Granata Bio Reports Strong Enrollment Momentum in Pivotal Phase III GRACE Study of Investigational Gonadotropin for Assisted Reproductive Technology

BOSTON, Dec. 3, 2025 /PRNewswire/ -- Granata Bio Corporation, a biotechnology company advancing innovative reproductive health solutions, announced strong momentum in its pivotal Phase III clinical study, with multiple subjects already screened to evaluate the safety and efficacy of its investigational gonadotropin product for use in assisted reproductive technology (ART). The GRACE multicenter study is now actively enrolling across leading fertility centers throughout the United States.

The randomized, controlled trial will assess cumulative live birth rates and safety outcomes in women undergoing in vitro fertilization (IVF) treatment, with the goal of providing a new therapeutic option for patients.

"As reproductive endocrinologists, we see firsthand the challenges our patients face in accessing effective, affordable fertility treatments," said Dr. John Park, Carolina Conceptions, lead investigator of the Phase III study. "We're excited to participate in a study that has the potential to expand patient choice and increase access to care for those pursuing IVF."

Granata Bio's gonadotropin program represents the company's continued commitment to innovation in fertility care, building on proven therapeutic classes while prioritizing modern manufacturing, quality, and accessibility.

"This milestone reflects our commitment to combining innovation with real-world impact," said Barbara Cometti, PhD, Head of Scientific Affairs, Granata Bio. "Beyond advancing our gonadotropin programs, we're also advancing several early-stage programs focused on novel biologics that have the potential to redefine reproductive care."

To learn more about the GRACE Study, visit https://www.graceivfstudy.com/

About Granata Bio Corporation
Granata Bio is a biopharma company that aims to shape the future of reproductive health by reimagining what's possible to help build families. Founded in 2018, the company is dedicated to developing and accelerating fertility treatments that expand therapeutic choices and improve access and affordability. The company credits its deep expertise in fertility, strong strategic partnerships, and commitment to steady progress for driving consistent milestone achievements across its innovative pipeline. Visit www.granata.bio to learn more.

SOURCE Granata Bio