Shares of Mylan NV (MYL) jumped 16.7% to $37.97 in morning trading on Wednesday, Oct. 4, after the company clinched the U.S. Food and Drug Administration's approval for its generic version of Teva Pharmaceutical Industries Ltd.'s (TEVA) multiple sclerosis drug Copaxone.
"After downplaying the possibility of a September approval and taking Copaxone out of its 2017 estimates, Mylan unexpectedly received FDA approval of both doses (40 mg 3x/week injection, and 20 mg/daily injection)," wrote Mizuho Securities USA LLC analyst Irina R. Koffler in a note.
Koffler said she expects Mylan shares to rally "because Copaxone approval has eluded it for years, and the news validates the company's ability to execute on complex generics," adding: "We think Advair is next."
The FDA approved Mylan's abbreviated new drug applications for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, a generic version of Teva's Copaxone 40 mg/mL, and Glatiramer Acetate Injection 20 mg/mL for once-daily injection, a generic version of Teva's Copaxone 20 mg/mL.
Teva's American depository receipts were down 12.4% to $16.49.
Meanwhile, shares of Momenta Pharmaceuticals Inc. (MNTA) were down 18.3% to $14.30. The FDA in 2015 approved Glatopa, which Momenta and its collaboration partner Sandoz developed as a generic version of daily Copaxone 20 mg. In 2014, the FDA accepted for review Sandoz's abbreviated new drug application for three-times-a-week generic Copaxone 40 mg/mL.
In February, Momenta said Sandoz's contracted fill/finish manufacturing partner, Pfizer, has received an FDA warning letter. In the Feb. 17 announcement, Momenta said an approval of the application is "dependent on the satisfactory resolution of the compliance observations at the Pfizer facility used to make the final product."
Among the other biotech stock movers on Wednesday was Amicus Therapeutics (FOLD) . Shares were up 3.8% to $15.44 after the Cranbury, N.J.-based firm unveiled additional positive data from a Phase 1/2 clinical study of ATB200/AT2221 in patients with Pompe disease.
-- Giovanni Bruno contributed to this article