Edge Therapeutics Inc. (NASDAQ: EDGE) is enjoying some regulatory priorities in the development of aneurysmal subarachnoid hemorrhage (aSAH) treatment EG-1962. The FDA has granted the compound both Fast-Track and Orphan drug designations. With Fast-Track, Edge will enjoy accelerated regulatory review of EG-1962, which should theoretically shorten the time it takes to bring the drug to market. But the question is, can Edge take advantage of the accelerated review to speed up the unlocking of the revenue potential in EG-1962?
Addressing the aSAH market
Edge Therapeutics Inc. (NASDAQ: EDGE) is hoping to overcome the limits of other therapies designed for treating aSAH. Its EG-1962 is a polymeric nimodipine microparticle and it is designed to deliver nimodipine at the site of the bleed. That sets it apart from the oral therapies that may take longer to act on the targeted areas. As such, Edge Therapeutics is hoping that EG-1962 will become the standard treatment for patients afflicted by aSAH.
Leveraging polymer technology
Edge is taking advantage of its polymer technology to optimize the delivery of nimodipine through EG-1962. By leveraging polymer technology, Edge Therapeutics says the drug can deliver the highest dose of nimodipine possible to correct the brain bleeding problem.
What the size of the problem?
It is estimated that 75% of patients suffering from brain bleeding never return when they are taken in for intensive care. The annual cost related to treatment of brain bleeding runs into billions of dollars.
Edge Therapeutics Inc. (NASDAQ: EDGE)’s Trial results
Edge Therapeutics Inc. (NASDAQ: EDGE)’s EG-1962 has gone through a number of clinical trials. A Phase 2 study of the compound in sufferers of aSAH showed that it performed better than oral nimodipine treatments. The company is now working on a Phase 3 study of the candidate to evaluate its safety and efficacy.
Besides FDA’s approval for accelerate review, Edge Therapeutics’ EG-1962 has also won orphan drug designation from the European Commission.
When you look at the regulatory goodwill around EG-1962 and the revenue potential, you get the sense that Edge Therapeutics Inc. (NASDAQ: EDGE) has greater incentives to push forward with the development of the drug.