PERTH, Australia – Neuren Pharmaceuticals Ltd.’s stock nearly doubled on positive top-line phase III results for trofinetide in Rett syndrome, meeting all primary and secondary endpoints in the pivotal phase III trial run by partner Acadia Pharmaceuticals Inc.
Nextsense Inc. reported partnerships with global biopharma company UCB SA, Heraus Holding GmbH, the University of California San Diego and Emory University at its first public appearance at the American Epilepsy Society Annual Meeting in Chicago this past weekend. The Nextsense platform uses biosensing earbuds to perform ongoing electroencephalograms (EEGs).
Despite hitting the primary endpoint in its phase III study of pegzilarginase in treating arginase 1 deficiency, Aeglea Biotherapeutics Inc. had a tough go of it Dec. 6 as the price of its stock (NASDAQ:AGLE) plunged 36.5% to close at $3.81 per share. The study hit its primary endpoint with a statistically significant reduction in plasma arginine from baseline after 24 weeks of treatment with pegzilarginase (p<0.0001). The study results were positive enough to prompt Aeglea to say it planned to submit a BLA to the FDA in the first half of 2022.
Shares in Isofol Medical AB dropped by 27% on Dec. 6 as the company informed investors that its ongoing phase III trial of arfolitixorin in metastatic colorectal cancer would not reach the predefined number of events needed to demonstrate a statistically significant effect on progression-free survival (PFS) based on the study’s present statistical plan.
Delcath Systems Inc.’s phase III FOCUS trial of its Hepzato Kit for metastatic hepatic dominant ocular melanoma (mOM) posted positive results for this challenging and aggressive cancer. Nearly a third of patients responded to the therapy – more than three times the rate seen in those receiving the best available choice – and just under 7% had a complete response. The treatment, known as Chemosat in Europe, isolates the liver for treatment then purifies the blood exiting the liver before it returns to circulation to reduce systemic effects.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 180 Life Sciences, Acasti, Amgen, Arbutus, Arca, Bonus, Hepagene, Humanigen, India Globalization, Immutep, Karyopharm, Redhill, Revelation, Spago, VBI, Ysopia.
LONDON – Each of six different COVID-19 vaccines given as booster doses were safe and increased immunity when administered after two doses of either Pfizer Inc.’s or Astrazeneca plc’s vaccine, according to the latest data from the U.K. Cov-Boost trial.
Wave Neuroscience Inc.’s study of the use of electromagnetic stimulation to treat post-traumatic stress disorder (PTSD) entered its second phase, building on the positive outcomes seen in the phase I collaboration with the U.S. military. Texas A&M University Health Science Center is directing the trial, which will expand the study to civilians.