Clinical Trial News

B.Riley raises Viridian Therapeutics' price target to $22.00 following positive Phase III THRIVE study results for VRDN-001 (veligrotug), projecting $500-$700 million in annual sales. Viridian also initiates $150 million stock offering and reports $571.4 million in cash reserves. Analysts predict VRDN-001 could capture 25-35% of Tepezza's market share.

Dr. Charles Ndawula from Uganda is researching vaccines against East Coast Fever at the Department of Medical Biotechnology. His approaches include developing vaccines against the tick vector and the parasite Theileria parva. The project runs until 2027.

Agios Pharmaceuticals received FDA orphan drug designation for tebapivat (AG-946) in MDS treatment, aiming to be the first oral therapy for anemia in lower-risk MDS, affecting 75,000-80,000 patients in the U.S. and EU5. The designation offers tax credits and potential market exclusivity, with Agios completing a Phase 2a study and initiating a Phase 2b study.

Sanofi and Regeneron's Dupixent showed significant improvement in chronic spontaneous urticaria patients in a Phase 3 trial, with 30% achieving complete response versus 18% on placebo, moving closer to FDA approval.

Viridian Therapeutics' veligrotug met all primary and secondary endpoints in Phase III THRIVE trial for active thyroid eye disease (TED), showing significant improvements in signs and symptoms. The treatment group saw a 70% proptosis responder rate and a 2.9mm mean reduction in proptosis, compared to 5% and 0.5mm in the placebo group. Veligrotug was generally well-tolerated with mild adverse events and no serious treatment-related AEs. The company's stock price rose by 32% following the trial results.

Arch Biopartners announces Alberta Health Services approval for Phase II trial of LSALT peptide to prevent and treat cardiac surgery-associated acute kidney injury (CS-AKI). The trial, an international, multi-center, randomized, double-blind, placebo-controlled study, aims to evaluate the percentage of subjects with AKI within seven days following on-pump cardiac surgery, as defined by KDIGO criteria.

Decentralised clinical trials, leveraging tech for remote participation, ease patient burden, enhance engagement, and support sustainable research. Chiesi Farmaceutici's study on asthma patients found 80-90% positive response to home-based e-Consent, spirometry, e-Diary, and telemedicine, though challenges remain, especially for less digitally literate elderly.

FDA rejected Lykos Therapeutics' NDA for MDMA treatment of PTSD, citing insufficient evidence of efficacy and safety. The rejection followed an advisory committee meeting where concerns were raised about the study's functional unblinding and the combined drug-therapy approach. Lykos plans to meet with the FDA to discuss resubmission, while the broader impact on psychedelic research remains debated.

Multiple studies report on survival outcomes and therapies for multiple myeloma, including retrospective analyses, phase trials, and real-world data, highlighting advancements in treatment strategies and overall survival improvements.

Praxis Precision Medicines Inc. (NASDAQ:PRAX) maintains positive outlook from H.C. Wainwright, with Buy rating and $120.00 price target. Recent successes include positive Phase 2 data for relutrigine and favorable peer review results for PRAX-628. Praxis is advancing its epilepsy portfolio with key milestones expected in the next 12 months, including initial pivotal readout for PRAX-628 in focal onset seizures. Analysts highlight potential of Praxis Precision's relutrigine, with interim Essential3 Part1 analysis expected in Q4 2024.