Momenta Pharmaceuticals, Inc. (MNTA) stock is exploding higher by more than 12% Thursday after the company announced that the FDA granted approval of ANDA for Glatopa(TM) (glatiramer acetate injection), the first substitutable generic for COPAXONE(R) (glatiramer acetate injection) 20mg.
“We are proud to be able to offer patients with multiple sclerosis the first generic version of daily COPAXONE and the first generic product in this space,” said in a statement Craig Wheeler, President and CEO, Momenta Pharmaceuticals. “The FDA approval of the ANDA for once daily Glatopa further validates Momenta’s approach of using innovative physicochemical and biologic characterization to gain approval of complex generics, biosimilars and novel drugs, and advances Momenta’s goal of expanding access to high quality, more affordable medicines.”
MNTA shares recently gained $2.15 to $18.25. In the past 52 weeks, shares of Cambridge, Massachusetts-based biotechnology company have traded between a low of $9.38 and a high of $20.43. Shares are up 50.19% year-over-year and 33.72% year-to-date.