Pivotal IVF study advances into pregnancy follow-up, with the first GRACE baby expected by year-end

BOSTON, Oct. 22, 2026 /PRNewswire/ — Granata Bio Corporation, a biopharmaceutical company dedicated to advancing reproductive medicine, today announced the completion of screening in its Phase III GRACE study evaluating Granata Bio Human Menopausal Gonadotropin (GB-hMG) in women undergoing in vitro fertilization (IVF).

More than 750 women have been screened for GRACE, which is expected to enroll approximately 625 participants across two cohorts spanning ages 18–42. With screening complete, the study is progressing through treatment, embryo transfer and pregnancy follow-up, with the first live birth expected by the end of 2026.

“Fifteen exceptional fertility clinics chose to participate in GRACE, and their investigators and study teams have done a tremendous job identifying, screening and enrolling these cohorts,” said Evan Sussman, Chief Executive Officer of Granata Bio. “We’re grateful to everyone who considered participating in GRACE, and we hope that those who enrolled have great outcomes – both in the study and in building their families.”

“GRACE is designed to evaluate the cumulative live birth rate following a single stimulation cycle with Granata’s GB-hMG,” said Barbara Cometti, PhD, Head of Scientific Affairs at Granata Bio. “This means following participants throughout their entire treatment journey, from ovarian stimulation through all available embryo transfers. While this approach requires time, it allows us to assess the outcome that ultimately matters most: the chance of achieving a live birth.”

Participants will continue through the study’s planned treatment and follow-up periods. Granata Bio expects to share further updates as the study progresses.

Granata Bio expects GRACE to support a potential Biologics License Application for GB-hMG and will continue to follow participants through the study’s planned treatment and follow-up periods.

About the GRACE Study
The GRACE investigational study is a multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of GB-hMG in the development of multiple follicles, pregnancy and cumulative live birth as part of an assisted reproductive technology (ART) cycle in women. The study is being conducted at fertility clinics across the United States. To learn more or to find a participating IVF clinic near you, please visit GraceIVFStudy.com.

About Granata Bio
Granata Bio Corporation is a biopharmaceutical company focused exclusively on reproductive health, dedicated to reimagining what’s possible to help build families. Founded in 2018, the company develops and accelerates fertility treatments that expand therapeutic choices and improve access and affordability. Backed by deep fertility expertise, strategic partnerships, and a growing pipeline, Granata Bio is advancing innovation across reproductive medicine. For more information, visit Granata.bio

Forward‑Looking Statements

This press release contains forward‑looking statements, including statements regarding the progress, potential outcomes, and anticipated significance of the GRACE study and related development programs. Forward‑looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks include, but are not limited to, clinical trial enrollment and execution, variability in clinical outcomes, regulatory review, and other factors inherent in the development of biopharmaceutical products. Granata Bio undertakes no obligation to update or revise these forward‑looking statements to reflect events or circumstances after the date of this release. 

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SOURCE Granata Bio