Nortiva Bio has launched as a clinical-stage biopharmaceutical company focused on developing long-acting oral medicines based on its proprietary LYNX drug delivery platform. The company, a wholly owned subsidiary of Innoviva, aims to convert daily oral therapies into long-acting formulations with single doses that can last up to a month across multiple therapeutic areas. The LYNX platform originated from research in the laboratories of Robert Langer and Giovanni Traverso at MIT and has been advanced through years of development and clinical validation, including proof of concept in several indications and a successful Phase 3 study. Innoviva acquired the LYNX platform from Lyndra Therapeutics in 2025.
According to Nortiva, the LYNX system uses a standard-size capsule containing a structure that unfolds in the stomach and remains there for a programmed delivery window, releasing a stable dose of drug over time. By smoothing out the peaks and troughs associated with daily pills, the platform is designed to reduce side effects linked to high peak concentrations and to improve efficacy by preventing drug levels from falling too low between doses. LYNX is described as modular, able to accommodate a range of small-molecule active pharmaceutical ingredients with varying potency, solubility and molecular weight, and is protected by more than 50 granted patents. To date, more than 270 individuals have been dosed in clinical studies, with nearly 600 human administrations and over 1,300 administrations in animal trials, supporting clinical proof of concept in multiple therapeutic areas.
Nortiva’s lead development program is a once-monthly oral contraceptive, supported by a $5 million grant from the Gates Foundation. The program builds on preclinical work showing that LYNX can steadily deliver contraceptive hormones to enable monthly dosing. The company notes that this approach could help address a significant unmet need, as an estimated 50% of women miss contraceptive doses at least once per month, which can reduce efficacy and complicate family planning, particularly in low-resource settings. Nortiva plans to advance this program as both a demonstration of the platform’s capabilities and a contribution to improving access to family planning worldwide.
In parallel, Nortiva is pursuing a partnering strategy aimed at biotech and pharmaceutical companies interested in converting approved or development-stage small-molecule therapies into long-acting oral formulations. The company says the LYNX platform can potentially differentiate marketed and pipeline drugs by offering once-monthly oral dosing that may improve adherence and clinical profiles in a range of indications.
Nortiva has also established an advisory board composed of figures from academia, industry and regulation. Members include Robert Langer, who serves as board chair; Giovanni Traverso; former FDA Acting Commissioner and former CDER director Janet Woodcock; Jay Galeota, president and CEO of Kallyope and former chief strategy and business development officer at Merck; Scott Braunstein, M.D., operating partner at Aisling Capital and former CEO of Marinus Pharmaceuticals; and Sophie Kornowski, PharmD, MBA, former CEO of Boston Pharmaceuticals and former global head of Roche Partnering. The company’s management team is led by president Austin Hackett, M.D., with Jessica Stromme as chief development officer, Kelly Foster, Ph.D., as senior vice president of translational medicine, and Stephen Huang, M.D., as senior vice president of clinical development.
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