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.

Cesca Therapeutics Inc. (NASDAQ:KOOL) Receives Notice from USPTO

Cesca Therapeutics Inc. (NASDAQ:KOOL)

Shares of Cesca Therapeutics Inc. (NASDAQ:KOOL) gained 33.6% after the U.S Patent and Trademark Office (USPTO) issued a Notice of Allowance for the company’s pending patent application. The patent application covers the company’s proprietary method for separating rare, therapeutically critical target cells from the blood, bone marrow, and other cell sources.

Casca’s Investor Reaction

The company seeks to patent, Buoyancy-Activated Cell Separation (X-BACS). This technology is key to the development of the CAR-TXpress platform. If issued, it will be Cesca second patent in relation to the technology.

The X-BACS technology uses microscopic bubbles to isolate specific cell type from a complex mixture of cells. Cesca Therapeutics Inc. (NASDAQ:KOOL) plans to work with innovative biopharmaceutical companies to enhance the commercial viability of the technology.

Investors reacted to the Notice of Allowance by sending the stock to $6.44. However, by the end of the trading session, it closed at $4.81 per share. The new 52-week high supports the stock bullish run that has been in play since March. KOOL is up by more than 2% for the year.

Cesca Therapeutics Inc. (NASDAQ:KOOL)

“CAR-T represents the future of cancer treatment, yet we believe speed, cost and consistency will likely emerge as significant industry challenges. With the X-BACS technology embedded in CAR-TXpress, manufacturers will be able to improve the yield and consistency of CAR-T cells in less time and at a lower cost,” said CEO Chris Xu.

Cesca’s FY2017 Financials

Separately, the leader of automated cell processing and point-of-care has announced financial results for the fiscal year ending June 30, 2017. Net revenue for the full year totaled $14.5 million compared to $11.9 million reported the prior year. The company attributes the increase to an increase in shipments of AXP disposables, to distributors in China and Europe.

Gross profit for the full year more than doubled to $5.8 million from $2.7 million, due to higher average sales on product mix and reduction of overhead costs. However, Cesca Therapeutics Inc. (NASDAQ:KOOL) posted a wider than expected net loss of ($29.1) million or (-$3.27) a share compared to a net loss of ($18.7) million reported last year.

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.

Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV)

Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV) NDA Application

Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV)

Shares of Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV) fell 10.7% after the innovative biopharmaceutical announced that the U.S. Food and Drug Administration (FDA) had accepted its New Drug Application (NDA) for KIT-302, for a full review.  According to Chief Medical Officer, Paul Waymack, acceptance of the filling marked a key achievement towards commercialization of the company’s lead candidate drug which is a combination of celecoxib and amlodipine.

Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV)

Kit-302 Development

Kitov Pharmaceuticals is developing KIT-302 for the treatment of osteoarthritis pain and hypertension. The FDA has set a target date of May 31, 2018, for a complete review of the drug candidate.

Data from Phase 3 clinical trial demonstrated that KIT302 met its primary endpoints with a statistical significance of p=0.001.

“We appreciate the hard work of our internal regulatory team in the preparation of NDA package, the participation of various clinics and hospitals in the United Kingdom in the trial, and the European Contract Research Organizations that collected, stored, and performed statistical analysis of the data,” said Dr. Waymack.

Investors pushing the stock lower on the milestone achievement came as a surprise as the stock had been trading in an uptrend after bouncing from this year’s lows of $1.27 a share. Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV) has underperformed the overall industry after losing more than 30% in market value since the start of the year.

Disappointing Earnings Results

A wider than expected net loss of (-$6) million for the first six months of the year compared to a net loss of (-$3) million reported last year continues to affect investors’ confidence on the stock. The company’s cash and cash equivalent as of the end of June 30, 2017, stood at $8.1 million compared to $14.7 million as of December 31, 2016.

In July Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV) ventured into the debt market to raise additional capital. The innovative biopharmaceutical company raised $3.1 million through a direct registered offering.

In a bid to strengthen investor confidence after a poor performance for the first six months of the year, Kitov Pharmaceuticals Holdings Ltd (ADR) (NASDAQ:KTOV) continues to tout progress made on the development of its pipeline of drugs. The company says it expanded its pipeline with the acquisition of NT-219 for the treatment of a variety cancers.

“Our plan is to continue growing Kitov as an innovative, emerging pharmaceutical company. Our mission is to leverage the significant potential of our product development pipeline to create long-term shareholder value,” said CEO Isaac Israel.

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 $KTOV 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.

Endocyte, Inc. (NASDAQ:ECYT)

Endocyte, Inc. (NASDAQ:ECYT) Signs Licensing Agreement

Endocyte, Inc. (NASDAQ:ECYT)

The stock price of Endocyte, Inc. (NASDAQ:ECYT) more than doubled in value after the biopharmaceutical company announced the completion of a licensing agreement with ABX for a Phase 3 ready prostate cancer drug. The stock was up by 157.5% in Monday’s trading session, to end the day at $3.63 a share.

The rally helped reverse a strong selling pressure that had pushed the stock to multi-year lows. ECYT has since recorded a new 52-week high of $3.75, waiting to see if it will continue to rise. The stock is also up by more than 20% for the year after gapping higher in Monday’s trading session.

Endocyte, Inc. (NASDAQ:ECYT)

Endocyte-ABX Licensing Agreement

Under the terms of the licensing agreement, Endocyte, Inc. (NASDAQ:ECYT) owns exclusive worldwide rights for the development and commercialization of the prostate cancer candidate drug 177PSMA-617. The biopharmaceutical company is also to make an upfront payment of $12 million to ABX.

Endocyte, Inc. (NASDAQ:ECYT) has also agreed to grant ABX 2 million shares of its common stock and warrants for the purchase of up to 4 million additional shares. ABX is also entitled to regulatory and commercial milestones payments totaling up to $160 million.

Lu-PSMA-617 Prospects

Lu-PSMA-617 is a radioligand designed to target the prostate-specific membrane antigen present in 80% of patients with metastatic castration-resistant prostate cancer. According to the Chief Executive Officer, Mike Sherman, the candidate drug has the potential to be the first in class RLT, for addressing both bone and soft tissue disease.

The drug has already shown a remarkable 57% PSA response rate. The studies show the drug to be well tolerated with low rates of adverse effects and no renal toxicity.

“We intend to seek regulatory approval to initiate a Phase 3 registration trial of 177Lu-PSMA-617 in early 2018. By focusing the company’s resources on the execution of this program, we project trial completion as early as 2020,” said Mr. Sherman.

First developed at the DFKZ (German Cancer Research Center), PSMA-617 has so far been evaluated in hundreds of patients through both compassionate and prospective trials. Preliminary clinical trial results indicate that the drug has the potential to be a promising target in prostate cancer especially in areas where the disease has become resistant to current therapies.

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 $ECYT 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.

Galena Biopharma Inc. (NASDAQ:GALE)

Galena Biopharma Inc. (NASDAQ:GALE) Drug Development Continues

Galena Biopharma Inc. (NASDAQ:GALE)

Galena Biopharma Inc. (NASDAQ:GALE) shares fell 4.7% after the biopharmaceutical company announced the completion of patient enrollment in two NeuVax clinical trials. The company is investigating the drug in combination with Trastuzumab as a prevention for breast cancer recurrence in patients with no other treatment options.

According to the Chief Medical Officer, Bijan Nejadnik, completion of patient enrollment marks a major milestone on Neuvax development. Shareholders reacted negatively to the sentiments pushing the stock near all-time lows.

Galena Biopharma Inc. (NASDAQ:GALE) is trading in a strong downtrend after losing more than 70% in market value since the start of the year. The stock is currently trading at the lower end of its $0.35 – $ 0.38 trading range and close to its 52-week low of $0.26 a share.

Galena Biopharma Inc. (NASDAQ:GALE)

Neuvax is the company’s lead candidate drug expected to affect the stock’s direction of trade. A Phase 2b clinical trial of the drug has already enrolled 300 patients. Preliminary clinical trial results presented last year indicate that NeuVax in combination with trastuzumab remains well tolerated with no safety concerns.

“The combination of trastuzumab and NeuVax has been shown to be synergistic in preclinical investigation, and we believe could be an effective treatment to prevent breast cancer recurrence in patients with no other treatment options,” said Mr. Nejadnik.

GALE-401 Development Partnership

Separately, Galena Biopharma Inc. (NASDAQ:GALE) has reaffirmed its partnership with BioVascular Inc. for the development of GALE-401. The two companies have amended a previously signed license agreement to facilitate the development of the asset either through internal clinical development or by seeking a licensing partner.

GALE-401 is a controlled version of the approved drug anagrelide, for the treatment of elevated platelets in patients struggling with myeloproliferative neoplasms (MPNs). Given that it is a release formulation, GALE-401 is being developed with a view of reducing some of the side effects associated with anagrelide.

Galena Biopharma Inc. (NASDAQ:GALE) has already completed a majority of the work needed for the commencement of Phase 3 trials.

“GALE-401 is a Phase 3-ready asset, and this joint collaboration between Galena, SELLAS, and BioVascular endorses our mutual belief in the value of the program for patients with ET or other MPN disorders,” said Stephen F. Ghiglieri, Interim Chief Executive Officer.

According to BioVascular CEO, John H Parish, the combined company should be able to come up with a viable path for advancing the development of GALE-401.

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 $GALE 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.

Ritter Pharmaceuticals Inc. (NASDAQ:RTTR)

Ritter Pharmaceuticals Inc. (NASDAQ:RTTR) Slumps 29%

Ritter Pharmaceuticals Inc. (NASDAQ:RTTR)

Ritter Pharmaceuticals Inc. (NASDAQ:RTTR) fell 29.3% after announcing the pricing of an underwritten public offering consisting of Class A units made up of 34.6 million shares of common stock and warrants for the purchase of an additional 34.6 million shares of common stock. Ritter expects gross proceeds of close to $23 million.

Public Offering

The developer of novel therapeutic products is also offering Class B units made up of 9,180 shares of series A preferred stock priced at $1,000 a unit. Ritter Pharmaceuticals Inc. (NASDAQ:RTTR) has granted underwriters a 45-day option for the purchase of additional shares of common stock or warrants for the purchase of common stock. The offering should close on or about October 3, 2017.

Ritter Pharmaceuticals Inc. (NASDAQ:RTTR) stock dropped to multi-year lows of $0.35 a share after the offering was priced. The stock is currently trading in a strong downtrend and close to its 52-week low of $0.34 a share.

Ritter Pharmaceuticals Inc. (NASDAQ:RTTR)

RP-G28 Phase 3 Study

Separately, Ritter Pharmaceuticals Inc. (NASDAQ:RTTR) will commence Phase 3 study of RP-G28 for the treatment of lactose intolerance following End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The company has already taken direction from the agency on the key elements of the proposed study after receiving clear guidance and expectations on necessary components.

“We are pleased with the productive discussion and open dialog we had with the FDA regarding our Phase 3 plans. We are confident we can execute a successful Phase 3 program furthering our goal to ultimately file a successful NDA and commercialize RP-G28 as the first FDA-approved treatment for lactose intolerance,” said Andrew J. Ritter, co-founder, and president of Ritter Pharmaceuticals, Inc.

Primary/Secondary Endpoints

The proposed Phase 3 clinical program should commence in the first half of 2018 and will consist of two confirmatory clinical trials with similar trial design and size. It will consist of multicenter randomized double-blind placebo-controlled parallel group trials, designed to determine efficacy, safety, and durability of RP-G28.

The primary endpoint will be to determine and evaluate patient’s composure L1 symptoms that include abdominal pain cramping after lactose challenge. Secondary endpoints will evaluate L1 signs and symptoms in addition to evaluating patients continued meaningful treatment benefit.

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 $RTTR 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.

Catabasis Pharmaceuticals Inc. (NASDAQ:CATB) Gains on DMD Presentations

Catabasis Pharmaceuticals Inc. (NASDAQ:CATB)

Catabasis Pharmaceuticals Inc. (NASDAQ:CATB) resurgence from all-time lows continued in Thursday’s trading session as its shares gained 21.9% to end the day at $2.23 a share. The rally followed the announcement that the clinical stage biopharmaceutical company will present results from a joint research collaboration with Sarepta Therapeutics Inc. (NASDAQ:SRPT).

Catabasis DMD Presentation

The presentation touches on a research collaboration for Duchene Muscular Dystrophy (DMD). The two companies are currently investigating CAT-1004, a known NF-Kb inhibitor, known to enhance myotube formation in-vitro.

In addition, Catabasis Pharmaceuticals Inc. (NASDAQ:CATB) will present results from an open-label extension of the MoveDMD trail, following five weeks of edasalonexent treatment in boys with DMD.

Shares of Catabasis closing above the $2 could be the catalyst needed to push the stock to the $2.50 mark, another key resistance level. CATB has underperformed the overall industry after losing more than 40% in market value since the start of the year. The clinical stage biopharmaceutical company is still trading in a downtrend even with the recent resurgence.

Catabasis Pharmaceuticals Inc. (NASDAQ:CATB)

Catabasis Q2 Earnings

Catabasis Pharmaceuticals Inc. (NASDAQ:CATB) bounce follows a second-quarter earnings report that showed substantial progress in trimming its net loss. For the three months ended June 30, 2017, the company reported a net loss of (-$7) million or (-$0.32) cents a share, down from a net loss of (-$9.4) million reported in Q2 2016.

Research and development expenses dropped to $4.5 million from $6.8 million a year ago, attributed to the completion of certain clinical activities. Headcount reductions led to a decline in General and Administrative expenses that totaled $2.4 million compared to $2.6 million as of Q2 2016. Catabasis Pharmaceuticals exited the quarter with cash and cash equivalent of $29.4 million compared to $31.8 million as of March 31, 2017.

“In the second quarter, we presented an important prespecified crossover analysis of data from boys with Duchenne in our Phase 2 edasalonexent trial. We are very excited to see improvements in the rate of decline of muscle function across multiple assessments in boys treated with edasalonexent for 12 weeks,” said CEO Jill C. Milne.

Catabasis Pharmaceuticals Inc. (NASDAQ:CATB) is also working on CAT-5571 a potential oral treatment for cystic fibrosis.

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 $CATB 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.

Axovant Sciences Ltd (NASDAQ:AXON)

Axovant Sciences Ltd (NASDAQ:AXON) Alzheimer’s Treatment Flops

Axovant Sciences Ltd (NASDAQ:AXON)

Pharmaceutical firm Axovant Sciences Ltd (NASDAQ:AXON) has disclosed that development for a trial Alzheimer’s drug would be halted after it failed to meet its endpoints. Consequently shares of the company fell by 74.7% to settle at $6.13 on Tuesday – a record low.

According to the New York-based firm, there was no difference between a placebo and the drug (known as intepirdine) in the trial involving 1,150 participants. The trial measured the ability of trial participants to carry out regular daily activities such as bathing and dressing. The drug did not affect brain power significantly.

Axovant Sciences Ltd (NASDAQ:AXON)

5-HT6 antagonists

Intepirdine was meant to be taken daily. It is in the class of treatments known as 5-HT6 antagonists. These drugs work by assisting in the release of acetylcholine by blocking 5-HT6 receptors. Acetylcholine is a neurotransmitter which is required in order to perform normal cognitive activities. The failure has raised doubts over whether the mechanism has potential in the development of Alzheimer’s treatments.

“Following a slew of failures with other 5-HT6 receptor antagonists, Axovant Sciences Ltd (NASDAQ:AXON)’s intepirdine put the nail in the coffin for the mechanism in Alzheimer’s disease,” Brian Skorney an analyst at Baird wrote in a research note.

Alzheimer’s is the most common type of dementia. In the United States it affects approximately 5.5 million people. Earlier in the year Lundbeck, a pharmaceutical firm based in Denmark, revealed that the late-phase trials of a similar drug using the same mechanism had failed to meet the endpoints as well. Other pharmaceutical companies that have failed to develop an Alzheimer’s drug include Merck and Eli Lilly.

Consistent failure

Over the years drug companies have invested billions of dollars trying to find a treatment for Alzheimer’s since the potential global market for a cure is 44 million-strong. So far only four Alzheimer’s drugs have received U.S. Food and Drug Administration (FDA) approval. The last time the FDA greenlit a new Alzheimer’s drug was 14 years ago. According to some analysts and doctors, pharmaceutical firms are conducting trials without having a full understanding of the science behind the disease.

Axovant Sciences Ltd (NASDAQ:AXON) did not develop intepirdine from the ground up and had actually bought the rights from GlaxoSmithKline three years ago at a price of $5 million. The pharmaceutical startup went public a year later in 2015 achieving a valuation of close to $3 billion. At the time questions were raised over the lofty valuation given that it was based on a drug which in the hands of the previous owner, GSK, had flopped consistently in trials.

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 $AXON 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.

CareDx Inc. (NASDAQ:CDNA)

CareDx Inc. (NASDAQ:CDNA) Spikes

CareDx Inc. (NASDAQ:CDNA)

Shares of CareDx Inc. (NASDAQ:CDNA) gained 23.7% after the molecular diagnostics company received a notice indicating that Medicare reimbursement for Allosure will be pegged at $2,840.75. The notice comes days after Medicare confirmed that reimbursement for AlloMap will increase from $2,840 to $3,240 starting in 2018. AlloSure attaining Medicare Coverage is a milestone achievement given that very few diagnostic tests ever achieve the milestone.

Investors Reaction

Buoyed by the newly released Medicare rates, investors pushed CareDX stock above $3.40, which had acted as a key resistance level. The stock has since recorded a new 52-week high of $4.59 a share as it continues to trade around this year’s highs.

CareDx Inc. (NASDAQ:CDNA)

AlloSure Prospects

AlloSure Medicare reimbursement approval follows a rigorous assessment by the Molecular Diagnostics Services (MolDX) Program after clinical trials in 14 leading transplant centers and 400 patients. The new rates should allow CareDx Inc. (NASDAQ:CDNA) to make more money on reimbursements of kidney transplants. Medicare covers about 80% of kidney transplants across the U.S thus presenting a unique opportunity for the company to generate significant value from the noninvasive test. The test has the potential to generate up to $200 million for the molecular diagnostics company.

“We are pleased to see Medicare reimburse AlloSure at the same level as AlloMap, highlighting the value of advanced diagnostic tests to measure organ health for transplant recipients. AlloSure testing provides the precision medicine approach needed for individual transplant recipient clinical management,” said CareDx Inc. (NASDAQ:CDNA) Chief Commercial Officer, Sasha King.

CDNA Stock Rating

Analysts have already taken note of the potential impact of AlloSure on CareDx Inc. (NASDAQ:CDNA) earnings in the wake of the Medicare reimbursement milestone. Piper Jaffray analyst, William Quirk, has raised his share price target on the stock to $7 a share from $3 a share. According to the analyst, the new rates should jump-start the company’s push to profitability.

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 $CDNA 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.

Aradigm Corporation (NASDAQ:ARDM): Linhaliq gets FDA Priority Review

Aradigm Corporation (NASDAQ:ARDM)

Aradigm Corporation (NASDAQ:ARDM) skyrocketed more than 32.8% yesterday following news that the U.S. Food and Drug Administration (FDA) agreed to accelerate the approval review of its lead drug candidate.

The stock rose 32.81% in regular trading hours to $3.36 and jumped an additional 2.38% in trading after-hours to end at $3.44. The day was characterized by modest volume of shares changing hands. The gains left Aradigm up 110% for the year and cut its losses over the last 12 months to 48.3%. In the last 12 months, Aradigm has declined to a low of $0.78 and risen to a high of $7.19.

Aradigm Corporation (NASDAQ:ARDM) is engaged in the development and commercialization of treatment and prevention therapies of severe respiratory diseases.

Linhaliq gets accelerated review

On September 25, Aradigm Corporation (NASDAQ:ARDM) released an announcement stating that the FDA accepted to grant priority review to new drug application (NDA) for Linhaliq. Priority Review status implies a faster a FDA review of a drug application compared to regular review process. As such, Priority Review should shorten the time of bringing a new drug to market if the application is approved.

In light of the Priority Review, Aradigm Corporation (NASDAQ:ARDM) is expecting to hear from the FDA regarding the outcome of Linhaliq review by January 26, 2018.

Aradigm developed Linhaliq as a treatment for NCFBE (non-cystic fibrosis bronchiectasis) in patients with chronic infections with Pseudomonas aeruginosa (P. aeruginosa). The company said it will continue working with the FDA during the review period to support approval of Linhaliq so that the drug can provide much-needed treatment for the targeted patients.

Unmet medical need

NCFBE is a severe, chronic, and rare disease frequently associated with chronic lung infections. More than 150,000 people in the U.S. are victims of NCFBE, while more than 200,000 people in Europe suffer from the disease. NCFBE represents an unmet medical need, and there is currently no drug approved for treatment of NCFBE patients with chronic infections with P. aeruginosa. This category of NCFBE patients has three times higher mortality and a worse quality of life compared to the group of NCFBE patients without P. aeruginosa infections.

Aradigm Corporation (NASDAQ:ARDM)’s Linhaliq has obtained several favorable regulatory labels, implying that it could come to market with a strong profile. For example, the FDA granted Linhaliq Orphan Drug Designation for the management of bronchiectasis. The candidate also carries Fast Track Designation and Qualified Infectious Disease Product (QIDP) Designation for the treatment of NCFBE patients who also have chronic lung infections with P. aeruginosa.

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 $ARDM 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)

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX): Coversin Trial Overshadows

Akari Therapeutics PLC (ADR) (NASDAQ:AKTX)

Akari Therapeutics PLC (ADR)(NASDAQ:AKTX) fell 6.4% days after announcing it will proceed with Phase 3 trial for Coversin, a novel treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH), following advice from the U.S. Food and Drug Administration (FDA). According to the Chief Executive Officer, David Horn Solomon, the proposed trial is part of an effort that seeks to make good use of a recently issued Fast Track designation status for the treatment.

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

Coversin Clinical Trials

A positive FDA recommendation has helped strengthen Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) sentiments among investors at a time when it is facing a string of class action lawsuits. The stock has already closed above the $7 a share mark, a key resistance level, waiting to see if it will continue to edge higher at the back of the recent pullback.

However, the stock is still down for the year after slumping from highs of $22 per share registered in April. Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) faces immediate resistance at $10, above which it could make a push for $14.

Positive trial results for Coversin could help push Akari Therapeutics higher after a poor run in recent months. The FDA has already indicated that safety and efficacy data in PNH patients for more than a year could be reasonable for review purposes.

“Akari continues to build momentum in its complement focused therapy by advancing Coversin towards Phase III in PNH and Phase II in aHUS. With Coversin delivered subcutaneously, patients may have greater independence due to self-administration,” said Mr. Solomon.

In addition to investigating Coversin for the treatment of PNH, Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) is also investigating the candidate drug for the treatment of keratoconjunctivitis a rare eye disorder. The company is also investigating the drug for the treatment of bullous pemphigoid a rare skin disorder.

Misleading Statements?

Separately, Akari Therapeutics PLC (ADR) (NASDAQ:AKTX) continues to face allegations that it provided materially false and misleading statements that led to shareholders incurring some losses. Law Firm Khang & Khang LLP alleges that former CEO Dr. Gur Roshwalb and other executives published false information about Phase 2 PNH trial of Coversin.

In May, the former Chief Executive Officer was placed on administrative leave by the board of directors after publishing the misleading reports that were later withdrawn on April 26, 2017.

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.