Is this a Turn-Around for TrovaGene Inc (NASDAQ:TROV)

TrovaGene Inc (NASDAQ:TROV)

Shares of TrovaGene Inc (NASDAQ:TROV) are trading with exceptionally heavy volume after the biotechnology company’s drug candidate PCM-075 was granted an Orphan Drug designation by the U.S. Food and Drug Administration (FDA). PCM-075 is being developed for the treatment of patients with Acute Myeloid Leukemia (AM).

TROV Stock Movement

TrovaGene Inc (NASDAQ:TROV) shares have a listed 30-day, daily average volume of less than 650,000. However less than 30 minutes into trading over 3.5 million shares have traded hands. On Friday, TROV stock closed at $0.85 but gapped up to open at $1.02 before hitting an inter-day high, as of 10AM, of $1.03. TROV shares have since come off those levels and are trading near $0.90.

TROV investors have not had a good 2017. Year-to-date shares are down over 50% and down over 30% for the quarter. TROV stock has done well more recently though. In mid-July investors sent shares tanking from $1.60 and, until last Friday, the shares languished below $1 for all of September and October. Earlier this year, TROV shares hit their 52-week of $4.75.

TrovaGene Inc (NASDAQ:TROV)

TrovaGene Developments

The granting of the Orphan Drug designation allows the drug, once ap[proved, to be eligible for a seven-year period of U.S. marketing exclusivity, as well as other development assistance and financial incentives.

Acute myeloid leukemia (AML) is a hematologic malignancy in which myeloid lineage cells of the bone marrow cease to differentiate appropriately, resulting in a marked increase in the number of circulating immature blast cells. As a consequence, the counts of mature red blood cells, platelets, and normal white blood cells decline, causing fatigue, shortness of breath, bleeding, and increased susceptibility to infection.

Bill Welch, Chief Executive Officer of TrovaGene Inc (NASDAQ:TROV) stated in a press release,”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.”

Analysts have a consensus price target of $6 on shares of TrovaGene Inc (NASDAQ:TROV). Three analysts cover TROV stock. Two rte it as a “Strong Buy” while one rates it as a “Hold”.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Benitec Biopharma Limited (Nasdaq: BNTC) Secures EU Exclusivity

Benitec Biopharma Limited – Nasdaq: BNTC

Benitec Biopharma Limited shares are up over 75% from their Friday close of $1.85. The Australian company trades on the Nasdaq as an American Depository Share (ADR) under ticker BNTC. Investors seem to be responding to news that the European Union designated Benitech Biopharma’s BB-301 as an Orphan Drug for the treatment of oculopharyngeal muscular dystrophy. The designation of Benitec’s drug as an Orphan drug carries with it a 10-year exclusivity for the EU market.

Benitec Biopharma is a biotechnology company developing a therapeutic technology platform that combines gene silencing and gene therapy with a goal of providing sustained, long-lasting silencing of disease-causing genes from a single administration. The company belives their technology has the potential to be a “one shot” cure for a wide range of diseases that are currently addressed by strict ongoing treatment regimens or that have no effective treatment or only palliative care options. Using proprietary technology, Benitec is developing a pipeline of product candidates for the treatment of several chronic and life-threatening human diseases. They expect a Phase 1 and 2 study to begin in 2018.

The single firm that follows Benitec Biopharma Limited rates shares of BNTC as a “Hold”. As of this writing, BNTC has no reported EPS and sales of $7 million.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.