Monica Gray

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.

ITUS Corp (NASDAQ:ITUS) Licenses CAR-T Technology

ITUS Corp (NASDAQ:ITUS)

ITUS Corp (NASDAQ:ITUS) traded higher after providing an update on its new cancer detection system, Cchek, and a new CAR-T initiative for ovarian cancer. The stock was up by 6.21% to cap an impressive week that saw the stock rally by more than 40%.

ITUS Corp (NASDAQ:ITUS)
One month ITUS stock price chart

Investors Reaction

However, ITUS shares are still down by more than 50% for the year after coming under immense selling pressure. It is currently trading in a $1.92- $2.35 trading range awaiting to see if the current bullish momentum will push the stock above the $2.35 mark – the next resistance level.

Renewed investor interest follows the announcement that Cchek can detect up to 15 types of cancers. The U. S Patent and Trademark Office (USPTO) has already granted the company a patent for the technology developed by Anixa Diagnostics Corporation, a wholly-owned subsidiary.

“We continue to make progress in our R&D efforts as we work with our partners, MD Anderson, U. Pennsylvania’s Abramson Cancer Center, Delaware Valley Urology, Virtua Hospitals, and others. Cchek™, which has demonstrated 91% sensitivity and specificity in a preliminary study, continues to perform at that level or better,” said CEO, Amit Kumar.

ITUS Corp (NASDAQ:ITUS) is currently conducting studies with a number of collaborators as it seeks to expand the indications of the cancer detection technology. The ongoing studies seek to determine whether the technology can be used as a monitoring therapy as well as for evaluating patient response to various immuno-oncology drugs.

CAR-T Initiative

In addition to helping in the detection of cancer, ITUS Corp (NASDAQ:ITUS) is expanding its footprint into the business of fighting cancer. The company has signed an exclusive agreement with the Wistar Institute for the licensing of the company’s Chimeric Antigen Receptor T-cell CAR-T.

The CAR-T technology paves way for ITUS Corp (NASDAQ:ITUS) to flex its muscle on the development of treatments for ovarian cancer as well as Prostate, Pancreatic among other cancers.

“In addition to our ongoing discussions with The Wistar Institute, we are concurrently negotiating with one of the country’s top cancer centers to further develop the technology, aiming to complete the studies necessary to submit to the US FDA, enabling human testing on ovarian cancer patients,” stated Dr. Kumar.

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.

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) Explodes On FDA Validation

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX)

Shares of Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) jumped 56.4% after the biopharmaceutical company said it will advance its lead investigational drug Coversin on advice from the U.S. Food and Drug and Administration (FDA). The company plans to commence Phase 3 studies of the novel treatment for Paroxysmal Nocturnal Hemoglobinuria in the first quarter of 2018.

AKTX Stock Performance

Positive feedback from the FDA is one of the reasons the stock spiked higher as it shows the agency remains confident about the drug’s prospects. Thursday’s rally saw the stock close above a key support level, providing support to a bullish momentum that began last month.

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) has traded in a downtrend since reaching highs of $22 a share in April. However, AKTX shares appear to be picking up after plunging to multi-year lows of $3 a share.

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX)
One month AKTX stock price chart

Coversin Prospects

Coversin has already attained Fast Track status in the U.S. – a designation that allows it to enjoy expedited regulatory review. PNH, for which the candidate drug is indicated, is a rare, life-threatening disease of the blood characterized by the destruction of red blood cells and blood clots. The condition affects 1 to 1.5 persons per million people – mostly young adults.

Phase 3 studies of Coversin will target naïve PNH patients that have not used eculizumab as a standard care. Primary endpoints will be based on hemoglobin and transfusion data

“Akari continues to build momentum in its complement focused therapy by advancing Coversin towards Phase III in PNH and Phase II in has. With Coversin delivered subcutaneously, patients may have greater independence due to self-administration,” said Dr. David Horn Solomon, Chief Executive Officer of Akari Therapeutics PLC (ADR) (NASDAQ:AKTX).

Class Action Lawsuit

Separately, Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) is still the subject a class action lawsuit over claims it provided misleading statements between March 30, 2017 and May 11, 2017. According to law firm Khang & Khang LLP, former Chief Executive Officer, Dr. Gur Roshwalb, and other executives published incorrect information about the Phase 2 trial of Coversin. The law firm alleges that the company’s action resulted in the stock price losing a significant amount of value which harmed investors.

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 $AKTX 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.

PhaseRx Inc. (NASDAQ:PZRX)

PhaseRx Inc. (NASDAQ:PZRX) Spikes 66% On Orphan Drug Designation

PhaseRx Inc. (NASDAQ:PZRX)

PhaseRx Inc. (NASDAQ:PZRX) shares jumped 66.45% after the U.S. Food and Drug Administration (FDA) granted an Orphan Drug Designation for its treatment of argininosuccinate lyase deficiency (ASLD), PRX-ASL. According to Chief Executive Officer, Robert W. Overell, the designation represents an important milestone in the development of the company’s second therapeutic candidate.

Stock Performance

The Orphan Drug Designation helped reverse a strong downtrend that had plagued the stock since May. The stock has since risen above the $1.20 mark, a key resistance level. It awaits to be seen if the close above the $1.20 mark will help fuel a run to $1.90, which acts as another resistance level.

One month PZRX stock price chart

PhaseRx Inc. (NASDAQ:PZRX) Surges 66.45% is a biopharmaceutical company specializing in the development of mRNA products targeting life-threatening inherited liver disease in children. PRX-ASL is the company’s candidate drug for ASLD, a rare liver disorder caused by a single-gene deficiency that most of the time results in elevated ammonia in the blood.

PhaseRx’s PRX-ASL is a replacement therapy designed to replace missing or defective enzyme in patients with ASLD. Clinical trials have shown that the candidate drug can reduce compounds that form the hallmark of ASLD including Plasma and blood ammonia.

“PRX-ASL is our second drug to show preclinical proof of concept using our Hybrid mRNA Technology. Like our lead candidate PRX-OTC, we believe PRX-ASL also has the potential to correct the disease in children, a population that could particularly benefit from treatment for this rare disease,” said Mr. Overell.

Orphan Drug Designation Synergies

The Orphan Drug Designation is an important milestone because PhaseRx Inc. (NASDAQ:PZRX) will now be able to get assistance in clinical studies as well as design and drug development from the FDA. The company could also receive tax credits for clinical trial costs as well as exemptions from certain FDA applications.

Seven years of market exclusivity upon regulatory approval is another benefit that the company stands to enjoy. The European Medicine Agency has also granted Orphan Drug Designation for the novel treatment.

Separately, PhaseRx Inc. (NASDAQ:PZRX) posted a net loss of (-$3.5) million for Q2 2017 – less than half the net loss of (-$11.1) million the company reported a year ago. Operating expenses in the quarter totaled $3.3 million, down from $9.8 million reported in Q2 2016. The biopharmaceutical company exited the quarter with cash and cash equivalent of $8.4 million.

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.

HTG Molecular Diagnostics Inc. (NASDAQ:HTGM)

HTG Molecular Diagnostics Inc. (NASDAQ:HTGM) Jumps 5% On Patents

HTG Molecular Diagnostics Inc. (NASDAQ:HTGM)

HTG Molecular Diagnostics Inc. (NASDAQ:HTGM) shares jumped 5.98% after the United States Patent Office (USPTO) granted it two new patents.

HTG Molecular Diagnostics Inc. (NASDAQ:HTGM) shares jumped 5.98% after the United States Patent Office (USPTO) granted it two new patents.
One month HTGM stock price chart

HTG’s Two Patents

The first patent, Molecular Malignancy in Melanocytic Lesions, details a new method for treating indeterminate or typical nevi by measuring nucleic acid expression of biomarkers.

The second patent dubbed Nuclease Protection Methods for Detection of Nucleotide Variants details a Nuclease protection based method for targeted detection of single nucleotide variants.

“The newly issued patents substantiate the proprietary nature of our business and represent an important step in protecting our technology and its applications. As we grow, we will continue to pursue additional protection around our instrument portfolio and our testing methods,” said CEO TJ Johnson.

News of the new patent did little to reverse a strong downtrend that has engulfed the stock since early April. The stock is already down by more 60% from its April highs as it continues to trade at levels last seen at the beginning of the year. The stock faces immediate resistance at the $2 a share level above which it could make a push for the $4 a share mark, which acts as another resistance level.

A net loss of (-$5.5) million for the second quarter fueled a selling wave on the stock. The molecular diagnostics company reported revenues of $1.8 million. Customer revenue accounted for $1.4 million of the total revenue as consumable revenue came in at $4 million. HTG Molecular Diagnostics Inc. (NASDAQ:HTGM) expects its full-year revenue to range between $9 million and $12 million.

According to the Chief Executive Officer, the second quarter performance underscored the expansion of the company’s diagnostic pipeline. HTG Molecular Diagnostics Inc. (NASDAQ:HTGM) has three clinical development programs including two with Qiagen.

HTG EdgeSeq AKKPlus ASSAy

Separately HTG Molecular diagnostics is in the process of filing the fourth and final module related to the premarket approval application for HTG EdgeSeq AKKPlus ASSAy. The in vitro diagnostic is designed it measure and analyze mRNA gene rearrangements.

The U.S. Food and Drug Administration (FDA) has already completed a review of two of the three submitted modules. HTG Molecular Diagnostics Inc. (NASDAQ:HTGM) plans to carry out a method comparison study whose data is to be used to support the fourth and final module.

“Importantly, we believe our commercialization efforts with the HTG EdgeSeq ALKPlus Assay EU, our CE/IVD marked product in Europe, are going well, and we intend to launch the HTG EdgeSeq ALKPlus Assay in the U.S. once we receive PMA approval,” said Mr. Johnson.

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 $HTGM 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.

Neos Therapeutics Inc. (NASDAQ:NEOS) Trades Lower after FDA Approval

Neos Therapeutics Inc. (NASDAQ:NEOS)

Neos Therapeutics Inc. (NASDAQ:NEOS) shares fell 3.45% a day after the U.S. Food and Drug Administration (FDA) approved its treatment for Attention Deficit Hyperactivity Disorder, Adzenys. The approval brings the number of the company’s ADHD products approved in the past three years to three.

NEOS Stock Performance

Tuesday’s sell-off threatened to bring to an end a bullish that began last month. The stock has struggled to close above the $9 a share mark on two attempts. However, it is still up by more than 20% for the year, compared to the industry average of 2.9%.

Neos Therapeutics Inc. (NASDAQ:NEOS)
One month NEOS stock price chart

It awaits to be seen if investors will continue to push the stock higher in the wake of the FDA milestone. The FDA approval unlocks yet another treatment option for people struggling with Attention Deficit Disorder in addition to strengthening the company’s ADHD portfolio.

“Neos Therapeutics Inc. (NASDAQ:NEOS) has now successfully gained FDA approval of three ADHD products in just two years. We are very proud of this accomplishment and believe it speaks to the strength of our technology platform. Our commitment to ADHD and addressing the individual needs of patients is clear, and we look forward to the commercial launch of this product in early 2018,” said Vipin K. Garg, Ph.D.

ADHD Treatment Push

Adzenys is a once-daily extended release liquid medication that does not require refrigeration to reconstitute at the pharmacy level. It utilizes the same principle as Adzenys XR-ODT that allows healthcare providers to transition patients from liquid to ODT formulations.

Just like Adzenys XR-ODT, the newly approved drug is designed to stimulate the central nervous system of patients six years and older. Neos Therapeutics Inc. (NASDAQ:NEOS) plans to launch the drug in the first half of the year. Adzenys XR-ODT generated sales of $7.3 million in the first half of the year representing a 35.5% year-over-year growth.

While ADHD is one of the largest and fastest growing business segments, it continues to attract a number of companies, gunning for market share with novel treatments. Johnson & Johnson (NYSE:JNJ) is pushing for market share with its Concerti treatments and so is Pfizer Inc. (NYSE:PFE) with PFE Quilivant.

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.

Dimension Therapeutics Inc. (NASDAQ:DMTX) Up 40% on $138 Mln Acquisition

Dimension Therapeutics Inc. (NASDAQ:DMTX)

Shares of Dimension Therapeutics Inc. (NASDAQ:DMTX) rallied 40.48% after Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) proposed to buy all its outstanding shares for $5.50 a share. The acquisition bid values the company at $138 million, representing a 358% premium to the stock’s share price as of August 24, 2017.

Dimension Therapeutics Inc. (NASDAQ:DMTX)
One month DMTX stock price chart

Bidding war

The bid comes just days after Dimension Therapeutics announced it had received an acquisition bid from Regenxbio Inc. (NASDAQ:RGNX) of about $3.41 a share. Ultragenyx is hoping that its improved offer, which guarantees more shareholder value, will sway Dimension Therapeutics Inc. (NASDAQ:DMTX) management and shareholders to agree to a merger.

Dimension Therapeutics has been trading in an uptrend ever since it emerged it was an acquisition target. Regenxbio bid helped push the stock from lows of $1.50 a share to highs of $4 a share. The stock has since risen above the $4.50 a share mark which had acted as a key resistance level. The stock is currently trading in a $5.35 – $5.90 trading range as it closes in on its 52-week high of $9.98 a share.

Ultragenyx Takeover Plan

Ultargenyx’s Board of Directors has already approved the proposed $138 million takeover as it awaits a response from Dimension Therapeutics Inc. (NASDAQ:DMTX). The Company plans to finance the transaction with cash resources from its balance sheet and expects the transaction to close over the next 25 business days.

According to Ultargenyx CEO, Emil Kakkis the merger would not face any regulatory scrutiny given that the two companies products are highly complementary and don’t overlap.

“This transaction provides a compelling opportunity to create value by leveraging Ultragenyx’s advanced clinical and regulatory expertise, as well as its rare metabolic disease commercial infrastructure to advance Dimension’s rare disease-focused gene therapies and bring much-needed new treatments to market,” said Mr. Kakkis.

Ultargenyx’s CEO says they are pushing for a merger because the two companies share a vision of coming up with therapies for unmet medical conditions. The two companies also boast of a strong track record of advancing rare disease candidate drugs through clinical and regulatory processes.

Ultargenyx vision with the acquisition bid is to help accelerate the development of Dimension Therapeutics Inc. (NASDAQ:DMTX) gene therapies by leveraging its clinical and regulatory experience. The company also intends to form a gene therapy development and manufacturing unit.

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 $DMTX 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.

Microbot Medical Inc (NASDAQ:MBOT)

Microbot Medical Inc (NASDAQ:MBOT) Gets Indian Patent For TipCAT Platform

Microbot Medical Inc (NASDAQ:MBOT)

Microbot Medical Inc (NASDAQ:MBOT) has been granted a patent in India for its TipCAT technology platform. The technology is used in a semi-disposable endoscope which is flexible, self-propelled, and used to provide see-and-treat capabilities in the body’s tubular lumens. This includes the urinary tract, blood vessels, and the colon.

“As a pioneer in micro-robotic surgery, this will allow us to add value to our assets as it is expected to enhance our ability to access global markets and create additional competitive advantages and barriers to entry,” said Harel Gadot, the chairman, president and chief executive officer of Microbot Medical Inc (NASDAQ:MBOT), after the firm was granted patent number 286765 in India.

Microbot Medical Inc (NASDAQ:MBOT)
One month MBOT stock price chart

Locomotion mechanism

The locomotion mechanism of the TipCAT platform allows endoscopes to crawl and navigate through both artificial and natural tubular lumens. Minimal pressure is applied in order to realize the level of friction necessary for movements within the body.

India is not the only big market that Microbot Medical Inc (NASDAQ:MBOT) has been granted a patent in for its TipCAT technology platform. Other countries include Europe, China, and the United States – as well as several other markets. The medical device manufacturer intends to use its TipCAT platform technology in developing multiple products which address various unmet needs in diverse medical applications.

ViRob technology platform

Currently Microbot Medical Inc (NASDAQ:MBOT)’s patent portfolio has reached 23 while there are another 13 patent pending applications across the globe. The patent that has been issued in India also covers the ViRob technology platform. While the TipCAT technology platform is self-propelled, the ViRob technology platform is autonomous. This microbot can crawl inside the body while it is being remotely controlled.

Due to its small size, it is capable of navigating and in the respiratory system, the digestive tract, and blood vessels. The microbot is also safely able to remain for prolonged lengths of time inside the human body.

With the TipCAT and ViRob platforms, Microbot Medical Inc (NASDAQ:MBOT), which was started seven years ago and which only listed on the NASDAQ last year in November, is looking to develop two product candidates. One of them is Normal Pressure Hydrocephalus, an endoscope, and a Self Cleaning Shunt.

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 $MBOT 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.

Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) Unveils Robust Drug Platform

Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR)

Shares of Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) skyrocketed more than 18% after the company announced a new drug development platform alongside a slew of drug candidates. Arrowhead is a clinical-stage pharmaceutical company. The company previously called itself Arrowhead Research Corporation.

The shares rose settled at $3.30 after hitting a high of $3.43 and a low of $2.75. The gain pushed Arrowhead’s market cap to $246.8 million. Over the past year, the stock has rallied between a high of $8.09 and a low of $1.20.

Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR)
One month ARWR stock price chart

Arrowhead unveils TRiM platform

Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) announced on Thursday that it had developed what it suggested to be a more robust drug development platform. The new drug development platform is called Targeted RNAi Molecule, or simply TRiM platform.

The TRiM platform could be a game-changer for Arrowhead in its drug development efforts. According to the company, TRiM platform brings with it simplified manufacturing processes. As such, TRiM platform is also billed as a lower-cost drug development platform.

Additionally, TRiM platform supports faster development time, multiple drug-delivery options and the potential to diversify drug development. Furthermore, the TRiM platform promises wide safety margins in the drug development process.

Arrowhead introduces several drug candidates

Alongside unveiling TRiM platform, Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) announced several drug candidates it had developed using the new platform. The candidates include ARO-HBV, which is being developed as treatment for chronic hepatitis B infection; ARO-AAT, which is being developed to tackle alpha-1 antitrypsin deficiency liver disease; and then ARO-APOC3 and ARO-ANG3, both targeting hypertriglyceridemia.

With TRiM platform, Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) seems to have moved several steps closer to its goal of bringing a new drug product to market. Arrowhead CEO Chris Anzalone noted that the TRiM platform will open up opportunities to target diseases beyond what was possible with RNAi therapeutics.

Inside the financials

Arrowhead Pharmaceuticals Inc (NASDAQ:ARWR) reported revenue of $9.3 million for its fiscal Q32017 and had cash and short-term investments amounting to $75.1 million at the end of the quarter. The company’s operating expenses were $15.1 million in the last quarter, down from $19.4 million in a similar quarter last year.

Research and development (R&D) is one of the largest pieces of Arrowhead’s expenses. R&D spending in the latest quarter was $6.91 million, down slightly from $6.98 million a year earlier.

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 $ARWR 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.

Atossa Genetics Inc. (NASDAQ:ATOS) Reports Topline Trial Results

Atossa Genetics Inc. (NASDAQ:ATOS)

Atossa Genetics Inc. (NASDAQ:ATOS) slumped 11.95% after announcing preliminary results from a Phase 1 study of its novel treatment for  breast cancer, Endoxifen.  Thursday’s sell-off came as a surprise given that it came after positive news. The stock has also been on an impressive run since the start of the month.

The stock is currently trading in a $0.54 – $0.93 trading range after gapping lower in March. It faces immediate resistance at the $1.00 a share mark above which it could rise to the $1.50.

Atossa Genetics Inc. (NASDAQ:ATOS)
One month ATOS stock price chart

Endoxifen Phase 1 Results

The clinical stage pharmaceutical company says its novel treatment for breast cancer, Endoxifen, was well tolerated at all dose levels, during the phase 1 trial. The treatment tropical formulation did not trigger any significant safety signals or adverse events. The top line results thus demonstrated its suitability for further clinical development.

“Based on these positive preliminary results, we are advancing our topical Endoxifen into Phase 2 studies,” commented Dr. Steven C. Quay, CEO, and President.  “We look forward to announcing the results from the oral arm of our Phase 1 study in the coming 30 to 60 days,” continued Dr. Quay.

Atossa Genetics Inc. (NASDAQ:ATOS) Endoxifen is an active metabolite of Tamoxifen, which is an FDA approved drug for preventing breast cancer. According to the company a topical formulation of the drug could help combat breast density, which is an independent breast cancer risk.

Endoxifen Edge

Tamoxifen has, to date, been used to prevent new and recurrent forms of breast cancers. However, its benefits-cost ratio has always raised concerns. Only 2% of women at a high risk of developing breast cancer currently use the formulation. The risk or actual side effects associated with the treatment has always been a big concern for patients and physicians.

Taking into consideration the number of women who are at a high risk of developing breast cancer, Atossa Genetics Inc. (NASDAQ:ATOS) could generate up to $1 billion in sales on the approval of its topical formulation Endoxifen.

Separately, Atossa Genetics Inc. (NASDAQ:ATOS) did not generate any revenue for the three and six months ended June 30, 2017. Total operating expenses for the three and six months totaled $1.9 million and $3.6 million respectively. During the quarter, the company completed a capital raise of $4.4 million to be use d on the clinical development of Endoxifen development as well as for working capital purposes.

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 $ATOS 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.

Marinus Pharmaceuticals Inc. (NASDAQ:MRNS)

Marinus Pharmaceuticals Inc. (NASDAQ:MRNS) Gains After Epilepsy Study

Marinus Pharmaceuticals Inc. (NASDAQ:MRNS)

Marinus Pharmaceuticals Inc. (NASDAQ:MRNS) shares rallied 2.56% after the clinical stage biopharmaceutical company announced plans to carry  out a public offering of shares of its common stock. The company intends to use net proceeds from the offering to advance the development of its treatment for rare genetic pediatric epilepsy and for working capital purposes.

Epilepsy Study Big Win

Renewed investor interest on the stock comes on the company reporting top line results in a Phase II study of ganaxolone for the treatment of the CDKL5 disorder. The stock is currently trading in an uptrend after gapping higher from $3.20 a share to highs of $5.40 a share on the positive trial results.

Marinus Pharmaceuticals Inc. (NASDAQ:MRNS)
One month MRNS stock price chart

CDKL5 is a severe, rare genetic epilepsy that results in treatment refractory-seizures, pervasive Neuro-developmental delay and disabling behavioral issues. Phase 2 trial results indicate that ganaxolone resulted in sizable and durable seizure frequency reduction. Some of the patients also achieved an increase in the number of seizure-free days with some enjoying behavioral benefits. Ganaxolone met its primary endpoints by achieving a median decrease of 43% in 28-day seizure frequency in addition to demonstrating a 73% increase in seizure-free days.

“The durable anti-epileptic effect seen in several children distinguishes ganaxolone efficacy from the more than 20 currently available anti-epileptic drugs that provide limited seizure control lasting a few weeks to months,” said Orrin Devinsky, MD, Director of the NYU Langone Medical Center.

Regulatory Approval Push

Ganaxolone was well tolerated with no serious adverse events reported during the trials. Marinus Pharmaceuticals Inc. (NASDAQ:MRNS) plans to meet with regulatory agencies to discuss a clinical development plan that would form the basis ganaxolone approval as a novel treatment for the CDKL5 disorder.

Ganaxolone has already received an orphan drug designation from the Food and Drug Administration for the treatment of CDKL5 in adult patients. Currently, there are no approved or effective treatment options for the condition.

Separately, Marinus Pharmaceuticals Inc. (NASDAQ:MRNS) reported a net loss of (-$4.6) million or 21 cents a share for the second quarter ended June 30, 2017. Research and development expenses decreased to $2.8 million from $4.4 million, attributed to the discontinuation of the drug resistant focal onset seizure program.  The company exited the quarter with cash and cash equivalent of $2.3 million which is adequate to finance operations into the fourth quarter of 2018.

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 $MRNS 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.