Medical Transcription Billing Corp (NASDAQ:MTBC)

Medical Transcription Billing Corp (NASDAQ:MTBC) Stock Price Jumps ahead of Earnings

Medical Transcription Billing Corp (NASDAQ:MTBC)

Medical Transcription Billing Corp (NASDAQ:MTBC) shareholders are enjoying a jump in their stock price of over 30% for the week. The movement in the stock price is likely due to an upward revision in the company’s revenue guidance for the year coupled with their Q2 financial release scheduled for tomorrow before the market opens. Volume for MTBC shares are on pace to exceed seven times their daily average. MTBC stock price chart:

Medical Transcription Billing Corp (NASDAQ:MTBC)
Candlebar stock price chart for MTBC

Before the July 27th announcement, management of Medical Transcription Billing Corp (NASDAQ:MTBC) provided revenue guidance for FY 2017 between $30 – $31 million. That guidance was revised on the 27th and is now pegged between $31 – $32 million. Those revised figures represent a 27% – 31% increase over FY 2016 figures.

Mahmud Haq, MTBC’s Chairman and CEO stated in the press release “We’re very pleased to see our revenue growth outpace our initial full year revenue guidance. Having also achieved our highest adjusted EBITDA as a public company during the second quarter of 2017, we anticipate a remarkable year of achievement for MTBC.”

Medical Transcription Billing Corp (NASDAQ:MTBC) shareholders have had a stellar run with the company. Over the past year, the stock price is up over 53% and is up over 120% YTD. Currently MTBC stock is trading just below $2 or over 500% its 52-week low of $0.29. Importantly, the stock has reached a Relative Strength Index figure of over 72. That level is normally associated with a stock that is overbought.

Medical Transcription Billing Corp (NASDAQ:MTBC) management will host a conference call at 8:30 a.m. EDT on Thursday, August 3, 2017, to discuss the first half 2017 results. The live webcast of the conference call can be accessed under Events & Presentations at ir.mtbc.com or by dialing 412-317-5131 and referencing “MTBC Second Quarter 2017 Earnings Call.” A replay of the conference call will be available approximately one hour after conclusion of the call at the same link. An audio replay can also be accessed by dialing 412-317-0088 and providing access code 10110213.

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

About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Dynavax Technologies Corporation (NASDAQ:DVAX)

FDA Committee Vote Boosts Dynavax Technologies Corporation (NASDAQ:DVAX)

Dynavax Technologies Corporation (NASDAQ:DVAX)

Dynavax Technologies Corporation (NASDAQ:DVAX) shares are up over 70% on positive news from the U.S. Food and Drug Administration (FDA) and ratings upgrades from RBC Capital Markets and JP Morgan. The listed average daily volume for DVAX shares is 1.8 million but by 11:40 AM EST, over14.6 million shares had traded.

Dynavax Technologies Corporation (NASDAQ:DVAX)
One month daily candlebar graph for $DVAX

The catalyst for the share increase was news, dated last Friday, that the FDA’s Related Biological Products Advisory Committee (VRBPAC) voted 12 to 1 that for Dynavax’s HEPLISAV-B vaccine’s safety data support licensure for immunization against hepatitis B infection in adults. Established hepatitis B vaccines are administered in three doses over a six-month schedule. The HEPLISAV-B schedule is two doses over one month. Results of a published Vaccine Safety Datalink study showed that only 54 percent of adults completed the three-dose hepatitis B vaccine series in one year. Hepatitis B is a viral liver disease that can lead to cirrhosis of the liver, hepatocellular carcinoma, and death. In the U.S., the number of reported cases of acute hepatitis B increased more than 20 percent in 2015.

Eddie Gray, CEO of Dynavax, stated “Clinical studies of HEPLISAV-B have shown that the vaccine provides increased rates of seroprotection. In addition, the two-dose regimen offers the potential to increase patient compliance, which physicians and advocates agree is essential to preventing more cases of hepatitis B and achieving the public health goal of eradication. We look forward to completing our ongoing discussions with the FDA regarding an appropriate post-marketing commitment as it finalizes its review.”

Over 11% of Dynavax Technologies Corporation (NASDAQ:DVAX) outstanding shares are held short. In 2012 DVAX shares had an EPS loss, adjusted for dilution, of (-$4.10). In the years that followed losses continued but were steadily narrower: (-$3.83), (-$3.45), (-$3.25), and in 2016 the loss was (-$2.92). However, the number of outstanding shares follows a steady upward trend. In 2012 there were 17.05 million outstanding shares. By 2016 that number had steadily grown and stood at 38.51 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.

Portlogic Systems Inc. (OTCMKTS:PGSY)

Here’s the deal that sparked shares of Portlogic Systems Inc. (OTCMKTS:PGSY)

Portlogic Systems Inc. (OTCMKTS:PGSY)

Shares of Portlogic Systems Inc. (OTCMKTS:PGSY) shot up in the last session as the market continued to react positively to the news that the company had entered into a strategic partnership with a firm that previously employed its current chief technology officer.

The stock rose more than 17.6% to close at $0.16 after trading between a low of $0.14 and a high of $0.16 during the day. A larger-than-usual stock volume also changed hands in the last session. Nearly 5.2 million shares were traded, significantly higher than the daily average volume of about 1.5 million over the last several months.

Shares of Portlogic Systems Inc. (OTCMKTS:PGSY) have gained more than 172% since the beginning of the year and have climbed 257.9% over the last year.

Portlogic Systems Inc. (OTCMKTS:PGSY)
One month daily candle bar graph for $PGSY

The update that moved the stock

In a press release, Portlogic Systems Inc. (OTCMKTS:PGSY) announced that it had entered into a partnership with Mobicloud Technologies, a company that describes itself as a global interactive software developer.

Portlogic has tapped Mobicloud Technologies to provide IT consulting and help with the development of mobile apps as well as unspecified VoIP products. Mobicloud’s contractual scope includes providing a broad range of cloud-based, end-to-end solutions to Portlogic customers.

Portlogic Systems Inc. (OTCMKTS:PGSY) itself is focused on providing mobile apps, including marketing apps, and telecom solutions. Its customers include enterprises. Therefore, the deal with Mobicloud seems to be aimed at bolstering its position in the sector of mobile communication as it seeks to take advantage of the global proliferation of smartphones.

Financial terms kept under wraps

The financial terms of the agreement weren’t disclosed, but Portlogic Systems Inc. (OTCMKTS:PGSY) pointed out that its current CTO, Meeta Litake, previously worked for Mobicloud.

Of note is that the deal seems to have come soon after PGSY appointed Litake to the CTO position. Litake, who has 18 years of academic and corporate experience in engineering and computer science as well as startup consulting, was made CTO on July 18. In that position, Litake’s roles include developing Portlogic’s technology strategy.

Litake commented on Portlogic Systems Inc. (OTCMKTS:PGSY)’s deal with Mobicloud, saying the arrangement would help Portlogic in building its customer base.

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

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

Naked Brand Group Inc (NASDAQ:NAKD)

Key Acquisition for Naked Brand Group Inc (NASDAQ:NAKD)

Naked Brand Group Inc (NASDAQ:NAKD)

Naked Brand Group Inc (NASDAQ:NAKD) shares are up over 30% before lunch on news that it has acquired the sole owner of intimate clothing brand Frederick’s of Hollywood global online license. NAKD shares end Tuesday at $1.26 but before lunch shares had hit $1.82 on a volume figure over 18 times the daily average.

Naked Brand Group Inc (NASDAQ:NAKD)
One month daily candle-bar graph for $NAKD

Naked, Bendon, and Bendon Group Holdings Limited (“Holdco”) recently entered into a merger agreement under which both of Naked and Bendon will become wholly owned subsidiaries of Holdco, a newly formed Australian holding company.

Bendon will acquire all of the outstanding common stock of FOH in exchange for the forgiveness of debt owed by FOH to Bendon. As a result, Bendon will control FOH’s existing license to develop and sell online products under the Fredrick’s of Hollywood name. As part of the transaction, Holdco will issue to FOH shares, which would have otherwise been issued to Bendon at the time of the merger. Most of these shares will be transferred to the affiliate of Bendon which initially funded FOH. The issuance of the Holdco shares is expected to have a minimal impact on the amount of shares Naked Brand Group Inc (NASDAQ:NAKD) stockholders will have in Holdco.

Naked Brand Group Inc (NASDAQ:NAKD) sales have increased each year since 2015 when the company reported $0.6 million in sales. That number was followed by annual sales figures of $1.4 million and $1.8 million. However profit has been harder to grasp for the apparel company. In 2015, Naked Brand Group Inc (NASDAQ:NAKD) shareholders suffered a per share loss of (-$23.33). That loss narrowed in 2016 to (-$10.13), then narrowed again in 2017 to (-$1.77).

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

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

Aurora Cannabis $ACBFF

AURORA CANNABIS IN COM NPV (OTCMKTS:ACBFF) Debuts on TSX After German Expansion

AURORA CANNABIS IN COM NPV (OTCMKTS:ACBFF)

Shares of AURORA CANNABIS IN COM NPV (OTCMKTS:ACBFF) jumped 5.31% after the company made its debut on the Toronto Stock Exchange. Trading on Canada’s flagship stock exchange marks yet another milestone achievement for a company that has added more than $600 million in shareholder value and seen its monthly revenues more than triple over the past year.

Aurora Cannabis $ACBFF
Two Month Chart for $ACBFF

Toronto Stock Exchange Milestone

AURORA CANNABIS IN COM NPV (OTCMKTS:ACBFF) shares are currently trading on the flagship exchange under the symbol ACB. Its shares have also been voluntarily delisted from the TSX Venture Exchange. The upgrade, according to the Chief Executive Officer Terry Booth, reflects the remarkable commercial and operational progress made since late last year.

“We are achieving record yields at our Mountain View County production facility, progressing rapidly with the construction of our 100,000+ kg per annum Aurora Sky facility at Edmonton International Airport, and are executing consistently on our national and international expansion strategy,” said Mr. Booth.

AURORA CANNABIS IN COM NPV (OTCMKTS:ACBFF) is a licensed producer of medical cannabis with operations in the U.S. and Canada. The company currently operates a 55,200 square foot, state of the art facility from where it develops its proprietary cannabis products. It is also in the process of constructing a second 800,000 square foot production facility as it looks to strengthen its position in the fast growing industry.

AURORA CANNABIS IN COM NPV (OTCMKTS:ACBFF) is currently in the process of acquiring its third production facility in Pointe Claire, Quebec, to further support domestic growth. In addition to pursuing growth opportunities back at home, Aurora Cannabis is also looking to grow its footprint on the international scene.

Germany Expansion

AURORA CANNABIS IN COM NPV (OTCMKTS:ACBFF), through its subsidiary Pedanios, has passed the first application to become a licensed medical cannabis operator in Germany. The subsidiary is set to participate in a second and final stage of the application process. The process involves contract negotiations for cultivation, processing, storing, packaging and delivery of medical cannabis products.

Pedanios is German’s largest importer, exporter, and distributor of medical cannabis. The company has shipped to more than 1,000 German pharmacies. Germany is poised to be one of the biggest markets in medical cannabis given that the country’s healthcare system covers the cost of medical cannabis. A population of more than 80 million people also presents a unique target market that AURORA CANNABIS IN COM NPV (OTCMKTS:ACBFF) can rely on for sales growth.

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

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

DryShips Inc. (NASDAQ:DRYS)

DryShips Inc. (NASDAQ:DRYS) Shares Crumble On Stock Manipulation Claims

DryShips Inc. (NASDAQ:DRYS)

Shares of DryShips Inc. (NASDAQ:DRYS) crumbled in Friday’s trading session after the company became the subject of class action lawsuits over claims of stock manipulation. The stock was down by 27.91% to end the week at $2.17 a share. Last week’s sell off also came after the company effecting another reverse stock split and issuing an updated financial report.

Stock Manipulation Claims

DryShips Inc. (NASDAQ:DRYS) is an international shipping company that operates ocean cargo vessels worldwide. The firm operates through two segments – drybulk and offshore support. Founded in 2014, the company currently owns 13 Panamax Drybulk vessels, and 6 offshore support vessels.

The Greek carrier finds itself in a tight spot over stock manipulation claims that have seen it shed more than 90% in value over the last six months. Law firms behind the class action lawsuits allege that in a series of transactions beginning last year, DryShips Inc. (NASDAQ:DRYS) raised hundreds of millions of dollars by selling newly issued shares directly to Kalani Investments Ltd.

The money that came from Kalani allowed the shipping company to double the size of its fleet even as the stock continued to plunge.

Reports indicate that the company sold the vast numbers of newly issued shares to the British Virgin Island firm at a discount. The firm in return unloaded most of the shares immediately after the stock soared to all-time highs in November, followed by the stock’s plunge.

In their class action lawsuits, law firms allege that because Kalani purchased the shares with the intention of reselling them immediately the transactions amounted to ‘Pseudo underwriting.’

Reverse Stock Split

In a bid to counter the downward pressure, DryShips Inc. (NASDAQ:DRYS) has resorted to reverse stock splits as it tries to stay afloat. Late last year, the company carried out a 1:15 reverse stock split as it sought to strengthen the value of its share price. The company is also fresh from effecting a 1:7 reverse stock split as it tries to shore up the share price even further.

Extreme dilution is now a point of concern given the amount of DryShips Inc. (NASDAQ:DRYS) shares that are floating in the market. A massive net loss in the recent quarter has also rattled investors fuelling the sell-off wave that now threatens to push the stock to all-time lows. The company has already suspended debt payments arousing concerns over its financial stability.

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

About the author: Marc has a degree in economics and a MSc. in Finance. Marc worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.

Moleculin Biotech Inc (NASDAQ:MBRX)

Moleculin Biotech Inc (NASDAQ:MBRX) Spikes On MD Anderson Cooper Center Technology Licensing Agreement

Moleculin Biotech Inc (NASDAQ:MBRX)

Moleculin Biotech Inc (NASDAQ:MBRX) traded higher in Tuesday’s trading session after announcing the signing of a new technology license agreement with MD Anderson Copper Center for the Leukemia drug Annamycin. The stock was up by 20.59% to end the day at $2.05 a share. The rally also comes after the company regained compliance with the NASDAQ Listing Requirements.

Moleculin Biotech Inc (NASDAQ:MBRX)
Bar Graph $MBRX

Technology License Agreement

Moleculin Biotech Inc (NASDAQ:MBRX) is a preclinical stage pharmaceutical company specializing in the development of anti-cancer drugs. Annamycin is the company’s lead drug candidate for the treatment of refractory acute myeloid leukemia. The company is also working on two other molecular portfolios, one of which is working on the modulation of hard-to-target tumor cell signaling mechanisms. The other molecule targets the metabolism of tumors.

The technology license agreement with MD Anderson’s Cooper Cancer Center is based on new patent applications that Moleculin is set to file. The patents are in relation to the company’s candidate drug Annamycin.

“In anticipation of beginning our planned clinical trials for Annamycin. One of our priorities has been to ensure the best possible protection for our intellectual property. Some key patent applications had yet to be filed and signing a new license agreement with MD Anderson clears the way for those patents,” said Walter Klemp, Moleculin Biotech Inc (NASDAQ:MBRX) CEO.

Dr. Gill Appointment

Moleculin Biotech Inc (NASDAQ:MBRX) has already appointed Dr. Lidia Gil of Poznan University to act as the lead European Principal Investigator. Dr. Gil is to oversee the planned Phase I/II clinical trial for Annamycin for the treatment of acute myeloid leukemia. The company has also expanded its engagement with CRO to include clinical sites in Poland.

Mayo Clinic WP1066 Partnership

Separately, Moleculin Biotech Inc (NASDAQ:MBRX) has entered into an agreement with Physicians at the Mayo Clinic as part of an effort that seeks to enable additional research on WP1066 molecule as a possible treatment for a rare form of pediatric tumors.

Under the terms of the agreement, the company is to supply Mayo Clinic physicians and scientists with WP1066 for preclinical testing as a novel treatment for Pediatric Diffuse Intrinsic Pontine Gliomas. The primary target with the upcoming trials is cell signaling protein STAT3. Initial studies have shown that WP1066 has the potential to suppress xenograft of human brain tumors transplanted into mice

“This, along with the physician efforts at MD Anderson to secure an IND to study WP1066 for the treatment of adult brain tumors, continues to validate the potential importance of WP1066 in the treatment of difficult tumors,” said Mr. Klemp.

I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.

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

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

Is RightsCorp Inc (OTCMKTS:RIHT) on the Rocket Pad?

RightsCorp Inc (OTCMKTS:RIHT)

RightsCorp Inc (OTCMKTS:RIHT) has been posting news that observers believe may propel shares higher in the coming weeks. Currently, RIHT shares are trading well above their 52-week low of $0.01 per share and are within striking distance of their $0.059 52-week high.

RightsCorp Inc (OTCMKTS:RIHT)
Daily Candle Bar for $RIHT

Intellectual property (IP) protection is a huge business. The U.S. Chamber of Commerce Intellectual Property Center has calculated the worth of intellectual property in the United States as being between $5 trillion and $5.5 trillion. Reports suggest that the U.S. economy loses $58 billion each year to copyright infringement including $16 billion in lost revenue to the owners of the IP, and $3 billion in lost tax revenue.

RightsCorp Inc (OTCMKTS:RIHT) provides data and analytics services to owners of copyrighted property such as artists or media firms. The company’s patent-pending digital technology focuses on the infringement of intellectual property rights and ensures that the legal owner’s rights are protected.

RightsCorp Recent History

At the end of February, RightsCorp Inc (OTCMKTS:RIHT) announced Mr. Cecil Bond Kyte as the company’s new Chief Executive Officer. Mr. Christopher Sabec, the Company’s current CEO, will serve as President and continue to spearhead RightsCorp’s intellectual property litigation support and copyright monetization services.

In late June, RightsCorp Inc (OTCMKTS:RIHT) announced that it has been granted an Israeli Patent for the company’s “System to Identify Multiple Copyright Infringements and Collecting Royalties”. Cecil Bond Kyte, CEO of Rightscorp, stated “Online piracy continues to be a major concern worldwide with Israel holding one of the highest rates outside Europe. Last year, it was recorded that approximately 66% watch movies and TV shows online with only 2% using legal direct-view websites. There is a need in Israel for content protection and our technology is an ideal solution for curbing piracy,”.

RightsCorp Can Scale

Clearly, there is positive movement in the ability for RightsCorp to execute on their business model. Their approach is to use their proprietary software to monitor global Peer‐to‐Peer (P2P) file sharing networks. As they monitor the P2P network, the software continuously scans for illegally downloaded digital media.

Once the software finds an illegally downloaded file, it sends an email to the internet service provider (ISP) using the notice format as specified in the Digital Millennium Copyright Act. The notice includes the date, time, song title and other specific technology identifiers to confirm the infringement by the ISP’s customer. Under Federal Copyright Law, once the ISP has actual knowledge of copyright infringements that take place using its network, it has specific duties in relation to the enforcement of the rights of the owners of the material in question. The ISP can legally cut off service to repeat offenders.

Fines for downloading IP without proper authority or permission can reach $150,000 per violation. However, RightsCorp provides these illegal users with a link to remit payment to Rightscorp who will then pay the IP owner a percentage of the collected fee. RightsCorp Inc (OTCMKTS:RIHT) believes this arrangement is economical and mutually beneficial to both the infringer and owner of the IP.

One thing is certain if the company is able to fully execute its business model – it could be a massive cash-flow generating machine.

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

About the author: Marc has a degree in economics and a MSc. in Finance. Marc worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant

VOXX International Corp (NASDAQ:VOXX)

VOXX International Corp (NASDAQ:VOXX)’s Q1 2018 Sales Growth Offsets Net Loss Concerns

VOXX International Corp (NASDAQ:VOXX)

VOXX International Corp (NASDAQ:VOXX) traded higher in Monday trading session after posting modest top line growth in Q1 2018. A 17.4% increase in Premium Audio sales helped offset investors’ concerns about a (-$3) million loss in the quarter.

$VOXX Daily Candle graph
Candle Graph $VOXX

VOXX International Corp (NASDAQ:VOXX) is a renowned worldwide leader in automotive consumer electronics. The company boasts of an extensive distribution network that includes power retailers, mass merchandisers and 12-volt specialists. Its footprint extends into some of the biggest markets in Europe, Asia, Mexico, and South America.

VOXX Q1 2018 Financial Results

Net sales for the quarter ending May 31, 2017, increased by 3.6% to $159.1 million compared to $155.5 million reported a year ago. Gross margin, however, dropped to 27.5% from 29.7% due to increased promotion activities geared towards clearing inventory levels.

VOXX International Corp (NASDAQ:VOXX) expects gross margins to improve in the second quarter due to new products coming to market and partnerships in the Automotive and Consumer Accessories segments.

Operating expenses dropped to $51.6 million from $53.2 million as of Q1 2017. Net loss attributed to shareholders dropped to ($3) million from (-$4.3) million reported in Q1 2017. Operating net loss, on the other hand, increased to $7.8 million from $7.1 million as of last year.

Hirschmann Car Communication GmbH Sell

During the quarter, the company entered into a definitive agreement with a subsidiary of TE Connectivity Ltd for the sale of Hirschmann Car Communication GmbH and its subsidiaries. The chief Executive Officer, Pat Lavelle, expects the transaction to lead to a greater concentration of the company’s business in North America.

“While Hirschmann has been a great contributor to our business and has the industry-leading technology, we believe the opportunity to sell at the proposed value is a benefit for our shareholders. Upon completion, we will have a clean balance sheet, lower working capital needs and we expect greater cash flow,” said Mr. Lavelle.

Under the terms of the agreement, Voxx International is to receive €148.5 million for the unit. The transaction is subject to regulatory approval among other customary closing conditions.

VOXX International Corp (NASDAQ:VOXX) Shares have been on an impressive run since the start of the year, a trend that could continue especially with the filling of stellar Q1 2018 financial results. The stock is up by more than 80% since the start of the year having tripled in value in the last 12 months.

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

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

Ocular Therapeutix Inc. (NASDAQ:OCUL)

FDA Concerns Over Ocular Therapeutix Inc. (NASDAQ:OCUL) Manufacturing Process

Ocular Therapeutix Inc. (NASDAQ:OCUL)

Shares of Ocular Therapeutix Inc. (NASDAQ:OCUL) plunged 25.05% in Friday’s trading session as investors reacted to concerns raised by the U.S. Food and Drug Administration (FDA) about the company’s manufacturing processes. The resignation of the entire management team also continues to fuel a selloff of the stock – a problem that has since attracted a wave of class action lawsuits.

The biopharmaceutical company bills itself as a leading developer of innovative therapies, using the hydrogel platform technology, for diseases and conditions affecting the eye. The company’s lead candidate product DEXTENZA has already completed its Phase 3 clinical trial as a novel treatment for ocular pain after ophthalmic surgery.

Ocular Therapeutix Inc. (NASDAQ:OCUL) has filed an NDA resubmission for DEXTENZA awaiting the final FDA stance on the product. The company is also evaluating a number of injectable drug delivery depots for back-of-the-eye diseases.

Manufacturing Concerns

Ocular Therapeutix Inc. (NASDAQ:OCUL) appears to be facing serious manufacturing issues after the Food and Drug’s Administration raised concerns in a second 483 statement. The agency, after carrying out an inspection of the company’s manufacturing plant, says it discovered an unknown matter in the company’s candidate product DEXTENZA.

The FDA has since accused the biopharmaceutical company of releasing the product without carrying out a risk assessment on its quality or safety. In one of the observations, the FDA raises concerns about the company’s laboratory controls which it says does not include scientifically sound and appropriate test procedures that can guarantee high-quality products.

The company has also been taken to task for not providing written procedures for production and process controls that can affirm products and drugs have the strength and quality they purport to have.

Management Stance

Many observers believe the management has yet to grasp the magnitude of the matter if remarks by the chief executive officer, Amar Shawnee, during Q1 earnings call is anything to go by.

“We were pleased during the re-inspection that the FDA investigator was able to confirm our corrective action plan from prior observations, and indicated that there was no further follow-up necessary to close out those issues. So I think that’s a strong sign that the manufacturing process has moved forward significantly, and is in a fully developed mode,” said Mr. Shawnee.

Ocular Therapeutix Inc. (NASDAQ:OCUL) maintains that its manufacturing process is fully developed and that the concerns raised can be resolved quickly. However, the company needs to revamp the manufacturing process if its lead product DEXTENZA is to stand a chance of gaining the much needed FDA approval.

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

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