By Daniella Parra
Gameto, a female-led biotechnology firm, said it received tentative FDA approval to move to Phase 3 trials for Fertilo, a pivotal step towards Biologic License Application approval, the company said.
The primary efficacy endpoint will assess pregnancy at 12 weeks of gestation and previous data showed no abnormalities in live births of mice using Fertilo, they said.
“This is a significant milestone in our journey to bring innovative treatment options to patients, and we are fully committed to meeting the rigorous standards set by the FDA to advance our product through the final phases of clinical development,” said CEO Dina Radenkovic. “IVF is a relatively new field and navigating the regulatory pathways in this industry poses unique challenges.”
Separately, Dr. Carlos Lejtik joined as Medical Director, bringing over 20 years of experience in human reproduction and medical management, including roles at Pfizer. Dr. Pietro Bortoletto, a reproductive endocrinologist, and Dr. Michel de Vos, a gynecologist and senior medical director, have joined as advisors as well, Gameto said.
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