Tonix Pharmaceuticals

We’re proud to report the FDA has cleared our IND for TNX-102 SL in Major Depressive Disorder. Clinical trials in MDD are scheduled to start in 2026. This milestone reflects our commitment to studying TNX-102 SL in new indications where there is significant unmet medical need. Read more here: https://bit.ly/4polmpL

Today we launched the first therapy approved in the US for fibromyalgia in 15 years. We are proud to provide patients a new therapeutic option. Read more here: https://bit.ly/48fcayl

It’s today! Tune in at 10:00 AM ET as Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, presents at the Stifel 2025 Healthcare Conference. Catch the live webcast here: http://bit.ly/4p1RY8G

Today, Tonix Pharmaceuticals announced its Q3 2025 earnings, highlighting $190 million in cash as of the end of Q3, with a cash runway into Q1 2027, and strong momentum heading into the end of the year as the company prepares to launch Tonmya, the first FDA-approved treatment for fibromyalgia in over 15 years. Tonix is also advancing programs for Lyme disease prevention and kidney transplant rejection, underscoring its commitment to innovative science and driving future growth. Read more here: https://lnkd.in/eB9p2qCu

We’re heading to the Stifel 2025 Healthcare Conference this week. Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, will present on Thursday, November 13 at 10:00 AM ET. Join the live webcast here: https://lnkd.in/eZPjv-vK

Tonix Pharmaceuticals announced a collaboration with Massachusetts General Hospital to advance an investigator-initiated Phase 2 study of TNX-1500, a dimeric Fc-modified anti-CD40L antibody, in kidney transplant recipients. The study is expected to begin in the first half of 2026 and will evaluate TNX-1500’s safety and activity as a potential new monotherapy to reduce conventional immunosuppressive use and improve outcomes. Read more here: https://lnkd.in/eQ_hdFZQ

Even today, gender bias continues to shape how patients are heard and treated. In his latest Substack essay, Tonix CEO Seth Lederman reflects on how outdated assumptions in medicine can delay diagnosis, limit access to care, and impact outcomes for both women and men. He also highlights how better data, listening, and awareness can help close the care gap and improve patient experiences.  Read the full essay on Substack: https://bit.ly/4omALXA #HealthEquity #WomensHealth #MensHealth #BiasInMedicine #PatientCare #TonixPharma

Tonix Pharmaceuticals will present at BIO-Europe 2025, taking place November 3–5 in Vienna, Austria. Seth Lederman, M.D., Chief Executive Officer, will present on Tuesday, November 4, highlighting Tonix’s strategy, pipeline, and upcoming milestones.

Behind every breakthrough are patients who never stopped believing science would catch up. In his new op-ed, Tonix CEO Seth Lederman reflects on how patient experience helped guide the development of the first new FDA-approved fibromyalgia therapy in adults in over 15 years and how their voices are shaping the next generation of innovation in chronic pain. Because progress happens faster when patients and science move together. 🔗 Read here: http://bit.ly/47oLppC #Fibromyalgia #ChronicPain #PatientVoices #NonOpioidTherapies #BiomedicalInnovation #TonixPharmaceuticals

Tonix Pharmaceuticals presented data on TNX-102 SL (cyclobenzaprine HCL sublingual tablets) at the 2025 ACR Convergence, highlighting clinically meaningful pain reduction and symptom improvement in the Phase 3 RESILIENT study. TNX-102 SL significantly reduced fibromyalgia pain versus placebo (p<0.0001) and improved sleep quality, fatigue, and daily functioning, while remaining well tolerated with minimal effects on weight or blood pressure. Read more here: https://lnkd.in/dhRifDr4