Grifols’ SPARTA phase 3 trial is designed to evaluate the clinical efficacy and safety of two separate weekly dose regimens of Grifols’ Prolastin ®-C (Alpha1-Proteinase Inhibitor [Human] modified process) in patients with emphysema due to alpha-1 antitrypsin (AAT) deficiency (known as alpha-1) The trial is the largest randomized, double-blind, placebo-controlled study on alpha-1 and augmentation therapy to-date and has the potential to provide clinical evidence on slowing progression of lung tis

Aug. 14, 2026 -- Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio") today announced that the U.S. Food and Drug Administration (FDA) has approved ziresovir (AK0529) for a phase II clinical trial in the severely ill RSV infected infant patients, including the ones in pediatric intensive care unit (PICU). RSV is the leading pathogen of lower respiratory tract infections (LRTIs) in infants and young children globally, causing approximately 33 million LRTI cases, 3.6 million hospitalizations, and m

First patient dosed in an outpatient setting, discharged the same day; multiple patients in the process of screening at several activated sites Trial advances FT819 toward a potential accelerated regulatory pathway supported by RMAT designation and participation in the FDA CMC Development and Readiness Pilot program Study expected to enroll approximately 53 patients with refractory moderate-to-severe systemic lupus erythematosus (SLE) with Class III or IV lupus nephritis; study anticipated to co

After a yearslong struggle, Jazz Pharmaceuticals has called time on Zepzelca as a second-line treatment for small cell lung cancer. In alignment with the FDA, Jazz plans to ask the agency to remove the second-line SCLC indication from Zepzelca’s label, the company said Monday alongside its second-quarter earnings report. The decision comes after the confirmatory phase 3 Lagoon trial recently failed on its primary endpoint of overall survival. In the study, Zepzelca (lurbinectedin) monotherapy

Aug. 04, 2026 -- Healis Therapeutics announced that it has opened an IND with the U.S. FDA for Tyemvers®, a new botulinum toxin type A product. The milestone enables Healis to initiate its U.S. clinical trial, enter clinical-stage research and development, and advance toward participation in the therapeutic botulinum toxin market. The Phase 1 single-ascending-dose study will evaluate Tyemvers’ safety and tolerability. Completion is expected to support Phase 2 studies in major depressive disor

DNTH312 is an internally developed bifunctional fusion protein targeting potent inhibition of active C1s (aC1s) and BAFF/APRIL, two validated pathways with complementary disease modifying mechanisms DNTH312 demonstrated comparable in vitro potency and aC1s inhibition to claseprubart, with a comparable non-human primate (NHP) half-life DNTH312 showed similar depth of Ig reductions vs. povetacicept following a single dose in NHPs By building on claseprubart’s best-in-class profile, DNTH312 strengt

Aug. 5, 2026 -- SystImmune, Inc., a clinical-stage biotechnology company and subsidiary of Biokin, today announced that the first patient has been dosed in BrenDeLL-Lung01 (NCT07625644), a global Phase 3 registrational trial evaluating BL-M14D1 in combination with atezolizumab for the treatment of patients with previously untreated extensive-stage small cell lung cancer (ES-SCLC). BL-M14D1 is an investigational DLL3-targeted antibody-drug conjugate (ADC) built on SystImmune's proprietary brengi

Silexion Therapeutics Reports New Positive Preclinical Findings Demonstrating Multi-Mechanism Immune Sensitization by SIL204 in KRAS-Driven Cancers Silexion to present SIL-204 data at leading Cancer Symposium designed to feature the latest science in the field of GI cancers New preclinical data demonstrate that SIL204 treatment produced statistically significant upregulation of FAS (CD95), the immune “death receptor,” and statistically significant downregulation of HLA-G, an established immune c

-- First-in-human trial of LBL-051 is enrolling patients with refractory autoimmune diseases to rapidly generate broad proof of concept -- August 4, 2026 - Oblenio Bio (“Oblenio” or “the Company”) today announced that the first patients have been dosed in its Phase 1a first-in-human clinical trial evaluating LBL-051, the company's tri-specific T cell engager targeting BCMA, CD19 and CD3. Specifically engineered for autoimmune patients, LBL-051 is designed to safely induce complete depletion of

Aug. 3, 2026 -- GlycoNex Inc. (TPEx: 4168) today announced that the first patient has been successfully dosed in the First-in-Human (FIH) Phase I clinical trial of GNX1021, the Company's novel glycan-targeting antibody-drug conjugate (ADC), in Japan. The milestone marks GNX1021's transition into clinical development and initiates the generation of the first human data for the Company's lead oncology asset. The start of dosing represents an important value inflection point for GlycoNex. It advan