• TANGENT met its primary and secondary endpoints with a high level of statistical significance vs. placebo at 6 months, including ORR by RECIST V1.1 and Tumor Volume Score (TVS), and clinically meaningful improvements in PROMIS-PF and other patient -relevant functional measures
• Rapid onset and significant functional improvement observed
• Short-course regimen demonstrated sustained and durable clinical benefits, highlighting the potential to avoid chronic treatment burden
• Emactuzumab demonstrated a manageable safety profile, highly consistent with prior clinical experience
• These data reinforce emactuzumab’s differentiated profile as a next-generation, short-course therapy with the potential to address important limitations of chronic oral treatment approaches in TGCT
• Biologics License Application (BLA) submission planned for H2 2026; EU Marketing Authorization Application (MAA) to follow

SynOx Therapeutics Limited  announced positive topline results from the pivotal Phase 3 TANGENT study of emactuzumab in adult patients with TGCT.

Emactuzumab is a targeted CSF-1R inhibitor that is being developed as a short-course treatment for patients with TGCT, which is designed to deliver rapid and durable disease control without the need for continuous treatment. In the TANGENT study, patients were randomized to receive either emactuzumab or placebo. Patients assigned to the treatment arm received emactuzumab at a dose of 1,000 mg administered every two weeks, for a total of five doses over an 8-week period.

Results across the primary and key secondary endpoints demonstrated clinically meaningful and statistically significant benefit consistent with emactuzumab’s differentiated profile. These included measures of tumor volume reduction and patient-reported and functional outcomes, including PROMIS-PF, physical function, pain, range of motion, and stiffness. Importantly, these benefits were achieved rapidly in the short-course treatment cycle, were durable and were observed across clinically relevant patient segments.

Emactuzumab demonstrated a manageable safety profile in TANGENT, consistent with prior clinical experience. In a patient population with a chronic, debilitating but non-lethal disease, tolerability remains an important consideration, particularly when compared with long-term treatment approaches.

“The TANGENT results represent an important step in advancing a potential next-generation treatment for patients with TGCT,” said Dr. Ray Barlow, CEO of SynOx Therapeutics. “Emactuzumab’s combination of rapid onset, response rate, meaningful functional improvement, and a defined short-course regimen positions it as a potential alternative to chronic therapy. We believe this approach directly addresses key limitations of existing treatments and represents an important advancement for patients suffering from this debilitating disease. We look forward to engaging with the FDA as we advance toward a planned BLA submission in the second half of 2026.”

Dr. Jean-Yves Blay, Principal Investigator, commented further:

“Emactuzumab is the only short course treatment option in late-stage development for patients suffering with TGCT. These Phase 3 data provide compelling evidence of tumor response, a manageable safety profile, and most importantly for patients, of significant durable functional and quality of life benefits that allow patients struggling with TGCT to move forward with their lives, without continuous therapy.”

SynOx continues to follow patients enrolled in the TANGENT study to further characterize the durability of response, and the potential role of retreatment and crossover open label emactuzumab.

SynOx intends to present full data from the TANGENT trial at an upcoming medical meeting and in a peer-reviewed publication.

Based on these data, SynOx plans to submit a BLA to the U.S. Food and Drug Administration for emactuzumab in TGCT in the second half of 2026 and a MAA in the EU thereafter.