Lexington, Mass. — Nortiva Bio, Inc. has launched as a clinical-stage biopharmaceutical company focused on developing long-acting oral medicines using its proprietary LYNX drug delivery platform.
The company said the platform is designed to transform daily pills into long-acting oral therapies, with single doses that can last up to a month across multiple therapeutic areas. Nortiva said the approach could improve medication adherence, optimize safety and efficacy, and enhance patients’ quality of life.
The LYNX platform is based on foundational science from the laboratories of Robert Langer and Gio Traverso at MIT. Nortiva said the platform has been supported by years of research, development and clinical validation, including proof of concept in multiple therapeutic areas and a successful Phase 3 study.
Nortiva is a wholly owned subsidiary of Innoviva, Inc. (NASDAQ: INVA), which acquired the LYNX platform from Lyndra Therapeutics, Inc. in 2025.
“Long-acting oral medicines have the potential to meaningfully reshape how patients manage their health and lead to better outcomes,” said Austin Hackett, MD, President of Nortiva Bio. “The LYNX platform is built on innovative science and supported by robust clinical evidence. Our work now is to build on that foundation to revolutionize drug delivery by advancing our development programs and forming industry partnerships to bring multiple long-acting oral therapies to patients.”
“The LYNX platform attracted us with its potential to address significant unmet medical needs,” said Pavel Raifeld, Chief Executive Officer of Innoviva. “We are excited about Nortiva’s ability to develop truly differentiated long-acting therapies that improve patients’ lives and create value for partners.”
Nortiva has also formed an advisory board that includes leaders in drug delivery, medicines development and pharmaceutical business strategy. Members include Langer, MIT Institute Professor and co-founder of more than 40 biotechnology companies, including Moderna and Lyndra Therapeutics; Traverso, Associate Professor of Mechanical Engineering at MIT, gastroenterologist at Brigham and Women’s Hospital, and Associate Member of the Broad Institute; Janet Woodcock, MD, former Acting FDA Commissioner and former Director of the FDA’s Center for Drug Evaluation and Research; Jay Galeota, President and CEO of Kallyope and former Chief Strategy and Business Development Officer at Merck; Scott Braunstein, MD, 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 LYNX platform uses a standard-size capsule that contains a structure designed to unfold in the stomach and remain there for the duration of the programmed drug delivery window. The company said the platform delivers a stable dose of medicine during that window, reducing the peaks and troughs in drug concentration often associated with daily oral therapies.
Nortiva said the platform is modular and can accommodate a broad range of small-molecule active pharmaceutical ingredients with different potency, solubility and molecular weight profiles. The platform is protected by more than 50 granted patents covering design, engineering and materials science, according to the company.
The company said LYNX has been tested in more than 270 individuals across multiple therapeutic areas and drug classes, with nearly 600 total administrations in humans and more than 1,300 administrations in animal studies.
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 research showing that LYNX can steadily deliver contraceptive hormones to support once-monthly dosing.
The company said the program could address an unmet need in the U.S. and globally, noting that an estimated 50 percent of women miss doses at least once per month, which can reduce contraceptive efficacy and complicate family planning, especially in low-resource settings.
“Our oral contraceptive program is both a mission-driven commitment to improving access to family planning worldwide and a powerful proof point for the LYNX platform,” said Dr. Hackett. “We are proud to advance this work with support from the Gates Foundation.”
Nortiva said it is also seeking partnerships with biotech and pharmaceutical companies interested in developing long-acting oral versions of approved or development-stage small molecule therapies.
“Long-acting oral dosing could significantly differentiate many marketed and pipeline drugs across multiple therapeutic areas,” said Dr. Hackett. “With possibility of improving both clinical factors and patient satisfaction, the LYNX platform provides an opportunity to stand out in competitive indications.”
