Eagle Pharmaceuticals’ Japanese Licensing Partner SymBio Announces Completion of Clinical Trial Enrollment for TREAKISYM® Rapid Infusion Liquid Bendamustine Formulation
Eagle Pharmaceuticals, Inc. (EGRX)
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Source: Business Wire
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (“Eagle” or the “Company”) (NASDAQ: EGRX) today announced that its marketing partner SymBio Pharmaceuticals Limited (“SymBio”) has completed patient enrollment in a clinical trial for TREAKISYM rapid infusion (“RI”), a liquid bendamustine injection with a 10-minute administration time, in Japan. The study’s primary objective is to confirm the safety of the RI product. SymBio expects to obtain regulatory approval in the second half of 2022.SymBio intends to submit a New Drug Application (“NDA”) for the RI product for all indications for which TREAKISYM is currently approved (low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia). As previously disclosed, SymBio filed an NDA for its TREAKISYM ready-to-dilute (“RTD”) product in October 2019.In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of TREAKISYM in J
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News
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- Eagle Pharmaceuticals Appoints Christopher Krawtschuk as Chief Financial OfficerGlobeNewswire
EGRX
Sec Filings
- 11/19/24 - Form 3
- 11/15/24 - Form 8-K
- 11/14/24 - Form SC
- EGRX's page on the SEC website