FEMASYS (FEMY) Stock News

Femasys (NASDAQ:FEMY) announced that the U.S. FDA has approved its modular premarket approval (PMA) submission approach for FemBloc, the company’s investigational non-surgical permanent birth control technology in the United States.

According to Femasys, the modular PMA allows FDA to review key components of the FemBloc submission before final clinical data are available, creating a clearer regulatory framework toward potential U.S. approval. FemBloc is already approved for marketing in Europe and select international markets. In parallel, Femasys is building a U.S. commercial team and expanding distribution of its fertility portfolio from infertility specialists to OB/GYNs, with the intention that this team will ultimately also support FemBloc.

FemBloc is designed as an office-based, first-of-its-kind permanent birth control solution that uses a patented delivery system and polymer placed into both fallopian tubes, which degrades and promotes natural scar tissue for permanent occlusion, without anesthesia, incisions, or recovery time.

Femasys (NASDAQ:FEMY) reported second-quarter and six-month 2026 results and a major financing. The company completed a $30 million private placement with potential proceeds up to $90 million upon full cash exercise of warrants, and subsequently believes it has resources to execute its U.S. commercial and clinical strategy.

For the six months ended June 30, 2026, sales were $756,716, up 0.8% year over year, with net loss $3.6 million versus $10.5 million in 2025, helped by a 25.7% reduction in R&D expenses. For Q2 2026, sales declined 18.9% to $331,827 and net loss was $4.5 million. Cash was $1.4 million at June 30, 2026, before the private placement.

Corporate updates include regaining Nasdaq listing compliance, new U.S. and international patents for FemBloc, CE Mark approval for FemHSG Catheter, initial commercial use and launch of FemaSeed Complete, a commercialization partnership in Israel, and appointment of a new COO.

Femasys (NASDAQ:FEMY) announced new issued patents in the United States and multiple key international markets that protect the blended polymer component of FemBloc, its non-surgical permanent birth control technology. These patents complement existing delivery system patents, broadening and extending FemBloc’s global intellectual property coverage.

The protected blended polymer is delivered into both fallopian tubes, degrades, and induces scar tissue for permanent occlusion. FemBloc is approved for marketing in Europe and select international markets but remains investigational in the United States, where a pivotal clinical trial is ongoing.

Femasys (NASDAQ:FEMY) entered a securities purchase agreement for a $30 million private placement with accredited investors led by Nantahala Capital, joined by Rosalind Advisors and company management. Closing is subject to customary conditions and is expected around August 10, 2026.

The company is selling an aggregate of 9,374,999 common shares and pre-funded warrants, plus accompanying warrants to purchase 18,749,998 common shares. The purchase price is $3.20 per share and $3.1999 per pre-funded warrant, with pre-funded warrants exercisable at $0.0001 per share. Accompanying warrants have a $2.95 exercise price and three-year term. If fully exercised for cash, warrants could provide up to an additional $60 million.

Milestone warrants for 9,374,999 shares become exercisable 12 months after closing and require specified U.S. revenue and share-price milestones plus an effective resale registration statement. According to Femasys, proceeds will support commercialization of its fertility portfolio and advancement of the U.S. FemBloc clinical and regulatory program.

Femasys (NASDAQ:FEMY) announced it has regained compliance with Nasdaq Listing Rule 5550(a)(2), the minimum bid price requirement for continued listing. Nasdaq confirmed the matter is now closed.

According to Femasys, the company will now focus on advancing strategic priorities and expanding access to its reproductive health solutions.

Femasys (NASDAQ:FEMY) received CE Mark approval for its FemHSG Catheter, expanding its fertility care portfolio in Europe through commercial partners. Used with the FemVue device, FemHSG supports streamlined, in-office ultrasound-based evaluation during the initial fertility workup, enhancing OB/GYNs’ ability to provide comprehensive, accessible fertility diagnosis and care.

Femasys (NASDAQ: FEMY) reported results for the quarter ended March 31, 2026, highlighting early commercial adoption of FemaSeed Complete, initiation of the FINALE pivotal trial for FemBloc, new international distribution partnerships, and leadership additions.

Financials: Q1 sales $424,889 (+24.5% YoY), R&D -55.9% to $1.31M, net income of $846,100, cash ~$5.4M expected to fund operations into Q3 2026, accumulated deficit ~$145.0M.

Femasys (NASDAQ: FEMY) announced the first revenue-generating commercial use of its fertility portfolio in the OBGYN setting on May 5, 2026, deploying FemaSeed as a first-line infertility treatment with supporting FemSperm for in-office sperm preparation.

The company says this enables earlier, lower-cost, in-office fertility care within routine OB/GYN practice and follows earlier-than-expected U.S. FDA clearance and clinical validation of FemaSeed.

Femasys (NASDAQ: FEMY) announced the commercial launch of FemaSeed Complete on April 22, 2026, a fertility solution enabling OB/GYNs to perform first-line insemination entirely in-office.

The product targets expanded access: an estimated 10 million U.S. women with infertility, leverage of >b>40,000 OB/GYNs versus fewer than 2,000 infertility specialists, and will be showcased at ACOG May 1–3, 2026.