Needham: Aerie Pharma's FDA Agreement 'Re-Establishes A Clinical Path Forward' For Rhopressa

Aerie Pharmaceuticals Inc AERI has created a lot of buzz this morning as shares jumped 56 percent in pre-market trading following news that the FDA has allowed the company to modify the primary endpoint of its second Phase 3 trial of Rhopressa; an eye drop that alleviates intraocular pressure. The second Phase 3 trial is called Rocket 2.

Under the agreement, Aerie will now include patients with baseline intraocular pressures ranging from above 20 millimeters to below 25 millimeters of mercury in its primary endpoint. Before the change, the primary endpoint range was above 20 millimeters to below 27 millimeters of mercury. This parameter will now be a secondary endpoint collection for Rocket 2.

Aerie assured investors that the new endpoint range will not involve extra patients for the existing trial and that the company should expect results by the third quarter.

Vicente Anido, Jr., Ph.D., Chairman and CEO, said of the FDA’s decision, “We are extremely pleased with the outcome of our communications with the FDA. If Rocket 2 results resemble those of Rocket 1, we believe we may have a much greater opportunity for success in meeting the clinical endpoint of non-inferiority to timolol. We are also very appreciative of the thoughtful guidance provided by the FDA, and believe their feedback will prove very useful as our programs progress.”

On June 16, Needham & Company analyst Serge Belanger upgraded Aerie Pharmaceuticals from Hold to Buy with a $27 price target in light of the FDA’s decision to allow the company to change its primary endpoint for Rocket 2. The analyst believes the “FDA agreement re-establishes a clinical path forward for Rhopressa as a treatment for a large subset (70-80 percent) of glaucoma patients.”

Serge Belanger currently has an overall success rate of 67 percent recommending stocks and a +43.7 percent average return per recommendation.

Out six analysts polled by TipRanks, four analysts recommend Buying the stock while two analysts rate it a Hold. The current 12-month average price target on AERI is $28.60, marking a potential upside of 42 percent. On average, the all-analyst consensus for AERI on TipRanks is Moderate Buy.