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.

Don’t miss out! Stay informed on $TROV and receive breaking news on other hot stocks by signing up for our free newsletter!

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.

Verastem Inc (NASDAQ:VSTM) Blood Cancer Drug Meets Primary Endpoints

Verastem Inc (NASDAQ:VSTM)

Shares of Verastem Inc (NASDAQ:VSTM) rallied 28.13% after the company announced positive Phase 3 trial results for its blood cancer drug. The stock had initially jumped 50.3% after the company announced that Duvelisb met its primary endpoints in the late stage trial.

Duvelisib is an oral inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma under trial for the treatment of hematologic cancers such as indolent non-Hodgkin lymphoma (iNHL) and other T cell lymphomas. Verastem Inc (NASDAQ:VSTM) tested the drug on 319 patients suffering from chronic lympocytic leukemia or small lymphocytic lymphoma

In addition to the positive Phase 2 trial results, the drug is also supported by compelling Phase 1 results that demonstrated a 50% investigator-assessed response rate.

VSTM Investor Reaction

The positive clinical trial results saw the stock gap higher to highs of $5.50 a share before retreating to end the day at $4.92 a share. The stock has already broken key resistance levels of $4.00 and $4.50 a share, further affirming a bullish run that began in July. Verastem Inc (NASDAQ:VSTM) shares are already up by more than 300% for the year.

Verastem Inc. (NASDAQ:VSTM) is currently trading near all-time highs. Renewed investor interest on the stock comes on the biopharmaceutical company saying that Duvelisib reduced the risk of disease progression or death by 48%, compared to standard care Arzerra.

Fuelling investor interests are reports that the Duvelisib, if approved, could generate as much as $400 million in sales for the company. Equity firms have already taken note of Duvelisib potential, with analysts at Oppenheimer initiating coverage of the stock with a ‘buy’ rating.

One month VSTM stock price chart

Regulatory Push

Verastem Inc (NASDAQ:VSTM) plans to share the clinical data with the U.S Food and Drug Administration (FDA) with the goal of filling a New Drug Application (NDA). The filling is to be supported by results from DUO study and CLL/SLL and the DYNAMO study – all of which achieved primary endpoints. The company has also confirmed plans to file for a marketing application for the drug.

Verastem Inc (NASDAQ:VSTM) is also planning to expand Duvelisb development program with a view of carrying out trials on its ability to treat Peripheral T-Cell Lymphoma. Duvelisib has already been granted Fast Track Designation by the FDA for the treatment of PTCL.

“Expansion of the Duvelisib clinical development program, and the accompanying receipt of Fast Track designation from the FDA are important steps in Verastem’s strategy to efficiently develop the potential of duvelisib in additional cancers such as T-cell malignancies,” said Robert Forrester, President and Chief Executive Officer of Verastem Inc (NASDAQ:VSTM).

Board Appointment

Following the positive Duvelisib trial results, Verastem Inc. (NASDAQ:VSTM) has confirmed the appointment of Brian Stuglik to the board of directors. He joins the company with over 30 years’ experience in Pharmaceutical and oncology commercialization.

“Brian Stuglik is an accomplished executive with significant oncology commercialization expertise who can bring immediate value to Verastem as we now move towards commercializing duvelisib,” said Mr. Forrester.

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.

Don’t miss out! Stay informed on $VSTM and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.

Despite Oncoming Class Action Lawsuit, TG Therapeutics, Inc. (NASDAQ:TGTX) Shares Rocket

TG Therapeutics, Inc. (NASDAQ:TGTX)

Most of this year’s press for TG Therapeutics involved announcements of law firms asking clients who had held the shares between September, 2014 and October 2016, to contact them about joining in a class action lawsuit against the biotech company. But today TG Therapeutics Inc. (NASDAQ:TGTX) is making news for all the right reasons and TGTX is up almost 100% in mid-morning trading.

TG Therapeutics has been accused of making misleading or false public statements regarding an FDA Phase 3 clinical trial regarding the firm’s proprietary combination of TG-1101 (ublituximab), its glycoengineered anti-CD20 monoclonal antibody, plus TGR-1202, the company’s once-daily PI3K-delta inhibitor, for the treatment of Chronic Lymphocytic Leukemia (“CLL”). The Phase III clinical trial, is referred to by the Company as “GENUINE”.

It is alleged by the law firms that TG Therapeutics Inc. made false and/or misleading statements and/or omitted material information concerning the GENUINE Phase III trial, assuring investors it was a “best-in-class treatment” that would be “successful” and “offer patients a novel chemo-free treatment option”. The deadline to become a plaintiff in the case is March 7, 2017.

Today, however, TG Therapeutics Inc. (NASDAQ:TGTX) saw its share price more than double when they released news that positive topline results from its Phase 3 GENUINE clinical trial of TG-1101 (ublituximab) plus ibrutinib achieved positive topline results in patients with previously treated high risk Chronic Lymphocytic Leukemia (CLL).

The clinical study involved adult patients with high-risk chronic lymphocytic leukemia (CLL) who have undergone at least one prior therapy. The Phase 3 trial was designed to assess whether adding ublituximab would induce a statistically significant improvement in overall response rate – defined as at least 20 percent between the two groups of patients. TG Therapeutics reported the absolute difference between the two groups was about 30 percent.

Shares of TG Therapeutics Inc. (NASDAQ:TGTX) have gained since the beginning of the year despite the threats posed by the class action lawsuit. Over the past year, and prior to today, TGTX shares had lost over 40% but were actually up over 15% YTD. On Friday TGTX closed at $5.35 and have reached an inter-day high of $11.6 – representing a gain of over 115%.

Complete results are expected to be presented at a future medical meeting in the first half of 2017. TG Therapeutics Inc. (NASDAQ:TGTX) is expected to meet with the FDA to pursue accelerated approvals.

3/6/2017
Ticker Symbol TGTX
Last Price a/o 11:08 AM EST  $                    10.60
Average Volume                    423,500
Market Cap (mlns)  $                  306.50
Sales (mlns) $0.20
Shares Outstanding (mlns) 57.29
Share Float (mlns) 40.91
Shortable Yes
Optionable Yes
Inside Ownership 19.50%
Short Float 14.15%
Short Interest Ratio 13.67
Quarterly Return -6.96%
YTD Return 15.05%
Year Return -41.78%

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.

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.

Actinium Pharmaceuticals (NYSE: ATNM) Jumps Over 30% on Massive Volumes

Actinium Pharmaceuticals Inc. – NYSE: ATNM

Actinium Pharmaceuticals gained over 30% in today’s trading on exceptionally heavy volumes. ATNM, traded on the NYSE, has an average daily volume of 275k, but today over 5.5 million shares traded hands.

New York, NY-based Actinium Pharmaceuticals is a biotech company that develops innovative targeted payload immunotherapies for the treatment of advanced cancers. The Company’s radioimmunotherapy product candidates are based on the combination of the cancer targeting precision of monoclonal antibodies (mAb) that seek out specific types of cells combined with the cytotoxic killing power of radioisotopes that unleash their energy once they have reached their target.

Actinium’s lead product is Iomab-B and is in its crucial Phase 3 clinical trial. Iomab-B is a myeloablative therapy, designed to destroy a patient’s bone marrow so that a patient can receive bone marrow from a donor via a transplant. Also in Actiniumn’s pipeline is its Alpha Particle Immunotherapy (APIT) platform. Being 100 times more powerful than beta particles, alpha therapy is effective in cancers that are not sensitive to beta irradiation such as victims of Acute Myeloid Leukemia (AML). AML treatment utilizing APIT has demonstrated extremely high cancer cell kill levels.

On January 27 – 28, 2017, in Dallas, TX, Chief Medical Officer, Dr. Mark Berger will present at the 3rd Annual Think Tank on Integrating New Molecular Targets in Acute Leukemias and Myeloproliferative Neoplasms. Dava Oncology is sponsoring the event as part of their Oncology Meeting Innovations program. Dr. Berger’s talk will focus on Actinium’s Iomab-B.

ATNM shares took a 20% dive in September when the company announced a public offering of an additional 8 million shares at $1.25 a piece plus offering the underwriters a 30-day option on an additional 15% of the sold stock. The price gapped down to below $1.40 and broke the $1 barrier in late October. Shares rebounded slightly and traded around the $1 handle until today when the stock took off and closed at $1.36 – just two cents short of the daily high.

Actinium Pharmaceuticals has yet to post any sales but institutions own over 10% of its shares – a fact which comforts some investors. ATNM had its largest earnings loss in 2012 when the company announced a loss of $7.58 per share. Earnings have never been positive; the last three years have seen per share losses under $1 with 2015 posting a loss of $0.55. Two firms follow Actinium Pharmaceuticals and both rate ATNM shares as a “Strong Buy”.

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.

2/3/2017
Ticker Symbol ATNM
Last Price a/o 3:59 PM EST  $                      1.36
Average Volume                    274,270
Market Cap (mlns)  $                    57.42
Sales (mlns)
Shares Outstanding (mlns) 55.75
Share Float (mlns) 51.06
Shortable Yes
Optionable Yes
Inside Ownership 8.50%
Short Float 2.31%
Short Interest Ratio 4.3
Quarterly Return 4.99%
YTD Return 17.17%
Year Return -50.00%