SAN FRANCISCO – At what BIO CEO and President Jim Greenwood called a "Dickensian moment in the history of biotechnology – arguably the best of times and the worst of times" for U.S. industry players, new rules piloted by the Committee on Foreign Investment in the U.S. (CFIUS) have made things even more challenging. Confusion about CFIUS has led to a decline in Chinese venture capital investment in U.S. biotech and, at some firms, even a pause in cross-border investment as they wait for the dust to clear, experts said.
A tepid reception to new top-line phase III data on the long-acting growth hormone (GH) somatrogon nudged Opko Health Inc. shares (NASDAQ:OPK) about 4 cents higher to $2.13 Monday, leaving it overshadowed by competitor Ascendis Pharma A/S, the developer of Transcon-hGH. Ascendis' shares (NASDAQ:ASND) rose 4.5% to $103.36.
Israel's Protalix Biotherapeutics Inc., the first company to gain FDA approval for a protein therapy produced by plant cell cultures in 2012, has moved one step closer to seeking FDA approval for a second such product with new phase III data supporting its experimental therapy for Fabry disease.
Eli Lilly and Co.'s $1.48 billion acquisition of Armo Biosciences Inc., intended to broadly bolster its immuno-oncology program, fell short of that goal in its first big test, a phase III trial in second-line pancreatic cancer called Sequoia.
Briefing documents released ahead of Wednesday’s meeting of the FDA’s Antimicrobial Drugs Advisory Committee, slated to review Shionogi & Co. Ltd.’s cefiderocol for treatment of complicated urinary tract infections (cUTIs), spotlighted a finding of increased mortality among critically ill cefiderocol-treated patients in the company’s Credible-CR study.
Cyteir Therapeutics Inc., a Lexington, Mass.-based company exploiting synthetic lethality to fight cancer, is extending its series B financing with $40.2 million to support a recently launched phase I/II study of its lead candidate, CYT-0851, an oral small-molecule inhibitor of the protein RAD51.
Briefing documents released ahead of Wednesday's meeting of the FDA's Antimicrobial Drugs Advisory Committee, slated to review Shionogi & Co. Ltd.'s cefiderocol for treatment of complicated urinary tract infections (cUTIs), spotlighted a finding of increased mortality among critically ill cefiderocol-treated patients in the company's Credible-CR study. Unclear whether it was "a chance finding or truly reflects a deficit in the activity of cefiderocol," FDA reviewers asked committee members to discuss the point.
Even priced at a bottom-of-range $20, shares of Vir Biotechnology Inc. (NASDAQ:VIR) fell 30% to $14.02 in the first day of trading after the infectious disease specialist priced a $142.9 million IPO, intended to back its development of medicines targeting hepatitis B virus, influenza A, HIV and tuberculosis. The company, led by former Biogen Inc. CEO George Scangos, is largely owned by Arch Venture Partners and Softbank's Vision Fund.
Reata Pharmaceuticals Inc. has agreed to pay former partner Abbvie Inc. $330 million plus royalties to reacquire ex-U.S. development, manufacturing and commercialization rights for the Nrf2 activators bardoxolone methyl and omaveloxolone, as well as other next-generation candidates in the class. Rights to certain Asian markets for bardoxolone remain licensed to Kyowa Kirin Co. Ltd.
Cygnal Therapeutics Inc., a Cambridge, Mass.-based startup devoted to developing new cancer and immunotherapy drugs, has raised $65 million from Flagship Pioneering to advance research in a field it is calling "exoneural biology" in an effort to deliver relief via the peripheral nervous system. The company is led by Pearl Huang, a veteran of Roche Holding AG and Glaxosmithkline plc. Calling exoneural biology "a new way to look at something that has always been there," she said Cygnal's platform has uncovered "new drivers of disease that are both profound and actionable."
