Ocera Therapeutics Inc. (Nasdaq: OCRX) Up Big in Pre-Market

Ocera Therapeutics Inc. – Nasdaq: OCRX

Shares of Ocera Therepeutics Inc are up over 25% in pre-market trading. Shares are traded on the Nasdaq under the ticker symbol OCRX. Ocera Therapeutics is a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics for patients with serious diseases in areas of high unmet medical need.

Ocera’s lead drug candidate, OCR-002, is an ammonia scavenger which aims to remove ammonia from the blood. Elevated ammonia is believed to be one of the primary causes of hepatic encephalopathy (HE). OCR-002 is the subject of STOP-HE, a Company-sponsored Phase 2b trial, a Company-sponsored Phase 1 trial, and two externally-sponsored Phase 2a trials. OCR-002 has received Orphan Drug designation in both the U.S. and Europe and has been granted Fast Track status by the U.S. Food and Drug Administration.

Four firms follow Ocera Therapeutics. All four of their analysts rate OCRX a “Strong Buy” with a consensus price target of $10. Analyst confidence may be rewarded as OCRX has experienced increasing, though negative, EPS every year since 2011. However sales have been minimal and interested investors should view OCRX and all biotech companies with extreme caution and perform their own due diligence.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

12/28/2016
Ticker Symbol OCRX
Last Price a/o 8:13 AM EST  $               3.00
Average Volume 266,900
Market Cap $50.95 million
Sales $0.1 million
Shares Outstanding 23.2 million
Share Float 22.7 million
Shortable Yes
Optionable Yes
Inside Ownership 0.40%
Short Float 0.74%
Short Interest Ratio 0.63
Quarterly Return -15.38%
YTD Return -29.49%
Year Return -30.60%

 

Synergy Pharmaceutical Inc. (Nasdaq: SGYP) Soars on Positive Results

Synergy Pharmaceuticals Inc.; Nasdaq: SGYP

Shares of Synergy Pharmaceuticals Inc jumped more than 20% today in heavy trading. The New York City-based biotechnology firm trades on the Nasdaq under the ticker symbol SGYP. SGYP ended Thursday’s trading session at $4.74 and closed today up over 21% at $5.77.

Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced on December 22, 2016 (after market close) that positive top-line results from the second of two pivotal phase 3 clinical trials evaluating the efficacy and safety of plecanatide, an investigational once-daily orally-administered compound, in 1,054 adult patients with irritable bowel syndrome with constipation (IBS-C).

Preliminary analysis of the data indicates that both plecanatide 3 mg and 6 mg doses met the study’s primary endpoint and showed statistical significance in the percentage of patients who were Overall Responders compared to placebo during the 12-week treatment period

Synergy Pharmaceuticals has pioneered discovery, research and development efforts around analogs of uroguanylin, a naturally occurring human GI peptide, for the treatment of GI diseases and disorders. Synergy Parmaceuticals has research, technical operations, and commercial offices in suburban Philadelphia. They have discovered, are developing, and control 100% worldwide rights to our proprietary uroguanylin analog platform that includes two lead product candidates – plecanatide and dolcanatide.

Plecanatide is their first uroguanylin analog currently being evaluated for use as a once-daily tablet for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Dolcanatide is their second uroguanylin analog currently being explored for ulcerative colitis.

Synergy Pharmaceuticals is covered by two firms and both give SGYP a “Strong Buy” rating. However the biotech company has yet to announce any revenues and has had negative EPS since it was listed on the Nasdaq in 2008.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

12/23/2016
Ticker Symbol SGYP
Last Price a/o 4:00 PM EST  $               5.77
Average Volume 3.05 million
Market Cap $852.2 million
Sales
Shares Outstanding 179.8 million
Share Float 172.1 million
Shortable Yes
Optionable Yes
Inside Ownership 7.01%
Short Float 13.77%
Short Interest Ratio 7.78
Quarterly Return -15.50%
YTD Return -16.40%
Year Return -18.13%

Second Sight Medical Products, Inc. (Nasdaq: EYES) Up on UK Gov’t Acceptance

Second Sight Medical Products Inc.; Nasdaq: EYES

The UK publicly-funded NHS system will fund blind patients with Retinitis Pigmentosa (RP) to receive treatment with the Argus® II Retinal Prosthesis System (Argus II) “bionic eye”. This news has sent shares of Second Sight Products, Inc. to $2.48 highs before settling back to a 13% gain at a price of $2.19. Second Sight Products, Inc. trades on the Nasdaq under the ticker EYES.

Will McGuire, President and CEO of Second Sight, said, “This is a major milestone for Second Sight because we are the only company able to demonstrate a favorable long-term benefit-to-risk statement up to five years after implantation for some RP patients. NHS England is known to be under significant financial pressure and also extremely selective in adopting innovative technologies – which must demonstrate sufficient value for money. We expect that this decision will be observed throughout the world by other healthcare agencies.”

Second Sight Medical Products, Inc., located in Sylmar, California, was founded in 1998 by Mr. Alfred Mann, Dr. Sam Williams and Gunnar Bjorg with the goal of creating a retinal prosthesis to provide sight to subjects blinded from outer retinal degenerations, such as retinitis pigmentosa. Second Sight currently employs over 85 employees and has a European office in Lausanne, Switzerland.

H.C. Wainwright initiated coverage of Second Sight Medical Products in June of 2015 and assigned EYES a rating of “Buy” with a price target of $21. Sales have increased year-on-year since 2012 when reported sales were $1.4 million. In 2015 reported sales were $9 million. EYES EPS have not performed as well however – Second Sight Medical Products has never posted a positive EPS and last year lost $0.56 EPS.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

12/22/2016
Ticker Symbol EYES
Last Price a/o 1:10 PM EST  $               2.18
Average Volume 316,600
Market Cap $81.9 million
Sales $5.6 million
Shares Outstanding 42.23 million
Share Float 24.36 million
Shortable Yes
Optionable Yes
Inside Ownership 0.50%
Short Float 14.94%
Short Interest Ratio 11.5
Quarterly Return -42.09%
YTD Return -67.06%
Year Return -72.64%

 

Heat Biologics Inc. (Nasdaq: HTBX) Up in Early Trading on Heavy Volume

Heat Biologics Inc.; Nasdaq: HTBX

Biotechnology firm Heat Biologics, Inc. are up over 20% in early trading on heavy volume. The Durham, NC-based biotechnology firm trades on the Nasdaq under the ticker HTBX. Shares closed yesterday at $0.77 but quickly rose above $0.90 in the first thirty minutes of trading.

Heat Biologics is a clinical-stage biotechnology company focused on developing its novel off-the-shelf ImPACT therapeutic vaccines to combat a wide range of cancers and infectious diseases. ImPACT Therapy exploits the natural ability of antigens to activate the immune system by utilizing live, irradiated, off-the-shelf, genetically modified cells injected into a patient designed to elicit a powerful immune response against the disease target. Heat biologics is currently conducting multiple clinical trials in two indications with its ImPACT therapy based products, HS-410 to treat Non-Muscle Invasive Bladder Cancer (NMIBC) and HS-110 to treat Non-Small Cell Lung Cancer (NSCLC).

In a December 6, 2016 press release, Heat Biologics Inc. stated that principal investigator, Daniel Morgensztern, MD, Associate Professor of Medicine and Director of Thoracic Oncology, Washington University School of Medicine, reported that one-year results from the first eight trial patients showed that the HS-110/nivolumab combination was well-tolerated, with a safety profile consistent with single agent nivolumab.

“These new data are further confirmation of the ability of our ImPACT platform, which has been administered to over 200 patients in 4 clinical studies, to generate a robust antigen-specific immune response, an important component of immunotherapy,” said Jeff Wolf, Heat’s CEO.  “The future of immuno-oncology lies in combining synergistic modalities to create more effective treatments. At Heat, we are actively pursuing opportunities to combine our ImPACT and ComPACT platforms with checkpoint inhibitors, and other promising immunotherapies to improve patient outcomes.”

One analyst follows Heat Biologics, Inc. and assigns a “Strong Buy” rating to HTBX with a price target of $4.00.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

Ticker Symbol HTBX
Last Price a/o 10:16 AM EST  $                    0.92
Average Volume 2.38 million
Market Cap $17.79 million
Sales $0.20 million
Shares Outstanding 23.23 million
Share Float 21.66 million
Shortable No
Optionable No
Inside Ownership 30.02%
Short Float 8.42%
Short Interest Ratio 0.76
Quarterly Return -45.29%
YTD Return -68.61%
Year Return -67.54%

Merrimack Pharmaceuticals Inc. (Nasdaq: MACK) Halts Phase 2 Study – Shares Plummet

Merrimack Pharmaceuticals Inc.; Nasdaq: MACK

Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) shares have dropped over 18% in pre-market trading following today’s announcement that, following a recent independent Data and Safety Monitoring Board (DSMB) recommendation and subsequent futility analysis, it has decided to stop the Phase 2 HERMIONE study of MM-302 (HER2 antibody-targeted liposomal doxorubicin) in HER2-positive metastatic breast cancer patients who had previously been treated with trastuzumab (Herceptin®), pertuzumab (Perjeta®) and ado-trastuzumab emtansine (T-DM1, Kadcyla®).

The decision to stop the trial was made following the DSMB’s opinion that continuing would be unlikely to demonstrate benefit over the comparator treatments. Subsequent to this recommendation, a futility assessment was performed that confirmed the DSMB’s opinion. Both the treatment and control arms were found to have shorter than expected median progression free survival.

From Merrimack Phamaceutical’s press release:

“Late line HER2-positive breast cancer is very difficult to treat, especially in this new and previously unstudied group of patients who appear to experience rapid cancer progression following treatment with trastuzumab, pertuzumab and ado-trastuzumab emtansine,” said. “While we are disappointed with this outcome, we would like to thank the study Steering Committee, the investigators and, most importantly, the patients who participated in the HERMIONE trial. We will report our learnings from this study at a later date.”

Three analysts cover Merrimack Pharmaceuticals Inc. All have given MACK a rating of “Hold” but it is important to note that none of the ratings have been reviewed since today’s announcement. MACK shares have never had a positive EPS – in 2015 Mack had a loss of $1.33 EPS. Sales have performed better. In 2012, sales were reported at $34.2 million and in 2015 sales were reported at $89.3 million.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

Ticker Symbol MACK
Last Price a/o 8:10 AM EST  $                    4.60
Average Volume 3.4 million
Market Cap $678.7 million
Sales $104.5 million
Shares Outstanding 126.4 million
Share Float 119.32 million
Shortable Yes
Optionable Yes
Inside Ownership 0.10%
Short Float 32.17%
Short Interest Ratio 11.29
Quarterly Return 5.71%
YTD Return -32.03%
Year Return -30.71%

Regulus Therapeutics(Nasdaq: RGLS) Up Big in After-Market for Unknown Reasons

Regulus Therapeutics Inc.; Nasdaq: RGLS

San Diego, CA-based Regulus Therapeutics Inc. is trading higher on average volumes. Traded on the Nasdaq under ticker symbol RGLS, the shares closed over 6% down at $2.30. However, RGLS is trading up almost 24% in the after-hours market and reached $2.85 at the time of this writing. Regulus Therapeutics website and a web search revealed no new news on the company.

Regulus was formed in September 2007 by Alnylam Pharmaceuticals (Nasdaq: ALNY) and Isis Pharmaceuticals, now Ionis Pharmaceuticals (Nasdaq: IONS) and has continued to build upon its thought leadership, knowledge base, and intellectual property to become the leader in microRNA therapeutics.

Seven firms follow Regulus Therapeutics Inc. Four rate RGLS as a “Strong Buy”; one rates it a “Buy”; and two rate it as a “Hold”. The consensus price target is $9.00. In 2015 the company reported sales of $20.8 million and an EPS loss of $1.08.

According to InsiderMonkey.com’s research into 13-F filings, the number of long hedge fund positions recently went up by four. A total of 9 of the hedge funds tracked by Insider Monkey were bullish on this stock – an 80% jump from one quarter earlier.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

Ticker Symbol RGLS
Last Price a/o 4:00 EST  $               2.30
Average Volume 486,900
Market Cap $114.15
Sales $12 million
Shares Outstanding 49.63
Share Float 34.56 million
Shortable Yes
Optionable Yes
Inside Ownership 42.92%
Short Float 8.79%
Short Interest Ratio 6.24
Quarterly Return -32.55%
YTD Return -73.62%
Year Return -73.32%

Akebia Therapeutics (Nasdaq: AKBA) Up on News of Partnership

Akebia Therapeutics; Nasdaq: AKBA

Shares of Cambridge, MA-based Akebia Therapeutics (Nasdaq: AKBA) were up over 40% on company reports that they have formed a $1 billion partnership with Otsuka Pharmaceutical for its late-stage drug Vadadustat, an oral treatment for anemia related to chronic kidney disease. The deal includes $265 million in committed cash, with $125 million as an upfront payment and another $35 million due in early 2017.

President and CEO of Akebia Therapeutics, John Butler remarked on the deal in a press release:

“Our alliance with Otsuka, one of the world’s innovative pharmaceutical leaders, also allows us to prepare an optimal launch of Vadadustat, as we will equally share commercial responsibility. Otsuka brings a well-established commercial presence and infrastructure in the U.S., and we share a strong commitment to improving patients’ lives by delivering important new therapeutic options. This deal also underscores the confidence that we and others have placed in the underlying value of Vadadustat and in our ability to bring innovative therapies to patients.”

In the phase 2a trial Vadadustat significantly increased hemoglobin levels compared to baseline in a dose-dependent manner across all treatment arms (P < .0001). Further, Vadadustat provides a physiologic reticulocyte response, ie, newly formed red blood cells (RBCs), which leads to a more gradual and consistent increase in hemoglobin levels than what is seen with injectable rESA therapies. This means that these improvements occur without causing patients’ hemoglobin to rise to levels that cause concern.

The consensus pricae target among anayalsts is $17. Four analysts cover AKBA with two assigning a rating of “Buy’ and two with a rating of “Strong buy”. Akebia Therapeutics has no reported sales and has never experienced positive EPS. In the past AKBA has trade near $7 but also traded near the $10 handle this past April.

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

Ticker Symbol AKBA
Last Price a/o 10:00 AM EST  $               9.96
Average Volume 143,400
Market Cap $311.2 million
Sales $-
Shares Outstanding 37.27 million
Share Float 31.53 million
Shortable Yes
Optionable Yes
Inside Ownership 0.50%
Short Float 5.94%
Short Interest Ratio 13.05
Quarterly Return -9.73%
YTD Return -35.37%
Year Return -32.39%

Egalet Corporation (Nasdaq: EGLT) Up on Positive News

Egalet Corporation – Nasdaq: EGLT

Shares of Egalet Corporation, based in Wayne, PA, are up today on heavy volume in response to positive news as reported by the company. Egalet Corporation announced positive top-line results from a Category 3 intranasal human abuse potential study of Egalet-002, an abuse-deterrent, extended-release oxycodone product candidate which uses Egalet’s Guardian™ Technology. Egalet-002 is in late-stage development for the management of severe pain that requires around-the-clock, long-term opioid treatment and for which other treatment options are inadequate.

From Egalet Corporation’s press release:

“Given that intranasal abuse is the most common form of non-oral oxycodone abuse, these results, having hit the primary endpoint of reduced maximum drug liking, are promising,” said Bob Radie, president and chief executive officer. “We will look to submit the full data for presentation at a medical meeting in 2017.”

Shares of EGLT closed at $7.01 yesterday but at 2:33 EST shares were trading at $8.12 on heavy volume. Shares of EGLT traded below $4.00 in mid-2015 and above $19.00 in early 2015. Corporate sales rocketed in 2015 – $22.8 million from just $600k in 2011. However, EPS have suffered. In 2015 there was an EPS loss of $2.94, preceded in 2014 by an EPS loss of $2.97. EGLT is traded on the Nasdaq. It is also note-worthy that EGLT has a large short-sale float: 31.7%.

Always perform your own due diligence before making any decisions regarding the buy or sale of any stock. All information or data is provided without any guarantee of its accuracy.

Ticker Symbol EGLT
Last Price a/o 2:44 EST  $                     8.28
Average Volume 556,730
Market Cap $167.12 million
Sales $30.2 million
Shares Outstanding 22.84 million
Share Float 21.99 million
Shortable Yes
Optionable No
Inside Ownership 1.80%
Short Float 31.70%
Short Interest Ratio 12.52
Quarterly Return -1.68%
YTD Return -36.39%
Year Return -34.73%

 

Interspace Diagnostics Group Inc. (Nasdaq: IDXG) – One to Keep Your Eye On?

Interspace Diagnostics Group – Nasdaq: IDXG 

For most of November, Interspace Diagnostics Group Inc. shares (Nasdaq: IDXG) traded below $0.20. That price action resulted in the Nasdaq notifying, on November 29, 2016, Interspace Diagnostics that it was in violation of maintaining the minimum required $2.5 million in shareholder equity. Failure to bring IDXG into compliance could result in the shares being delisted from the Nasdaq. Since then IDXG has traded just short of $2.00 and closed on Tuesday December 13, 2016 at $1.13. This price action has resulted in a monthly return of over 700%.  

About Interspace Diagnostics Group Inc.: 

Interpace Diagnostics is focused on developing and commercializing molecular diagnostic tests, leveraging the latest technology and personalized medicine for better patient diagnosis and management. The company currently has three commercialized molecular tests; PancraGen for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; ThyGenX, for the diagnosis of thyroid cancer from thyroid nodules utilizing a next generation sequencing assay and ThyraMIR, for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay. Interpace Diagnostics mission is to provide personalized medicine through molecular diagnostics and innovation to advance patient care based on rigorous science. 

On December 13, 2016 Interspace Diagnostics Group announced that it has launched a multi-site study to provide further evidence of the Clinical Utility of the ThyGenX/ThyramiR tests in accurately identifying malignancy or benign status in indeterminate thyroid nodules.  The primary objective of the study is to demonstrate the real world clinical utility of the test, i.e. the degree to which the tests impact physician decision-making and positively affect patient outcomes.  To date, the Company has performed the combination assay on over 5,000 patients on behalf of over 200 physicians and hospitals nationwide. 

The company needs good news going forward. In 2011, Interspace Diagnostics reported a loss of $0.26 EPS on sales of $157.3 million. Last year, shares of IDXG lost $2.01 EPS on sales of just $9.4 million. At the time of this writing no analysts covered the stock but press reports put unattributed rumors of a $3.00 price target. Shares have recently seen highs on larger than average volumes and it is interesting to note that IDXG is not maligned by a large short-sale effort.  

Always perform your own due diligence before making any decisions regarding the buy or sale of any stock. The below data is provided without any guarantee of its accuracy.

Ticker Symbol IDXG
Last Price a/o 9:20 EST  $               1.07
Average Volume 3.7 million
Market Cap $13.15 million
Sales $12.5 million
Shares Outstanding 13.6 million
Share Float 11.3 million
Shortable Yes
Optionable No
Inside Ownership 1.10%
Short Float 3.40%
Short Interest Ratio 0.1
Quarterly Return 410.50%
YTD Return 106.40%
Year Return 70.20%

Neovasc Inc. (Nasdaq: NVCN) Up on BSX Agreement

Neovasc Inc. Announces BSX Agreement – Shares/Volumes Skyrocket!

Shares of Neovasc Inc, a Canadian based company trading on the Nasdaq under ticker NVCN, were up over 38% in early trading. Neovasc Inc. is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. Shares of NVCN are apparently reacting to news of an agreement with Boston Scientific Corporation (NYSE: BSX). In the agreement, Boston Scientific would acquire Neovasc’s advanced biologic tissue capabilities, specified manufacturing assets, and $75 million in cash in exchange for a 15% equity share in Neovasc Inc.

Earlier this month NVCN was the subject of a SNU article based on Neovasc Inc.’s update on its clinical experiences with its Tiara transcatheter mitral valve – a device that treats conditions that can lead to heart failure and death. Investors welcomed the December 6th news as NVCN volumes exploded to over two million shares in early trading. NVCN ended with a closing price of around $1.42 but NVCN had traded over $2.00.

Today NVCN traded over $3.00 in early trading before settling back to the $2.50 handle. Volumes are heavy just one hour into trading – so far, about three times the average daily volume.

NVCN is covered by four analysts who have assigned target prices from $9.25 to $15.00.

Information provided below is not guaranteed for its accuracy. As always perform your own due diligence before taking any action regarding any stocks. Biotechnology stocks are inherently risky.

Ticker Symbol NVCN
Last Price a/o 10:25 EST  $               2.50
Average Volume 4.7 million
Market Cap $151.1 million
Sales $9 million
Shares Outstanding 66.8 milion
Share Float 45.19 million
Shortable No
Optionable No
Inside Ownership 6.28%
Short Float 3.45%
Short Interest Ratio 0.34
Quarterly Return 317.28%
YTD Return -49.78%
Year Return -50.00%