{"success":true,"data":{"pressRelease":{"id":"70189","rtpr_id":"nGNE8cX3vP","ticker":"MGNX","exchange":"NASDAQ","all_tickers":["MGNX"],"title":"MacroGenics to Receive Milestone Payment from Sanofi for Recent TZIELD® Approval","author":"Globe Newswire","published_at":"2026-06-22T20:43:38.208Z","article_body":"ROCKVILLE, MD, June 22, 2026 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:\nMGNX), a clinical-stage biopharmaceutical company focused on developing\ninnovative antibody-based therapeutics for the treatment of cancer, today\nannounced that it will receive a $24.5 million regulatory milestone payment\nfrom Sanofi following the U.S. Food and Drug Administration’s (FDA)\naccelerated approval of TZIELD® (teplizumab-mzwv) to delay the decline in\nendogenous insulin production in children aged eight to 17 years recently\ndiagnosed with stage 3 type 1 diabetes (T1D). The approval expands the\ntherapeutic potential of TZIELD as a disease-modifying therapy for type 1\ndiabetes.\n\nUnder the terms of MacroGenics’ agreement with Sanofi, the recent FDA\napproval triggered a $24.5 million regulatory milestone payable to\nMacroGenics. The Company remains eligible to receive up to $305 million in\nadditional milestone payments and retains the right to receive a single-digit\nroyalty on global net sales above a specified annual threshold.\n\nAbout TZIELD\n\nTZIELD (teplizumab) is a CD3-directed monoclonal antibody. TZIELD is the first\ndisease-modifying therapy in autoimmune T1D; it was approved in the U.S. in\nNovember 2022 to delay the onset of stage 3 T1D in adults and children eight\nyears and older diagnosed with stage 2 T1D. In April 2026, the FDA expanded\nthis indication to include children aged one year and above. TZIELD is also\napproved in adults and children eight years and older with stage 2 in the UK,\nthe EU (under the name TEIZEILD), China, Australia, Canada, Israel, Saudi\nArabia, the UAE, Kuwait, Brazil and Switzerland. In June 2026, the FDA\napproved TZIELD to delay the onset of Stage 3 T1D in adults.\n\nAbout MacroGenics, Inc.\n\nMacroGenics (the Company) is a biopharmaceutical company focused on developing\ninnovative antibody-based therapeutics for the treatment of cancer. The\nCompany generates its pipeline of product candidates primarily from its\nproprietary suite of next-generation antibody-based technology platforms,\nwhich have applicability across broad therapeutic domains. The combination of\nMacroGenics' technology platforms and protein engineering expertise has\nallowed the Company to generate promising product candidates and enter into\nseveral strategic collaborations with global pharmaceutical and biotechnology\ncompanies. For more information, please see the Company's website at\nwww.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or\nregistered trademarks of MacroGenics, Inc.\n\nCautionary Note on Forward-Looking Statements\n\nAny statements in this press release about future expectations, plans and\nprospects for MacroGenics (“Company”), including statements about the\nCompany’s strategy, future operations, clinical development of and\nregulatory plans for the Company’s therapeutic candidates, expected timing\nof the release of clinical updates and safety and efficacy data for the\nCompany’s ongoing clinical trials, anticipated cash runway and other\nstatements containing the words “subject to”, \"believe\", “anticipate”,\n“plan”, “expect”, “intend”, “estimate”, “potential”,\n“project”, “may”, “will”, “should”, “would”, “could”,\n“can”, the negatives thereof, variations thereon and similar expressions,\nor by discussions of strategy, including our ability to execute on our key\nstrategic priorities for 2026, constitute forward-looking statements within\nthe meaning of Section 27A of the Securities Act of 1933 and Section 21E of\nthe Securities Exchange Act of 1934. Actual results may differ materially from\nthose indicated by such forward-looking statements as a result of various\nimportant factors, including: risks that TZIELD, lorigerlimab, ZYNYZ, or any\nother product candidate’s revenue, expenses and costs may not be as\nexpected, risks relating to TZIELD, lorigerlimab, ZYNYZ, or any other product\ncandidate’s market acceptance, competition, reimbursement and regulatory\nactions; future data updates, including timing and results of efficacy and\nsafety data with respect to product candidates in ongoing clinical trials; our\nability to provide manufacturing services to our customers; the uncertainties\ninherent in the initiation and enrollment of future clinical trials; the\navailability of financing to fund the internal development of our product\ncandidates; expectations of expanding ongoing clinical trials; expectations\nfor the timing and steps required in the regulatory review process; the\nexpected closing of our planned sale of our CDMO operations (the\n“Transaction”); our ability to provide manufacturing services to our\ncustomers prior to the closing of the Transaction; expectations for regulatory\napprovals; expectations regarding the amount and timing of future milestone\npayments under our collaboration with Sanofi and other collaborators; our\nability to receive any royalties under our collaborations with Sanofi and\nother collaborators; the impact of competitive products; our ability to enter\ninto agreements with strategic partners and other matters that could affect\nthe availability or commercial potential of the Company's product candidates;\nbusiness, economic or political disruptions due to catastrophes or other\nevents, including natural disasters, terrorist attacks, civil unrest and\nactual or threatened armed conflict, or public health crises; costs of\nlitigation and the failure to successfully defend lawsuits and other claims\nagainst us; the risk that one or more of the closing conditions to the\nTransaction may not be satisfied or waived, on a timely basis or at all,\nincluding the risk that any required landlord consents or other third-party\nconsents are not obtained; the risk that the Transaction may not be completed\non the timeline currently expected, or at all, or on the terms currently\ncontemplated; the occurrence of any event, change, or other circumstance that\ncould give rise to the termination of the purchase agreement related to the\nTransaction; the effect of the announcement, pendency, or consummation of the\nTransaction on the Company's business, operating results, employees,\ncustomers, suppliers, and other business relationships, including the\nCompany's CDMO operations; risks related to the transition of the CDMO\noperations to the purchaser in the Transaction, including the diversion of\nmanagement's attention from the Company's ongoing business operations; risks\nrelated to the Company's post-closing manufacturing arrangements with the\npurchaser in the Transaction including under the manufacturing and supply\nagreement and the transition services agreement; the possibility that the\nanticipated benefits of the Transaction, including that the additional\npost-closing cash payments may not be earned or received, in whole or in part;\nthe costs and expenses associated with the Transaction; potential litigation\nrelating to the Transaction; and other risks described in the Company's\nfilings with the Securities and Exchange Commission. In addition, the\nforward-looking statements included in this press release represent the\nCompany's views only as of the date hereof. The Company anticipates that\nsubsequent events and developments will cause the Company's views to change.\nHowever, while the Company may elect to update these forward-looking\nstatements at some point in the future, the Company specifically disclaims any\nobligation to do so, except as may be required by law. These forward-looking\nstatements should not be relied upon as representing the Company's views as of\nany date subsequent to the date hereof.\n\n\nJim Karrels, Senior Vice President, CFO \n1-301-251-5172 \ninfo@macrogenics.com \n\nArgot Partners\n1-212-600-1902\nmacrogenics@argotpartners.com","article_body_html":"","raw_payload":{"data":{"id":"nGNE8cX3vP","title":"MacroGenics to Receive Milestone Payment from Sanofi for Recent TZIELD® Approval","author":"Globe Newswire","ticker":"MGNX","created":"2026-06-22T20:43:38.208Z","tickers":["MGNX"],"exchange":"NASDAQ","article_body":"ROCKVILLE, MD, June 22, 2026 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:\nMGNX), a clinical-stage biopharmaceutical company focused on developing\ninnovative antibody-based therapeutics for the treatment of cancer, today\nannounced that it will receive a $24.5 million regulatory milestone payment\nfrom Sanofi following the U.S. Food and Drug Administration’s (FDA)\naccelerated approval of TZIELD® (teplizumab-mzwv) to delay the decline in\nendogenous insulin production in children aged eight to 17 years recently\ndiagnosed with stage 3 type 1 diabetes (T1D). The approval expands the\ntherapeutic potential of TZIELD as a disease-modifying therapy for type 1\ndiabetes.\n\nUnder the terms of MacroGenics’ agreement with Sanofi, the recent FDA\napproval triggered a $24.5 million regulatory milestone payable to\nMacroGenics. The Company remains eligible to receive up to $305 million in\nadditional milestone payments and retains the right to receive a single-digit\nroyalty on global net sales above a specified annual threshold.\n\nAbout TZIELD\n\nTZIELD (teplizumab) is a CD3-directed monoclonal antibody. TZIELD is the first\ndisease-modifying therapy in autoimmune T1D; it was approved in the U.S. in\nNovember 2022 to delay the onset of stage 3 T1D in adults and children eight\nyears and older diagnosed with stage 2 T1D. In April 2026, the FDA expanded\nthis indication to include children aged one year and above. TZIELD is also\napproved in adults and children eight years and older with stage 2 in the UK,\nthe EU (under the name TEIZEILD), China, Australia, Canada, Israel, Saudi\nArabia, the UAE, Kuwait, Brazil and Switzerland. In June 2026, the FDA\napproved TZIELD to delay the onset of Stage 3 T1D in adults.\n\nAbout MacroGenics, Inc.\n\nMacroGenics (the Company) is a biopharmaceutical company focused on developing\ninnovative antibody-based therapeutics for the treatment of cancer. The\nCompany generates its pipeline of product candidates primarily from its\nproprietary suite of next-generation antibody-based technology platforms,\nwhich have applicability across broad therapeutic domains. The combination of\nMacroGenics' technology platforms and protein engineering expertise has\nallowed the Company to generate promising product candidates and enter into\nseveral strategic collaborations with global pharmaceutical and biotechnology\ncompanies. For more information, please see the Company's website at\nwww.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or\nregistered trademarks of MacroGenics, Inc.\n\nCautionary Note on Forward-Looking Statements\n\nAny statements in this press release about future expectations, plans and\nprospects for MacroGenics (“Company”), including statements about the\nCompany’s strategy, future operations, clinical development of and\nregulatory plans for the Company’s therapeutic candidates, expected timing\nof the release of clinical updates and safety and efficacy data for the\nCompany’s ongoing clinical trials, anticipated cash runway and other\nstatements containing the words “subject to”, \"believe\", “anticipate”,\n“plan”, “expect”, “intend”, “estimate”, “potential”,\n“project”, “may”, “will”, “should”, “would”, “could”,\n“can”, the negatives thereof, variations thereon and similar expressions,\nor by discussions of strategy, including our ability to execute on our key\nstrategic priorities for 2026, constitute forward-looking statements within\nthe meaning of Section 27A of the Securities Act of 1933 and Section 21E of\nthe Securities Exchange Act of 1934. Actual results may differ materially from\nthose indicated by such forward-looking statements as a result of various\nimportant factors, including: risks that TZIELD, lorigerlimab, ZYNYZ, or any\nother product candidate’s revenue, expenses and costs may not be as\nexpected, risks relating to TZIELD, lorigerlimab, ZYNYZ, or any other product\ncandidate’s market acceptance, competition, reimbursement and regulatory\nactions; future data updates, including timing and results of efficacy and\nsafety data with respect to product candidates in ongoing clinical trials; our\nability to provide manufacturing services to our customers; the uncertainties\ninherent in the initiation and enrollment of future clinical trials; the\navailability of financing to fund the internal development of our product\ncandidates; expectations of expanding ongoing clinical trials; expectations\nfor the timing and steps required in the regulatory review process; the\nexpected closing of our planned sale of our CDMO operations (the\n“Transaction”); our ability to provide manufacturing services to our\ncustomers prior to the closing of the Transaction; expectations for regulatory\napprovals; expectations regarding the amount and timing of future milestone\npayments under our collaboration with Sanofi and other collaborators; our\nability to receive any royalties under our collaborations with Sanofi and\nother collaborators; the impact of competitive products; our ability to enter\ninto agreements with strategic partners and other matters that could affect\nthe availability or commercial potential of the Company's product candidates;\nbusiness, economic or political disruptions due to catastrophes or other\nevents, including natural disasters, terrorist attacks, civil unrest and\nactual or threatened armed conflict, or public health crises; costs of\nlitigation and the failure to successfully defend lawsuits and other claims\nagainst us; the risk that one or more of the closing conditions to the\nTransaction may not be satisfied or waived, on a timely basis or at all,\nincluding the risk that any required landlord consents or other third-party\nconsents are not obtained; the risk that the Transaction may not be completed\non the timeline currently expected, or at all, or on the terms currently\ncontemplated; the occurrence of any event, change, or other circumstance that\ncould give rise to the termination of the purchase agreement related to the\nTransaction; the effect of the announcement, pendency, or consummation of the\nTransaction on the Company's business, operating results, employees,\ncustomers, suppliers, and other business relationships, including the\nCompany's CDMO operations; risks related to the transition of the CDMO\noperations to the purchaser in the Transaction, including the diversion of\nmanagement's attention from the Company's ongoing business operations; risks\nrelated to the Company's post-closing manufacturing arrangements with the\npurchaser in the Transaction including under the manufacturing and supply\nagreement and the transition services agreement; the possibility that the\nanticipated benefits of the Transaction, including that the additional\npost-closing cash payments may not be earned or received, in whole or in part;\nthe costs and expenses associated with the Transaction; potential litigation\nrelating to the Transaction; and other risks described in the Company's\nfilings with the Securities and Exchange Commission. In addition, the\nforward-looking statements included in this press release represent the\nCompany's views only as of the date hereof. The Company anticipates that\nsubsequent events and developments will cause the Company's views to change.\nHowever, while the Company may elect to update these forward-looking\nstatements at some point in the future, the Company specifically disclaims any\nobligation to do so, except as may be required by law. These forward-looking\nstatements should not be relied upon as representing the Company's views as of\nany date subsequent to the date hereof.\n\n\nJim Karrels, Senior Vice President, CFO \n1-301-251-5172 \ninfo@macrogenics.com \n\nArgot Partners\n1-212-600-1902\nmacrogenics@argotpartners.com"},"type":"article","timestamp":"2026-06-22T20:43:38.329848619Z","server_sent_at_ms":1782161018329},"received_at":"2026-06-22T20:43:38.381Z","source_url":null},"analysis":{"id":"59585","press_release_id":"70189","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"partnership","narrative":"MacroGenics announced it will receive a $24.5 million regulatory milestone payment from partner Sanofi following the FDA's accelerated approval of TZIELD for delaying insulin decline in children aged 8 to 17 with stage 3 type 1 diabetes.\n\nUnder the collaboration agreement, MacroGenics remains eligible to receive up to $305 million in additional milestone payments and retains single-digit royalty rights on global net sales above a specified threshold.\n\nThe FDA approval expands the therapeutic potential of TZIELD, marking a significant commercial step for the asset which was previously approved for stage 2 type 1 diabetes.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"MacroGenics secures $24.5M milestone from Sanofi as TZIELD gains FDA approval for Stage 3 T1D, bolstering runway."},"keyFigures":{"drugName":"TZIELD (teplizumab-mzwv)","customDimensions":{"milestone_payment":24500000,"potential_additional_milestones":305000000}},"quotedText":"","namedEntities":{"people":[{"name":"Jim Karrels","role":"Senior Vice President, CFO"}],"products":["TZIELD","teplizumab-mzwv"],"companies":[{"name":"Sanofi","relationship":"partner"}],"dollarAmounts":[{"amount":"$24.5 million","context":"regulatory milestone payment from Sanofi"},{"amount":"$305 million","context":"additional milestone payments eligible to receive"}]},"materialImpact":{"score":3,"reasoning":"Receipt of a $24.5 million milestone payment provides material cash flow extension for a clinical-stage biopharma. Additionally, the potential for up to $305 million in future milestones de-risks the balance sheet, though the asset is partnered with Sanofi."},"tickerRelevance":{"others":[],"primary":"MGNX"},"globalImportance":25,"audienceRelevance":25,"eventTypeSecondary":[],"importanceComponents":{"cashImpact":"material","tickerTier":"small-cap","eventGravity":"partnership-milestone"}},"event_type":"partnership","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"MacroGenics announced it will receive a $24.5 million regulatory milestone payment from partner Sanofi following the FDA's accelerated approval of TZIELD for delaying insulin decline in children aged 8 to 17 with stage 3 type 1 diabetes.\n\nUnder the collaboration agreement, MacroGenics remains eligible to receive up to $305 million in additional milestone payments and retains single-digit royalty rights on global net sales above a specified threshold.\n\nThe FDA approval expands the therapeutic potential of TZIELD, marking a significant commercial step for the asset which was previously approved for stage 2 type 1 diabetes.","key_figures":{"drugName":"TZIELD (teplizumab-mzwv)","customDimensions":{"milestone_payment":24500000,"potential_additional_milestones":305000000}},"named_entities":{"people":[{"name":"Jim Karrels","role":"Senior Vice President, CFO"}],"products":["TZIELD","teplizumab-mzwv"],"companies":[{"name":"Sanofi","relationship":"partner"}],"dollarAmounts":[{"amount":"$24.5 million","context":"regulatory milestone payment from Sanofi"},{"amount":"$305 million","context":"additional milestone payments eligible to receive"}]},"model_name":"qwen3_6_27b_awq","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-06-22T20:45:35.722Z","global_importance":25,"audience_relevance":25,"importance_components":{"cashImpact":"material","tickerTier":"small-cap","eventGravity":"partnership-milestone"}},"durationMs":117323,"modelName":"george-droid-qwen-72b"}}