AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) Continues Rocket Ride

AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO)

AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) shares look to continue their rise after last Friday’s 71% gain on huge volumes. On Thursday, AVEO shares closed at $0.73 then gapped up on Friday to open at $1.13 before hitting an inter-day high of $1.38 and closing at $1.25. Volumes were over 54 million shares for a stock that typically trades less than one million shares daily. Today, traders are seeing a repeat performance. AVEO shares have gapped up to open at $1.36 and have hit a high of $1.53, where shares are now trading less than an hour into Monday’s session. Volumes once again are massive – over 6.3 million shares have traded hands which indicates a relative volume figure of over 50 times what could be expected based on a 30-day, daily average trading volume.

AVEO Announcement

The catalyst for the price and volume gains is the announcement by AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has recommended FOTIVDA™ (tivozanib) for approval as a treatment for patients with advanced renal cell carcinoma (RCC). The European Commission (EC) normally accepts the CHMP’s recommendation although it is not bound to follow suit. The EC’s final decision is expected in less than nine weeks. If approved by the EC, marketing authorization for tivozanib will be for all the countries in the European Union as well as Norway, Iceland and Liechtenstein.

AVEO Share History

In 2011, AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) shares hit their all-time high at around $21 per share. A slide in share price then followed and by 2013 AVEO shares could be obtained for less than $2 per share. Prior to Friday’s breakout, AVEO shares hit a lot of resistance around $1.20 and that resistance lowered to $1 in October of 2016.

AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) sales have been inconsistent. In 2012 the biotech firm reported sales of $19.3 million followed by annual figures of $1.3 million, $18.1 million, $19 million, and in 2016 a figure of $2.5 million was reported. Those sales have not correlated to earnings though. In 2012, the company reported an loss of (-$2.64) per share. That EPS loss continued, but narrowed, through 2016 when the company posted a loss of (-$0.39). Share dilution has been a constant. In 2012 there were 43.37 million shares outstanding and that number grew steadily until, in 2016, AVEO Pharmaceuticals, Inc. (NASDAQ:AVEO) reported 69.27 million shares outstanding.

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.

OWC Pharmaceutical Research Corp (OTCMKTS:OWCP) Teams Up With CFN Media

OWC Pharmaceutical Research Corp (OTCMKTS:OWCP)

OWC Pharmaceutical Research Corp (OTCMKTS:OWCP) has engaged the services of CFN Media as part of an effort that seeks to attract high-quality investors. The company also plans to use the partnership to broaden its product’s target market.

CFN Media Agreement

CFN Media will conduct a 2-month investor and market visibility program as part of the agreement. The company’s President, Frank Lane, has welcomed the partnership, which he says will help millions of people gain access to their high-quality cannabinoid psoriasis cream. The Israel-based company plans to use its presence in the cannabinoid sector to promote OWC Pharmaceutical Research Corp (OTCMKTS:OWCP) offerings.

“We are very excited to cooperate, again, with CFN Media. In the near future, OWC will report developments that we believe are material. CFN has proven themselves as a reliable and professional media outlet with exceptional editorial skills. Together with their video interviews we will have the best channel to convey our message to the investment community,” said OWC Pharmaceutical Research Corp (OTCMKTS:OWCP) CEO, Mordechai Bignitz.

CFN Media’s collaboration builds on a similar agreement signed with Mediq Innovation partners last month. Under the items of that agreement, the German-based company has agreed to market OWC Pharmaceutical Research Corp (OTCMKTS:OWCP) products in Europe.

Mediq’s will offer both strategic and scientific assistance geared towards developing a commercial market for OWC Pharmaceutical Research Corp (OTCMKTS:OWCP) proprietary cannabinoid products. Plans are already underway to unveil products in Germany since the country’s law and regulations allow for the sale of non-smokable cannabis.

Europe Push

Germany’s health care sector will be key for growth as it offers reimbursement for medical cannabis. Other countries where cannabis has a legal status do not yet offer reimbursement for cannabinoid treatment(s). Scientific collaboration should also benefit the company as it continues to explore new products in a bid of taking advantage of growing demand for cannabis products.

“We’re looking forward to initiating our efforts on behalf of OWCP in Europe, starting in our home market of Germany. Since German laws and regulations allow non-smokable forms of medical cannabis, we believe that OWCP’s proprietary cannabinoid-based topical psoriasis cream is the right product at the right time,” said Mediq Managing Director, Jan Wende.

Separately, OWC Pharmaceutical Research Corp (OTCMKTS:OWCP) has confirmed that its wholly owned Israeli subsidiary, One World Cannabis Ltd, has designed the road map for a Multiple Myeloma study. The study builds on promising results from an earlier vitro study. The purpose of the next phase of study is to investigate the dose levels and delivery systems for a future planned study on human patients.

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: 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.

TrovaGene Inc (NASDAQ:TROV) Signs Agreement with AstraZeneca (AZN)

TrovaGene Inc (NASDAQ:TROV)

TrovaGene Inc (NASDAQ:TROV) has announced entering into an agreement with AstraZeneca plc (ADR) (NYSE:AZN) that will see the latter supply Trovera® urine ctDNA biomarker tests and services. TrovaGene Inc is a precision medicine biotechnology company.

Initially, the Trovera® EGFR urine liquid biopsy test will be applied in an open label prospective biomarker trial to evaluate whether the collective use of noninvasive testing i.e. blood and urine testing are as effective and reliable as tissue testing in identifying the mutation status of the epidermal growth factor receptor (EGFR) T790M.

In a statement, TrovaGene Inc (NASDAQ:TROV) Chief Executive Officer, Bill Welch, said they are pleased to work AstraZeneca and to have their urine liquid biopsy test incorporated in a trial intended to explore new and non-invasive means of detecting the EGFR mutation.

TrovaGene Inc (NASDAQ:TROV) offers CLIA laboratory testing services for several clinical research third parties and biopharmaceutical companies. It is this expertise that has supported the development of biomarkers for PCM-075, a polo-like kinase 1 (PLK1) inhibitor. The company intends to use an acute myeloid leukemia (AML) genetic panel to evaluate the response to PCM-075 in its phase 1/2 trial.

Recently AstraZeneca got the US Food and Drug Administration for its Tagrisso (osimertinib) used in the treatment of metastatic EGFR T790M mutation-positive non-small cell lung cancer.

Additionally, AstraZeneca recently announced getting marketing approval from the Drug Controller General of India (DCGI) for asthma drug Symbicort. According to the company, Symbicort is a non-variable dose drug combination made of formoterol fumarate and budesonide dehydrate which are administered through a special device. The drug is meant for treatment of severe asthma as well as patients with severe chronic obstructive pulmonary disease (COPD) and who have a history of exacerbations.

Symbicort has been approved for use in asthma and COPD treatment in 910 countries. According to two major studies, the addition of budesonide to formoterol led to improvement in asthma symptoms and lung function in addition to reducing exacerbation.

Additionally, in two one-year clinical studies in patients suffering from COPD, Symbicort exhibited superior to placebo, formoterol, and budesonide in regards to lung function in addition to registering reduction in the rate of exacerbation as compared to formoterol and placebo.

TrovaGene Inc (NASDAQ:TROV) surged 37.36% and closed at $1.30 in Thursday’s trading session.

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: 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.

OvaScience Inc (NASDAQ:OVAS) Welcomes New CEO

OvaScience Inc (NASDAQ:OVAS)

OvaScience Inc (NASDAQ:OVAS) shares are up over 13% on volumes in excess of four times their normal average. Waltham, MA-based OvaScience Inc (NASDAQ:OVAS) today announced that Christopher Kroeger, M.D., M.B.A., has been appointed Chief Executive Officer. The appointment will take effect on September 1, 2017. Dr. Kroeger is reported to possess extensive experience leading, building and advising development-stage therapeutic and medical device companies. Dr. Kroeger brings a strong clinical and research background as a practicing physician and scientist. Upon Dr. Kroeger’s transition to OvaScience Inc (NASDAQ:OVAS), Michelle Dipp, M.D., Ph.D., Co-Founder and Executive Chairman of OvaScience plans to step down as Executive Chairman and will serve as an advisor to the Company.

Terms of employment include stock options. OvaScience Inc (NASDAQ:OVAS)’s Compensation Committee approved the terms of compensation on June 21, 2017. Dr. Kroeger’s compensation consists of options to purchase up to 1,783,106 shares of common stock. The options are exercisable at $1.46 per share, equal to the closing price per share of OvaScience’s common stock as of June 21, 2017. The stock options vest over about 5 years and 7 months, subject to continued service with OvaScience Inc (NASDAQ:OVAS) through the applicable vesting dates.

OvaScience, Inc. (NASDAQ: OVAS) discovers, develops and commercializes new fertility treatments. OvaScience treatments are based on their proprietary technology platform that leverages the breakthrough discovery of egg precursor (EggPC℠) cells – immature egg cells found inside the protective ovarian lining. OvaScience is developing OvaTure℠, a potential next-generation in vitro fertilization (IVF) treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections and OvaPrime℠, which could increase a woman’s egg reserve. Importantly, this treatment is unavailable inside the United States.

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: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Shares of DelMar Pharmaceuticals Inc (NASDAQ:DMPI) Gaining

DelMar Pharmaceuticals Inc (NASDAQ:DMPI)

Biotechnology firm DelMar Pharmaceuticals Inc (NASDAQ:DMPI), based in Vancouver, Canada, shares are rising on large volumes. DMPI shares closed yesterday at $1.85 and gapped up to open at $1.95 before reaching an inter-day high of $2.73. As of 12:30 PM EST, DMPI shares are up over 22% at $2.27. Trading volume has increased to an extraordinary level when compared to the listed 30-day, daily average trading volume as over 2.1 million shares have traded hands by lunch. DMPI has a 52-week high of $9.90 and a 52-week low of $1.66.

Investor attention seems to have been heightened after DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) today announced that it will present an abstract at the 12th Meeting of the European Association of Neuro-Oncology. The presentation will take place in Mannheim, Germany from October 12 – 16, 2016. DelMar’s presentation will center around their lead drug candidate VAL-083 and how it attacks cancer cells utilizing methods that separate it from other chemotherapy treatments for glioblastoma multiforme (GBM) which is the most common and aggressive form of brain cancer. Specifically, DelMar will present data supporting the potential of VAL-083 to treat patients whose tumors exhibit resistance to existing chemotherapies used in the treatment of GBM.

DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI)’s VAL-083 is a “first-in-class,” small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 clinical studies, VAL-083 demonstrated clinical activity against a range of cancers. Importantly for investors, VAL-083 has received an orphan drug designation (ODD) in Europe for the treatment of malignant gliomas; and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.

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 $AMCN and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Moleculin Biotech Inc (NASDAQ:MBRX) Shares Rocketing

Moleculin Biotech Inc (NASDAQ:MBRX)

Moleculin Biotech Inc (NASDAQ:MBRX) shares are rocketing higher by almost 30% after this morning’s announcement that the biotech company has discovered a metabolic inhibitor with the potential to treat pancreatic cancer. MBRX shares closed Tuesday at $0.85 and gapped up to open today at $1.14 before hitting an inter-day high of $1.30. At 11:10 AM EST MBRX shares are trading aournd $1.10. Volumes are extraordinarily heavy. Data suppliers list the 30-day, daily, average trading volume at around 717,000. However by 11 AM EST, over 11.4 million shares have exchanged hands.

Moleculin Biotech Inc (NASDAQ:MBRX) is a preclinical pharmaceutical company that develops anti-cancer drug candidates. Moleculin develops some of these drug candidates, utilizing license agreements, with The University of Texas System on behalf of the M.D. Anderson Cancer Center.

Walter Klemp, Chairman and CEO of Moleculin Biotech Inc (NASDAQ:MBRX) stated “In pre-clinical testing, WP1234 has shown improved drug characteristics when compared with WP1122 and a 20 to 50-fold greater ability to kill pancreatic cancer cell lines when compared with traditional inhibitors of glycolysis. We know that pancreatic cancer thrives even in a reduced oxygen environment, which indicates it may be highly dependent on glycolysis to survive. This discovery now makes WP1234 a promising drug candidate to be studied for the treatment of pancreatic cancer.”

The news is sure to be welcomed by beleaguered Moleculin shareholders. While MBRX shares are up 33% so far today, they are down over 62% YTD, and down over 86% for the year. Moleculin Biotech Inc (NASDAQ:MBRX) has never reported any sales and has three years of negative earnings, last year being the largest at (-$0.40). However the consensus target price amongst analysts covering MBRX is above $9.00.

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 $MBRX and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Lipocine Inc. (NASDAQ:LPCN) Trades Higher On Candidate Efficacy Results

Lipocine Inc. (NASDAQ:LPCN)

Lipocine Inc. (NASDAQ:LPCN) has reported positive efficacy results regarding its Dosing Validation and Dosing Flexibility studies for oral testosterone candidate 1021. According to Lipocine, the study results validate a fixed dose approach without the need for dose titration.

Topline LCPN 1021 Results

Study results indicate that LPCN 1021 achieved all of the predetermined FDA primary efficacy guidelines. 70% of the subject’s average testosterone levels were restored and 81% of the subjects achieved average testosterone levels. The trial also confirmed that twice-daily dosing would be the appropriate dosing regimen.

“We are pleased with the confirmation of LPCN 1021 efficacy, especially with a more practical patient and physician preferred “no titration” dosing regimen. We believe the results should address the label-related deficiency cited by the FDA in our NDA submission. We consider LPCN 1021 to be a differentiated TRT option for treating hypogonadism in men with the potential to both improve patient compliance and eliminate the risk of testosterone transference,” said Lipocine Inc. (NASDAQ:LPCN) CEO, Dr. Mahesh Patel.

Lipocine Inc. (NASDAQ:LPCN) is developing LCPN 1021 as an oral testosterone replacement therapy designed to help restore normal testosterone levels in hypogonadal men. Current treatment options rely on short acting injectable products. The company wants to do away with these treatment options given that they carry an FDA ‘black box’ warning.

Lipocine Pipeline

In addition to LCPN 1021 DF study, Lipocine Inc. (NASDAQ:LPCN) is currently undertaking preclinical toxicology tests for LCPN 111. Trials should be complete by midyear paving way for an end-of-phase 2 meeting with the FDA. The company expects approval sometime in 2019 with the drug set to go on sale in 2020.

LCPN 1107 is another candidate drug that Lipocine is working on as a novel prevention option for recurrent preterm birth. Lipocine Inc. (NASDAQ:LPCN) expects LCPN to become the first oral HPC product for prevention of preterm birth in women with a prior history. Its potential benefits, when compared to injectable products, include the elimination of pain and site reactions associated with injections.

Separately, law firm, Robinson Arroyo LLP, has lodged a class action complaint against Lipocine. The law firm alleges that the company misled investors on Phase 3 clinical results for its candidate drug 1021. The company officials are accused of using a different dosing scheme compared to the one described in the New Drug application.

Lipocine Inc. (NASDAQ:LPCN) stock was up by 5.47% in Tuesday’s trading session to end the day at $4.24 a share.

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 $LPCN and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.

Delcath Systems, Inc. (NASDAQ:DCTH) Market Value Doubles

Delcath Systems, Inc. (NASDAQ:DCTH)

On Monday, Delcath Systems, Inc. (NASDAQ:DCTH) exploded by more than 90% as traders reacted to a short-sale circuit breaker triggered on Friday. The stock price more than doubled on heavy volumes doubling the company’s market value.

Short Sale Circuit Breaker

The short-sale circuit breaker, adopted in 2010 by the Securities and Exchange Commission (SEC), halts the trading of a security for a pre-specified amount of time. One reason Delcath Systems, Inc. (NASDAQ:DCTH) was up in Monday’s trading session was that traders could not short the stock.

The fact that that the short sale circuit breaker is a temporary provision raises concerns of whether the stock will be able to sustain the massive movement to the upside. Prior to the breaker being triggered, Delcath Systems had been trading on minimal volume.

Upcoming Events

The specialty pharmaceutical and medical device company will release Phase 2 clinical data for a combination of Melphalan and its Hepatic Delivery System before the end of the month. The treatment is being developed as a novel treatment for cancer of the liver and bile duct.

Delcath Systems, Inc. (NASDAQ:DCTH) is also testing Melphalan Hydrochloride in a phase 3 clinical trial in patients with Ocular Melanoma. Developments in the oncology space should have a significant impact on the stock once the short sale circuit breaker is withdrawn.

Mid and late-stage clinical trial results should set the tone on the stock’s trading. Positive trial results could position the company as a takeover target. Large pharmaceutical companies normally look for such small-cap companies as part of an effort that seeks to gain access to novel treatments for unmet medical conditions.

Financial Woes

Delcath Systems, Inc. (NASDAQ:DCTH) has incurred losses since inception as its accumulated deficit has soared to $290.5 million as of the end of the first quarter. A wider than expected net loss of (-$11.3) million compared to (-$8.3) million last year, continues to raise concerns about its prospects and financial health.

“The Company’s existence is dependent upon management’s ability to obtain additional funding sources or to enter into strategic alliances. There can be no assurance that the Company’s efforts will result in the resolution of the Company’s liquidity needs,” said the company in a regulatory filing.

Delcath Systems, Inc. (NASDAQ:DCTH) stock was up over 122% in Tuesday’s trading session to end the day at $0.220 a share.

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 $DCTH and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Shareholders Hit Again by Celsion Corporation (NASDAQ:CLSN)

Celsion Corporation (NASDAQ:CLSN)

Celsion Corporation (NASDAQ:CLSN) announced that it has entered into definitive agreements with several institutional investors to purchase an aggregate of approximately $5.4 million of shares of common stock, or pre-funded warrants in lieu thereof, in a registered direct offering. The market responded by punishing the shares, dropping almost 24%. CLSN shares ended yesterday at $3.20 but after the news of the share dilution hit the streets, sellers took over and CLSN closed the day at $2.44. Volumes were double their 30-day, daily averages.

Celsion Corporation (NASDAQ:CLSN) agreed to sell an aggregate of approximately 2 million shares of common stock, or pre-funded warrants in lieu thereof, at a price of $2.75 per common share or warrant share, respectively, in the registered direct offering.   Additionally, the investors will receive, for each share of common stock or pre-funded warrant purchased in the registered direct offering, a Series AAA warrant to purchase one (1) share of common stock and a Series BBB warrant to purchase one (1) share of common stock. The Series AAA warrants have an exercise price of $2.75 per share, are initially exercisable six months following issuance, and terminate five and one-half years following issuance. The Series BBB warrants have an exercise price of $8.00 per share, are immediately exercisable, and terminate one year following issuance.

Celsion Corporation (NASDAQ:CLSN) is a fully integrated biopharmaceutical company focused on developing a portfolio of innovative cancer treatments, including directed chemotherapies, DNA-mediated immunotherapy, and RNA-based therapies. The company has a poor history with their shareholders. In 2012, shareholders experienced an EPS loss of (-$48.11). That was followed by losses of (-$13.29), (-$19.32), (-$14.42), and, in 2016, (-$11.90). Meanwhile, the number of shares outstanding has increased every year since 2012 when Celsion Corporation (NASDAQ:CLSN) reported 0.55 million shares. Unfortunately that number had steadily increased and by 2016 the number of outstanding shares was reported at 1.85 million.

Performance has not been attractive. Celsion Corporation (NASDAQ:CLSN) are down over 42% YTD, down over 65% for the past six months, and down over 86% for the year.

Despite the poor performance, two analysts rank Celsion Corporation (NASDAQ:CLSN) shares as a “Strong Buy” and one ranks CLSN shares 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 $CLSN and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.

Delcath Systems, Inc. (NASDAQ:DCTH) Doubles!

Delcath Systems, Inc. (NASDAQ:DCTH)

Shares of Delcath Systems, Inc. (NASDAQ:DCTH) doubled today on heavy volumes. DCTH shares closed at $0.099. The 30-day, daily average volume is listed at just over 73 million but today over 233 million shares traded hands. Typically, the doubling of a firm’s market capitalization would have been motivated by a major news item or company announcement that forecast increased revenues. A review of the major news sources and the company’s own website reveals no such news or announcement has been published. However, some stock news websites are postulating that DCTH shares may be entering an overbought condition.

Delcath Systems, Inc. (NASDAQ:DCTH) is a specialty pharmaceutical and medical device company in the oncology sector. Delcath’s proprietary product is Melphalan Hydrochloride. It is injected for use with the Delcath Hepatic Delivery System (Melphalan/HDS) and is designed to administer high dose chemotherapy to the liver, while controlling the systemic exposure to those agents. Delcath Systems, Inc. (NASDAQ:DCTH)’s principal focus is on the treatment of primary and metastatic liver cancers. In the United States, the Melphalan/HDS system is considered a combination drug and device product, and is regulated as a drug by the U.S. Food and Drug Administration (FDA). The FDA has not approved the sale or use of the Melphalan/HDS system. In Europe, Delcath has received approvals for their proprietary system to deliver and filter melphalan hydrochloride. This system, or device, is marketed under the trade name Delcath Hepatic CHEMOSAT® Delivery System for Melphalan (CHEMOSAT).

The financials of Delcath Systems, Inc. (NASDAQ:DCTH) are not a shareholder’s dream. While Delcath has had increasing revenues every year since 2013, they have yet to turn a profit. In 2013 the net income loss was $30.3 million and in 2016 that loss shrank to a loss of $17.9 million. Delcath Systems, Inc. (NASDAQ:DCTH) has a 52-week high/low difference that stands out. Itts 52-week low is a single penny, $0.01. Its 52-week high is $6.49.

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 $DCTH and receive breaking news on other hot stocks by signing up for our free newsletter!

About the author: Steve Clark is a 23-year Wall St professional with stints in M&A, risk management, and algorithm trading. Steve keeps his head in the game by looking for, and writing about, small companies that often get overlooked by the big investment firms.