Fireworks Continue for Viking Therapeutics Inc (NASDAQ:VKTX)

Viking Therapeutics Inc (NASDAQ:VKTX)

Viking Therapeutics Inc (NASDAQ:VKTX) shares continued their strong upward trajectory today as the biotechnology firm’s stock rose over 25% in today’s trading to end the day at $2.60. Volume was heavy, almost ten times their normal daily average. The gains came in two waves, one right from the moment the market opened, and another buying wave began one hour before the market close.

A 2-day chart:

Viking Therapeutics Inc (NASDAQ:VKTX)

Viking Therapeutics Recent Developments

Viking Therapeutics Inc (NASDAQ:VKTX) is a clinical-stage biopharmaceutical company focused on the development of therapies for metabolic and endocrine disorders. On October 4, 2017 VKTX shares jumped almost 9% when the company announced positive top-line results from a 25-week proof-of-concept study of VK0214 in an in vivo model of X-linked adrenoleukodystrophy (X-ALD). X-ALD is a rare and often fatal metabolic disorder characterized by a breakdown in the protective barriers surrounding brain and nerve cells. X-ALD is estimated to occur in approximately 1 in 17,000 births. The results showed that 25 weeks of treatment with VK0214 led to robust effects on multiple very long chain fatty acids.

VKTX Stock

Performance for shares of Viking Therapeutics Inc (NASDAQ:VKTX) has been strong despite the lack of any sales – though that is not unusual for a clinical-stage biotechnology firm. Over the past year shares have risen over 126% and are up 134% for the past quarter. Today’s spike eclipsed the previous 52-week high of $2.44. In 2015 the company posted a per share loss of (-$3.68) but that shrank to a per share loss of (-$0.91) in 2016. However it should be noted that in 2016 the company diluted shareholder value. In 2015 there were 6.36 million shares outstanding and then in 2016 that number grew to 16.28 million.

Viking Therapeutics Inc (NASDAQ:VKTX) is covered by two analysts. Both rate VKTX shares as a “Strong Buy”.

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.

Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) Receives FDA Protocol Guidance

Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN)

Shares of Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) gained 20.5% after the clinical stage biotechnology company received a final protocol guidance from the U.S. Food and Drugs Administration (FDA) for its lead compound Trans sodium crocetinate (TSC). The company is a preparing for Phase 3 trials of the compound in patients newly diagnosed with inoperable Glioblastoma multiforme, a type of brain cancer.

Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN)

DFFN Stock Investor’s Reaction

The stock spiked by 35% as investors reacted to the favorable FDA ruling. However, the stock continues to trade in a downtrend after coming under pressure for the better part of the year. Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) is down by more than 50% for the year.

Renewed investor interest comes on reports that the company responded to all outstanding points raised by the FDA on protocols for a protracted Phase 3 trial. The trial will compare the survival rates at two years for both the patients receiving the Trans sodium crocetinate and patients receiving chemotherapy and radiation as part of standard care.

“This Phase 3 study will focus on treating newly diagnosed GBM patients who have been judged by their medical team to be inoperable because of the size or location of the tumor. In Diffusion’s Phase 2 proof-of-concept trial, the inoperable GBM patients who were treated with TSC plus standard of care showed a nearly four-fold increase in survival at two years compared with standard of care patients only,” said CEO David Kelergis.

TSC Phase 3 Trial

Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) has already contracted a research organization to oversee to oversee the Phase 3 TSC trial as per the FDA standards. The company plans to carry out the trials in about 100 sites spread across the U.S. and Europe. Patient enrollment should begin before the end of the year.

Phase ½ clinical trial of TSC showed a 380% increase in survival rates at two years in inoperable patients. Trial results also indicate that 71% of the people treated by TSC were alive at one year compared to 61% of the people on historical group control.

A major difference between Phase ½ and Phase 3 will be the inclusion of TSC during Chemotherapy. In Phase ½, it was administered prior to radiation.

Glioblastoma is the most aggressive among known tumors and usually leads to death in one or two years. Standard care treatment consists of surgery to resect the tumor.

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.

Ampio Pharmaceuticals Inc. (NYSEAMERICAN:AMPE) Drops After Pricing

Ampio Pharmaceuticals Inc. (NYSEAMERICAN:AMPE)

Ampio Pharmaceuticals Inc. (NYSEAMERICAN:AMPE) shares fell 13.36% after the development stage biopharmaceutical company announced it had entered into a securities purchase agreement with certain investors. Pursuant to the agreement, the company has agreed to sell approximately $6.75 million worth of shares at a price of $0.875 a share.

AMPE Stock Investor Reaction

The offering will to close on or about October 18, 2017. Ampio Pharmaceuticals Inc. (NYSEAMERICAN:AMPE) plans to use the net proceeds for working capital and general corporate purposes. Proceeds will also to be used for to fund the Ampion clinical trial.

The share offering appears to have spooked investors. The stock had been on an impressive run for the last month. Over the past month, AMPE is up by more than 100% as it continues its recovery from multi-year lows of $0.42 a share. However, the stock has underperformed the overall industry and is down by more than 10% compared to its January levels.

Ampion Clinical trials

Separately, Ampio Pharmaceuticals Inc. (NYSEAMERICAN:AMPE) has completed enrollment and dosing of patients as part of a 12-week pivotal study of Ampion on patients with severe osteoarthritis of the knee (OAK). The primary endpoint of the study follows the Osteoarthritis Research Society International guidance.

“Announcing the close of enrollment so quickly speaks to the unmet medical need. We have found Ampion™ to be both safe and effective in the clinical development of over 1900 patients, many of whom have no other alternative treatment options,” said CEO Michael Macaluso.

Ampion is currently in late-stage study for the treatment of signs and symptoms of OAK. A recent randomized placebo-controlled trial focused on a subset of patients with severe OAK. The study examined the safety and efficacy of an intra-articular injection of Ampion compared to Saline.

Trial results indicate that a single injection of Ampion was well tolerated across all trials with patients showing significant response compared to saline.

Ampio Pharmaceuticals Inc. (NYSEAMERICAN:AMPE) remains confident that the U.S. Food and Drug Administration (FDA) will approve Ampion as a reference product. If achieved, that will grant it 12 years of exclusivity. Ampio already has patent coverage in major jurisdictions of the likes of Europe, Brazil, Australia and Canada.

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.

Directionless Akers Biosciences Inc (NASDAQ:AKER)

Akers Biosciences Inc (NASDAQ:AKER)

Akers Biosciences Inc (NASDAQ:AKER) stock is unchanged in the after-hours market after dropping over 15% today on heavy volume. No news was released that might account for the price drop. However AKER shares had been trending down or sideways since early April. The biotech firm hit its 52-week low of $0.70 in early October before jumping above $1.75 last week. Two days of losses followed that large move upwards.

Akers Biosciences Inc (NASDAQ:AKER)

About Akers Biosciences

West Deptford, NJ-based Akers Biosciences Inc (NASDAQ:AKER) was founded in 1989. The company develops in vitro diagnostic technologies that allow clinicians, and in some cases consumers, more quickly obtain health information. Their proprietary tests and sample preparation devices provide the same level of accuracy as traditional laboratory testing methods, but at a fraction of the cost and turn-around time. The company offers a alcohol breath detector, a breath ketone device for weight loss, and a device to measure oxidative stress among others.

In March Akers shares jumped when First Check Diagnostics, LLC placed an order with Akers Biosciences Inc (NASDAQ:AKER) for its cholesterol self-test. First Check Diagnostics LLC owns the First Check brand. Its products are distributed through such well-known stores such as CVS, Rite Aid, Target, and Kmart.

AKER Stock Review

Although AKER shares have a target price of $4, the shares have spent a considerable amount of time below $1 which is a threshold compliance level for the NASDAQ Market. A prolonged absence from a pricing above $1 may force the NASDAQ to issue a warning notice, and if unaddressed, a potential delisting. Akers Biosciences Inc (NASDAQ:AKER) stock has a 52-week high of $3.60 which was reached in late 2017. The 52-week low of $0.70 was hit in late September.

Sales and earnings have been inconsistent over the years. The company posted sales of just $1.6 million in 2012 and in 2014 hit a high of $4.4 million. However last year Akers posted a sales figure of only $3 million. Similarly, per share losses have been a regular event but there has been no trend that could provide investors with more confidence on the stock’s direction. In 2012, there was a per share loss of (-$2.24). That was followed by two years of lower losses but then in 2015 the loss expanded to (-$1.81), but then shrank to (-$0.61) for 2016. Unfortunately, the trend in the number of outstanding shares has been clear. In 2012 there were 1.14 million outstanding shares. That number has increased, and diluted shareholder value, every year. By 2016 the number of outstanding shares was posted at 5.43 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.

Don’t miss out! Stay informed on $AKER 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.

Orexigen Therapeutics, Inc. (NASDAQ:OREX) Shares Drop after Court Win

Orexigen Therapeutics, Inc. (NASDAQ:OREX)

Curiously, Orexigen Therapeutics, Inc. (NASDAQ:OREX) traded lower after a United States District Court issued a favorable ruling in a patent litigation case involving three patents for its obesity drug Contrave. Shares of the company fell 3.43% in Friday’s trading session to end the week at $1.97 a share.

Orexigen Therapeutics, Inc. (NASDAQ:OREX)

Orexigen Sell-Off

Friday’s sell-off strengthened a bearish tone that has seen the stock drop from $5.20 a share in February to current trading levels. While the stock is down by more than 60%, it is still above January’s trading levels.

Investor confidence has taken a hit following the termination of a collaboration agreement with Takeda. The agreement was for the commercialization of Orexigen’s obesity drug Contrave. The termination initially resulted in an increase in sales leading to net revenue increase, per unit, of 37%.

However, the increase was later offset by costs for commercialization of the drug. Orexigen Therapeutics, Inc. (NASDAQ:OREX) has sought to change the situation by taking several steps to drive Contrave sales, in a bid to offset the costs. The company has already initiated speaker programs, as well as patient starter kits and promotional materials.

Orexigen Therapeutics, Inc. (NASDAQ:OREX) faces an uphill task to boost its prospects in the already crowded obesity market. A variety of options exist from the likes of Vivus Inc., Novo Nordis,k and Arena Pharmaceuticals..

Contrave Patent Protection

The company is to provide a business update at the 2017 BIO investor forum on October 17, 2017. The Chief Executive Officer has already pointed out that the company is on a path to profitability by 2019. The executive made the remarks after the District Court extended the exclusivity of the company’s lead obesity drug through 2030.

Orexigen Therapeutics, Inc. (NASDAQ:OREX) has successfully defended its lead product, Contrave from Actavis which was planning to launch a generic version prior to the expiration of U.S Patents.

“Orexigen’s intent was to vigorously defend our intellectual property and we are very pleased with the Court’s decision upholding the validity of all of the patents involved in the case,” said Michael Narachi, President, and CEO of Orexigen. “The Court’s positive decision allows Orexigen to continue to fulfill its mission to provide innovative medicine to treat patients who are overweight or struggling with obesity.

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 $OREX Symbol 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.

Zosano Pharma Corp (NASDAQ:ZSAN) Spikes On Migraine Data

Zosano Pharma Corp (NASDAQ:ZSAN) Spikes On Migraine Data

Zosano Pharma Corp (NASDAQ:ZSAN) traded higher after announcing the publication of positive pivotal data for its proprietary Adhesive Dermally-Applied Microarray technology. The stock was up by 5.6% in Thursday’s trading session, to end the day at $1.13 a share.

ZSAN Stock Performance

Shares of Zosano Pharma Corp (NASDAQ:ZSAN) are currently trading in a downtrend, after dropping from $3.50 a share in February. While the stock is slightly up for the year, it has underperformed the overall industry. Data compiled by Zacks Investment Research indicates that the stock is rated as a ‘buy,’ by one analyst firm and as a ‘hold’ by another.

Zosano Pharma Corp (NASDAQ:ZSAN)

Zosano Pharma Corp (NASDAQ:ZSAN) is a clinical-stage biopharmaceutical company focused on providing rapid systemic administration of therapeutics to patients using its ADAM technology. The investigational technology platform is designed to offer rapid drug absorption into the bloodstream resulting in improved pharmacokinetic profile compared to other dosage forms.

A publication by Cephalalgia contains positive results from Zosano Pharma Corp (NASDAQ:ZSAN)’s Zotrip Pivotal study. The multicenter, double-blind randomized trial analyzed the safety and efficacy of ADAM Zolmitriptan for the treatment of acute migraine.

“We are pleased to have the results of ZOTRIP, our pivotal study, published in Cephalalgia. The recognition of the results from ZOTRIP in such a well-known journal will continue to raise awareness of M207, and its ability to address an unmet need for patients struggling to find rapid and durable pain relief for migraine episodes,” said CEO John P. Walker.

Board Appointment

In addition to the publication, Zosano Pharma Corp (NASDAQ:ZSAN) has confirmed the appointment of Mr. Kenneth R. Greathouse to the board of directors. His experience in the field of neurology will be a key asset in bringing M207 to market.

He joins the company with over 40 years of experience in sales marketing and business development. Greathouse is also a co-founder of various pharmaceutical companies, including Manchester Pharmaceuticals.

“I look forward to working with the management team and Board as our lead program progresses towards an NDA filing and, if approved, towards commercialization,” said Mr. Greathouse.

Zosano Patent Application

Separately, Zosano Pharma Corp (NASDAQ:ZSAN) says it is in active discussions with the U.S Patent and Trademark Office (USPTO), regarding a patent application covering M207. The patent application details a method of rapidly achieving therapeutic concentrations of triptans for the treatment of migraines. If issued, the patent would extend coverage of the current patent from 2027 to 2037.

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 $ZSAN 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.

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) Implodes After FDA Rejection

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) shares fell 59.8% after the U.S. Food and Drug Administration declined to approve its opioid painkiller Dsuvia. The agency raised a number of issues that the company needs to address pending any future consideration.

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)

FDA Recommendation

One of the recommendations requires AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) to collect additional data on at least 50 patients, assessing the safety of DSUVIA at the maximum amount described in the labeling. The company will also have to ensure proper administration of the tablet with the single dose applicator.

The regulator is also demanding changes to the “Directions for Use” instructions that come with the drug, to address issues of tablets that may need to be disposed of.

The FDA decision rattled investors as most of them were expecting the painkiller to achieve regulatory approval. Analysts were optimistic about the drug gaining regulatory approval on its limited abuse potential. The stock consequently suffered its biggest one-day sell-off since it went public in 2011.

AcelRX Defense

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) has sought to quash investor concern and prevent a further slide in the stock price by insisting that the recommendations by the FDA are manageable. In a statement, the company says it will request a meeting with the FDA to discuss topics in the Complete Response Letter.

“We believe the recommendations stated in the CRL are manageable and plan to fully cooperate with the FDA. We remain focused on the NDA resubmission and our mission to provide physicians and patients with precise and efficient non-invasive pain management options for moderate-to-severe acute pain within medically supervised settings,” said CEO Vincent J. Angotti.

The Chef Executive Officer says they have a sufficient cash runway of $67.9 million to complete the Dsuvia marketing application resubmission. The company also plans to make a marketing submission application for its other drug, Zalviso.

Opioid Epidemic

The FDA decision comes at a time when the United States is grappling with a major opioid epidemic. The agency has become cautious in recent years in issuing new approvals on heavy-duty painkillers after more than 33,000 deaths were reported in 2015.

Last month the regulator rejected another opioid painkiller from Intellipharmaceutics as it requested additional data to prove the drug’s ability to prevent abuse.

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 $ACRX 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.

OncoSec Medical Inc. (NASDAQ:ONCS) To Make Key Presentations

OncoSec Medical Inc. (NASDAQ:ONCS)

OncoSec Medical Inc. (NASDAQ:ONCS) shares gained 10.1% after the company said it will present updated clinical data on the study of ImmunoPulse IL-12, its lead oncology program. The biotechnology company will make the presentation at the upcoming 9th World Congress of Melanoma.

OncoSec Medical Inc. (NASDAQ:ONCS)

ImmunoPulse IL-12 Presentations

In addition, OncoSec Medical Inc. (NASDAQ:ONCS) is to present updated clinical data from its Phase 2 Investigator Sponsored trial in patients with unresectable metastatic melanoma. The presentation will occur at the upcoming Society for Immunotherapy of Cancer (“SITC”) 32nd Annual Meeting to be held on November 8-12, 2017,

ImmunoPulse IL-12 is a nonviral gene delivery platform designed to utilize the power of the human immune system to target and attack tumors in the body. It is currently in Phase 2 clinical monotherapy trial, for the treatment of stage three and four melanoma.

A presentation by Dr. Alain Algazi will contrast the candidate drug to its combination with pembrolizumab. The presentation will also include clinical and biomarker data from a recently completed Phase 3 monotherapy trial.

“These data, along with the emerging clinical data from the phase 2 combination study, further support the rationale for our global, open-label, registration-directed phase 2b clinical trial, PISCES/KEYNOTE-695, which we anticipate reporting initial data in mid-2018,” said CEO Punit Dhillon.

 ONCS Stock Performance

Investor confidence on OncoSec Medical Inc. (NASDAQ:ONCS) is slowly building following a string of positive news on the development of the company’s lead oncology program. The stock has bounced back from multi-year lows of below $1 a share and bullish momentum continues to grow in strength.

However, the stock is still down by more than 5% for the year after coming under pressure after rising to $1.50 share. OncoSec Medical Incorporated faces immediate resistance at $1.25 a close above which could see the stock making a push for the $1.50 mark.

OncoSec Medical Inc. (NASDAQ:ONCS) has elicited significant investor interest in the recent past as most of them take note of its robust and differentiated approach in developing cancer treatments. The company is currently merging over two decades of research and development processes to accelerate the development of its lead candidate product.

The company’s flagship product, ImmunoPulse IL-12 has already shown to deliver equal gene transmission rates while maintaining a high safety profile. OncoSec Medical Inc. (NASDAQ:ONCS) is advancing the treatment into Phase 2 trials with projected milestone for treatment approval set for 2019.

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 $ONCS 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.

RXi Pharmaceuticals Corp (NASDAQ:RXII) To Make Presentation

RXi Pharmaceuticals Corp (NASDAQ:RXII)

RXi Pharmaceuticals Corp (NASDAQ:RXII) has announced that its research vice president, Karen Bulock, will make a presentation at this year’s Annual BIO Investor Forum – taking place in San Francisco, California. At the forum, Bulock will talk about the RNAi platform which is self-delivering as well as demonstrate how it can be applied in the treatment of cancer using cell-based immunotherapies.

The expected attendees of the investor conference include the industry executives of various biotech and pharmaceutical companies, research analyst, public investors, and private equity investors. The event will also be webcast.

RXi Pharmaceuticals Corp (NASDAQ:RXII)

September presentations

Last month RXi Pharmaceuticals Corp (NASDAQ:RXII) made a series of presentations at various events. This included a presentation made by the company’s intellectual property and business development director, James Cardia, at the 10th Annual International Partnering Conference which took place in Boston, Massachusetts.

At the event Cardia gave a corporate overview which included the RNA therapeutic platform which is self-delivering. Cardia also talked about the company’s ongoing clinical and research programs especially in the areas of ophthalmology, dermatology and immunotherapy. The event had drawn leaders from various sectors including pharmaceutical, finance and biotech.

Another presentation that was made last month was by the chief development officer of RXi Pharmaceuticals Corp (NASDAQ:RXII), Gerrit Dispersyn. This was at the Ladenburg Thalmann Healthcare Conference which took place in New York City. Dispersyn’s presentation revolved around RNAi which is a self-delivering platform and applicable in various therapeutic areas. His presentation also touched on various RXi programs including ophthalmology, dermatology and immune-oncology.

RXi Executive departure

Last month also saw the RXi’s chief business officer, Alexey Eliseev, leave the company. Eliseev had joined RXi at the beginning of the year after RXi acquired Mirimmune, a privately-held firm which develops therapeutics used in the treatment of cancer.

“The Company would like to thank Dr. Eliseev for his support in integrating MirImmune into our Company’s day-to-day activities, and for providing RXi exposure to some of the key players in this new and exciting space,” RXi Pharmaceuticals Corp (NASDAQ:RXII)’s chief executive officer and president, Dr. Geert Cauwenbergh, said after the departure of Eliseev.

While at RXi the group that was led by Cardia was involved in discovering and optimizing rxRNAs which are self-delivering. Cardia’s group was also responsible for the characterization and development of RXI-109, an anti-fibrotic agent which is currently being tested as a therapy for retinal and dermal scarring.

Following Eliseev’s exit, Cardia took over the business development and partnering responsibilities. Eliseev obtained a chemistry Ph.D from Boston College and received his postdoctoral training at Harvard University.

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 $RXII Symbol 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.

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) Skyrockets 22%

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX)

Shares of Akari Therapeutics PLC (ADR)(NASDAQ:AKTX) skyrocketed over 22%, after the biopharmaceutical company announced further clinical progress in its ongoing Phase 2 Clinical trial of Coversin. The company is investigating the drug candidate for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH).

Patient Enrollment

Three additional patients have been enrolled in the program, bringing the total to eight, in the open-label single-arm clinical trial. The new patients were enrolled pursuant to an amended protocol based on a revised dosing regimen. Only one patient has withdrawn from the COBALT trial so far.

The primary endpoint in the trial is the reduction of serum to less than or equal to 1.8 times the upper limit of normal for investigators reference laboratory. Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) will provide an update in all PNH patients enrolled at the America Society of Hematology Annual Meeting next month.

AKTX Stock Rating

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) is currently rated as a ‘sell’ by one investment firm according to data compiled by Zack Investment Research. The sell rating does not come as a surprise, and the stock has underperformed the overall industry this year.

Akari Therapeutics PLC (ADR)(NASDAQ:AKTX)

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) has shed more than 50% in market value since May after rising to $20 a share. However, the stock is flat for 2017 as it continues to trade at levels last seen in January. The stock received a boost earlier after the biopharmaceutical company said it will move forward with the Phase 3 development of Coversin on the treatment of Paroxysmal Nocturnal Hemoglobinuria.

“Following our recent FDA meeting, we are working to initiate a Phase III clinical trial of Coversin in PNH in Q1 2018,” said Dr. David Horn Solomon, Chief Executive Officer of Akari Therapeutics. “We will continue to work closely with the FDA, benefitting from our Fast Track status in the U.S., and with the EMA towards submission of a BLA and MAA, respectively, for Coversin in PNH.

PNH is a rare life-threatening disease of the blood characterized by destruction of red blood cells, blood clots, and impaired bone marrow function. The condition affects 1 to 1.5 person per 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.

Don’t miss out! Stay informed on $AKTX Symbol 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.