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, Inc. (OTC: EVFM) regularly issues news and updates focused on women’s sexual and reproductive health, its FDA-approved products, and its corporate strategy. Company press releases highlight developments around PHEXXI, a hormone-free, on-demand prescription contraceptive vaginal gel, and SOLOSEC, a single-dose oral antimicrobial treatment for bacterial vaginosis and trichomoniasis.
News items cover a range of topics, including quarterly and annual financial results, cost-of-goods initiatives, and progress on international expansion. For example, Evofem has announced licensing arrangements with Pharma 1 Drug Store in the Middle East and North Africa, regulatory submissions for PHEXXI and SOLOSEC in the United Arab Emirates, and steps toward commercialization in Gulf Cooperation Council states. These updates provide context on how the company is seeking to diversify and expand its revenue stream beyond the United States.
Evofem’s releases also describe marketing and educational campaigns such as the "Say Vagina" initiative, which the company presents as an effort to normalize clinical language and address stigma around vaginal health. Other news has detailed the impact of social media campaigns on traffic to the PHEXXI website, engagement from healthcare providers, and broader brand awareness.
In addition, investors can find news about corporate actions and governance, including information on a previously proposed merger with Aditxt, Inc. and its subsequent termination, reverse stock split authorization, and capital raises through notes and warrants. This news page aggregates such announcements so readers can follow product, regulatory, commercial, and corporate developments related to Evofem Biosciences and its EVFM stock symbol over time.
Evofem Biosciences (NASDAQ: EVFM) announced on May 12, 2021, that the FDA granted Fast Track designation for EVO100, aimed at preventing urogenital gonorrhea in women. This designation accelerates the development of new therapies for serious health needs. With over 600,000 gonorrhea cases reported in 2019, the need for a preventive solution is critical. EVO100 also holds prior Fast Track and Qualified Infectious Disease Product status for chlamydia prevention. A pivotal Phase 3 trial is underway, with positive results potentially leading to a New Drug Application by late 2022.
Evofem Biosciences (NASDAQ: EVFM) reported a significant increase in net revenue, reaching $1.1 million for Q1 2021, up from $0.2 million in Q4 2020 due to the success of its DTC campaign for Phexxi, which led to an 83% growth in total prescriptions. Operating expenses surged to $46 million, resulting in a net loss of $46.2 million, or $(0.56) per share. The company is focused on improving gross-to-net adjustments and is advancing the EVOGUARD Phase 3 trial for EVO100. Cash reserves were $45.3 million at the end of March 2021.
Evofem Biosciences (NASDAQ: EVFM) will present two new data sets from its Phase 3 AMPOWER trial on Phexxi at the 2021 ACOG Annual Clinical Meeting from April 30 to May 2. The data will highlight women's usage and pregnancy feelings related to Phexxi, which is crucial for clinicians. In total, 1,384 women participated, with 84% compliant in using Phexxi correctly during intercourse. These findings emphasize the product's significance for women's reproductive health and its role in contraceptive counseling.
Evofem Biosciences, Inc. (NASDAQ: EVFM) will host a webcast and conference call on May 6, 2021, at 4:30 p.m. ET to discuss its financial results and business highlights for the first quarter ended March 31, 2021. Interested parties can access the live event via the company's website or by calling (866) 503-5561 in the U.S. A replay will be available for 24 hours after the event. Evofem focuses on innovative solutions for women’s health, having launched the FDA-approved product Phexxi in September 2020.
Evofem Biosciences (NASDAQ: EVFM) will present a keynote address and two posters on Phexxi at the NCODA 2021 National Spring Forum from April 28-30. CEO Saundra Pelletier will address the importance of Phexxi for female cancer patients. The two posters from the Phase 3 AMPOWER trial will cover sexual satisfaction and pregnancy rates associated with Phexxi. NCODA will also publish a Positive Quality Intervention to support oncologists in prescribing Phexxi. This initiative highlights the need for hormone-free contraceptive options for women undergoing cancer treatment.
Evofem Biosciences, Inc. (NASDAQ: EVFM) announced the closing of its underwritten public offering of 17,142,857 shares of common stock at $1.75 per share, generating gross proceeds of $30 million. The proceeds will fund commercialization activities related to Phexxi®, a contraceptive vaginal gel, ongoing clinical trials for EVO100, and other corporate purposes. The offering was conducted under Evofem's existing shelf registration statement. Morgan Stanley and Stifel acted as joint book-running managers for the offering.
Evofem Biosciences (NASDAQ: EVFM) has priced an underwritten public offering of 17,142,857 shares at $1.75 per share, aiming for gross proceeds of approximately $30 million. The closing is expected around March 29, 2021. Morgan Stanley and Stifel are the joint book-running managers. The net proceeds will support the commercialization of Phexxi®, an innovative contraceptive vaginal gel, and fund the ongoing EVOGUARD Phase 3 clinical trial for EVO100 targeting STIs. The shares are offered under a shelf registration effective since March 11, 2021.
Evofem Biosciences plans to offer and sell $30 million of its common stock in an underwritten public offering, with a potential additional $4.5 million from underwriters. The offering is contingent on market conditions and does not guarantee completion or specific terms. Proceeds will support commercialization of Phexxi contraceptive gel in the U.S., fund the ongoing EVOGUARD Phase 3 clinical trial for EVO100, and cover general corporate expenses. The offering is registered under Form S-3 and details will be filed with the SEC.
Evofem Biosciences (NASDAQ: EVFM) announced impressive initial results from its "Get Phexxi" direct-to-consumer campaign, launched on Valentine's Day. The campaign, aimed at promoting its non-hormonal birth control, Phexxi, generated over 173 million views in three weeks. Key metrics included a 73% rise in monthly ex-factory sales of Phexxi in February and a significant boost in brand awareness, with total prescriptions for Phexxi growing by 32%. The number of healthcare providers prescribing Phexxi increased by 25% in February 2021 compared to January.
Evofem Biosciences (NASDAQ: EVFM) announces the publication of the AMPREVENCE trial manuscript in the American Journal of Obstetrics and Gynecology. The trial of EVO100, a preventive gel for chlamydia and gonorrhea, met primary and secondary efficacy endpoints, showing a 50% reduction in chlamydia and 78% in gonorrhea infections in women at high risk. Currently, there are no FDA-approved products for these infections. Evofem is enrolling patients for the EVOGUARD Phase 3 trial, with data expected in mid-2022, aiming for FDA submission by the end of 2022.