FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]

CalciMedica, Inc. (NASDAQ:CALC) shares are down on Wednesday after the company announced the discontinuation of its Phase 2 KOURAGE clinical trial.The trial was evaluating Auxora in patients with Stage 2 or Stage 3 acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF). Data was expected in the first half of 2026.The stock is trading lower with a session volume of 23.27 million, compared to the average volume of 84.063 thousand.CalciMedica Halts KOURAGE Trial Due to Safety Conc ...

Core Insights - CalciMedica is advancing its clinical programs, particularly the Phase 2 KOURAGE trial for Auxora in acute kidney injury (AKI) with respiratory failure, with data expected in the first half of 2026 [1][5] - Positive discussions with the FDA regarding a pivotal trial in acute pancreatitis (AP) are ongoing, with final trial design anticipated in the first half of 2026 [1][2] - The company's cash position is projected to support operations into the second half of 2026 [1][8] Clinical Updates - Enrollment in the KOURAGE trial is ongoing, targeting 150 patients with Stage 2 or Stage 3 AKI with respiratory failure, with results expected in 1H 2026 [5] - Recent animal model data presented at ASN Kidney Week 2025 supports the efficacy of Auxora in improving kidney function and reducing renal injury [5][7] - Collaboration with Telperian aims to utilize AI-driven analytics to enhance the design of the pivotal trial in AP [2][6] Financial Results - As of September 30, 2025, CalciMedica reported cash, cash equivalents, and short-term investments totaling $14.1 million [8] - Research and development expenses for Q3 2025 were $3.9 million, up from $3.6 million in Q3 2024, primarily due to increased clinical trial activities [9] - General and administrative expenses decreased to $1.8 million in Q3 2025 from $2.2 million in Q3 2024 [10] - The net loss for Q3 2025 was $7.8 million, or $0.52 per share, compared to a net loss of $5.6 million, or $0.50 per share, in Q3 2024 [12]