The Company is well on track with Phase 1 enrollment now that both patients in Cohort 3 have successfully initiated treatment with no evidence of dose-limiting toxicities or tolerability concerns to date The first patient in Cohort 3 has shown promising evidence of immune activation consistent with levels of activity observed in patients from the previous two lower-dose cohorts; additional update anticipated by year-end Upon successful completion of the Cohort 3 safety assessment, the trial will

Migaldendranib (MGB), a subcutaneous nanomedicine, represents potential paradigm shift from frequent intravitreal injections Oct. 08, 2025 -- Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company developing a nanomedicine therapeutic that traverses the blood-retinal barrier in regions of inflammation selectively targeting and reprogramming activated cells in the retina, today announced an upcoming presentation at Innovate Retina 2025, taking place in Orlando, FL on October 16, 2025, a

U.S. Food and Drug Administration (FDA) open to pooling data from ongoing Phase I/II studies of LX2006 with pivotal data to support a Biologics License Application (BLA) for Accelerated Approval Interim clinical data show sustained or deepening improvements in the majority of participants across both cardiac and neurologic measures of Friedreich ataxia Participants with abnormal left ventricular mass index (LVMI) at baseline achieved 18% mean reduction in LVMI at 6 months and 23% mean reduction

JADE201 builds on clinical proof-of-concept for BAFF-R targeting, adding half-life extension technology to provide extended receptor occupancy with the goal of delivering deeper, more durable B cell depletion with less frequent subcutaneous dosing JADE201’s high affinity binding and extended half-life enabled dose-dependent BAFF receptor occupancy and sustained B cell depletion in non-human primates First-in-human trial in rheumatoid arthritis expected to begin in the first half of 2026; potenti

Marker Therapeutics initiated Phase 1 RAPID study to investigate Multi-Antigen Recognizing (MAR) T cells as an Off-the-Shelf (OTS) product to accelerate time to treatment OTS product was well tolerated - safety data consistent with other MAR-T cell studies Oct. 06, 2025 -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indicati

Oct. 07, 2025 -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that new data will be presented supporting the combination regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor and ruzasvir, an NS5A inhibitor, as a potential best-in-class regimen for the treatment of hepatitis C (HCV) infection at The Liver Meet

Nausea and Vomiting Are the Most Frequent Reasons for Discontinuing GLP-1 Therapies, Significantly Impacting Adherence, Titration and Preventing Achievement of Proven Long-Term Benefits Oct. 07, 2025 -- Neurogastrx, Inc., today announced that it will share proof-of-concept data from the clinical study of NG101 (metopimazine mesylate) for the treatment of semaglutide-induced nausea and vomiting in an oral presentation at ObesityWeek® 2025. NG101 is an oral, peripherally restricted dopamine D2 r

Nimacimab monotherapy did not meet its primary endpoint for weight loss; preliminary pharmacokinetic analysis showed lower than expected drug exposure, potentially indicating the need for higher dosing as a monotherapy. Clinically meaningful additional weight loss observed with combination of nimacimab, a peripheral CB1 inhibitor, and semaglutide compared to semaglutide alone. Nimacimab alone and in combination demonstrated a clean safety profile, with no added gastrointestinal adverse events an

The DECLARATION (safety and efficacy vs. placebo) and LIBERTY (exploratory safety head-to-head and combination with mRNA-based COVID vaccination) clinical trials are expected to begin around year-end 2025; top-line data anticipated mid-2026 DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate prevention of COVID, at three months, from a single intramuscular (IM) dose of VYD2311, with longer-term protection anticipated. A second VYD2311 arm will evaluate monthly IM

OCTOBER 6, 2025 — Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT23, a proposed biosimilar to Xolair®