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Gainers & Losers Of The Day: BIOC, CUR, ONTX, EGLT, ABAX...

Jan10 Pharma 011017

The following are the biotech stocks that made their way onto the Day's Gainers & Losers' list of January 10, 2017.

Signal Genetics Inc. (SGNL)

Gained 264.93% to close Tuesday's trading at $17.48.

News: No news

Anticipated event:

Last October, Signal Genetics and privately-held Miragen Therapeutics Inc. agreed to merge to create a clinical-stage, NASDAQ-listed, biopharmaceutical company developing proprietary micro RNA-targeted therapeutics. The combined company will change its name to Miragen Therapeutics Inc., and ticker to MRGN.

A special meeting of Signal stockholders related to the proposed merger with Miragen is scheduled for February 10, 2017.

The proposed merger is expected to close in the first quarter of 2017.

Signal implemented a 1-for-15 reverse stock split of its common stock on November 7, 2016.

ImmunoCellular Therapeutics Ltd. (IMUC)

Gained 91.78% to close Tuesday's trading at $4.20.

News: No news

Near-term catalyst:

Preliminary data from phase 1 open-label trial of ICT-121 in recurrent glioblastoma expected around mid-2017.

Biocept Inc. (BIOC)

Gained 77.45% to close Tuesday's trading at $1.81.

News: Biocept is partnering with Blue Cross Blue Shield of Texas, the largest provider of health benefits in that state.

The partnership with Blue Cross Blue Shield of Texas will help to increase physician access to the company's liquid biopsy technology for their patients and provide timely adjudication of claims for patients. The company has commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma.

GenVec Inc. (GNVC)

Gained 76.86% to close Tuesday's trading at $8.79.

News: No news

GenVec's lead product candidate is CGF166, which is licensed to Novartis and is currently in a Phase 1/2 clinical study for the treatment of hearing loss and balance disorders.

Last week, the company entered into an exclusive option agreement with Washington University in St. Louis to license intellectual property and technology related to gene editing and pulmonary endothelial cell targeting.

GNVC has gained more than 133% in the last two trading days.

Neuralstem Inc. (CUR)

Gained 59.06% to close Tuesday's trading at $6.06.

News: The company has been issued a patent (No. 9,540,611) covering methods for the treatment of neurological diseases/disorders using neural stem cells (NSCs) obtained from a spinal cord tissue by the USPTO.

EnteroMedics Inc. (ETRM)

Gained 56.50% to close Tuesday's trading at $27.70.

News: No news

EnteroMedics shares extended the rally to a third day. The stock has been on a tear since the January 5th announcement about the availability of its VBLOC neurometabolic therapy for the treatment of obesity at two additional institutes - which brings the total number of institutes to have implanted the therapy to 13.

The stock has gained a whopping 597% in just the last four trading days.

Diffusion Pharmaceuticals Inc. (DFFN)

Gained 46.49% to close Tuesday's trading at $8.35.

News: No news

Anticipated event:

The company's lead investigational drug is Trans Sodium Crocetinate or TCS, which is being investigated to enhance the efficacy of radiation and chemotherapy. TSC is designed to work by safely re-oxygenating oxygen deprived (hypoxic) tissue. Hypoxia is an especially critical obstacle in the treatment of cardiovascular and respiratory diseases, as well as in cancer.

A phase II study of TCS in Glioblastoma produced encouraging results - with overall survival increasing by 37% at 2 years. An end of phase II meeting with the FDA was held in May 2015 and the company was informed that a single phase III study could serve as the basis for approval.

Diffusion Pharma expects to begin enrollment in the phase III study of TSC in Glioblastoma in the first half of this year.

DFFN has gained an impressive 234% in the last two trading days.

CombiMatrix Corp. (CBMX)

Gained 30.36% to close Tuesday's trading at $3.65.

News: No news

Anticipated event: Q4 and Full-year financial results to be reported on February 15, 2017.

The last what we heard from the company was on November 29, 2016 when it announced that its pre-implantation genetic screening (PGS) by next generation sequencing (NGS) test has received conditional approval from the New York State Department of Health. The test assists in maximizing the chance of successful implantation and pregnancy progression, while decreasing the likelihood of miscarriage. This test is an important contributor to revenue, according to the company.

Onconova Therapeutics Inc. (ONTX)

Gained 31.95% to close Tuesday's trading at $3.18.

News: No news

Anticipated event: Corporate overview to be presented at Biotech Showcase 2017 on January 11, 2017 at 2:00 p.m.

Moleculin Biotech Inc. (MBRX)

Gained 25.94% to close Tuesday's trading at $2.67.

News: No news

Near-term catalyst: Report data from phase II trial evaluating Annamycin as a potential treatment for relapsed or refractory acute myeloid leukemia by the second half of 2017.

Roka Bioscience Inc. (ROKA)

Gained 22.45% to close Tuesday's trading at $6.00.

News: No news

Anticipated event: Q4 and Full-year financial results to be reported on March 2, 2017.

Sarepta Therapeutics Inc. (SRPT)

Gained 21.21% to close Tuesday's trading at $37.89.

News: Sarepta enters into license agreement with Nationwide Children's Hospital for Galgt2 gene therapy program.

The Galgt2 gene therapy has the potential to treat all patients suffering from Duchenne muscular dystrophy regardless their mutation, according to the company.
The company expects to begin clinical trial of Galgt2 gene therapy during this year.

As you may know, Sarepta has one approved drug - Exondys 51 - for treatment of patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with Duchenne muscular dystrophy.

Apricus Biosciences Inc. (APRI)

Gained 20.76% to close Tuesday's trading at $1.57.

News: Corporate presentation J.P. Morgan 35th Annual Healthcare Conference

Near-term catalysts:

Up to thirteen Vitaros launches/re-launches planned in Europe, Latin America and Middle East through Q2 2017. Vitaros is a topical cream for the treatment of erectile dysfunction, approved in Canada and certain countries in Europe, Latin America and the Middle East and is being commercialized in several countries in Europe. It is not approved in the U.S. yet.

Identify a potential partner for RayVa, an investigational topical cream that is being developed to treat the symptoms associated with Raynaud's Phenomenon secondary to systemic sclerosis.

Resubmit Vitaros NDA to the FDA in 3Q, 2017.

Aradigm Corporation (ARDM)

Gained 17.14% to close Tuesday's trading at $2.05.

News: No news

Near-term catalysts:

Submit NDA for Pulmaquin for the treatment of non-cystic fibrosis bronchiectasis in the first half of this year and file for approval in the European Union in the second half.

Illumina Inc. (ILMN)

Gained 16.60% to close Tuesday's trading at $165.04.

News: No news

Anticipated event: Q4 and Full-year financial results to be reported on January 31, 2017.

InspireMD Inc. (NSPR)

Gained 14.80% to close Tuesday's trading at $3.18.

News: No news

The company's CGuard Embolic Prevention System (EPS) is designed to prevent peri-procedural and late embolization. It is CE Marked and not approved for sale in the U.S. by the FDA.

Anticipated events:

Commercial launch of CGuard EPS in Brazil in the first half of 2017.
Commercial launch of CGuard EPS in India in the second half of 2017.
File an IDE submission for CGuard EPS in the United States this year.

Losers

Egalet Corp.(EGLT)

Lost 22.20% to close Tuesday's trading at $6.52.

News: FDA approved ARYMO ER tablets C-II for treatment of chronic pain. But investors disappointed about the drug's labeling statement.

ARYMO ER has received FDA approval for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

However, the FDA has not supported the company's claim on ARYMO ER labeling that the pain pill deters abuse through injection, chewing or snorting.

The FDA in a statement has said that "abuse of Arymo ER by injection is difficult. However, abuse by the intravenous, intranasal, and oral routes is still possible".

NanoString Technologies Inc. (NSTG)

Lost 21.75% to close Tuesday's trading at $17.99.

News: Preliminary Q4 and Full-year 2016 financial results announced.

The company expects total revenue to be in the range of $24.2 to $25.7 million for the fourth quarter of 2016 and range between $85.5 and $87.0 million for full year 2016. But analysts were expecting total revenue of $29.07 million for Q4 and $90.59 million for the full year.

The company is scheduled to report Q4 and Full-year 2016 financial results on March 1, 2017.

Akers Biosciences Inc. (AKER)

Lost 12.90% to close Tuesday's trading at $1.35.

News: Secondary offering

The company has offered to sell 1.66 million shares of common stock to the public at a price of $1.20 per share together with the issuance of 833,500 five-year warrants to purchase common stock with an exercise price of $1.50. The gross proceeds are expected to be about $2 million. The offering is expected to close on January 13, 2017.

Abaxis Inc. (ABAX)

Lost 11.69% to close Tuesday's trading at $48.59.

News: Preliminary financial results for Q3 ended December 31, 2016 announced.

Abaxis expects revenues in the third fiscal quarter to be in the range of $52.0 million to $53.0 million, flat with last year's comparable quarter. This estimate is well short of analysts' consensus forecast of $58 million.

Abaxis plans to announce its detailed earnings results on January 26, 2017.

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