Despite an outcome that TD Cowen analyst Tyler Van Buren called ”fantastic,” shares of Tyra Biosciences Inc. (NASDAQ:TYRA) closed Oct. 25 at $21.93, down $6.68, or 23%, as Wall Street digested new phase I/II data with FGFR3 inhibitor TYRA-300 in metastatic urothelial cancer from the Surf301 phase I/II study in progress.
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).
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alexion, Astrazeneca, Axovia, Bayer, Dewpoint, Kisoji, Monopar, Rhythm.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hibercell, Merck & Co., Omeros, Pfizer, Telix, Up.
Currently, cancer therapy trial-and-error methodology is inefficient and unsustainable. Oncology is the worst therapeutic area for drug trial success; only 3.4% of drugs that enter phase I end up being FDA approved, and 57% fail due to poor drug efficacy in trials. Building tools that may aid in predicting an individual’s response to a specific therapy may help in reducing costs, guesswork, and importantly improve the outcome of patients and accelerate new drug development.
For a company that was running out of money, a missed phase III endpoint for its only development product knelled a death blow for Marinus Pharmaceuticals Inc., tanking its stock by 82%. The Radnor, Pa.-based company will no longer develop oral ganaxolone for seizures associated with tuberous sclerosis complex, or for any other indication, as it reduces its workforce and explores strategic alternatives.
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