On October 19, 2026, the first patients in the Phase 1/2 clinical trial ATL001-PII-CEP received their first dose and will continue on a daily oral dose over the coming months. On October 19, 2026, the first three patients with congenital erythropoietic porphyria (CEP) enrolled in the ATL001-PII-CEP clinical trial received their first dose of ATL-001, Atlas Molecular Pharma’s investigational oral drug for CEP. This is the first timeATL-001 h as been given to people with this severe, ultra-rare d

Oral olorofim was non-inferior to AmBisome® followed by standard of care (AmBisome®+SOC), with Day 42 all-cause mortality of 23.8% for olorofim versus 24.3% for AmBisome®+SOC in patients with invasive aspergillosis1 Enrolled patients had invasive aspergillosis for which standard mould-active azole therapy was either not appropriate (known or suspected azole resistance, intolerance to azole therapy, drug-drug interactions, or breakthrough infection while on azole) or had been ineffective1 Fewer p

Saniona (OMX: SANION), a clinical-stage biopharmaceutical company focused on neurological and psychiatric disorders, today announces the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for SAN2465 for the treatment of major depressive disorder (MDD). The Phase 1 study is expected to be initiated by the end of 2026, contingent on FDA clearance of the IND application. “The IND submission for SAN2465 represents an important milestone for Sa

The US Food and Drug Administration (FDA) has granted Roche a label expansion for its ophthalmology therapy, Enspryng (satralizumab), in thyroid eye disease (TED), with the benefit of an at-home administration. This means that the interleukin 6 (IL-6) inhibitor is now greenlit for use in adults with TED – a condition where the body’s own cells attack the muscles, tear glands and connective tissues behind the eyes. Following its label expansion, healthcare providers can now prescribe Enspryng to

The trial met the primary and secondary endpoints with statistically significant placebo-adjusted improvements at Week 3 in the YMRS total score (3.1 points; p=0.045) and CGI-BP Severity of Mania score (0.4 points; p=0.024) RAP-219–treated patients had a 15.4-point mean reduction in YMRS total score from baseline at Week 3 All 11 items measured by the YMRS improved numerically compared to placebo at Week 3, with improvements in irritability, thought content, disruptive-aggressive behavior, and s

Designation covers AV-1959R for people with amyloid buildup in the brain but no symptoms, a population for whom no preventive therapy is approved Fast Track allows more frequent FDA interaction and potential eligibility for rolling review, Accelerated Approval and Priority Review Nuravax plans to evaluate AV-1959R in AREVIA, a 160-participant Phase 2 prevention study Oct. 20, 2026 -- Nuravax, Inc., a clinical-stage biotechnology company developing vaccines for neurodegenerative diseases, today

Four abstracts accepted for presentation at European Society for Medical Oncology (ESMO) 2026 demonstrate the breadth of clinical development across multiple tumor types and treatment settings Oct. 19, 2026 -- SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, today announced that four abstracts for iza-bren (izalontamab brengitecan), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC), will be presented at the European Society for Medical Oncolog

– Peer-Reviewed Paper Introducing QRX003 and Its Mechanism of Action in Netherton Syndrome Now Published – Case Report Details 21 Months of Compassionate Use Treatment in a Pediatric Patient – Patient’s Skin Improved from Severe to Clear with Complete Elimination of Pruritus (itch) – After 21 Months of Treatment with QRX003, Patient’s Skin Remains Fully Clear and Pruritus Free – No Adverse Events have Been Reported for the Patient – Full Recruitment in Ongoing Phase 2/3 Netherton Syndrome Study

Positive Phase 1 data were previously presented in an oral session at ASCO 2026 Emi-Le received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the proposed treatment of patients with locally advanced, recurrent or metastatic ACC with solid histology or high-grade transformation Oct. 19, 2026 -- Servier today announced the first patients have been dosed in the pivotal Phase 2 cohort (EMBLEM-1) of a Phase 1/2 study of Emiltatug Ledadotin (Emi-Le) in solid tu

OptimUM-01 and OptimUM-02 data supports the broad potential of darovasertib plus crizotinib to drive meaningful clinical benefits for patients with metastatic uveal melanoma, irrespective of HLA-A*02:01 allele status or line of therapy OptimUM-01 data demonstrates encouraging clinical activity from darovasertib combined with crizotinib in both treatment-naïve (7.4 month PFS, 27.1 month mOS, n=13) and heavily pretreated HLA-A*02:01-positive metastatic uveal melanoma, including in 2L patients foll