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Momenta Pharma sees market launch of Glatopa 40 mg by mid-year; shares ahead 8% premarket

Published 01/30/2018, 09:07 AM
© Reuters. Momenta Pharma sees market launch of Glatopa 40 mg by mid-year; shares ahead 8% premarket
  • Momenta Pharmaceuticals (NASDAQ:MNTA) is up 8% premarket on light volume on the heels of its announcement that the FDA has classified its Q4 2017 reinspection of Pfizer (NYSE:PFE)'s McPhearson manufacturing site as "Voluntary Action Indicated" which means that some minor deficiencies were observed but the issues do not warrant further regulatory action.
  • The McPhearson site will manufacture Momenta's generic 40 mg version of Teva Pharmaceutical Industries' (NYSE:TEVA) top seller Copaxone (glatiramer acetate injection). The FDA would not approve its ANDA until the issues at the plant were resolved. Momenta now believes it will receive U.S. approval by next quarter. It will market its offering under the brand name Glatopa.
  • Teva is down 6% premarket on robust volume.
  • Previously: FDA OK of Momenta's 40mg Glatopa delayed due to compliance issues at manufacturing site; shares down 15% (Feb. 21, 2017)
  • Now read: 3 Things In Biotech You Should Learn Today: January 17, 2018


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