Welcome to our dedicated page for Evofem Bioscienc news (Ticker: EVFM), a resource for investors and traders seeking the latest updates and insights on Evofem Bioscienc stock.
Evofem Biosciences commercializes FDA-approved sexual and reproductive health products for women’s health. Its product portfolio includes PHEXX® (lactic acid, citric acid and potassium bitartrate), a hormone-free contraceptive vaginal gel, and SOLOSEC® (secnidazole) 2g oral granules, an oral antibiotic for bacterial vaginosis and trichomoniasis.
Company news commonly covers product sales, operating results, commercialization partnerships, distribution agreements and international regulatory activity for PHEXX and SOLOSEC. Updates also include manufacturing and supply arrangements, stockholder votes, capital-market actions and education or advocacy initiatives tied to women’s health communication.
Evofem Biosciences (Nasdaq: EVFM) announced the publication of a peer-reviewed article in the Journal of Therapeutic Advances in Reproductive Health, detailing the mechanism of action of Phexxi®, a non-hormonal contraceptive. The article emphasizes Phexxi's role in maintaining vaginal pH to prevent pregnancy. Dr. Todd Chappell, lead author, highlighted its importance amid current contraceptive access discussions. This marks the second peer-reviewed publication on Phexxi in 2022, following data published in the Journal of Sexual Medicine earlier this year.
Evofem Biosciences (Nasdaq: EVFM) announced a Notice of Allowance from the USPTO for patent application 16/738,868, covering the composition of Phexxi® (lactic acid, citric acid, potassium bitartrate). This patent is expected to provide protection until at least 2033, consolidating Evofem's existing portfolio of over 40 patents. CEO Saundra Pelletier emphasized the significance of this patent in strengthening Phexxi's market potential, which offers women a hormone-free contraceptive option. The company aims to address unmet needs in women’s reproductive health.
Evofem Biosciences (Nasdaq: EVFM) has secured a significant agreement with a major pharmacy benefit manager (PBM) to enhance access to its hormone-free contraceptive Phexxi for millions of women. The deal removes prior authorization barriers, effective July 1, 2022, and is expected to save the company approximately $400,000 by the end of 2022 and close to $1 million annually. Evofem anticipates an increase in Phexxi prescriptions due to this broader access and is working to finalize similar agreements with additional payers.
Evofem Biosciences (Nasdaq: EVFM) disclosed results from a post hoc analysis of the Phase 3 AMPOWER trial for Phexxi, showing it prevented 99% of pregnancies per act of intercourse. Based on 101 pregnancies from 24,289 acts of intercourse among 1,182 women, this paralleled a pregnancy risk of 0.415%. The FDA-approved Phexxi exhibited a 7-cycle cumulative pregnancy rate of 13.7% with typical use. Previous studies indicated that 88.7% of women reported improved sexual quality of life, while urinary tract infections were lower compared to the general population.
Evofem Biosciences (Nasdaq: EVFM) announced that the FDA has extended the shelf life of its contraceptive Phexxi® from three to four years. This extension signals both the safety and high manufacturing standards of the product. The previous shelf life was 30 months, later increased to 36 months in April 2022, and now to 48 months with the latest FDA approval. The company is also expecting to release Phase 3 trial data for EVO100, Phexxi's investigational name, later this year, concerning its effectiveness in preventing sexually transmitted infections.
Evofem Biosciences (Nasdaq: EVFM) announced a public offering of 22,665,000 shares of common stock, 12,835,000 pre-funded warrants, and warrants for 71,000,000 shares, priced at $0.75 and $0.749, respectively. The company aims to raise approximately $26.6 million from the offering, expected to close around May 24, 2022. Proceeds will fund commercialization of Phexxi® and the Phase 3 'EVOGUARD' clinical trial for new indications against chlamydia and gonorrhea.
Evofem Biosciences (Nasdaq: EVFM) announced a proposed underwritten public offering of its common stock, pre-funded warrants, and warrants to purchase common stock. The offering is subject to market conditions and the final terms remain uncertain. The net proceeds will be used for commercialization of its product Phexxi®, continuing the Phase 3 clinical trial 'EVOGUARD' for new indications, and general corporate purposes. Piper Sandler & Co. is the sole book-running manager for this offering.
Evofem Biosciences (Nasdaq: EVFM) has partnered with Bora Pharmaceuticals Services Inc. to manufacture its hormone-free contraceptive, Phexxi. This collaboration is projected to reduce the cost of goods by 45%, aimed at improving the company's gross margin and operational efficiency. The manufacturing process will commence in Q4 2022, with Phexxi also set for regulatory approval in countries like Mexico and Nigeria. Evofem continues to see an increase in demand, having reported consecutive revenue growth quarters following Phexxi's FDA approval in May 2020.
Evofem Biosciences (Nasdaq: EVFM) announced findings from the Phase 3 AMPOWER clinical trial of Phexxi, revealing a significantly lower urinary tract infection (UTI) rate among participants, with only 5.8% experiencing UTIs compared to 11% in the general population. The results will be presented on May 7, 2022, at the ACOG Annual Meeting. The study involved 1,339 women and aimed to assess Phexxi's efficacy for pregnancy prevention. Evofem anticipates further data later this year from the Phase 3 EVOGUARD trial, which could enhance Phexxi's market potential for preventing chlamydia and gonorrhea.
Evofem Biosciences, Inc. (Nasdaq: EVFM) has approved a 1-for-15 reverse stock split to boost its common stock price, enabling compliance with Nasdaq's minimum bid price requirement. This decision was made at the annual meeting on May 4, 2022, and will take effect post market close on May 5, 2022. The reverse split reduces outstanding shares from approximately 187.7 million to around 12.5 million. Stockholders will automatically see adjustments in their holdings, and a cash payment will be provided for fractional shares.