Shares of PTC Therapeutics (PTCT) - Get Report rose 12.4 % to $11.03 in premarket trading on Monday. The South Plainfield, N.J.-based company said the U.S. Food and Drug Administration has acknowledged the filing over protest of the company's new drug application for Translarna, a protein restoration therapy for the treatment of nonsense mutation Duchenne muscular dystrophy.
The FDA has granted standard review and given a Prescription Drug User Fee Act date of Oct. 24, 2017.
In August 2014, Translarna obtained marketing authorization for patients with nmDMD in the European Union. Translarna is currently available in more than 25 countries.
Meanwhile, Teligent shares (TLGT) - Get Report were up 3.65% to $7.10. The Buena, N.J.-based company said the FDA has approved the company's abbreviated new drug application for Triamcinolone Acetonide Ointment USP, 0.5%.
Other stock movers include Minerva Neurosciences (NERV) - Get Report , whose shares were up 3.61% to $8.60 after Jefferies on Monday assumed coverage of Waltham, Mass.-based Minerva at buy and a price target of $17.
"We believe NERV's two candidates MIN-101 and -202 offer upside to shares," wrote Jefferies analysts in a note.
Minerva is developing MIN-101 for the treatment of schizophrenia. Minerva and Janssen Pharmaceutica are jointly developing MIN-202 (JNJ-42847922) as a treatment for insomnia and major depressive disorder.
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