Scattered investor qualms about Nuvalent Inc.’s largely upbeat data during the European Society for Medical Oncology (ESMO) meeting in Barcelona didn’t stop the firm from pricing an upsized $500 million public offering. The Cambridge, Mass.-based firm is selling 5 million shares of class A common stock at $100 each. The offering is expected to close on Sept. 18, with underwriters holding a 30-day option to purchase up to 750,000 more shares.
Instil Bio Inc. and Immuneonco Biopharmaceuticals Inc. laid out their global registrational strategy for the PD-L1xVEGF bispecific antibody SYN-2510 (IMM-2510) in front-line non-small-cell lung cancer and front-line triple-negative breast cancer amid a wild stock ride for the former over the past week and a half.
Australia’s Health Department has released the final report of the Health Technology Assessment (HTA) Review that makes 50 recommendations for improving access to new health technologies while tackling inequity, simplifying HTA processes and making it easier for consumers and clinicians to participate.
One of the current challenges of immunotherapy is the hunt for good targets, and the Claudins – a family of roughly two dozen transmembrane proteins – would appear to have a lot going for them. “Some Claudins distribute in a tissue-specific manner, and malignant transformation causes their exposition,” Cinta Hierro told the audience at the European Society of Medical Oncology (ESMO) 2024 Congress. “Others are rarely expressed in healthy tissue.”
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Eli Lilly, Genentech, Halozyme, Medexus, Poseida, Regeneron, Roche, Simcere, Somite, Zentalis.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akeso, Bristol Myers Squibb, Equillium, Immatics, Immuneonco, Intercept, Korro, Merck, Novo Nordisk, Quine, Roche, Sama, Summit, Tonix, Vivtex.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ascendis, Bioinvent, BMS, Boehringer, Evaxion, Gan & Lee, GSK, Immvira, Immutep, Ipsen, Iteos, Nuvalent, Scorpion, Transgene.
While it’s called the FDA Modernization Act (FDAMA) 3.0, the short bipartisan bill introduced in the U.S. Senate Sept. 15 is basically a message to the FDA: “The move away from animal testing in FDAMA 2.0 wasn’t a congressional suggestion. It’s a mandate, so get it done.”
Putting in writing what it’s been saying at advisory committee meetings, the U.S. FDA is issuing a draft guidance on multiregional clinical trials for cancer drugs that underscores the need for applicability to the U.S. population and medical practices.
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