GlycoMimetics, Inc.’s (GLYC - Free Report) shares plunged 12.6% immediately after the company’s announcement regarding a considerable delay in the commencement of a phase III study on rivipansel. Shares further fell 0.8% in the subsequent trading session. Overall, shares are down 13.4% since the announcement.
Late last week, GlycoMimetics announced that the initiation of a phase III study on rivipansel, to be conducted by its partner Pfizer Inc. (PFE - Free Report) , will be delayed indefinitely due to a manufacturing problem, which will impact formulated supply of the product. Rivipansel is being developed for the treatment of patients suffering from sickle cell disease who are hospitalized for vaso-occlusive crisis (VOC).
We remind investors that in Oct 2011, GlycoMimetics had entered into a licensing agreement with Pfizer for the development of rivipansel for several indications including vaso-occlusive crisis associated with sickle cell disease. Under this agreement, Pfizer gained an exclusive worldwide license to rivipansel for these indications and is responsible for its development, regulatory approval and commercialization.
GlycoMimetics said that Pfizer is working toward the identification of the specific cause and associated remedy regarding the manufacturing issue. Pfizer will notify GlycoMimetics about the specific timeframe of commencement of the study on rivipansel once it identifies the particular cause and remedy for the issue.
We note that the phase III rivipansel study was previously scheduled for commencement before the end of 2014. The study will be conducted under the FDA’s special protocol assessment (SPA) requirement.
Rivipansel has orphan drug designation and fast track status for the treatment of VOC in the U.S.
We believe the delay in initiation of the phase III study on rivipansel, GlycoMimetics’ most advanced candidate, for an undefined period of time is a major setback for GlycoMimetics. This reduces visibility on the future of the study. We expect investors to remain focused on updates on the study’s status.
GlycoMimetics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the pharmaceuticals sector are Endo International plc (ENDP - Free Report) and Lannett Company, Inc. (LCI - Free Report) . While Lannett carries a Zacks Rank #1 (Strong Buy), Endo holds a Zacks Rank #2 (Buy).