Safety concerns overrode benefit when the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously, 19-0, Sept. 21 that the potential risks of Intarcia Therapeutics’ ITCA-650 outweighed the compliance and A1C-lowering benefits the twice-yearly implantable exenatide-device combination product could provide for adults with type 2 diabetes.
A Sept. 21 U.S. FDA advisory committee meeting will either be a “Hail Mary” or a last gasp of life for ITCA-650, a twice-yearly implantable exenatide-device combination product intended to improve glycemic control in adults with type 2 diabetes.
Innovent Biologics Inc. announced a HKD$2.37 billion (US$306 million) placement on the Hong Kong Stock Exchange (HKEX) to advance its late-stage pipeline, including mazdutide, a GLP-1R/GCGR dual agonist for diabetes and obesity. The company plans to offer 68 million new shares priced at HKD$34.92, which represents an 8.8% discount to the previous closing price of HKD$38.30 per share, the company said in a filing on the HKEX. Morgan Stanley is the sole placing agent.
To bolster its obesity treatment pipeline, Eli Lilly and Co. is buying Versanis Bio Inc. in a massive cash deal that could reach $1.92 billion. The total amount of the deal includes an up-front payment and development and sales milestone payments. Privately held Versanis, of Boston, brings to Lilly its lead asset bimagrumab, a monoclonal antibody that’s enjoying a resurgence since a failure in treating sarcopenia.
Showing that much lower brand prices are possible, even in the U.S., Theracosbio Inc. announced July 13 that its diabetes drug, Brenzavvy (bexagliflozin), is coming to the U.S. market through the Mark Cuban Cost Plus Drug Co. at a monthly price that’s less than the copay most patients have to pay for other drugs in the class. A new molecular entity approved in January to improve glycemic control in adults with type 2 diabetes, Brenzavvy is an oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor that will be available through Cost Plus Drugs with a monthly price tag of $47.85, plus shipping and handling. A 30-day supply of other SGLT2 inhibitors costs hundreds of dollars, with some approaching $600 a month.
Two years after a U.S. FDA advisory committee agreed that Celltrans Inc.’s pancreatic islet cellular therapy had a favorable risk-benefit profile, the agency has finally approved Lantidra (donislecel) for treating adults with type 1 diabetes.
More evidence of big pharma’s interest in type 1 diabetes (T1D) arose as Eli Lilly and Co. disclosed its plan to buy encapsulated-cell-therapy collaborator Sigilon Therapeutics Inc., bringing aboard SIG-002, the early-stage drug on which the pair has been working since 2018. The news blasted upward shares of Cambridge, Mass.-based Sigilon (NASDAQ:SGTX), which closed June 29 at $21.15, up $17.24, or 441%.
New and updated clinical data presented by biopharma firms at the American Diabetes Association's 83rd Scientific Sessions, including: Biomea, Carmot, Eli Lilly, Inversago, Novo, Sernova, Vertex, Zealand.
As earlier-stage efforts in oncology continue with BMF-219, Biomea Fusion Inc. rolled out new clinical data June 23 from the first two cohorts of patients with type 2 diabetes enrolled in the phase II part of its ongoing phase I/II study called Covalent-111 testing the same compound, an oral covalent menin inhibitor.
Regulatory T-cell specialist Quell Therapeutics Ltd. has sealed a potential $2 billion agreement under which Astrazeneca plc is taking rights to two autologous Treg cell therapies for treating inflammatory bowel disease (IBD) and type 1 diabetes. Quell will receive $85 million up front, the majority of which is in cash, with a modest (undisclosed) equity investment. Reaching the $2 billion headline figure will involve a series of development and commercial milestones and royalties on sales.
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