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EBIO To Report Phase III Data In May, EYPT Catches Eyes, SIEN Gets FDA Nod


The following are some of today's top gainers in the pharma/biotech sector.

1. EyePoint Pharmaceuticals Inc. (EYPT)

Gained 15.13% to close Thursday's (Apr.19) trading at $1.75.

News: No news

Recent events:

-- On March 28, 2018, pSivida Corp. (PSDV) acquired specialty biopharmaceutical company Icon Bioscience Inc.
-- pSivida Corp. rebranded and changed its name to EyePoint Pharmaceuticals Inc., with ticker EYPT, effective April 2, 2018.

Near-term Catalysts:

-- DEXYCU, a dropless, long-acting therapeutic, which was approved by the FDA for the treatment of inflammation in post cataract surgery on February 9, 2018, is expected to be launched in the U.S. in the first half of 2019 following the successful scale up of commercial supplies.

-- The NDA for YUTIQ micro-insert, proposed for treatment of non-infectious posterior segment uveitis, is under FDA review - with a decision expected on November 5, 2018.

2. Bio-Path Holdings Inc. (BPTH)

Gained 14.46% to close Thursday's trading at $1.90.

News: The Company presented encouraging data from pre-clinical studies supporting the potential of Prexigebersen (BP1001, liposomal Grb2 antisense), in the treatment of solid tumors in gynecologic malignancies.

The data showed there was an eighty-six percent (86%) decrease in tumor burden, and multinodular burden in the combination Prexigebersen/paclitaxel group compared to control. In addition, there was no apparent toxicity associated with the combination therapy.

3. Bioblast Pharma Ltd. (ORPN)

Gained 13.64% to close Thursday's trading at $2.25.

News: No news


The Company's lead compound is Trehalose, which is being explored in the indications of oculopharyngeal muscular dystrophy (OPMD) and spinocerebellar ataxia type 3 (SCA3).

Recent event:

-- On November 2, 2017, while reporting third quarter 2017 financial results, the Company revealed that it has engaged JSB-Partners, a global life sciences advisor, to assist in executing its business development objectives that include selecting potential development and commercial partners for its investigational product Trehalose as well as exploring merger opportunities. The Company is devoting substantially all of its resources to this effort.

4. Galectin Therapeutics Inc. (GALT)

Gained 8.90% to close Thursday's trading at $3.67.

News: No news

Pipeline & Clinical Trials:

The Company's lead drug candidate is GR-MD-02 for the treatment of non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH related fibrosis.

GR-MD-02 has been successfully studied in a phase IIb clinical trial in NASH cirrhosis patients, dubbed NASH-CX trial.

On December 5, 2017, the Company announced that its NASH-CX trial of GR-MD-02 showed statistically significant and clinically meaningful results in reducing the primary endpoint measurement of HVPG (hepatic venous pressure gradient) in comparison to placebo in NASH cirrhosis patients without esophageal varices, which represented 50 percent of the patients enrolled in the clinical trial.

Near-term Catalyst:

-- Peter Traber, the Company's CEO and CMO, will participate in multiple presentations, including a keynote session, during the 2nd Annual NASH Summit being held at the Revere Hotel Boston Common in Boston on April 23-25, 2018.

5. Eleven Biotherapeutics Inc. (EBIO)

Gained 8.72% to close Thursday's trading at $1.62.

News: No news

Near-term Catalyst:

-- The first, topline data from its phase III trial of Vicinium in patients with high grade non-muscle invasive bladder cancer, dubbed VISTA, are expected to be presented on May 21, 2018, at this year's American Urological Association Annual Meeting being held in San Francisco.

6. Sientra Inc. (SIEN)

Gained 8.42% to close Thursday's trading at $11.98.

News: The FDA has approved the Company's PMA supplement allowing commercialization of its OPUS-branded breast implant products manufactured by Vesta, a Lubrizol LifeSciences company, at Vesta's Wisconsin-based manufacturing facility.

The commercial sale of U.S.-manufactured OPUS branded breast implants is expected to begin immediately.

The FDA approval entitles Sientra access to an additional $10.0 million tranche of term debt under its credit facility with MidCap Financial Services and Silicon Valley Bank.

Jeffrey Nugent, Chairman and Chief Executive Officer of Sientra, commented, "This FDA approval allows us to commercialize our OPUS-branded breast implants with an improved manufacturing process and represents a critical milestone for Sientra. The approval culminates over two years of successful collaboration between the Sientra and Vesta teams".

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