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Aerie Pharmaceuticals updates timing of NDA filing for Rhopressatm 0.02%; shares off 6% premarket

  • Aerie Pharmaceuticals (NASDAQ:AERI) reports that the manufacturing line related to Rhopressa in their Tampa, Florida facility will not be ready for pre-approval inspection by the FDA until the end of February 2017.
  • In October 2016, the Rhopressa NDA (New Drug Application) was withdrawn due to the third party contract manufacturer not being prepared for pre-approval inspection by the FDA. Aerie now expects to resubmit the Rhopressa NDA filing near the end of Q1 2017.
  • Rhopressa (netarsudil ophthalmic solution) 0.02%, is a novel eye drop that if approved, would become the only once-daily product available that specifically targets the trabecular meshwork, the eye’s primary fluid drain and the diseased tissue responsible for elevated intraocular pressure (IOP) in glaucoma.
  • Shares are down 6% premarket but only on 35 shares.

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Aerie Pharmaceuticals, Inc.