{"success":true,"data":{"pressRelease":{"id":"126366","rtpr_id":"nGNX34NSWf","ticker":"LKFT","exchange":"Euronext Amsterdam","all_tickers":["LKFT"],"title":"U.S. FDA Grants Orphan Drug Designation to Gamgertamig for the Treatment of Pemphigus","author":"Globe Newswire","published_at":"2026-08-24T20:01:00.286Z","article_body":"Mechelen, Belgium; 24 August 2026, 22.01 CET; regulated information –\nLakefront Biotherapeutics NV (Euronext & NASDAQ: LKFT) today announced that\nthe U.S. Food and Drug Administration (FDA) has granted Orphan Drug\nDesignation to gamgertamig for the treatment of pemphigus. Gamgertamig was\npreviously granted both Fast Track and Orphan Drug Designation by the U.S. FDA\nfor the treatment of autoimmune hemolytic anemia (AIHA) and immune\nthrombocytopenia (ITP).\n\nGamgertamig is being developed by Lakefront in collaboration with Gilead\nSciences. Ongoing clinical trials in autoimmune diseases are actively\nenrolling, and expansion of the clinical trials program is anticipated in\n2027.\n* Phase 1b study with gamgertamig in patients with autoimmune cytopenias\n(including ITP and AIHA) (NCT07083960), active in Australia and the United\nStates.\n* Phase 1b study with gamgertamig in seropositive autoimmune diseases\n(including idiopathic inflammatory myositis, Sjögren’s disease, pemphigus\nvulgaris (PV), and pemphigus foliaceus (PF)) (NCT07229144) active in\nAustralia, New Zealand, Czech Republic, and Japan. \n* Expect to initiate proof-of-concept basket studies assessing gamgertamig in\nadditional autoimmune indications.\n“We’re excited by the U.S. FDA’s award of Orphan Drug Designation for\ngamgertamig for the treatment of pemphigus as we continue to advance it for\npatients suffering with this debilitating and potentially life-threatening\nautoantibody-driven disease,” said Eric Hedrick MD, Chief Medical Officer of\nLakefront. “I continue to believe gamgertamig has the potential to represent\na transformative medicine in autoimmune diseases.”\n\nAbout Gamgertamig\nGamgertamig is an investigational BCMAxCD3 bispecific T cell engager for the\ntreatment of autoantibodies driven immune-mediated disease. Gamgertamig has\nbeen granted Orphan Drug Designation and Fast Track Designation by the U.S.\nFDA for certain autoimmune diseases. Gamgertamig is currently in Phase 2\nstudies and is expected to enter registrational studies in 2027. Gamgertamig\nis in-licensed from Keymed Biosciences, which owns the rights to develop the\nprogram in Greater China.\n\nAbout Lakefront Biotherapeutics\nLakefront Biotherapeutics is a biotechnology company dedicated to building a\ndifferentiated pipeline of medicines for patients with serious diseases in\nareas of high unmet need. The Company has established a clinical‑stage\nportfolio in immunology and inflammation, anchored by gamgertamig, a potential\nfirst‑in‑class and best-in-class BCMAxCD3 T‑cell engager for autoimmune\ndiseases. Backed by deep deal‑making expertise, operational flexibility, and\na strong capital position, Lakefront identifies, acquires, and advances\nhigh‑quality assets with clear potential to deliver meaningful patient\nimpact and long‑term shareholder value. For more information, visit\nhttps://www.lakefrontbio.com or follow us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=rpghkh35gUTVlp1-eDEMDAVUo0Ub8Ka0PsgetHg_a3OzKENjoq1ounChZ84Vgk4Ham_YMOF_pALhnUXKGZB95UXk_4I4zrNJbS0h36JX5K2pqkYSyQ0eGiidmERJ_zGd)\nor X\n(https://www.globenewswire.com/Tracker?data=AHS1_-wXRLDHMx2FSWFnE24qwyhuJz78jKUPdek1RlIbNoHtWm1z8ncDyVlcWg3VcqfhzvXg2dsco43B80GrCw==).\n\nFor further information, contact Lakefront Biotherapeutics:\nInvestor Relations \nSherri Spear\n+1 412 522 6418\nsherri.spear@lakefrontbio.com\n\nForward-looking statements\nThis press release includes forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995, as amended. These\nstatements are often, but are not always, made through the use of words or\nphrases such as “anticipate,” “expect,” “plan,” “estimate,”\n“will,” “continue,” “aim,” “intend,” “future,”\n“potential,” “could,” “indicate,” “forward,” as well as\nsimilar expressions. Forward-looking statements contained in this release\ninclude, but are not limited to, statements regarding gamgertamig’s phase 1b\nand proof-of-concept basket studies, statements regarding the expected timing,\ndesign and readouts of the gamgertamig studies, and statements regarding the\npotential benefits of gamgertamig. Forward-looking statements involve known\nand unknown risks, uncertainties and other factors which might cause\nLakefront's actual results to be materially different from those expressed or\nimplied by such forward-looking statements. These risks, uncertainties and\nother factors include, without limitation, the risk that preliminary or\ninterim clinical results may not be replicated in ongoing or subsequent\nclinical trials, the risk that ongoing and future clinical studies with\ngamgertamig may not be completed in the currently envisaged timelines or at\nall, the inherent uncertainties associated with competitive developments,\nclinical trial and product development activities and regulatory approval\nrequirements (including that data from the ongoing and planned clinical\ndevelopment program may not support registration or further development of\ngamgertamig due to safety, efficacy, or other reasons), Lakefront's reliance\non collaborations with third parties, and that Lakefront's estimations\nregarding its gamgertamig clinical program and regarding the commercial\npotential of gamgertamig may be incorrect, as well as those risks and\nuncertainties identified in Lakefront's Annual Report on Form 20-F for the\nyear ended December 31, 2025 filed with the U.S. Securities and Exchange\nCommission (SEC) and its subsequent filings with the SEC. All statements other\nthan statements of historical fact are statements that could be deemed\nforward-looking statements. The forward-looking statements contained herein\nare based on management’s current expectations and beliefs and speak only as\nof the date hereof, and Lakefront makes no commitment to update or publicly\nrelease any revisions to forward-looking statements in order to reflect new\ninformation or subsequent events, circumstances, or changes in expectations,\nunless specifically required by law or regulation.\n\nAttachment\n*     gamgertamig ODD\n(https://ml-eu.globenewswire.com/Resource/Download/87905420-f406-43a7-ae61-fe4d319799ab)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/5100317d-9c26-4bbc-9bcc-dd77343f5f96)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX34NSWf","title":"U.S. FDA Grants Orphan Drug Designation to Gamgertamig for the Treatment of Pemphigus","author":"Globe Newswire","ticker":"LKFT","created":"2026-08-24T20:01:00.286Z","tickers":["LKFT"],"exchange":"Euronext Amsterdam","article_body":"Mechelen, Belgium; 24 August 2026, 22.01 CET; regulated information –\nLakefront Biotherapeutics NV (Euronext & NASDAQ: LKFT) today announced that\nthe U.S. Food and Drug Administration (FDA) has granted Orphan Drug\nDesignation to gamgertamig for the treatment of pemphigus. Gamgertamig was\npreviously granted both Fast Track and Orphan Drug Designation by the U.S. FDA\nfor the treatment of autoimmune hemolytic anemia (AIHA) and immune\nthrombocytopenia (ITP).\n\nGamgertamig is being developed by Lakefront in collaboration with Gilead\nSciences. Ongoing clinical trials in autoimmune diseases are actively\nenrolling, and expansion of the clinical trials program is anticipated in\n2027.\n* Phase 1b study with gamgertamig in patients with autoimmune cytopenias\n(including ITP and AIHA) (NCT07083960), active in Australia and the United\nStates.\n* Phase 1b study with gamgertamig in seropositive autoimmune diseases\n(including idiopathic inflammatory myositis, Sjögren’s disease, pemphigus\nvulgaris (PV), and pemphigus foliaceus (PF)) (NCT07229144) active in\nAustralia, New Zealand, Czech Republic, and Japan. \n* Expect to initiate proof-of-concept basket studies assessing gamgertamig in\nadditional autoimmune indications.\n“We’re excited by the U.S. FDA’s award of Orphan Drug Designation for\ngamgertamig for the treatment of pemphigus as we continue to advance it for\npatients suffering with this debilitating and potentially life-threatening\nautoantibody-driven disease,” said Eric Hedrick MD, Chief Medical Officer of\nLakefront. “I continue to believe gamgertamig has the potential to represent\na transformative medicine in autoimmune diseases.”\n\nAbout Gamgertamig\nGamgertamig is an investigational BCMAxCD3 bispecific T cell engager for the\ntreatment of autoantibodies driven immune-mediated disease. Gamgertamig has\nbeen granted Orphan Drug Designation and Fast Track Designation by the U.S.\nFDA for certain autoimmune diseases. Gamgertamig is currently in Phase 2\nstudies and is expected to enter registrational studies in 2027. Gamgertamig\nis in-licensed from Keymed Biosciences, which owns the rights to develop the\nprogram in Greater China.\n\nAbout Lakefront Biotherapeutics\nLakefront Biotherapeutics is a biotechnology company dedicated to building a\ndifferentiated pipeline of medicines for patients with serious diseases in\nareas of high unmet need. The Company has established a clinical‑stage\nportfolio in immunology and inflammation, anchored by gamgertamig, a potential\nfirst‑in‑class and best-in-class BCMAxCD3 T‑cell engager for autoimmune\ndiseases. Backed by deep deal‑making expertise, operational flexibility, and\na strong capital position, Lakefront identifies, acquires, and advances\nhigh‑quality assets with clear potential to deliver meaningful patient\nimpact and long‑term shareholder value. For more information, visit\nhttps://www.lakefrontbio.com or follow us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=rpghkh35gUTVlp1-eDEMDAVUo0Ub8Ka0PsgetHg_a3OzKENjoq1ounChZ84Vgk4Ham_YMOF_pALhnUXKGZB95UXk_4I4zrNJbS0h36JX5K2pqkYSyQ0eGiidmERJ_zGd)\nor X\n(https://www.globenewswire.com/Tracker?data=AHS1_-wXRLDHMx2FSWFnE24qwyhuJz78jKUPdek1RlIbNoHtWm1z8ncDyVlcWg3VcqfhzvXg2dsco43B80GrCw==).\n\nFor further information, contact Lakefront Biotherapeutics:\nInvestor Relations \nSherri Spear\n+1 412 522 6418\nsherri.spear@lakefrontbio.com\n\nForward-looking statements\nThis press release includes forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995, as amended. These\nstatements are often, but are not always, made through the use of words or\nphrases such as “anticipate,” “expect,” “plan,” “estimate,”\n“will,” “continue,” “aim,” “intend,” “future,”\n“potential,” “could,” “indicate,” “forward,” as well as\nsimilar expressions. Forward-looking statements contained in this release\ninclude, but are not limited to, statements regarding gamgertamig’s phase 1b\nand proof-of-concept basket studies, statements regarding the expected timing,\ndesign and readouts of the gamgertamig studies, and statements regarding the\npotential benefits of gamgertamig. Forward-looking statements involve known\nand unknown risks, uncertainties and other factors which might cause\nLakefront's actual results to be materially different from those expressed or\nimplied by such forward-looking statements. These risks, uncertainties and\nother factors include, without limitation, the risk that preliminary or\ninterim clinical results may not be replicated in ongoing or subsequent\nclinical trials, the risk that ongoing and future clinical studies with\ngamgertamig may not be completed in the currently envisaged timelines or at\nall, the inherent uncertainties associated with competitive developments,\nclinical trial and product development activities and regulatory approval\nrequirements (including that data from the ongoing and planned clinical\ndevelopment program may not support registration or further development of\ngamgertamig due to safety, efficacy, or other reasons), Lakefront's reliance\non collaborations with third parties, and that Lakefront's estimations\nregarding its gamgertamig clinical program and regarding the commercial\npotential of gamgertamig may be incorrect, as well as those risks and\nuncertainties identified in Lakefront's Annual Report on Form 20-F for the\nyear ended December 31, 2025 filed with the U.S. Securities and Exchange\nCommission (SEC) and its subsequent filings with the SEC. All statements other\nthan statements of historical fact are statements that could be deemed\nforward-looking statements. The forward-looking statements contained herein\nare based on management’s current expectations and beliefs and speak only as\nof the date hereof, and Lakefront makes no commitment to update or publicly\nrelease any revisions to forward-looking statements in order to reflect new\ninformation or subsequent events, circumstances, or changes in expectations,\nunless specifically required by law or regulation.\n\nAttachment\n*     gamgertamig ODD\n(https://ml-eu.globenewswire.com/Resource/Download/87905420-f406-43a7-ae61-fe4d319799ab)\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/5100317d-9c26-4bbc-9bcc-dd77343f5f96)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-08-24T20:01:00.332141766Z","server_sent_at_ms":1787601660332},"received_at":"2026-08-24T20:01:00.383Z","source_url":"https://www.globenewswire.com/news-release/2026/08/24/3350092/0/en/u-s-fda-grants-orphan-drug-designation-to-gamgertamig-for-the-treatment-of-pemphigus.html"},"analysis":{"id":"115309","press_release_id":"126366","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"regulatory","narrative":"Lakefront Biotherapeutics received Orphan Drug Designation from the FDA for gamgertamig in the treatment of pemphigus, expanding the regulatory support for its lead asset.\n\nGamgertamig is currently in Phase 1b and Phase 2 trials for autoimmune cytopenias and seropositive autoimmune diseases, with registrational studies anticipated in 2027.\n\nThe drug is a BCMAxCD3 bispecific T cell engager being developed in collaboration with Gilead Sciences and in-licensed from Keymed Biosciences.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Regulatory milestone adds exclusivity potential for gamgertamig in pemphigus."},"keyFigures":{"drugName":"gamgertamig","phaseOfTrial":"Phase 1b and Phase 2"},"quotedText":"We’re excited by the U.S. FDA’s award of Orphan Drug Designation for gamgertamig for the treatment of pemphigus as we continue to advance it for patients suffering with this debilitating and potentially life-threatening autoantibody-driven disease","namedEntities":{"people":[{"name":"Eric Hedrick","role":"Chief Medical Officer"},{"name":"Sherri Spear","role":"Investor Relations"}],"products":["gamgertamig"],"companies":[{"name":"Lakefront Biotherapeutics NV","ticker":"LKFT"},{"name":"Gilead Sciences","relationship":"collaborator"},{"name":"Keymed Biosciences","relationship":"licensor"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Orphan Drug Designation for pemphigus provides regulatory incentives and validates the lead asset's breadth, but it is an incremental development milestone rather than a pivotal data readout or market approval."},"tickerRelevance":{"others":[],"primary":"LKFT"},"globalImportance":15,"audienceRelevance":20,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"small-mid-cap","eventGravity":"regulatory-milestone","sectorWeight":"biotech"}},"event_type":"regulatory","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":3,"narrative":"Lakefront Biotherapeutics received Orphan Drug Designation from the FDA for gamgertamig in the treatment of pemphigus, expanding the regulatory support for its lead asset.\n\nGamgertamig is currently in Phase 1b and Phase 2 trials for autoimmune cytopenias and seropositive autoimmune diseases, with registrational studies anticipated in 2027.\n\nThe drug is a BCMAxCD3 bispecific T cell engager being developed in collaboration with Gilead Sciences and in-licensed from Keymed Biosciences.","key_figures":{"drugName":"gamgertamig","phaseOfTrial":"Phase 1b and Phase 2"},"named_entities":{"people":[{"name":"Eric Hedrick","role":"Chief Medical Officer"},{"name":"Sherri Spear","role":"Investor Relations"}],"products":["gamgertamig"],"companies":[{"name":"Lakefront Biotherapeutics NV","ticker":"LKFT"},{"name":"Gilead Sciences","relationship":"collaborator"},{"name":"Keymed Biosciences","relationship":"licensor"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-24T20:09:01.306Z","global_importance":15,"audience_relevance":20,"importance_components":{"tickerTier":"small-mid-cap","eventGravity":"regulatory-milestone","sectorWeight":"biotech"}},"durationMs":286673,"modelName":"glm-4.7"}}