Crispr Therapeutics shares tumble after significant earnings miss
Investing.com - Femasys Inc. (NASDAQ:FEMY) stock rose after the company announced on June 25 that its FemBloc System received full CE Mark certification under European Union Medical (TASE:BLWV) Device Regulation for permanent birth control. The stock, which has gained over 11% in the past week according to InvestingPro data, continues to show strong momentum despite its small market cap of $32 million.
The certification marks the first global regulatory approval for FemBloc as a non-surgical permanent birth control option. The approval covers the Class III blended polymer component, which follows the March 13, 2025, approval for the delivery system.
The complete certification now allows Femasys to market the FemBloc System throughout the European Economic Area, including all 27 EU member states and 3 European Free Trade Association countries. The company plans to target markets in Spain, France, Italy, and Germany, which were significant markets for the now-discontinued competitor product Essure.
Femasys has already secured distribution partnerships in Spain and is expected to establish additional partnerships in other EU countries in the coming months. The company is expanding its international sales force to support commercial efforts in Europe.
H.C. Wainwright maintained its Buy rating and $12.00 price target on Femasys, noting the company could potentially begin recognizing FemBloc sales in Europe as soon as the second half of 2025 or first half of 2026, several years ahead of potential FDA approval in the United States.
In other recent news, Femasys Inc. has announced the pricing of its latest public stock offering and concurrent private placement. The company plans to raise approximately $4.5 million in combined gross proceeds from these transactions. Femasys intends to use the funds to expand commercial efforts, advance product development, and cover general corporate expenses. Additionally, Femasys received a notice from Nasdaq indicating it does not meet the minimum Market Value of Listed Securities requirement for continued listing, giving the company until November 17, 2025, to regain compliance.
In a separate development, Jones Trading has adjusted its price target for Femasys stock to $6.00 from $10.00, while maintaining a Buy rating. This adjustment follows the company’s first-quarter earnings report and reflects slower-than-expected uptake of FemaSeed in the U.S. market. The analyst from Jones Trading also noted the anticipation of a potential CE mark approval for FemBloc in mid-2025, which would allow marketing in the European Union.
Femasys has also appointed Kelley Nicholas as Chief Commercial Officer to lead its commercial strategy, emphasizing growth in the U.S. infertility market. Nicholas brings over 25 years of industry experience to her new role. These recent developments indicate Femasys’ ongoing efforts to strengthen its market position and address financial challenges.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.