delivered great news Thursday: All outstanding issues pertaining to the manufacturing of Feraheme, the company's iron replacement therapy, have been settled to the satisfaction of the Food and Drug Administration.
The agency also isn't requiring a re-inspection of AMAG's manufacturing plant in Cambridge, Mass.
In other words, the final approval of Feraheme appears to be close, very close.
The news, reported alongside AMAG's first-quarter financial results, sent the stock rocketing 20% to $54 during Thursday's after-hours session. The stock has more than doubled off its early March low.
AMAG and the FDA have been going back and forth over Feraheme's approval since last October, with unresolved manufacturing issues as the major sticking point. A face-to-face meeting between AMAG and FDA officials in March seemed to break the logjam.
"During the last several months, we worked with the FDA to address the outstanding regulatory issues referenced in the December 2008 Complete Response letter to our Feraheme New Drug Application," said AMAG CEO Brian Pereira, in a statement.
"We are delighted that the FDA has informed us that we have satisfactorily addressed the observations made during the inspection of our manufacturing facility. We look forward to bringing the approval process to closure," he added.
The company is seeking FDA approval for ferumoxytol, now known by its brand name Feraheme, as a treatment for iron-deficiency anemia in patients with chronic kidney disease.
On a Thursday night conference call, Pereira wouldn't predict an exact timing for a final approval of Feraheme. But with manufacturing issues behind the company, investors were acting as if Feraheme's final regulatory hurdle is a mere formality.
At the time of publication, Feuerstein's Biotech Select model portfolio was long AMAG.
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