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

ADPKD is an inherited, progressive disorder where fluid-filled cysts expand in both kidneys. Credit: sasirin pamai/Shutterstock.com. US-based genetic medicines developer Estuary Biotherapeutics has launched after securing $103m in total committed financing for developing targeted gene therapies to treat kidney diseases. The capital will fund clinical proof-of-concept testing for the biotechnology company’s lead gene therapy candidates, EST-101 and EST-201, whilst advancing its platform for direc

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

Germany’s Merck KGaA has picked up Silence Therapeutics to the tune of $1.3 billion in the wake of the British biotech’s mid-stage success for its challenger to Takeda’s Mimrylo. The all-cash deal will see Darmstadt-based Merck pay $20 per American depositary share, with each ADS representing three ordinary shares of Silence. The biggest prize for Merck is divesiran, a short interfering RNA (siRNA) drug candidate designed to treat a rare blood cancer called polycythemia vera (PV). The cancer is

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

Just weeks after IntraBio secured a label expansion for its lead asset Aqneursa, Japanese drugmaker Shionogi is moving in to take the reins. Shionogi is handing over $2 billion for the Austin, Texas-based commercial biotech, in a deal that—in addition to Aqneursa—will grant access to IntraBio’s rare disease expertise and pipeline. The acquisition builds on Shionogi’s plans to diversify beyond its anti-infectious disease drug base and to beef up its budding rare disease unit, which was founded

Oct. 19, 2026 -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that its partner, the University of Oklahoma (OU), has received $2.9 million in funding from the National Cancer Institute (NCI) to study, in clinical trials, whether RedHill's opaganib[1], given after CAR (chimeric antigen receptor) T-cell therapy, may help immune cells fight cancer more effectively. The five-year, $2.9 million grant from the NCI is planne