Elevation Oncology's EO-3021 Shows Promise in Gastric and GEJ Cancer Treatment
Elevation Oncology's EO-3021 demonstrated a 42.8% confirmed objective response rate (ORR) in Claudin 18.2-enriched gastric and GEJ cancer patients in Phase 1 trials.
Ionis Announces Phase 3 Trial Design for ION582 in Angelman Syndrome
Ionis Pharmaceuticals has reached an agreement with the FDA on the design of its Phase 3 REVEAL trial for ION582, a treatment for Angelman syndrome.
Lundbeck to Acquire Longboard for $2.6 Billion, Bolstering Neuro-Rare Disease Pipeline
Lundbeck will acquire Longboard for $2.6 billion, gaining access to bexicaserin, a novel 5-HT2C agonist for treating seizures associated with developmental and epileptic encephalopathies (DEEs).
Clearside Biomedical's CLS-AX Shows Promise in Wet AMD, Advancing to Phase III
Clearside Biomedical's CLS-AX, administered via suprachoroidal injection, demonstrated positive results in a Phase II clinical trial for wet age-related macular degeneration (AMD).
4SC AG's Resminostat Faces EMA Review Amidst Financial Constraints
4SC AG has filed for marketing authorization of Resminostat with the EMA for advanced cutaneous T-cell lymphoma, marking a key regulatory milestone.
Lenacapavir Demonstrates 100% Efficacy in HIV Prevention Trial
Lenacapavir, a novel long-acting HIV drug, achieved complete protection against HIV infection in a diverse population, including men, transgender women, and gender non-binary individuals.
J&J's Rybrevant Shows Promise in Colorectal Cancer, Phase 3 Trials Planned
Rybrevant plus chemotherapy achieved a 49% objective response rate in RAS/BRAF wild-type metastatic colorectal cancer patients who had not received anti-EGFR therapy.
Incyte's Zynyz Shows Promise in Frontline Anal Cancer Treatment
Incyte's Zynyz, combined with chemotherapy, significantly reduced the risk of disease progression or death in patients with squamous cell carcinoma of the anal canal (SCAC).
INmune Bio Completes Enrollment in Phase 2 Alzheimer's Trial and Reports Positive NK-Cell Data in Prostate Cancer Study
INmune Bio completed enrollment for its Phase 2 Alzheimer’s Disease trial (AD02) focused on early AD patients with elevated neuroinflammation biomarkers.
Turnstone Biologics Restructures to Focus on TIL Therapy, Extends Cash Runway into 2026
Turnstone Biologics is prioritizing its clinical program, TIDAL-01, a Selected TIL therapy, and streamlining operations to extend its cash runway into the second quarter of 2026.
iTeos Therapeutics Announces Strategic Priorities for 2025, Anticipating Multiple Data Readouts
iTeos Therapeutics is set to release multiple TIGIT clinical data readouts throughout 2025, involving over 400 patients from Phase 2 and Phase 1/2 trials.
LifeVantage Launches MindBody GLP-1 System for Sustainable Weight Management
LifeVantage has launched its MindBody GLP-1 System™ in the U.S., a dual-product solution designed to balance hunger hormones and support sustainable weight management.
Annovis Bio's Buntanetap Receives FDA Clearance for Phase 3 Alzheimer's Trials
Annovis Bio received FDA clearance to proceed with Phase 3 trials for buntanetap in early-stage Alzheimer's disease following a successful End-of-Phase 2 meeting.
Osimertinib Plus Savolitinib Shows Promise in MET-Aberrant EGFR-Mutant NSCLC
Osimertinib combined with savolitinib demonstrated a 90.5% objective response rate in first-line treatment of MET-aberrant, EGFR-mutant advanced NSCLC, significantly higher than osimertinib alone (60.9%).
Quanta's Home Hemodialysis System Receives FDA Clearance, Expanding Access to High-Flow Dialysis
Quanta Dialysis Technologies secures FDA 510(k) clearance for its hemodialysis system, enabling home use and marking a significant advancement in ESRD treatment.
NEFECON® Included in China's National Reimbursement Drug List for IgA Nephropathy
NEFECON®, Everest Medicines' etiological treatment for IgA nephropathy (IgAN), has been included in China's National Reimbursement Drug List (NRDL), effective January 1, 2025.
Viltolarsen Shows Positive Impact on Respiratory and Motor Function in DMD Patients
Analysis of the Phase 2 Galactic53 trial indicates that viltolarsen provides respiratory and motor function benefits for DMD patients amenable to exon 53 skipping.
Multiple Myeloma Treatment Advances: Belantamab Mafodotin's Comeback and New FDA Approvals
Belantamab mafodotin (Blenrep) was resurrected after being pulled from the market, demonstrating efficacy in combination therapies for relapsed/refractory multiple myeloma.
Intratumoral Heterogeneity Drives Therapy Resistance in Metastatic Prostate Cancer
A 76-year-old man with metastatic prostate cancer initially responded to nivolumab, but later developed resistance, highlighting the challenges of treating heterogeneous tumors.
BNC210 Shows Promise in Phase IIb Trial for PTSD Treatment
A Phase IIb trial of BNC210, a novel α7 nicotinic acetylcholine receptor modulator, demonstrated significant improvement in PTSD symptom severity as early as 4 weeks.