Nanox Imaging sees stock rebound sharply following sell-off, fueled by positive FDA clearance news
Imaging disrupter Nanox saw its stock trend upward Tuesday amid optimistic news about the U.S. Food and Drug Administration possibly greenlighting its novel imaging system.
The Israel-based startup had announced late Monday that its stockowners were selling off nearly 2.9 million shares, dragging the price downward. But it witnessed a rebound by the end of Tuesday thanks to comments included in a 269-page filing shared Monday with the Securities and Exchange Commission.
Nanox is attempting to create a novel system it says will offer high-end imaging capabilities at a fraction of the cost and footprint of traditional modalities. The firm has been seeking clearance from the FDA for its Nanox.ARC, but raised concerns after the agency cited “deficiencies” in the application.
But Nanox allayed those worries with Monday’s SEC filing, noting that reviewers recommended that the FDA clear its technology back in December.
“Today's SEC filing contained much more hopeful information—that clearance had already been recommended,” the Motley Fool investor news website noted on Tuesday. “Therefore, FDA approval perhaps isn't so far off after all. That's why this stock rebounded sharply today.”
Nanox had originally hoped to ship its first 1,000 imaging systems in late 2021 but shifted the timeline to early 2022 following the FDA’s request for more information. The company faced controversy late last year when one investment firm accused it of operating as nothing more than a stock promotion, which resulted in a class-action lawsuit from shareholders. Nanox called those claims baseless at the time and reiterated its stance in the Feb. 8 SEC filing.
“We believe this lawsuit is without merit and intend to defend the case vigorously,” officials noted, adding that they are unable to estimate potential losses in the event that Nanox loses in court.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.