncentral nervous system cells’ survival and function via a mechanism that\ntargets mitochondrial function and the NAD pathway while reducing oxidative\nstress. CNM-Au8(®) is a federally registered trademark of Clene\nNanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and\nmanufacturing operations in Maryland. For more information, please\nvisit www.clene.com or follow us on X\n(https://www.globenewswire.com/Tracker?data=UnAAud0W7MxkoAYsRQ1VaBn8I-emWW80Lf377NhZapY-pySrIcWB49HmL7Qhqqyl9K3x45ul6N8Cowz7ptsnqv7JXIUKWyAdll3tvH2pjXO5doxFLdpq2PTNKSvhFzVwo_6RQq1zcvoNZIAzeI6xy0AMZRgWJM1aFx_qdoa1QikSyjFLd2EN9D6aQFLmTQ7VfQdX7fYa47-aqphhSQDi1Dng2s5DpuQ5WYxrgLokkhTZKjCBaUWo3__W2ENIsV0PyuX0Ob3q4dMlxyL-CB58sFGdwx3xBSLC8etTwCtWIZicBQtGkrAdn4IRCZOIq7fYpj_-ESb2Mzc8wGas8NMFSM8mvFyagT4fC8b_3W1xzibLeQ2iUThDXXAaJ79aOf6f3W7ztjrVohHesunuWaQNHASDBWNb0tBttdsoE0OmRpwtHF9j_1kYhzkMZteUywZDUxb9ZKrYUq1VqzIy1UjBP7n8jPSFJNFUsZE86bJlrUX1WismwuJGaR1uPdk7NARZieOHwC8ekGHs1XS5MPxRDBEAo4ogJIMxewheb_owPlZkY0nArmTMpoBYiqUaW2FhF-B_-vGEY6jMoBfH2S7vZucbL-XIn65kiEsD7JF72uk=) (formerly Twitter\n(https://www.globenewswire.com/Tracker?data=ha4I-OMl0vOQvXpczf1IaaSt6jdDdZEFBUlChV_qU20g_eFPBGEC8mM4T4zIsB9NKgPxTIDP7C5QYSch7a6VxF0zN3SGzcCpPWuDEk3hH-taqlSe-I_cqnEbDuvhX5s9SiUO6nlP9S87fqdW_a2HNs5za-j5587mndHF30uPhd3awb15dbpjWKSsDys5RQ_hYpcgmgiTwjJ0yJtFm9F7fwX3P_Av-XcQPkSW5F6gDo92rp-8j4IWciR1MLTVjmw2VxcaFzW3No_UJG7tlQHqTUHAQ2CsgRHBGsN8gwKjdi_69-Oe_jynPNFJWWK4xMTUKcqTj5pMy8rolliXUEh5d3dzF2J-JQtr-WTxpOpp-VSlN27XhWvtiIEfnAaBWKmYbdMeIOXvWdd5lZ7rYg-fANAUjTPoNtJpQ4vnA1YK2FSnetPxHuJ14hkcGnqDD3-CbTqIfTYn0xup8bthpAx8lg5SsVoocIoCaklNnKox9eEoLbvEO4_-iC-mqwFO-LcuZAewrLQOu61xUE2eN728f_LNadphySMFOxnI9k1zGwCe6Pe5Ju_6TS8xxoRFvc0P2xx3eHkfXYBRGiJeuG1iHtQP2Ib6JzeuSabuCICPvR-fv6QGd_pj0FlRBrG7Ml7f_Bg9N2v0XbOkSYyveXyBTnz5v9DVJFkPN6nqtcQAXjI=))\nand LinkedIn\n(https://www.globenewswire.com/Tracker?data=eKAZv58AUQIQljfWD_vhVXY8JQoJSKi4-VeX0w3TSkJgalwZp0gtWNdFXss3KWmhxyf4sMNeJ8FAdmGC4UYDgZkUs39oqcC3kRp_tU88T3DqlU6i5iGNhzkcHHhjaVAl4hCSHN8lZQm_P9aGOOsGnvMiOE6JBjDrwQMQXix2zCOz4IJPo39NAHKUFzbY4pvoZNUEbN8iC7Rzy9coKPHrpRj-x3V6mPWX03NYIGtffpsqQHdHzOnLqWLRIcvLE3qRSgO7ttqHI98caJsxLYwHWzbq8YXn7SuSQPPoLDJKzVsEJWqDvqhEz7LZyZjRSm3r3yif9V_iRS6gBn-BXF5jteGk9gbXxDZnbE10QGB3d_7tZAs7o34tNLnoSZ_VWmJ7pUwbMOkswnoCyRlilftv2SNPRuoT7vyA1oO3EPr0YkwQDK9mhvNHdL3YldDk-NMiGBUkx9AIlkbPFJX6c2Pasn0Jh3IheBPr7JfHHCOLG8VnU8l6mrEj4N0-Arqldf5jb_ACaXTtZp8hRDVo_JofSYZPyoHGEuXraHdjXIhJnQyaFt8Kh-0XfQndqQKIrHyEHNJT4fkKr6UF4LYK9rzMXLI2b0gC47aT5IdkXKe2qom9PtV8h6F63Oe-PDJy7KdIaVz42UoXKuq32BmNXVQdkN7SNKD2EmPuWpd-yfGAvXCr9CHedmBIdZTnZbY-ls5dkpuallX4ttB0E7XtOiuLVkgadvatMeoH-8tvdCfeY_ofs6jpTFUB74HEpgsvVpkB).\n\nAbout CNM-Au8(®)\nCNM-Au8 is an oral suspension of gold nanocrystals developed to restore\nneuronal health and function by increasing energy production and utilization.\nThe catalytically active nanocrystals of CNM-Au8 drive critical cellular\nenergy producing reactions that enable neuroprotection and remyelination by\nincreasing neuronal and glial resilience to disease-relevant stressors.\nCNM-Au8(®) is a federally registered trademark of Clene Nanomedicine, Inc.\n\nForward-Looking Statements\n\nThis press release contains “forward-looking statements” within the\nmeaning of Section 21E of the Securities Exchange Act of 1934, as amended, and\nSection 27A of the Securities Act of 1933, as amended, which are intended to\nbe covered by the “safe harbor” provisions created by those laws.\nClene’s forward-looking statements include, but are not limited to,\nstatements regarding the timing of the Company’s NDA submission, that the\nbiomarker findings support an NDA submission, and the timing of the initiation\nof the Phase 3 trial. In addition, any statements that refer to projections,\nforecasts or other characterizations of future events or circumstances,\nincluding any underlying assumptions, are forward-looking statements. The\nwords “anticipate,” “believe,” “contemplate,” “continue,”\n“estimate,” “expect,” “intends,” “may,” “might,”\n“plan,” “possible,” “potential,” “predict,” “project,”\n“should,” “will,” “would,” and similar expressions may identify\nforward-looking statements, but the absence of these words does not mean that\na statement is not forward-looking. These forward-looking statements represent\nour views as of the date of this press release and involve a number of\njudgments, risks and uncertainties. We anticipate that subsequent events and\ndevelopments will cause our views to change. We undertake no obligation to\nupdate forward-looking statements to reflect events or circumstances after the\ndate they were made, whether as a result of new information, future events or\notherwise, except as may be required under applicable securities laws.\nAccordingly, forward-looking statements should not be relied upon as\nrepresenting our views as of any subsequent date. As a result of a number of\nknown and unknown risks and uncertainties, our actual results or performance\nmay be materially different from those expressed or implied by these\nforward-looking statements. Some factors that could cause actual results to\ndiffer include general market conditions, whether clinical trials demonstrate\nthe efficacy and safety of our drug candidates to the satisfaction of\nregulatory authorities, or do not otherwise produce positive results which may\ncause us to incur additional costs or experience delays in completing, or\nultimately be unable to complete the development and commercialization of our\ndrug candidates; the clinical results for our drug candidates, which may not\nsupport further development or marketing approval; actions of regulatory\nagencies, which may affect the initiation, timing and progress of clinical\ntrials and marketing approval; our ability to achieve commercial success for\nour drug candidates, if approved; our limited operating history and our\nability to obtain additional funding for operations and to complete the\ndevelopment and commercialization of our drug candidates; and other risks and\nuncertainties set forth in “Risk Factors” in our most recent Annual Report\non Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition,\nstatements that “we believe” and similar statements reflect our beliefs\nand opinions on the relevant subject. These statements are based upon\ninformation available to us as of the date of this press release, and while we\nbelieve such information forms a reasonable basis for such statements, such\ninformation may be limited or incomplete, and our statements should not be\nread to indicate that we have conducted an exhaustive inquiry into, or review\nof, all potentially available relevant information. These statements are\ninherently uncertain and you are cautioned not to rely unduly upon these\nstatements. All information in this press release is as of the date of this\npress release. The information contained in any website referenced herein is\nnot, and shall not be deemed to be, part of or incorporated into this press\nrelease.\n\nInvestor Contact: Kevin Gardner, LifeSci\nAdvisors; kgardner@lifesciadvisors.com; 617-283-2856\n\nMedia Contact: Caroline Wagner, Forbes Tate\nPartners; CWagner@forbes-tate.com; (267) 294-6563 \n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/e9de96a4-582e-4975-8e43-6f3e6259c075)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-05-04T12:00:01.178963466Z","server_sent_at_ms":1777896001178},"received_at":"2026-05-04T12:00:01.236Z","source_url":"https://www.globenewswire.com/news-release/2026/05/04/3286641/0/en/After-Successful-FDA-Meeting-Clene-Filing-Accelerated-Approval-NDA-for-ALS.html"},"analysis":{"id":"13703","press_release_id":"18885","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"Clene announced that following a Type C meeting, the FDA confirmed that neurofilament light (NfL) biomarker data may support an accelerated approval NDA submission for CNM-Au8 in ALS.\n\nThe company plans to submit the NDA in the third quarter of 2026, while a Phase 3 confirmatory study is intended to commence in the first quarter of 2027.\n\nManagement views the FDA's willingness to review the data dossier as a critical milestone for the company and the ALS community.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Regulatory path cleared for accelerated filing of ALS drug CNM-Au8 using biomarker data."},"keyFigures":{"drugName":"CNM-Au8","phaseOfTrial":"Phase 2","customDimensions":{"nda_submission_timeline":"third quarter of 2026","confirmatory_trial_start":"first quarter of 2027"}},"quotedText":"The filing of an NDA submission represents an important milestone for CNM-Au8 and for the ALS community","namedEntities":{"people":[{"name":"Rob Etherington","role":"President and CEO"},{"name":"Sandra Abrevaya","role":"Co-Founder and Board Member"}],"products":["CNM-Au8"],"companies":[{"name":"Clene Inc.","ticker":"CLNN"},{"name":"Clene Nanomedicine Inc.","relationship":"subsidiary"},{"name":"I AM ALS","relationship":"partner"}],"dollarAmounts":[]},"materialImpact":{"score":4,"reasoning":"The FDA confirmed that Clene's biomarker data (NfL) may support an accelerated approval NDA, significantly de-risking the regulatory pathway for CNM-Au8 in ALS. 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