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Tegoprubart-treated patients maintained statistically significantly higher kidney function as measured by mean eGFR through 24 months, with an approximately 13 mL/min/1.73 m² advantage versus tacrolimus (71 vs. 58 mL/min/1.73 m²) at month 24 No rejections occurred in the tegoprubart arm beyond six months post-transplant, compared with seven in the tacrolimus arm Tegoprubart granted U.S. FDA Fast Track designation for the prevention of rejection in kidney transplantation Phase 3 LEGACY study expe
IRVINE, Calif., Sept. 09, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced an oral presentation highlighting the long-term safety and efficacy of tegoprubart in preventing kidney transplant rejection will take place at the upcoming International Congress of The Transplantation Society in Sydney, Australia, from September 20–23, 2026. Details of the presentation are below: Oral Presentation Title: Phase 2 BESTOW trial and the BESTOW EXTENSION: Evalua
IND submitted to FDA for Eledon-sponsored, registrational study of tegoprubart in islet cell transplantation for patients with type 1 diabetes First patients enrolled in new investigator-initiated study of tegoprubart in patients with renal dysfunction receiving an islet cell transplant First patient dosed under compassionate use of tegoprubart for conversion from tacrolimus in islet cell transplant recipients with calcineurin inhibitor related kidney dysfunction First patients dosed under compa
Successful End-of-Phase 2 meeting with FDA supports advancement of tegoprubart into a global Phase 3 kidney transplantation trial, on track to initiate in late 2026 Long-term Phase 2 BESTOW data presented at ATC 2026 demonstrated sustained higher kidney function and improved patient-reported outcomes with tegoprubart compared with tacrolimus Updated islet cell transplantation data presented at ADA 2026 showed 100% insulin independence in all 12 patients with type 1 diabetes Cash, cash equivalent
(American News Group News Commentary) For the millions of people who manage diabetes with daily insulin injections, the holy grail has always been the same: a therapy that senses blood sugar and releases the right amount of insulin on its own, the way a healthy pancreas does. A growing group of biotech companies is chasing that goal with cell-based therapies, and this week one small player took a concrete step toward making its version real.
The appointment follows NewcelX's recently announced successful FDA Type B Pre-IND meeting for NCEL-101, providing a clear regulatory pathway toward clinical trials Dr. Ricordi to support advancement of NewcelX's Type 1 Diabetes program and strategic collaboration with Eledon Pharmaceuticals ZURICH, July 08, 2026 (GLOBE NEWSWIRE) -- NewcelX Ltd. (Nasdaq: NCEL), a clinical-stage biotechnology company developing regenerative cell therapies for type 1 diabetes and other serious diseases, today anno
FDA feedback supports NewcelX’s planned development strategy for NCEL-101 in combination with TegoprubartZURICH, July 01, 2026 (GLOBE NEWSWIRE) -- NewcelX Ltd. (“NewcelX”; Nasdaq: NCEL), a clinical-stage regenerative medicine company developing stem-cell-derived therapies, announced the successful completion of its Type B Pre-IND meeting with the U.S. Food and Drug Administration (“FDA”). The agency provided constructive feedback and alignment on the Company’s proposed development strategy, prov
AUSTIN, Texas & IRVINE, Calif., June 25, 2026--Natera, Inc. (Nasdaq: NTRA), a global leader in cell-free DNA and precision medicine, and Eledon Pharmaceuticals, Inc. (Nasdaq: ELDN), a clinical stage biotechnology company developing immune-modulating therapies for the management and treatment of life-threatening conditions, today announced a strategic partnership to incorporate Natera’s Prospera kidney transplant assessment test into Eledon’s planned Phase 3 clinical trial of tegoprubart, an inve
Tegoprubart-treated patients maintained higher mean eGFR over time, including a statistically significant approximately 12 mL/min/1.73 m² advantage at month 18 versus tacrolimus (74 vs. 61 mL/min/1.73 m²; p<0.05) No biopsy-proven acute rejection (BPAR) events were observed in tegoprubart-treated patients after the first six months post-transplant, compared with seven BPAR events (9.4% of tacrolimus-treated patients) reported in the tacrolimus arm Patient-reported outcomes at 52 weeks favored teg
While Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN) has gained 125.83% year-to-date, analysts continue to see 134.60% upside, helping it secure a spot on our list of the hot biotech stocks under $5 to buy. Updated clinical data presented at a major diabetes conference added weight to the case that Eledon Pharmaceuticals, Inc. (NASDAQ:ELDN)’s lead drug could reshape […]
– All 12 patients in study (100%) achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their T1D – All 12 patients also achieved an HbA1c below 6.5%, with a mean most recent HbA1c of approximately 5.4%, representing an approximately 2.6% average improvement in HbA1c from baseline – No severe hypoglycemic episodes were reported post-transplant, compared with a history of recurrent severe hypoglycemic events prior to transplantation
IRVINE, Calif., June 04, 2026 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced that updated results from an investigator-initiated trial being conducted at the University of Chicago Medicine Transplant Institute will be presented by Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the American Diabetes Association 86th Scientific Sessions, taking place June 5-9, 2026, in New Orleans, Louisiana.
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