Teplizumab

WEDNESDAY, July 1, 2026 -- The U.S. Food and Drug Administration has granted accelerated approval to Tzield (teplizumab-mzwv) to delay the decline in endogenous insulin production in children aged 8 to 17 years recently diagnosed with stage 3 type 1 diabetes. The approval was based on results of the PROTECT phase 3 study which randomly assigned 328 children and adolescents (aged 8 to 17 years) diagnosed with clinical stage 3 type 1 diabetes in the preceding six weeks to either Tzield or placebo. Results showed a significant slowing of the decrease in mean C-peptide levels compared to placebo. Adverse events observed in the PROTECT phase 3 study were consistent with previous studies and most commonly included lymphopenia, vomiting, rash, leukopenia, diarrhea, neutropenia, increased liver transaminase, and headache. Serious events (e.g., cytokine release syndrome and life-threatening cases of viral reactivation) have been reported with Tzield, with viral reactivation risk increased in immunocompromised patients. Tzield is not effective as a disease-modifying therapy in non-autoimmune dysglycemic conditions. "We welcome this accelerated approval by the FDA, which recognizes the potential of Tzield to delay the progression of recently diagnosed stage 3 type 1 diabetes in children aged 8 to 17 years," Christopher Corsico, from Sanofi, said in a statement. "Tzield will now offer a new pathway in the treatment paradigm of stage 3 type 1 diabetes, one that we hope will further enable health care providers in the U.S. to take a more proactive approach to disrupt the underlying autoimmune attack against insulin-producing beta cells." Approval of Tzield was granted to Sanofi. More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

ROCKVILLE, MD, June 22, 2026 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today announced that it will receive a $24.5 million regulatory milestone payment from Sanofi following the U.S. Food and Drug Administration’s (FDA) accelerated approval of TZIELD® (teplizumab-mzwv) to delay the decline in endogenous insulin production in children aged eight to 17 years recently diagnosed with stage 3 type 1 diabetes (T1D). The approval expands the therapeutic potential of TZIELD as a disease-modifying therapy for type 1 diabetes. Under the terms of MacroGenics’ agreement with Sanofi, the recent FDA approval triggered a $24.5 million regulatory milestone payable to MacroGenics. The Company remains eligible to receive up to $305 million in additional milestone payments and retains the right to receive a single-digit royalty on global net sales above a specified annual threshold. About TZIELD TZIELD (teplizumab) is a CD3-directed monoclonal antibody. TZIELD is the first disease-modifying therapy in autoimmune T1D; it was approved in the U.S. in November 2022 to delay the onset of stage 3 T1D in adults and children eight years and older diagnosed with stage 2 T1D. In April 2026, the FDA expanded this indication to include children aged one year and above. TZIELD is also approved in adults and children eight years and older with stage 2 in the UK, the EU (under the name TEIZEILD), China, Australia, Canada, Israel, Saudi Arabia, the UAE, Kuwait, Brazil and Switzerland. In June 2026, the FDA approved TZIELD to delay the onset of Stage 3 T1D in adults. About MacroGenics, Inc. MacroGenics (the Company) is a biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, expected timing of the release of clinical updates and safety and efficacy data for the Company’s ongoing clinical trials, anticipated cash runway and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential”, “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy, including our ability to execute on our key strategic priorities for 2026, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that TZIELD, lorigerlimab, ZYNYZ, or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, lorigerlimab, ZYNYZ, or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates, including timing and results of efficacy and safety data with respect to product candidates in ongoing clinical trials; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; the expected closing of our planned sale of our CDMO operations (the “Transaction”); our ability to provide manufacturing services to our customers prior to the closing of the Transaction; expectations for regulatory approvals; expectations regarding the amount and timing of future milestone payments under our collaboration with Sanofi and other collaborators; our ability to receive any royalties under our collaborations with Sanofi and other collaborators; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; the risk that one or more of the closing conditions to the Transaction may not be satisfied or waived, on a timely basis or at all, including the risk that any required landlord consents or other third-party consents are not obtained; the risk that the Transaction may not be completed on the timeline currently expected, or at all, or on the terms currently contemplated; the occurrence of any event, change, or other circumstance that could give rise to the termination of the purchase agreement related to the Transaction; the effect of the announcement, pendency, or consummation of the Transaction on the Company's business, operating results, employees, customers, suppliers, and other business relationships, including the Company's CDMO operations; risks related to the transition of the CDMO operations to the purchaser in the Transaction, including the diversion of management's attention from the Company's ongoing business operations; risks related to the Company's post-closing manufacturing arrangements with the purchaser in the Transaction including under the manufacturing and supply agreement and the transition services agreement; the possibility that the anticipated benefits of the Transaction, including that the additional post-closing cash payments may not be earned or received, in whole or in part; the costs and expenses associated with the Transaction; potential litigation relating to the Transaction; and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. CONTACT: Jim Karrels, Senior Vice President, CFO 1-301-251-5172 info@macrogenics.com Argot Partners 1-212-600-1902 macrogenics@argotpartners.com