Anti-aging specialist Juvenescence Ltd. reached the first close of its series B-1 at $76 million and said it is on course to close the round at $150 million in the third quarter of 2025. “The reason for the first close and not waiting for the very end is just so we can start to move the pipeline forward,” said Richard Marshall, CEO. “We’ve got molecules in and waiting to go, so the sooner we can get going on those, the better,” he told BioWorld.
A drug that failed in a phase III trial in 2019 is being brought back to the clinic by Repronovo SA, a fertility and women’s health startup that has raised $65 million in a series A. The money will fund a phase II study of nolasiban in improving success rates in assisted reproductive technology, the same indication as the previous phase III failure.
Although HER2-targeted therapies have become a mainstay in cancer treatment, some tumors evade them by stripping away the portion of the HER2 receptor that most therapies are built to recognize and bind to, but Taiwan’s AP Biosciences Inc. is developing bispecific antibody AP-402 to address treatment-resistant HER2+ cancers.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Canbridge, Fresenius, GSK, Novavax, SIFI, Wuxi, Zai Lab.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Appili, Arecor, BMS, Chugai, Prime Medicine, Rani, Skye.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alnylam, Apnimed, Applied, Armata, Atsena, Cytokinetics, Cytora, GT, Intellia, Ionis, Novelmed, Prime Medicine, Savara, Tectonic.
Five years after the COVID-19 pandemic gripped the world, the U.S. FDA is moving away from annual routine boosters for all children and adults. Instead of that one-size-fits-all regulatory framework by which it has granted broad COVID-19 vaccine marketing authorization for all Americans older than 6 months, the agency said it’s adopting a policy akin to that followed in Europe, which now restricts the vaccines to older adults and those at high risk for severe disease.
Pfizer Inc. is paying $1.25 billion up front and up to $4.8 billion in milestone payments to gain global, ex-China rights to SSGJ-707, a PD-1/VEGF bispecific antibody from 3Sbio Inc. that recently won China clearance for a phase III study in lung cancer as a potential first-line monotherapy. Announced after U.S. market hours May 19, the exclusive agreement for SSGJ-707 spells up to $6.15 billion combined for Shenyang, China-based 3Sbio, along with separate tiered double-digit royalty payments on sales of SSGJ-707, if approved.