The U.S. Food and Drug Administration accepted Femasys’ modular premarket approval application for FemBloc, an experimental non-surgical permanent birth control technology.
- The approval allows Femasys to submit completed sections of the tests while the overall clinical trial continues.
- The technology is already approved in Europe, the U.K. and New Zealand.
- Earlier this month, Femasys raised $30 million to fund, among other items, FemBloc’s U.S. clinical and regulatory program.
Shares of Femasys (FEMY) rallied more than 60% on Wednesday before giving up most of their gains after the U.S. Food and Drug Administration (FDA) accepted its modular premarket approval application for FemBloc, an experimental non-surgical permanent birth control technology.
At the time of writing, FEMY shares were trading 18% higher.
What Does The FDA Decision Mean?
The modular premarket approval pathway is a step-by-step process that allows Femasys to submit completed sections covering areas such as manufacturing and non-clinical testing while the clinical trial continues.
The FDA can review those sections before receiving the final clinical data, potentially making the overall process more efficient. The decision does not approve the marketing of FemBloc in the U.S.
Under the FDA’s modular PMA process, each section is submitted as it is ready, eventually forming a complete application. Femasys must still complete its clinical program and demonstrate that FemBloc is safe and effective.
A Non-Surgical Birth Control Option
FemBloc is designed to be delivered in an OB/GYN office without anesthesia or incisions. A biodegradable polymer is placed in both fallopian tubes, causing natural scar tissue to form and permanently block the tubes. The polymer then breaks down safely, leaving no permanent implant.
The technology is already approved in Europe, the U.K. and New Zealand.
FEMY Raises $30 Million
Earlier this month, Femasys raised $30 million through a private placement and said it could receive an additional $60 million if all accompanying warrants are exercised for cash.
The company plans to use the funding to advance FemBloc’s U.S. clinical and regulatory program and expand sales of its fertility products to OB/GYNs and fertility specialists.
FEMY Stock Could ‘Run For Days’
Retail sentiment surrounding FEMY on Stocktwits flipped to ‘extremely bullish’ from ‘bullish’ a day earlier, amid ‘extremely high’ message volumes.
One user said the stock has a 500% upside potential.
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Another user said the stock could ‘run for days’
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The stock has been under heavy selling pressure so far in 2026, declining around 68%.
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