DT-101 is designed to allow effective modulation of the AMPA receptor without compromising safety Phase 2 clinical trial initiation anticipated before the end of 2025 Trial builds on positive Phase 1 study that showed DT-101 was well tolerated and demonstrated target engagement 2 October 2025 – Draig Therapeutics (“Draig”), a clinical-stage company aiming to transform the treatment of neuropsychiatric diseases, today announces that it will initiate a Phase 2 study of DT-101, a next-generation A

50 mg once-daily dose of obefazimod led to a pooled 16.4% (p<0.0001) placebo-adjusted clinical remission rate at Week 8; met primary and all key secondary endpoints in both ABTECT 1 and ABTECT 2 ABTECT trials enrolled refractory patient population with 47% of participants having prior inadequate response to advanced therapy, among whom 21% had prior inadequate response to JAK inhibitor therapy Obefazimod treatment was well tolerated with no new safety signals identified for both the 25mg and

Oct. 02, 2025 -- CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based clinical stage biopharmaceutical company focused on harnessing its proprietary technologies to develop novel affordable donor-derived cell-based immunotherapies for the treatment of a broad range of cancers, including both blood and solid tumours, is pleased to announce the publication of a preclinical study, in a research article entitled “Donor-Derived Vγ9Vδ2 T Cells for Acute Myeloid Leuk

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study1 First and only combination therapy for the first-line maintenance treatment of ES-SCLC, which is critical to help address the high rate of relapse in ES-SCLC2 Regimen recommended in National Comprehensive Cancer Network® Guidelines for SCLC*3 3 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approv

Health Canada approved AGAMREE for the treatment of Duchenne muscular dystrophy in patients aged 4 years and older This approval makes AGAMREE the first and only approved therapy for DMD in Canada October 3, 2025 – Santhera Pharmaceuticals (SIX: SANN) today notes that Health Canada has approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older following Priority Review, marking the first approved treatment for the disease in Canada.

Oct. 02, 2025 -- Nacuity Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing treatments for retinitis pigmentosa, cataracts and other diseases caused by oxidative stress, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to NPI-001 (N-acetylcysteine amide) tablets, Nacuity’s proprietary, investigational therapy for the treatment of patients with retinitis pigmentosa (RP). “Breakthrough Therapy Designatio

Additional pre-planned analysis of the NCX 470 Denali trial completed NCX 470 maintains robust intraocular pressure lowering at 6, 9 and 12 months Other analyses broadly in line with the trends seen for Mont Blanc Data presentations planned for upcoming ophthalmology conferences October 2, 2025 – Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that it has completed the additional pre-planned analyses of the NCX 470 Denali Phase 3 cl

Biolab Farmacêutica gains exclusive rights in Brazil to GMRx2, an innovative single pill combination of three medicines, including two doses that are lower than those currently available in single pill combinations, designed to deliver the blood pressure-lowering benefits of triple combination therapy early in the treatment pathway, with an established safety profile George Medicines receives upfront licensing fee and is eligible for regulatory and commercial milestone payments, as well as a fut

Cirrus’ lead program is a novel AAV gene therapy designed to restore IRAK-M, a central regulator of the eye’s immune homeostasis, so as to prevent AMD progression and preserve central vision IRAK-M levels decrease with age and more prominently in people with dry AMD, presenting an important therapeutic target to combat this leading cause of vision loss in people over 50 Seed funding will advance the lead program into IND-enabling studies and support a growing pipeline of next-generation ocular m

Oct. 01, 2025 -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (“CRL”) relating to the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-ow