Aerie Pharma's FDA Briefing Docs: Good News With No Surprises; Shares Scale A Record

Reviewing all the data and the recent briefing documents, the firm said it believes Rhopressa will receive a favorable recommendation. The firm clarified that the briefing documents were the initial draft labelling for the potential therapy. The firm accorded an 80 percent probability for the approval of the drug.

Cantor Fitzgerald rates Aerie Pharma Overweight, with a $62 price target.

At last check, shares of Aerie Pharma were jumping 16.17 percent to $64.30, off the session's intra-day high of $65.85, which also happens to be an all-time high.

Rhopressa is a Rho kinase inhibitor being studied for treating interocular pressure, or IOP, in patients with open-angle glaucoma or ocular hypertension.

Analysts Elemer Piros and Justin Kim noted that the package insert highlighted no surprises and comprehensively addressed the occurrence of hyperemia and revised criteria to treat patients with an IOP of less than 26 mg of Hg. Additionally, the analysts said the questions for the meeting include a discussion on the initial draft labeling.

"We remain encouraged going into the advisory committee meeting and by Rhopressa's potential to become the first novel drug for glaucoma in 20 years," the analysts said.

Delving on Aerie Pharma's pipeline, Cantor Fitzgerald said the company is developing once-daily eyedrops Rhopressa and Roclatan. The firm noted that outstanding phase 3 data is available for both candidates.

The firm expects Rhopressa approval to come about by the first quarter of 2018, closely followed by Roclatan.