Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) Files An 8-K Regulation FD DisclosureItem 7.01. Regulation FD Disclosure.
On July23, 2018, Aerie Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it has received the “Day 74” notification from the U.S. Food and Drug Administration (“FDA”) earlier than scheduled, the FDA has completed its initial 60-day review of the New Drug Application (“NDA”) for RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% and the FDA has determined that the application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act goal date for the completion of the FDA’s review of the RoclatanTM NDA is set for March14, 2019. A copy of this press release is furnished as Exhibit 99.1 hereto and is hereby incorporated by reference into this Item 7.01.
The information in this Item 7.01 (including Exhibit 99.1) is being furnished, not filed, to Regulation FD. Accordingly, the information in this Item 7.01 will not be incorporated by reference into any registration statement filed by the Company under the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated therein by reference. The furnishing of the information in this Item 7.01 is not intended to, and does not, constitute a determination or admission by the Company that this information is material or complete, or that investors should consider this information before making an investment decision with respect to any security of the Company.
Item 7.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit relating to Item 7.01 shall be deemed to be furnished, and not filed:
| 99.1 | Press Release dated July23, 2018. |
EXHIBIT INDEX
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| 99.1 | Press Release dated July23, 2018. |
AERIE PHARMACEUTICALS INC ExhibitEX-99.1 2 d576211dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Aerie Pharmaceuticals Announces Early Notification of FDA Acceptance of NDA Submission for RoclatanTM (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% with PDUFA Date Set for March 14,…To view the full exhibit click here
About Aerie Pharmaceuticals, Inc. (NASDAQ:AERI)
Aerie Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company. The Company is engaged in the discovery, development and commercialization of therapies for the treatment of patients with glaucoma and other diseases of the eye. The Company’s primary product candidates are Rhopressa and Roclatan. Its product candidates are designed to lower intraocular pressure (IOP) in patients with open-angle glaucoma and ocular hypertension. Rhopressa is a once-daily eye drop and a triple-action netarsudil ophthalmic solution. The active ingredient in Rhopressa acts through the inhibition of both Rho Kinase (ROCK) and norepinephrine transporter (NET). Roclatan is a once-daily, quadruple-action product candidate and is a fixed-dose combination of Rhopressa and latanoprost, which is a prescribed drug for the treatment of patients with glaucoma. The Company is engaged in conducting Phase III clinical trials for Rhopressa and Roclatan.