Evofem Biosciences Inc EVFM shares gap-opened higher Tuesday morning after a binary event panned out in the company's favor.
FDA Greenlights Evofem's Contraceptive Gel
The San Diego, California-based biopharma, which focuses on therapies to address unmet needs in women's sexual and reproductive health, said late Friday the FDA approved Phexxi vaginal gel for the prevention of pregnancy as an on-demand method of contraception.
Phexxi is a vaginal pH regulator contraceptive designed to maintain vaginal pH within the normal range of 3.5 to 4.5 — an acidic environment that is inhospitable to sperm.
What It Means For Evofem
The company faced an earlier FDA rejection in April 2016. A resubmission was made in November 2019.
Phexxi presents a non-hormonal option to woman. Hormonal contraceptive treatments come with several side effects.
"Many of my patients have cycled through numerous contraceptive options and still have not found the right fit for their sexual and reproductive needs. Phexxi offers women freedom from hormones and control over how they choose to prevent pregnancy. I look forward to offering this new on-demand option to my patients," Michael Thomas, chair of the Department of Obstetrics and Gynecology at the University of Cincinnati College of Medicine, said in a statement.
Oppenheimer projects 2024 U.S. net Phexxi sales of $350 million in contraception.
What's Next For Evofem
Evofem said it expects to launch Phexxi in early September alongside the Phexxi Concierge Experience, a comprehensive patient and health care provider telemedicine support system.
"Through this offering, women would be able to secure a prescription, determine their insurance coverage and/or out-of-pocket costs, receive counseling support and refill reminders, and fill their prescription through their local neighborhood pharmacy or an online pharmacy that is expected to deliver Phexxi right to their door," the company said.
The company said it is also working to get Affordable Care Act coverage for Phexxi.
EVFM Price Action
The stock was rallying by 18.22% to $5.90 at the time of publication Tuesday.
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