Chatham, N.J., March 30, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present an oral presentation and poster at the 5th International Congress on Controversies in Fibromyalgia being...
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CHATHAM, N.J. — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals, will present at the 2025 BIO-Europe Spring Convention being held March 17-19,...
Ionis completed a Phase 2 clinical study evaluating cimdelirsen (IONIS-GHR-LRx) as an addon therapy in patients with uncontrolled acromegaly despite stable therapy with long-acting somatostatin receptor ligands (SRL). Based on the results of this Phase 2 study and a preliminary analysis of the ongoing open-label study, proof of mechanism was...
SAN DIEGO, Calif. — Tr1X, a clinical-stage biopharmaceutical company developing first-in-class allogeneic engineered type 1 regulatory (Tr1 Treg) and CAR-Tr1 Treg cell therapies with the potential to cure autoimmune and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND)...
Bottom Line: The MEK inhibitor trametinib (Mekinist) was an effective treatment for pediatric patients with relapsed or refractory juvenile myelomonocytic leukemia (JMML) enrolled in a phase II clinical trial, with seven of 10 patients alive after a median of two years. Journal in Which the Study was Published:...
BOSTON, Mass. — TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA therapeutics for the treatment of high risk and advanced cancer, today announced the publication of preclinical research supporting the application of its lead candidate, TTX-MC138, for the treatment of glioblastoma multiforme (GBM). The article was published...
SAN DIEGO, Calif. — Transposon Therapeutics, a biotechnology company developing a platform of novel, orally administered therapies for the treatment of neurodegenerative and aging-related diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TPN-101 for progressive supranuclear palsy (PSP). “Fast...
NANJING, China and GAITHERSBURG, Md. — TransThera Sciences Inc. (“TransThera”) announced the publication of clinical results from a US-based Phase 2 trial evaluating tinengotinib in patients with Cholangiocarcinoma (CCA) on The Lancet Gastroenterology and Hepatology (Impact Factor: 38.6). Cholangiocarcinoma (CCA) is an aggressive malignancy of the bile ducts, frequently driven by FGFR2 fusions-genomic...
SAN DIEGO, CA — Travere Therapeutics Inc. (Nasdaq: TVTX) today announced the completion of a successful pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for FILSPARI® (sparsentan) in IgA nephropathy (IgAN). The Company will submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for...
SAN DIEGO, Calif. — Travere Therapeutics, Inc., (Nasdaq: TVTX) announced that today the U.S. Food and Drug Administration (FDA) has extended the review timeline of its supplemental New Drug Application (sNDA) for FILSPARI® (sparsentan) in focal segmental glomerulosclerosis (FSGS). The new Prescription Drug User Fee Act (PDUFA) target action date is...