GlycoMimetics Up on FDA Agreement on Rivipansel Study

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GlycoMimetics, Inc. (GLYC) announced that its partner, Pfizer Inc. (PFE), has entered into an agreement with the FDA under a special protocol assessment (SPA) for a phase III study on rivipansel (GMI-1070). GlycoMimetics’ shares jumped around 9% following the announcement.

The companies are developing rivipansel for the treatment of patients suffering from sickle cell disease who are hospitalized for vaso-occlusive crisis (VOC). The study is expected to start by year end.

In May 2014, Pfizer paid $15 million to GlycoMimetics as per the terms of the 2011 agreement between the two companies. GlycoMimetics will receive $20 million payment following the initiation of the phase III study. While GlycoMimetics was responsible for phase II, Pfizer is in charge of the phase III study on the candidate.

Last year, GlycoMimetics announced positive results from a phase II study on rivipansel in hospitalized sickle cell disease patients experiencing VOC. Results revealed that reductions in time to reach resolution of VOC were observed in patients treated with rivipansel compared to those under placebo.

GlycoMimetics and Pfizer intend to file for approval of rivipansel in the U.S. for the VOC indication on the basis of results from the phase III study. Rivipansel enjoys both orphan drug and fast track designation in the U.S. for the VOC indication.

Both GlycoMimetics and Pfizer have progressed well with rivipansel. Successful development of rivipansel is crucial for GlycoMimetics which currently has no approved products.

GlycoMimetics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Synergy Pharmaceuticals, Inc. (SGYP) and Regeneron (REGN). Both stocks carry a Zacks Rank #1 (Strong Buy).
 

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