FDA Ruling Boosts Stock of Molecular Biosystems
Molecular Biosystems Inc.’s stock price jumped on record single-day volume Tuesday after the company announced that the federal Food and Drug Administration had given a medical device classification to its new Albunex ultrasound imaging agent.
MBI President Vincent Frank said his company was pleasantly surprised by the FDA’s ruling because it had anticipated that the agency would classify Albunex as a drug. The drug classification would have meant a three-year clinical trial process for Albunex, compared with one to two years of clinical tests required for medical devices.
“This means that if all goes well, we’ll get to the market (with Albunex) sooner,” Frank said. MBI has applied to the FDA for approval to begin the clinical trials of Albunex before year’s end.
Albunex consists of microscopic bubbles that are injected into the bloodstream, enabling doctors using ultrasound equipment to view images of blood coursing through the heart. The images help doctors evaluate cardiovascular performance. Frank said the market for ultrasound imaging agents could be in the millions of dollars.
On the strength of the announcement, MBI stock hit an all-time high of $15.50 Tuesday before closing at $15.125, up $2.25 on the day. Volume was 905,000 shares, 12th-highest issues traded on the NASDAQ Tuesday.
