This week's biotech landscape features key FDA approvals, clinical holds and go-aheads, trial discontinuations, and clinical trial data readouts across key therapeutic areas such as Endometrial cancer, Colorectal cancer, Weight Management, Acne, and Duchenne muscular dystrophy. Let us unpack the key developments and milestones in the biotech space this week.FDA Approvals & RejectionsIntellia Gets FDA Green Light to Resume MAGNITUDE-2 Phase 3 TrialIntellia Therapeutics, Inc. (NTLA) said the U.S. FDA has lif ...

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]