Teplizumab

NEW YORK, April 22, 2026 /PRNewswire/ -- Breakthrough T1D, formerly JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization, applauds today's decision by the U.S. Food and Drug Administration (FDA) to approve Sanofi's Tzield (teplizumab-mzwv) for use in children ages one and older to delay the onset of insulin-dependent T1D. Tzield, the world's first disease-modifying therapy for T1D, was approved by the FDA in 2022 to safely delay the progression of T1D from stage 2 to stage 3, when insulin therapy is required, in individuals 8 and older. Today's announcement marks a pivotal milestone for the T1D community, advancing disease-modifying care and extending new hope to young children with stage 2 T1D who are often at high risk of rapidly progressing to insulin-dependent T1D. "Tzield's approval for use in children ages one and older marks a defining moment in the treatment of type 1 diabetes," said Aaron Kowalski, Ph.D., Breakthrough T1D CEO. "By expanding the population eligible for this disease-modifying drug, we are taking a meaningful step toward changing the trajectory of type 1 diabetes. Intervening earlier and slowing the disease's progression will provide the gift of time to young children and their caregivers, potentially improving lifelong outcomes. I am immensely proud of Breakthrough T1D's role in advancing the research that made Tzield possible. Breakthrough T1D applauds the FDA for today's important decision to expand Tzield's use and thanks Sanofi for its continued commitment to therapies for the type 1 diabetes community." From its initial approval to today's expanded use, Tzield gives people in early-stage T1D the possibility of more years without the daily physical, emotional and financial burdens of the disease. By slowing the progression of T1D, Tzield also delays the onset of complications frequently associated with T1D including eye, kidney, nerve and heart disease. "The expanded approval of Tzield is encouraging and highlights the importance of Breakthrough T1D's commitment to advancing next-generation disease-modifying therapies for type 1 diabetes that can change the lives of people with the disease," said Breakthrough T1D Chief Scientific Officer Sanjoy Dutta, Ph.D. "Today's decision underscores the critical importance of early detection of type 1 diabetes through screening. The promise of Tzield can only be realized when we can identify those who may benefit from the disease-modifying therapy through screening." About Breakthrough T1D, Formerly JDRF As the leading global type 1 diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with type 1 diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition. About Type 1 Diabetes (T1D) T1D is an autoimmune condition that causes the pancreas to make very little insulin or none at all. This leads to dependence on insulin therapy and the risk of short and long-term complications, which can include highs and lows in blood sugar; damage to the kidneys, eyes, nerves, and heart; and even death. Globally, it impacts 9.5 million people. Many believe T1D is only diagnosed in childhood and adolescence, but diagnosis in adulthood is common and accounts for nearly 50% of all T1D diagnoses. The onset of T1D has nothing to do with diet or lifestyle. While its causes are not yet entirely understood, scientists believe that both genetic factors and environmental triggers are involved. There is currently no cure for T1D. Contact: [email protected] SOURCE Breakthrough T1D, Formerly JDRF 21% more press release views with Request a Demo

Nektar Therapeutics prices $325 million public offering: The Bay Area biotech is selling about 3.5 million shares of stock at $92 per share. The proceeds will fund “general corporate purposes,” including Phase 3 trials for its candidate rezpegaldesleukin in atopic dermatitis and alopecia areata. The drug, also known as rezpeg, failed a Phase 2b trial in alopecia areata last year. But data from the extension portion more or less met Wall Street analysts’ expectations, fueling Nektar’s ambitions. — Nicole DeFeudis Maze Therapeutics’ $150M offering: The San Francisco biotech now has enough cash to fuel its R&D into 2029 , supporting treatment candidates for APOL1-mediated kidney disease , phenylketonuria and chronic kidney disease. The biotech’s shares $MAZE were up nearly 9% in early Wednesday trading. — Kyle LaHucik Merck’s deal rumors: The company is reportedly interested in Inhibrx’s cancer drug INBRX-106, which is being tested alongside Merck’s blockbuster Keytruda, according to a Reuters exclusive . Unnamed sources told Reuters that talks are in early stages, and Merck isn’t the only company sizing up a potential deal. Merck didn’t immediately respond to a request for comment from Endpoints News. — Nicole DeFeudis Layoffs at Bristol Myers Squibb: The pharma giant will let go of 206 staffers in Lawrence, NJ, between July and December of this year, according to a state WARN notice . In February, BMS had disclosed 247 previous job cuts. CEO Chris Boerner laid out plans last year for major cost savings, and said the company would continue to be “very financially disciplined.” BMS didn’t immediately respond to a request for more information. — Nicole DeFeudis Nuvation Bio posts long-term lung cancer data: Ibtrozi achieved “highly durable responses” in long-term follow-up data from two pivotal trials, Nuvation announced on Tuesday. The drug was approved last year for advanced ROS1-positive non-small cell lung cancer. Trial investigator Lyudmila Bazhenova said the new data show “high rates of responses that last more than four years for many patients, and a median progression-free survival that’s nearly just as long.” And the safety profile was “favorable and manageable,” the company said. — Nicole DeFeudis FDA delays approval deadline for subcutaneous Sarclisa: Sanofi said the agency now expects to make a decision on subcutaneous Sarclisa by July 23, three months later than its original target. The drugmaker did not provide a reason for the delay. Sarclisa is currently available as an IV treatment for multiple myeloma. — Ayisha Sharma Sanofi’s Tzield wins FDA label expansion for diabetic children: The label expansion means Tzield will be available to delay onset of stage 3 type 1 diabetes in children as young as age 1. The drug was previously approved for adults and children aged 8 years or older. — Ayisha Sharma PureTech Health shares positive Phase 1b blood cancer data: The biotech’s antibody, called LYT-200, produced a 45.5% overall response rate in 11 evaluable patients with relapsed or refractory high-risk myelodysplastic syndromes (MDS). In 26 evaluable patients with relapsed or refractory acute myeloid leukemia, the candidate achieved a 42.3% ORR. PureTech said it plans to discuss the design of a potentially registrational MDS study with the FDA. — Ayisha Sharma Oncology Ventures bags a second fund: The Austin-based firm closed its $62 million sophomore fund , which is almost twice as large as its inaugural fund of $32 million. The firm said it invests in the “picks-and-shovels of a $225 billion oncology market.” Its limited partners include Texas Oncology, Fred Hutchinson Cancer Research Center, City of Hope and others. — Kyle LaHucik Roche’s Enspryng cuts relapse risk in rare autoimmune disease : Patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) who took Enspryng in a Phase 3 trial had a statistically significant 68% reduction in relapses versus placebo. The data , presented Tuesday at the American Academy of Neurology’s annual meeting, showed that 87% of Enspryng patients were relapse free, compared with 67% on placebo, at 48 weeks. Patients with the CNS disorder experience unpredictable attacks of the optic nerves, spinal cord or brain, which can be severe. Roche said it would take the data to regulators. — Elizabeth Cairns Endpoints is fielding the next Biopharma Sentiment Index (BPSI) — a concise, three-minute survey that distills thousands of industry views into a clear quarterly benchmark. This year is pivotal for biopharma, and we need your perspective on where things are going. Take the survey here.