Applied Therapeutics Inc. (ATI) CEO Shoshana Shendelman said positive top-line findings with aldose reductase inhibitor AT-007 in galactosemia were “the data we needed, and we’re going to move as quickly as we can to get in and speak to the FDA about this, not only to firm up our NDA filing but also to get into the pediatric study.” Read More
Adagene Inc., an immuno-oncology company with operations in both the U.S. and China, has raised a $69 million series D financing to support its development of two monoclonal antibodies (MAbs) and extension of its technology-driven in-house antibody design platform. Its two lead candidates are a phase I MAb targeting CD137 and a preclinical MAb targeting CTLA4. Read More
With a newly raised $60 million series B financing, Tarsus Pharmaceuticals Inc. plans to start a phase IIb/III trial of its lead product, TP-03, for treating demodex blepharitis, and to jumpstart two other clinical programs. Read More
LONDON – Northsea Therapeutics BV has closed a $40 million series B, providing the means to complete the ongoing U.S. phase IIb trial of its lead product for treating nonalcoholic steatohepatitis (NASH) and to launch clinical trials of two more products. Read More
DUBLIN – Shares in Targovax ASA rose as much as 26% Wednesday on news of an option and license agreement in China involving its peptide-based KRAS-directed cancer vaccines, TG-01 and TG-02. Read More
PERTH, Australia – Although Australia’s deadly bushfires continue to burn, and conditions are expected to worsen later this week as temperatures rise, Australia’s Therapeutic Goods Administration (TGA) is not anticipating any effect on business operations. Read More
HONG KONG – South Korean biopharma Genesen Inc. has secured ₩2.2 billion (US$1.9 million) in seed funding to advance its peptide-based drug candidates for the treatment of autoimmune and inflammatory diseases, including systemic lupus erythematosus (SLE), rheumatoid arthritis and psoriasis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
