While privately held Levo Therapeutics Inc.’s phase III study of LV-101 (intranasal carbetocin) for treating Prader-Willi syndrome (PWS) failed to meet its primary outcome measurements, the company’s CEO told Bioworld the first secondary endpoint showed a statistical significance that raised her hopes the FDA might approve the selective oxytocin-receptor agonist for the indication.
Matterhorn Bioscience AG has launched to develop T-cell receptor therapies based on the power of MR1T cells that have been found to find and kill a range of tumors in various tissue organs.
Since more than 40% of U.S. coronavirus deaths have links to U.S. long-term care facilities, Eli Lilly and Co. is getting on the road with a clinical trial design that takes researchers directly to outbreaks.
In deals worth billions, Sanofi SA and Glaxosmithkline plc (GSK) have made new agreements this week to supply the U.S. and U.K. governments with a COVID-19 vaccine. The two companies also are in advanced discussions with the European Union to supply up to 300 million doses of a vaccine.
By filing an IND with the FDA to initiate a phase II/III study of EB-05, a monoclonal antibody, Edesa Biotech Inc. joined the handful of companies developing COVID-19 treatments that inhibit Toll-like receptor 4 (TLR4) signaling. The Toronto-based company’s stock (NASDAQ:EDSA) responded by rocketing 81.38% upward Thursday to close at $9.45, after trading as high as $19.10.
Mantra Bio Inc., of San Francisco, plans to take its new $25 million series A financing and advance its pipeline and partnering efforts for engineering targeted exosome vehicles. The company platform integrates computational approaches, wet biology and robotics to leverage exosome diversity and enable rational design of therapeutics for a range of tissue and cellular targets.
As Pfizer Inc. and Biontech SE start their massive phase II/III safety and efficacy trial evaluating a single nucleoside-modified messenger RNA candidate from their BNT-162-based vaccine program against SARS-CoV-2, smaller, privately held Codagenix Inc. plans a different approach.
The FDA approved Kite Pharma Inc.’s Tecartus (brexucabtagene autoleucel, KTE-X19), the first cell-based gene therapy for adults with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment.
Four IPOs from biopharmas chasing an aggregate $781.8 million launched on Friday with mixed results. Two of the companies, Inozyme Pharma Inc. and Annexon Inc., finished the day in positive territory while the other two, Iteos Therapeutics Inc. and Nurix Therapeutics Inc., saw their shares close flat.
