Eli Lilly and Company (LLY) announced positive results from its TRAILBLAZER-ALZ 6 study, demonstrating a significant reduction in ARIA-E, a side effect associated with Alzheimer’s treatments, in patients receiving a modified dosing regimen of donanemab. The study revealed a 41% lower relative risk of ARIA-E in the modified group compared to standard dosing, with the most notable reduction seen in patients carrying the APOE4 gene, a known risk factor for Alzheimer’s.
Autonomix Medical, Inc. (AMIX) stock surged over 100% on Monday after the company announced promising preliminary results from its ongoing human trial evaluating a new treatment for pancreatic cancer pain. The trial, which utilizes a catheter-based microchip sensing array antenna to target and ablate pain-causing nerves, showed significant pain reduction and opioid elimination in patients treated with femoral access.
Tyra Biosciences has unveiled positive clinical proof-of-concept data for its investigational oral FGFR3-selective inhibitor, TYRA-300, in patients with metastatic urothelial (mUC) cancer. The data, presented at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, highlights the drug’s potential efficacy and safety profile in treating this aggressive form of bladder cancer.
Marinus Pharmaceuticals, Inc. (MRNS) experienced a significant stock decline following the release of disappointing data from its Phase 3 TrustTSC trial for oral ganaxolone in treating seizures associated with tuberous sclerosis complex (TSC). The trial failed to meet its primary endpoint, leading the company to discontinue further ganaxolone development and explore strategic alternatives.
Boston Scientific has temporarily halted enrollment in its AVANT GUARD trial, which is evaluating the FARAPULSE Pulsed Field Ablation (PFA) System for persistent atrial fibrillation (AFib). The pause is due to unanticipated observations in the trial, which is focusing on drug-naive patients, a population not currently indicated for PFA treatment. The company emphasizes that the observations are not life-threatening and that they remain confident in the FARAPULSE system’s overall performance.
Alto Neuroscience, Inc. (ANRO) announced disappointing results from its Phase 2b trial of ALTO-100 for major depressive disorder (MDD), leading to a significant drop in the company’s stock price. Despite the setback, Alto remains optimistic about its biomarker-driven approach and its other ongoing clinical trials.
BofA Securities has upgraded Tyra Biosciences, a clinical-stage biotech company, from Neutral to Buy, citing promising preclinical data for their drug TYRA-300 and its potential to treat urothelial carcinoma. The upgrade comes ahead of the presentation of phase 1/2 data at the ENA Meeting next week. BofA’s bullish outlook is based on the drug’s differentiated safety profile compared to existing treatments, leading to projected sales of $175 million by 2030.
MeiraGTx Holdings’ (MGTX) gene therapy candidate, AAV-GAD, for treating Parkinson’s disease (PD) has shown positive results in a clinical bridging study, meeting its primary objective of safety and tolerability. The study also demonstrated significant improvements in key efficacy endpoints, leading to a 14.9% surge in MGTX’s stock price. This promising development could pave the way for a potential phase III study and global approval of this disease-modifying treatment.
Wave Life Sciences’ stock surged on Wednesday after the company announced positive proof-of-mechanism data from its Phase 1b/2a RestorAATion-2 study of WVE-006 for alpha-1 antitrypsin deficiency (AATD). The data demonstrated successful RNA editing in humans, marking a significant milestone in the treatment of this inherited genetic disorder.
MeiraGTx Holdings plc (MGTX) announced positive topline data from its clinical bridging study of AAV-GAD for Parkinson’s disease, showing significant improvements in motor function and quality of life for patients in the high-dose group. The gene therapy was found to be safe and well-tolerated, with no serious adverse events related to the treatment.
