Paris, France – The US Food and Drug Administration (FDA) is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients. The target action date for the FDA decision is September...
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BASEL, Switzerland – TOLREMO therapeutics AG (TOLREMO), today announced that their lead candidate, TT125-802, received two Fast Track designations from the U.S. Food and Drug Administration (FDA) for the treatment of non-small cell lung cancer (NSCLC). One Fast Track designation was granted for the treatment of patients with locally advanced or metastatic NSCLC...
San Diego, Calif. – The BIO Convention always highlights new regulatory developments, cutting edge technologies and the best new companies that are going change the face of healthcare in the near future, and 2024’s conference did not disappoint. The first of a series of CheckOrphan articles highlighting companies changing the...
CHATHAM, N.J. — Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the U.S. Food and Drug Administration (FDA) has conditionally accepted the trade name, Tonmya™, for the company’s drug product candidate TNX-102 SL for the management of fibromyalgia. Tonmya...
CHATHAM, N.J. — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) approved Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults. Tonmya is a first-in-class, non-opioid, once-daily bedtime analgesic with a unique sublingual (under the...
CHATHAM, N.J. — Tonix Pharmaceuticals Holding Corp., a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the Phase 3 RESILIENT study evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) met its pre-specified primary endpoint in the second of two positive Phase 3 clinical trials, significantly...
CHATHAM, N.J. — Tonix Pharmaceuticals, Inc. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application to support clinical development of TNX-2900 (intranasal potentiated oxytocin), a proprietary magnesium (Mg2+)-enhanced formulation...
Chatham, N.J. — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will deliver an oral presentation and the Company will present a poster at the 5th International Congress on Controversies in Fibromyalgia being held March 30-31, 2023...
Chatham, N.J. — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, announced that Herbert Harris, M.D., Ph.D., Executive Vice President, Translational Medicine of Tonix Pharmaceuticals, will deliver a presentation at the Rare Disease Innovation and Partnership Summit, which will be held as a hybrid event in Philadelphia, Pa.,...
CHATHAM, N.J. — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced the presentation of new findings on TNX-801 (recombinant horsepox, live virus vaccine) at the Vaccine Congress 2025 in Vienna on July 10, 2025, by Sina...