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OHR Pharmaceutical Gains 7% Following Agreement With FDA

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Shares of OHR Pharmaceutical Inc (NASDAQ: OHRP), a nano-cap pharmaceutical company that focuses on the treatment of ocular diseases, spiked higher by more than 7 percent early Tuesday morning.

OHR Pharmaceutical announced it has reached an agreement on the Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration on the design of a Phase 3 trial for its lead drug candidate, Squalamine.

As part of the agreement, OHR Pharmaceutical has initiated the first of two planned Phase 3 global clinical studies evaluation the efficacy and safety of Squalamine, given in combination with Lucentis.

"We are extremely pleased to have completed the SPA process. This agreement with the FDA enables us to move forward with the Squalamine Phase III clinical program," commented Dr. Jason Slakter, CEO of Ohr. "The initiation of our Phase III clinical program is a monumental achievement for the company and represents an important step in our mission to develop and commercialize therapeutics for unmet medical needs in ophthalmology."

 

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Posted-In: Jason Slakter Lucentis Ocular Diseases OHR Pharmaceutical Special Protocal Assessment SqualamineNews FDA