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Gainers & Losers Of The Day: ACST, APRI, SBBP, NVDQ, NVCR

Jan11 Pharma 011117

The following are the biotech stocks that made their way onto the Day's Gainers & Losers' list of January 11, 2017.

GAINERS

1. Dextera Surgical Inc. (DXTR)

Gained 81.58% to close Wednesday's trading at $2.07.

News: No news

Anticipated event: Financial results of 2Q ended December 31, 2016 to be reported on Feb.2, 2017.

Ever since its launch last November, the company's MicroCutter 5/80 surgical stapler for minimally invasive surgical procedures is seeing strong demand, according to the company.

Dextera Surgical expects to report MicroCutter product sales of $260,000 to $280,000 for the second quarter of fiscal 2017, ended December 31, 2016. For the third quarter of fiscal 2017 ending March 31, 2017, Dextera anticipates MicroCutter product sales of $400,000 to $500,000 and for the fourth quarter of fiscal 2017 product sales of $700,000 to $800,000. Total MicroCutter product sales for fiscal 2017 are expected to be $1.4 million to $1.6 million compared to $0.4 million for fiscal 2016.

2. Biocept Inc. (BIOC)

Gained 49.72% to close Wednesday's trading at $2.71.

News: No news

Biocept commercializes liquid biopsy tests that provide clinically actionable information to physicians to improve cancer treatment.

The stock rally continued for a second day after the company secured an in-network provider agreement with Blue Cross Blue Shield of Texas, the largest provider of health benefits in that state, on January 10, 2017.

Anticipated event: 2016 Fourth Quarter and Full Year Financial Results to be reported on March 7, 2017.

3. Apricus Biosciences Inc. (APRI)

Gained 12.74% to close Wednesday's trading at $1.77.

News: No news

Anticipated event:

The company plans to re-submit NDA for Vitaros for the treatment of erectile dysfunction as soon as possible this year. Vitaros was turned down by the FDA in July 2008. However, it is approved in Canada and certain countries in Europe, Latin America and the Middle East and is being commercialized in several countries in Europe.

Last November, Apricus was notified about being non-compliant with the $35 million market value of listed securities ("MVLS") requirement. The company is working on its plan to regain compliance with all applicable requirements for continued listing on Nasdaq.

4. Champions Oncology Inc. (CSBR)

Gained 11.68% to close Wednesday's trading at $3.92.

News: No news

Anticipated event: Financial results for Q3 ended January 31, 2017 to be reported on March 13, 2017. In the previous quarter, the company delivered 50% revenue growth.

5. Strongbridge Biopharma plc (SBBP)

Gained 12.50% to close Wednesday's trading at $2.70.

News: No news

Near-term catalysts:

-- Launch Keveyis in April 2017. Keveyis was approved by the FDA in August 2015 to treat all forms of Primary Periodic Paralysis, which is a group of rare hereditary disorders that causes potentially severe episodes of muscle weakness and/or paralysis. Strongbridge acquired the U.S. rights to Keveyis from a subsidiary of Taro Pharmaceutical Industries Ltd. as recently as last month.

-- Enrollment in a phase III trial of COR-003 for the treatment of endogenous Cushing's syndrome, dubbed SONICS, is expected to be completed by end of Q2 2017, and top-line data is anticipated in Q1 2018.

-- Another phase III trial of COR-003 for the treatment of endogenous Cushing's syndrome, dubbed LOGICS, is planned for initiation - with topline data expected to be reported in Q3 2018.

6. Acasti Pharma (ACST)

Gained 11.29% to close Wednesday's trading at $1.38.

News: No news

Near-term catalysts

The company's lead product candidate is CaPre for the treatment of patients with severe hypertriglyceridemia.

-- Acasti plans to complete the protocol and planning of its CaPre phase III clinical trial in patients with severe hypertriglyceridemia in the first half of calendar year 2017, including an End-of-Phase 2 meeting with the FDA.

-- Complete the scale-up of the manufacturing process of CaPre under cGMP conditions in the first half of calendar year 2017, and complete the production of the clinical trial product for the initiation of the phase III trial.

-- Initiate the phase III clinical study for CaPre in patients with severe hypertriglyceridemia during the second half of calendar year 2017.

LOSERS

1. EnteroMedics Inc. (ETRM)

Lost 44.77% to close Wednesday's trading at $15.30.

News: No news

A pullback after an impressive rally. ETRM had gained significantly after 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 had touched a high of $30.41 on January 10, 2017, which is a gain of over 665% in just 3 trading days.

2. Signal Genetics Inc. (SGNL)

Lost 37.64% to close Wednesday's trading at $10.90.

News: No news

A pullback after yesterday's (Jan.10) gain of more than 264%.

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.

3. Diffusion Pharmaceuticals Inc. (DFFN)

Lost 28.14% to close Wednesday's trading at $6.00.

News: No news

Pullback after having had gained as much as 520% in just 2 trading days.

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.

4. GenVec Inc. (GNVC)

Lost 25.94% to close Wednesday's trading at $6.51.

News: No news

Pullback after having had gained as much as 177% in 2 trading days.

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.

5. Neuralstem Inc. (CUR)

Lost 23.27% to close Wednesday's trading at $4.65.

News: No news

Pullback after having had gained as much as 61% in 2 trading days.

A 1-for-13 reverse stock split was implemented by the company on January 9, 2017 in order to regain compliance with the $1.00 minimum bid price condition.

6. NOVADAQ Technologies Inc (NVDQ)

Lost 15.03% to close Wednesday's trading at $6.50.

News: Preliminary Q4 2016 revenue and 2017 revenue guidance announced

The company expects revenue for fourth quarter ended December 31, 2016 to be approximately $20.2 million, which is well short of analysts' expectation of $25.37 million.

NOVADAQ anticipates revenue for full year 2017 to be in the range of $98 million to $102 million, representing growth in the range of 22% to 27% year-over-year. The 2017 revenue guidance is also shy of analysts' estimate of $111.3 million.

7. Novocure (NVCR)

Lost 9.20% to close Wednesday's trading at $7.40.

News: No news

Anticipated event: Q4 and full-year 2016 financial results to be reported on February 23, 2017.

The company announced its preliminary operating statistics for the fourth quarter and full year 2016 on Jan.10, 2017.

According to the preliminary statistics, 706 prescriptions were received in the fourth quarter of 2016, up from 690 prescriptions in the prior quarter. (A "prescription received" is a commercial order for the company's commercialized product, Optune). 2,808 prescriptions were received in 2016, an increase of 58 percent versus 2015.

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