TrovaGene Inc (TROV) Officially Announces Orphan Drug Designation for PCM-075


TrovaGene Inc (NASDAQ:TROV) just made the news official today: As revealed by SmarterAnalyst on Friday (when shares were already roaring up 30%), the U.S. Food and Drug Administration (FDA) granted an orphan drug designation to the drug maker’s PCM-075, designed to treat patients with acute myeloid leukemia (AML). The agency awarded the AML drug orphan drug status on September 28, 2017 following August’s positive preclinical research results, which evaluated TrovaGene’s  Polo-like kinase 1 (PLK1) inhibitor coupled with a Histone deacetylase (HDAC) inhibitor in Non-Hodgkin Lymphoma (NHL) cell lines. 

Investors like what they see, as shares continue to fly today. PCM-075 is an oral, highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine Polo-like Kinase 1 (PLK1) enzyme, which appears to be over expressed in several different hematologic malignancies and solid tumor cancers.

“AML is an aggressive cancer of the blood and bone marrow with approximately 20,000 new cases in the U.S each year,” said Bill Welch, Chief Executive Officer of Trovagene.  “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.”

Orphan drug designation is granted by the FDA to drugs that are intended treat rare diseases or conditions for patients in the U.S. The orphan drug designation allows the orphan drug indication for the drug to be eligible for a seven-year period of U.S. marketing exclusivity upon approval of the drug, as well as other development assistance and financial incentives.

Trovagene is initiating a Phase 1b/2 open-label trial to evaluate the safety and anti-leukemic activity of PCM-075 in combination with standard-of-care in patients with AML, at ten research sites across the U.S., led by Hematologist Dr. Jorge Cortes, Deputy Department Chair, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.

Shares of TrovaGene are currently rising almost 3% to $0.875. TROV has a 1-year high of $4.75 and a 1-year low of $0.61. The stock’s 50-day moving average is $0.73 and its 200-day moving average is $0.89.

On the ratings front, Maxim Group analyst Jason McCarthy reiterated a Buy rating on TROV, with a price target of $4, in a report issued on August 22. The current price target represents a potential upside of 335% from where the stock is currently trading.

According to TipRanks.com, McCarthy has a yearly average return of 4.4%, a 42% success rate, and is ranked #1287 out of 4695 analysts.

Trovagene, Inc. is a molecular diagnostic company, which focuses on the development and commercialization of a proprietary urine-based molecular diagnostic technology for use in disease detection and monitoring across a variety of medical disciplines.