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

Months after reports first linked Curium to a potential Lantheus takeover, the radiopharma players have made it official with a deal worth up to $8 billion. Curium has agreed to buy all outstanding Lantheus shares for $102.50 apiece in cash at closing. Shareholders could receive up to another $12 per share through contingent value rights tied to sales milestones for Lantheus’ prostate cancer, neurology and Definity franchises through 2030. The companies expect to close the transaction in the f

As the pharmaceutical industry works to accelerate every aspect of the drug development process, Dash Bio is leveraging automation to speed up one specific step that is still largely manual — the lab-based testing needed to establish a compound's safety and pharmacokinetic profile using preclinical and clinical samples. The service provider on Monday raised a $30-million series A, led by Oak HC/FT, to scale its commercial bioanalysis platform and expand its assay offerings. Existing investors F

Obsidian Therapeutics to focus on the advancement of its pipeline of novel engineered TIL cell therapies for the treatment of patients with solid tumors Post-transaction cash and cash equivalents of approximately $350 million expected to fund operations into 2H 2028, including NSCLC Phase 1 data expected in 1H 2027 and melanoma registration-enabling data expected year-end 2027 Shares to begin trading on Nasdaq under ticker symbol “OBX” on August 4, 2026 Obsidian Therapeutics, Inc. (“Obsidian”)

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