Granata Bio Announces Completion of Cohort A Enrollment in Phase III GRACE Study
Enrollment Continues for Cohort B Across U.S. Clinical Sites
Granata Bio Corporation, a biopharmaceutical company dedicated to advancing reproductive medicine, today announced the successful completion of enrollment for Cohort A (women 18-34 years) of the Phase III GRACE Study, a randomized, double-blind clinical trial evaluating Granata Bio Human Menopausal Gonadotropin (GB-hMG). in women undergoing in vitro fertilization (IVF).
Completion of Cohort A marks an important operational milestone in the execution of the GRACE Study and reflects the continued commitment of participating patients, investigators, embryologists, study coordinators, and clinical research teams across the United States.
Enrollment remains open for Cohort B (women 35-42 years), and Granata Bio continues to recruit eligible participants through its network of clinical sites.
"Completing enrollment in Cohort A is an important milestone for the GRACE Study and reflects the dedication of our investigators, site teams, and patients," said Evan Sussman, Chief Executive Officer of Granata Bio. "As we continue advancing our late-stage gonadotropin programs toward commercialization, we are also investing in a pipeline of novel biologic therapies that have the potential to redefine reproductive medicine. Together, these programs represent our commitment to expanding treatment options and improving outcomes for patients."
Barbara Cometti, PhD Head of Scientific Affairs at Granata Bio, added, "Clinical trials are only possible through the collaboration of patients, physicians, embryologists, research coordinators, and our operational partners. This milestone reflects the strength of those partnerships as we continue working to generate high-quality evidence that has the potential to expand treatment options for individuals seeking fertility care."
The Phase III GRACE Study is designed to evaluate the efficacy and safety of GB-hMG in women undergoing controlled ovarian stimulation for IVF. The study continues to enroll participants in Cohort B at fertility centers throughout the United States.
Individuals interested in learning more about the GRACE Study or determining eligibility may visit www.graceivfstudy.com.
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.
Media Contact:
mediarelations@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.