TrovaGene Inc (NASDAQ: TROV) is having an incredibly strong start to the trading session this morning, and for good reason. The company announced that the United States Food and Drug Administration has granted orphan drug designation for one of it’s pipeline treatments. Of course, this caused excitement among investors, leading to gains in the value of the stock and prompting our partners at Trade Ideas to alert us to the movement. At the moment (9:28), TROV is trading at $1.01 per share after a gain of $0.16 per share or 18.82% thus far today.
TROV Gains On Orphan Drug Designation
As mentioned above, TrovaGene is having an incredibly strong start to the trading session this morning after the company announced that the FDA granted an orphan drug designation to PCM-075. PCM-075 is a pipeline treatment that TROV has been working on for patients with acute myeloid leukemia, also known as AML. The designation was given to the treatment on September 28th, 2017.
This is overwhelmingly positive news as the FDA only grants orphan drug designation to drugs that are designed to treat rare diseases or conditions in patients. As a result of the designation, the treatment is eligible for 7-year market exclusivity upon approval. This will also assist the company through development assistance as well as financial incentives.
TROV recently announced the initiation of a Phase 1b/2 open-label trial designed to evaluate the safety and anti-leukemic activity of PCM-075 in combination with the current standard of care in patients with AML. The company is performing this clinical trial across ten sites throughout the United States. The trial is being led by Dr. Jorge Cortes, a Hematologist that is the Deputy Department Chair of the Department of Leukemia and Devision of Cancer Medicine at the University of Texas MD Anderson Cancer Center. In a statement, Bill Welch, CEO at Trovagene, had the following to offer:
“AML is an aggressive cancer of the blood and bone marrow with approximately 20,000 new cases in the U.S. each year… We see the FDA’s granting of orphan drug designation for PCM-075 as underscoring the medical need for new therapies for patients with AML and an important step forward in our clinical development program.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on TROV. In particular, we’re interested in following the ongoing development of PCM-075 and excited for the benefits that the orphan drug designation will provide to the company. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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