Preliminary data show Biotron Ltd.’s lead compound BIT-225 met the primary objectives of the phase II BIT225-011 trial, a longitudinal, open-label trial designed to characterize the effect of the compound added to ongoing, suppressive antiretroviral therapy in HIV-1-infected, treatment-experienced patients who achieved only partial immune reconstitution.
Opthea Ltd. announced it plans to raise up to AU$227.3 million (US$150 million) to extend its cash runway through the data readout for its two phase III pivotal trials of sozinibercept (OPT-302) in wet age-related macular degeneration.
Phase II-stage Rapport Therapeutics Inc. began trading on Nasdaq June 7 under the ticker RAPP after pricing its IPO of 8 million shares at $17 each to raise $136 million, gaining $3.80, or 22.4%, to close its first day at $20.80. With offices in Boston and San Diego, Rapport is developing drugs for central nervous system (CNS) disorders. The IPO is expected to close June 10.
The U.S. FDA clamped a full clinical hold Biomea Fusion Inc.‘s phase I/II study of BMF-219 for treating type 1 diabetes and type 2 diabetes. The hold sank the stock on June 7 as the company looked to find answers so it could sit down with the agency to discuss next steps.
Obesity specialist Sixpeaks Bio AG emerged from stealth with $110 million in funding and an option to be acquired by Astrazeneca plc within the next two years, subject to filing an IND for the lead product.
Interim data from Biohaven Ltd.’s phase I study of BHV-1300, an IgG degrader using an ASGRP-bispecific, produced dose-dependent results in its first four cohorts, though not enough to satisfy investors.
Novo Nordisk A/S’s once-weekly human insulin analogue for adults with type 1 diabetes mellitus could be a useful tool for patients and physicians, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said May 24, but it also agreed that the risks outweighed the benefits for improving glycemic control.
Once-daily insulin treatment is getting a challenge from Novo Nordisk A/S’s once-weekly option. The U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meets Friday, May 23, to review the BLA for once-weekly Awiqli (insulin icodec), a human insulin analogue from Novo for adults with type 1 diabetes mellitus.
Prologue Medicines Inc. has launched to develop therapeutics created from the viral proteome, which are proteins produced across all viruses. It’s a newer twist on harnessing the power of the proteins that regulate biology.
“A white space opportunity.” That’s how Enlaza Therapeutics Inc. co-founder and CEO Sergio Duron described to BioWorld the company’s efforts to develop the first covalent biologics, an endeavor that has gained the backing of an impressive group of investors in a recently closed $100 million series A round.
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