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Gainers & Losers Of The Day: CATB, MCUR, BIOC, SSH, ZYNE…

Jan19 011917

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of January 19, 2017.

GAINERS

1. Catabasis Pharmaceuticals Inc. (CATB)

Gained 19.76% to close Thursday's (Jan.19) trading at $4.97.

News: Catabasis' positive phase I data on Edasalonexent (CAT-1004) published in the Journal of Clinical Pharmacology

The phase I data on Edasalonexent, a potential disease-modifying therapy being developed for Duchenne muscular dystrophy, demonstrating excellent safety and tolerability, was reported in 2013. The results have now been published in the Journal of Clinical Pharmacology.

A phase II trial of Edasalonexent in boys affected by Duchenne muscular dystrophy, dubbed MoveDMD, is ongoing, with top-line results anticipated in the first half of Q1 2017.

2. Macrocure Ltd. (MCUR)

Gained 15.53% to close Thursday's trading at $1.71.

News: Leap Therapeutics Inc., with which Macrocure is merging, has reported promising biomarker data from a clinical study of DKN-01 in combination with Paclitaxel in esophageal cancer.

In the study to date, Leap has enrolled 44 patients with advanced esophageal and gastroesophageal junction cancers who had received between 1 and 7 prior lines of therapy. 10 of 41 evaluable patients achieved a partial response and 15 patients achieved a best overall response of stable disease, representing a total disease control rate of 61%.

Upon completion of the prospective merger, Macrocure will become a wholly owned subsidiary of Leap, and Leap will become a public company that will trade on The Nasdaq Global Market under the symbol "LPTX".

3. DelMar Pharmaceuticals Inc. (DMPI)

Gained 14.86% to close Thursday's trading at $3.71.

News: No news.

The company's key product candidate is VAL-083. DelMar is preparing to advance VAL-083 into a pivotal Phase III clinical trial in the United States as a potential treatment for refractory glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.

In a previously conducted phase I/II clinical trial, the median survival of 22 patients receiving an assumed therapeutic dose of VAL-083 was 8.35 months following Avastin failure compared to published literature where survival of approximately two to five months has been reported.

4. Biocept Inc. (BIOC)

Gained 9.27% to close Thursday's trading at $1.65.

News: Biocept has been awarded patent in Australia for the use of antibodies in microchannels to capture circulating tumor cells and other rare cells.

The company noted that granting of patents in international markets supports its activities to expand distribution of its liquid biopsy platform worldwide. The liquid biopsy tests can provide an alternative to invasive tissue biopsies by using a simple blood sample to obtain valuable biomarker information.

LOSERS

1. Sunshine Heart Inc. (SSH)

Lost 19.74% to close Thursday's trading at $6.14.

News: No news

A 1-for-30 reverse split of common stock came into effect on January 13, 2017.
The number of authorized shares of the company's common stock will remain at 100,000,000, while the number of outstanding shares will be reduced from approximately 25.3 million to 0.8 million, noted the company in a Press release dated January 12, 2017.

Anticipated event: Q4 and full-year 2016 financial results are scheduled for March 1, 2017.

2. Zynerba Pharmaceuticals Inc. (ZYNE)

Lost 19.37% to close Thursday's trading at $18.11.

News: The company has priced its public offering of common stock at $18.00 per share.
Zynebra has offered to sell 2.8 million shares of its common stock to the public. The gross proceeds to Zynerba are expected to be $50.4 million.

The company's most-advanced product candidate is ZYN002-CBD Gel, which is under phase II development for refractory epilepsy, osteoarthritis of the knee and Fragile X Syndrome. The top-line results from all three phase II clinical trials are expected in the first half of 2017.

3. Diffusion Pharmaceuticals Inc. (DFFN)

Lost 16.77% to close Thursday's trading at $4.17.

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.

The company's shares were uplisted from OTC to the NASDAQ on November 9, 2016.

4. Apricus Biosciences Inc. (APRI)

Lost 16.43% to close Thursday's trading at $2.39.

News: No news

Pullback after yesterday's gain of 89%.

The news of the company's topical cream Vitaros getting approved for the treatment of erectile dysfunction in Mexico sent its shares soaring 89.40% to $2.86 on Jan.18, 2017.

5. Infinity Pharmaceuticals, Inc. (INFI)

Lost 9.88% to close Thursday's trading at $1.55.

News: No news

Looks like the stock has given up almost all of yesterday's (Jan.18) gain.

6. Strongbridge Biopharma plc (SBBP)

Lost 9.26% to close Thursday's trading at $2.45.

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 December 23, 2016.
-- 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.

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