Oct. 10, 2025 Data from first cohort of five participants suggest an acceptable safety profile for AB-1003 in participants with limb-girdle muscular dystrophy (LGMD) 2I/R9, with no dose-limiting toxicities or serious adverse events reported up to 52 weeks post-treatment Based on these data, the Data Safety Monitoring Board recommended advancing to the second cohort, announced earlier in 2025 AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary

Global Phase III trial has enrolled and randomised over 170 patients, reaching an important milestone as this is above the amount needed to conduct the futility analysis Over 100 clinical sites across 24 countries now activated and open for recruitment Futility analysis remains on track for completion in the first quarter of CY2026 Oct. 09, 2025 -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases,

EMA approval covers study sites in Germany and Poland as part of the Company’s global Phase 2 RENEW trial Trial will evaluate LTI-03, a first-in-class therapy designed to both reduce lung scarring and promote repair Oct. 09, 2025 -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced that it has received authorization

Oct. 09, 2025 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B in adults and adolescents who are at higher risk of influenza complications due to underlying immunodeficiency, are at higher risk of severe influenza despite influenza

Werewolf Therapeutics Receives Fast Track Designation from the U.S. FDA for WTX-124, an Investigational Therapy for the Treatment of Cancer Fast Track Designation underscores the promise of Werewolf’s INDUKINE™ platform Oct. 08, 2025 -- Werewolf Therapeutics, Inc. (the “Company” or “Werewolf”) (Nasdaq: HOWL), pioneering the development of therapeutics engineered to stimulate the body’s immune system for the treatment of cancer and other immune-mediated conditions, today announced that the Compa

RJVA-002 achieved ~30% weight loss at five weeks in a translational obesity model; weight loss not yet plateaued Preclinical results show that a single point-in-time treatment with RJVA-002 has the potential to achieve significant weight loss that can match or exceed best-in-class chronic drug therapy Oct. 07, 2025 -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company), a metabolic therapeutics company focused on pattern-breaking approaches to treat the root causes of obesity and type 2 diabete

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