On February 17, 2017, Momenta revealed that a contracted Pfizer facility that manufactures its Glatopa product was sent a warning letter from the U.S. Food and Drug Administration ("FDA"). Momenta's Abbreviated New Drug Application for its Glatopa 40 mg product candidate is still under regulatory review, and under FDA policy, final approval is reliant on the acceptable resolution of the compliance observations at the Pfizer manufacturing facility. On February 20, 2017, a Leerink Capital Partners LLC analyst said that the FDA warning letter raises concerns for Momenta, since manufacturing warning letters may take years to resolve, and that a lengthy delay could diminish Momenta's market opportunity for Glatopa. Following this news, Momenta stock has dropped as much as $4.30 per share, or 22.63%, during intraday trading on February 21, 2017.
If you are aware of any facts relating to this investigation, or purchased shares of Momenta, you can assist this investigation by visiting the firm's site: www.bgandg.com/mnta. You can also contact Peretz Bronstein or his Investor Relations Analyst, Yael Hurwitz of Bronstein, Gewirtz & Grossman, LLC: 212-697-6484.
Bronstein, Gewirtz & Grossman, LLC is a corporate litigation boutique. Our primary expertise is the aggressive pursuit of litigation claims on behalf of our clients. In addition to representing institutions and other investor plaintiffs in class action security litigation, the firm's expertise includes general corporate and commercial litigation, as well as securities arbitration. Attorney advertising. Prior results do not guarantee similar outcomes.
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