NEW YORK, NY / ACCESSWIRE / August 30, 2017 / Immunogen was one of the big winners in Tuesday trading after announcing a partnership with Jazz Pharmaceuticals. Acorda Therapeutics shares tumbled after it was revealed that the FDA has sent the company a refusal to file (RTF) letter over its new drug application that was sent in June on its Inbrija drug candidate to treat Parkinson's disease.
RDI Initiates Coverage on:
Acorda Therapeutics Inc.
ImmunoGen, Inc.'s shares closed up 17.34% yesterday and even saw more gains of nearly 2% in after-hours trading. Volume at nearly 13 million shares was significantly higher than normal. The big jump and trading activity came after the company announced that it has decided to collaborate with Jazz Pharmaceuticals PLC (JAZZ) for the development and commercialization of two early-stage, hematology-related antibody-drug conjugate (ADC) programs. The companies will also partner on an additional program to be designated during the term of the agreement. The programs include IMGN779, which is a CD33-targeted ADC for the treatment of acute myeloid leukemia (AML) in Phase 1 testing, and IMGN632, a CD123-targeted ADC for hematological malignancies. IMGN632 is expected to enter clinical testing before the end of the year. CEO of ImmunoGen, Mark Enyedy, commented, "This strategic partnership with Jazz significantly advances our goal of accelerating the development of our early-stage novel ADC assets."
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Acorda Therapeutics, Inc.'s shares closed down 24.32% yesterday on nearly 9 million shares traded. Shares crashed after the New York-based company received a refusal to file (RTF) letter from the FDA about its new drug application for its potential Parkinson's disease treatment, Inbrija. The company announced that the FDA has determined that the application the company had sent in June was not sufficiently complete for the FDA to do a substantive review. Acorda stated, "FDA specified two reasons for the RTF: first, the date when the manufacturing site would be ready for inspection, and, second, a question regarding the submission of the drug master production record. FDA also requested additional information at resubmission, which was not part of the basis for the RTF."
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