Aerie Pharmaceuticals Inc. (NASDAQ: AERI) was one of the more bullish health care stocks on Thursday morning, following the release of its interim safety results. The company reported the successful 12-month interim safety results of Rocket 2, Aerie’s second Phase 3 registration trial for Rhopressa (netarsudil ophthalmic solution).
Previously, Aerie reported that Rocket 2 had achieved its primary 90-day efficacy endpoint of demonstrating non-inferiority of intraocular pressure (IOP) lowering for Rhopressa QD compared to timolol BID. The Rocket 2 trial is a pivotal trial expected to be part of Aerie’s New Drug Application (NDA) filing for Rhopressa, which the company expects to submit to the FDA in the third quarter of 2016.
Management also said to expect the NDA filing to be on track for the third quarter of 2016,
Rhopressa is a novel once-daily eye drop being tested for its ability to lower IOP in patients with glaucoma or ocular hypertension. Aerie believes that if Rhopressa is approved, it 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 IOP in glaucoma.
Vicente Anido, Jr., Ph.D., chief executive officer and chairman at Aerie, commented on the results:
In addition to proceeding with our Rhopressa NDA filing, we also look forward to our first Phase 3 90-day efficacy readout for RoclatanTM, also expected in the third quarter of 2016. On a separate note, we are reporting that our preliminary cash burn for full-year 2015 is consistent with our earlier guidance of approximately $60 million, and our year-end 2015 cash, marketable securities and investments amounted to approximately $150 million. We remain well-financed for 2016.
Shares of Aerie were up 17.4% at $17.42 Thursday morning, with a consensus analyst price target of $45.14 and a 52-week trading range of $8.84 to $35.89.