Depomed Inc. (Nasdaq: DEPO) Buyout Imminent?

Depomed Inc. – Nasdaq: DEPO

A New York Post article is sending shares of Depomed Inc. higher in pre-market trading. Depomed Inc. trades on the Nasdaq under ticker DEPO. The article claims that famed Wall St buy-out firm KKR is interested in purchasing Depomed. Previous reports had put any buyout offer would be around $25 a share. At 9:00 AM EST trading for DEPO was under $20.

Newark, CA-based Depomed had previously rejected attempts to purchase the company before finally putting itself out for sale to the market. The moves to reject potential suitors brought scorn for Depomed’s board from shareholders who threatened to remove several board members.

Depomed Inc. specializes in the production of painkillers. Cambria is a drug that addresses migraine headaches but Nucynta, an opiod that carries addiction risks, is their largest source of revenue – $72 million in the last quarter. In addition to its ability to develop and commercialize new drugs, Depomed also has successfully developed and licensed its unique drug-delivery technology, Acuform®. This patented oral-delivery technology allows for the targeted, extended release of pharmaceutical compounds into the upper gastrointestinal tract.

Eight firms follow Depomed Inc. Shares of DEPO have been rated by five analysts as a “Strong Buy”; two as a “Hold”; and one rates it a “Sell”. Revenues and EPS both suffered in 2015 from their 2014 highs.

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.

1/3/17
Ticker Symbol DEPO
Last Price a/o 9:00 AM EST $19.87
Average Volume 1.68 million
Market Cap 1.11 Billion
Sales $443.2 million
Shares Outstanding 61.42 million
Share Float 60.98 million
Shortable Yes
Optionable Yes
Inside Ownership 0.40%
Short Float 20.61%
Short Interest Ratio 7.46
Quarterly Return -27.83%
YTD Return -0.61%
Year Return -0.61%

Inotek Pharmaceuticals Corporation (Nasdaq: ITEK) Reports Failed Phase 3 Results

Inotek Pharmaceuticals Corporation – Nasdaq: ITEK

Shares of Inotek Pharmaceuticals Corporation plunged over 65% in heavy trading this morning after the company announced disappointing results from their Phase 3 trial. Inotek Pharmaceuticals Corporation trades on the Nasdaq under the ticker symbol ITEK.

Lexington, MA-based Inotek Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for glaucoma and other eye diseases.

From the press release:

“The trial did not achieve its primary endpoint of superiority in reduction of intraocular pressure compared with placebo at all 12 time points. This was, in part, due to a placebo response that was 2-3 mmHg greater than that observed in Phase 2.”

David P. Southwell, President and Chief Executive Officer of Inotek stated, “We are disappointed that the primary endpoint of superiority at all 12 time points was not achieved. This result was driven primarily by the unexpectedly stronger placebo response at the 8AM time point.”

Five firms followed Inotek Pharmaceutical Corporation. All five gave shares of ITEK a rating of “Strong Buy” with a consensus price target of $22. ITEK has never reported any revenues and since 2012 ITEK has reported increasing negative EPS: 2012: -$0.52; 2015: -$3.72.

Inotek Pharmaceuticals Corporation ( ITEK ) will host a conference at 8:30 AM ET on January 3, 2017, to discuss the results from the MATrX-1 Phase 3 trial.

To access the live webcast, log on at www.inotekpharma.com

To listen to the call, dial (844) 358-9183 (US) or (478) 219-0400 (International)

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.

1/3/17
Ticker Symbol ITEK
Last Price a/o 7:48 AM EST $2.10
Average Volume 313,210
Market Cap $175 million
Sales
Shares Outstanding 28.69 million
Share Float 26.59 million
Shortable Yes
Optionable Yes
Inside Ownership 5.17%
Short Float 9.00%
Short Interest Ratio 7.65
Quarterly Return -25.65%
YTD Return -46.16%
Year Return -46.16%

Fortress Biotech Inc. (Nasdaq: FBIO) Soaring in Pre-Market

Fortress Biotech, Inc. – Nasdaq: FBIO

Shares of Fortress Biotech Inc. are up over 50% on heavy volume in pre-market trading. FBIO, traded on the Nasdaq, closed Wednesday at $2.29, but Thursday pre-market trading has seen the shares hit $3.50. Investors appear to be flocking to FBIO based on reports that a cancer-stricken patient had responded favorably to a treatment developed by Fortress’s Mustang Bio Inc. unit using T-Cells. The reports suggest that the patient had not experienced improvement with traditional approaches.

Dr. Lindsay A. Rosenwald, Fortress Biotech’s Chairman, President and Chief Executive Officer, said, “We are excited to share this unprecedented research conducted by Mustang’s partners at City of Hope, which confirms the potential of MB-101 to be a breakthrough immunotherapeutic targeted against GBM, an almost universally fatal brain tumor. MB-101’s compelling clinical activity adds to the growing pipeline of therapies developed by our Fortress Companies that have the potential to transform the treatment of life-threatening diseases.”

Michael S. Weiss, Mustang Bio’s Executive Chairman, commented, “We are extremely encouraged by the response seen in this patient.  As the first patient ever to receive intraventricular delivery of CAR T cells for brain tumors, we see this as proof of concept that CAR T cells can be delivered safely and with remarkable effect to patients with GBM.  This robust response has prompted the expansion of our Phase 1 study to evaluate intraventricular administration in a larger cohort of patients.  Given the poor outcomes for patients with GBM, we believe if we see additional patients with this type of response that we can explore a possible accelerated approval pathway, similar to that proposed by some of the other CAR T companies, which are targeting different forms of cancer.”

The sole analyst that covers FBIO rates it a “Strong Buy” with a price target of $11. FBIO had traded above $12 in 2013 and Fortress Biotech has never had a positive year of EPS. However, 2015 was the first year Fortress Biotech reported any sales – $900,000. FBIO appears to be a favored target of short-sellers and investors should perform their own due diligence prior to making any investment decisions as biotech shares are notoriously volatile.

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.

12/29/2016
Ticker Symbol FBIO
Last Price a/o 7:22 AM EST  $                      3.45
Average Volume 90,600
Market Cap $104.84 million
Sales $4.2 million
Shares Outstanding 45.78 million
Share Float 29.28 million
Shortable Yes
Optionable Yes
Inside Ownership 0.80%
Short Float 12.45%
Short Interest Ratio 40.23
Quarterly Return -22.11%
YTD Return -17.92%
Year Return -17.03%

 

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%