Preclinical data demonstrates that Shape’s engineered AAV5 variant, SHP-DB1, efficiently targets the NHP brain after intravenous injection and transduces >95% of neurons in the Parkinson's Disease-critical substantia nigra Shape’s novel RNAfix® gene therapy enables targeted knockdown of alpha-synuclein in mouse and NHP brain, supporting the therapeutic development of a first-in-class disease-modifying treatment for Parkinson's Disease Oct. 10, 2025 -- Shape Therapeutics, a leader in RNA-bas

Risvodetinib demonstrated to be safe and well-tolerated with preliminary clinical benefits Risvodetinib demonstrated to be the first treatment to reduce alpha-synuclein pathology, widely recognized as the underlying cause of Parkinson’s disease Blood-borne biomarkers evaluate target engagement and mechanism of action to confirm the Company’s underlying rationale for treatment Oct. 09, 2025 -- ABLi Therapeutics (“ABLi”), a biotechnology company developing therapeutics to address diseases that a

Idiopathic pulmonary fibrosis (IPF) is a progressive disease, causing a continuous decline in lung function.1 Approval is based on results from two clinical trials, which showed reduction in Forced Vital Capacity decline with JASCAYD versus placebo in adults with idiopathic pulmonary fibrosis (IPF).2,3 Nerandomilast is a new treatment option for adult patients with IPF with a well-tolerated safety profile.2,3 Boehringer Ingelheim’s JASCAYD® (nerandomilast) tablets has been approved by the U.S.

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