Shares of Tharimmune Inc. shot up more than 100% in early trading Oct. 30 as the firm disclosed regulatory backing to launch a phase II trial this quarter testing TH-104, a transdermal buccal film version of nalmefene, to treat pruritus that is associated with primary biliary cholangitis.
Synox Therapeutics Ltd. extended its series B by a further $17 million as it announced the first patients have been dosed in a phase III study of emactuzumab in the treatment of tenosynovial giant cell tumor, a rare condition in which benign tumors grow in the soft tissue lining of joints and tendons.
Two days after Monte Rosa Therapeutics Inc. signed a molecular glue degrader deal with Novartis AG, two other companies, Biogen Inc. and Neomorph Inc., are moving forward in the same space in a partnership worth up to $1.45 billion. Cambridge, Mass.-based Biogen and San Diego-based Neomorph will develop molecular glue degraders (MGDs) for priority targets in Alzheimer’s, rare neurological and immunological diseases, using Neomorph’s MGD platform to identify and validate novel small-molecule protein degraders.
Backed by AI technology, Aigen Sciences Inc. raised ₩12 billion (US$8.8 million) in a series A financing round to further advance its cancer and rare disease drug pipelines. Aigen said Oct. 16 that the series A round was joined by existing investors Partners Investment, Quad Investment Management and Medytox Venture Investment, as well new investors Premier Partners, K2 Investment Partners and Scale Up Partners.
Visterra Inc., a subsidiary of Otsuka Pharmaceutical Co. Ltd., reported positive top-line data from the ongoing Visionary phase III study of sibeprenlimab, an anti-APRIL monoclonal antibody for immunoglobulin A nephropathy (IgAN).
An old target that found new life at Monte Rosa Therapeutics Inc. has become the subject of a sizeable deal between the company and Novartis AG, as the pair set about developing molecular glue degraders (MGDs). Shares of Monte Rosa (NASDAQ:GLUE) closed Oct. 28 at $9.48, up $4.59, or 93.9%, on word of the Boston-based firm’s deal with Novartis to advance VAV1 MGDs, including MRT-6160, a prospect undergoing a phase I single ascending dose/multiple ascending dose study in healthy volunteers for immune-mediated conditions.
If the maximum fair prices the U.S. CMS announced after the first round of drug price negotiations are any indication, advocates of the government price setting may be settling for short-term wins at the cost of long-term, more sustainable price reductions driven by competition.
Visterra Inc., a subsidiary of Otsuka Pharmaceutical Co. Ltd., reported positive top-line data from the ongoing Visionary phase III study of sibeprenlimab, an anti-APRIL monoclonal antibody for immunoglobulin A nephropathy (IgAN).
DBV Technologies SA CEO Daniel Tasse said his firm will meet “very shortly” with the U.S. FDA for talks that will formalize an accelerated approval process for the Viaskin Peanut allergy patch. “Did this take longer than expected? Yes, it did,” Tasse said during a conference call update. “But this was a choice we made, and it was a necessary choice” in order to nail down precise requirements for the product.
The Japanese government, industry and academia are deliberating health care policies and initiatives to boost Japan’s role in the future of regenerative medicine, experts at Bio Japan 2024 said, as the fruits of cell and gene therapy research come to fruition with new approvals.
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