Tag Archive for: Phase 3

Calliditas Announces Positive NefIgArd Open Label Extension Results

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study across endpoints of urine protein to creatinine ration (UPCR) and estimated glomerular filtration rate (eGFR) at 9 months across all IgAN patients, including […]

Destiny Pharma plc – Positive findings from recent SAB meeting

Confirms proposed Phase 3 development pathway and identifies new life cycle management targets for XF-73 Nasal Brighton, United Kingdom – 6 July 2023 – Destiny Pharma (AIM: DEST), a clinical stage biotechnology company focused on the development and commercialisation of novel medicines to prevent life threatening infections, recently held a meeting with its Scientific Advisory Board […]

Calliditas Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Full Approval of TARPEYO®

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced the submission of a supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration (“FDA”) seeking full approval of TARPEYO® (budesonide) delayed release capsules for the entire study population from the Phase 3 NeflgArd study. TARPEYO is currently approved under accelerated approval to reduce […]

Calliditas Announces Primary Endpoint Successfully Met in Phase 3 NefIgArd Trial Evaluating Nefecon[®] in IgA Nephropathy

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon (TARPEYO®/Kinpeygo® (budesonide) delayed release capsules) versus placebo in patients with primary IgA nephropathy (IgAN). The trial met its primary endpoint with Nefecon demonstrating a highly […]

Verona Pharma Announces Ensifentrine Meets Primary and Key Secondary Endpoints in Phase 3 ENHANCE-1 Trial for COPD

Statistically significant improvements in lung function, symptoms and quality of life 36% reduction in rate of exacerbations over 24 weeks Well tolerated safety profile over 48 weeks NDA submission planned for 1H 2023 Conference call today at 8:30 a.m. EST / 1:30 p.m. GMT LONDON and RALEIGH, N.C., Dec. 20, 2022 (GLOBE NEWSWIRE) — Verona […]