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WednesdayJan 18, 2017 1:25 pm

NetworkNewsBreaks – aTyr’s (NASDAQ: LIFE) Resolaris™ Obtains Fast Track Designation from FDA, Partial Clinical Hold Removed

Shares of aTyr Pharma (NASDAQ: LIFE) climbed more than 25% in mid-day trade following news that the company’s Resolaris™ candidate was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of limb girdle muscular dystrophy 2B, making it the first known therapeutic candidate to receive the designation for this treatment. The FDA also removed its partial clinical hold on a dosing ceiling for Resolaris in clinical trials, providing dosing flexibility moving forward. "This Fast Track designation, which is granted to drug candidates addressing serious conditions and that demonstrate the potential to address unmet medical…

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WednesdayJan 18, 2017 1:21 pm

NetworkNewsBreaks – Apricus Biosciences (NASDAQ: APRI) Shares Skyrocket on Approval of Vitaros® in Mexico

Shares of Apricus Biosciences (NASDAQ: APRI) soared more than 153% after the company announced that Mexico has granted Apricus’ commercialization partner, Ferring Pharmaceuticals, market approval for Vitaros®, an on-demand topical cream for erectile dysfunction. Per an agreement between the two companies, Apricus has received a total of $4.5 million in upfront payments from Ferring, in addition to a regulatory milestone payment of $1.6 million. Apricus is eligible to receive up to an additional $28 million in regulatory, launch and sales milestones, plus royalties on future net sales. Ferring is anticipated to launch in Mexico and Argentina during the second quarter…

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WednesdayJan 18, 2017 10:45 am

NetworkNewsBreaks – Aegis Reiterates ‘Buy’ Rating for Xtant Medical Holdings, Inc. (NYSE: XTNT) following 2016 Preliminary Results, Guidance for 2017

Noting two quarters of double-digit growth, Aegis Capital has reiterated its 'Buy' rating and $3.50 price target for Xtant Medical (NYSE MKT: XTNT). Xtant Friday reported preliminary fourth quarter 2016 revenues of at least $24.5 million, an increase of 10% compared to the year ago quarter, and in line with Aegis estimates of $24.6 million. Adjusted EBITDA for the fourth quarter is expected to be at least $1.25 million vs a loss of $350,000 in the fourth quarter of 2015, shy of Aegis’ estimates of $1.5 million. Xtant estimates full-year 2016 revenue of at least $90 million, up 4.1% compared…

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TuesdayJan 17, 2017 3:50 pm

NetworkNewsBreaks – Veru Healthcare (NASDAQ: FHCO) Continues Rally on Launch of OTC Premature Ejaculation Product

Shares of Veru Healthcare (NASDAQ: FHCO) are higher in Monday trade, moving on momentum from the recent launch of the company's proprietary, over-the-counter PREBOOST® product to help prevent premature ejaculation (PE). As the only individually packaged medicated wipe that contains a desensitizing agent (4% benzocaine), PREBOOST allows for discrete, direct and precise dosage with each use. Top line results from an independent clinical study of PREBOOST show that men treated with PREBOOST had statistically significant improvement in their ability to control ejaculation, while 80% were no longer considered to have PE. The intended reach of PREBOOST is two-fold. On one…

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TuesdayJan 17, 2017 2:46 pm

NetworkNewsBreaks – Alcobra (NASDAQ: ADHD) Shares Plunge on Disappointing Results of MDX Clinical Trial

Shares of Alcobra (NASDAQ: ADHD) slumped 49% today after the company reported top-line results from MEASURE, its second phase 3 clinical trial for the investigational product Metadoxine Extended Release (MDX) for the treatment of ADHD in adult patients. MDX did not meet the primary endpoint of demonstrating a statistically significant difference from placebo in the change from baseline of the investigator rating of the Conners’ Adult ADHD Rating Scales (CAARS). "We are exceedingly disappointed with these top-line results. In the coming weeks, the Company intends to review the full data set from MEASURE. Consequently, we will evaluate our options and…

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TuesdayJan 17, 2017 2:05 pm

NetworkNewsBreaks – Top 10 Mid-day Percentage Gainers on January 17, 2017

Here is a list of stocks shaking up the markets today, with particular focus on NASDAQ and OTC small caps. The top gainers based on percentage: PULM 135.33% – News: PUR1900 obtains Qualified Infectious Disease Product designation by FDA OWCP 53.08% – News: Releases annual shareholders letter REXX 27.42% – News: Releases two-year financial and operational plan; provides financial update ITRO 25.19% – News: Ships first silver bullion produced by its e-scrap refining technology HTCO 23.33% – News: Introduces GrowLease: lease programs for its flagship of automated grow systems PME 13.67% – News: Declares Q1 2017 quarterly cash dividend CGIX…

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TuesdayJan 17, 2017 1:18 pm

NetworkNewsBreaks – Benitec (NASDAQ: BNTC) Shares Surge on Orphan Drug Designation for BB-301 in the EU

Benitec Biopharma (NASDAQ: BNTC; BNTCW) is trading 71% higher on news that the company’s BB-301 for the treatment of patients with oculopharyngeal muscular dystrophy (OPMD) has been granted Orphan Drug Designation by the European Commission. The designation, which provides regulatory and financial incentives including a 10-year period of marketing exclusivity in the EU after product approval and protocol assistance from the European Medicines Agency (EMA) during the product development phase, was based on favorable recommendation from the EMA Committee for Orphan Medicinal Products (COMP). Entry into the clinic with a phase I/II study in OPMD patients is anticipated in 2018,…

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TuesdayJan 17, 2017 12:17 pm

NetworkNewsBreaks – Gevo, Inc. (NASDAQ: GEVO) Receives EPA Pathway Approval for Isobutanol as Advanced Biofuel

Gevo (NASDAQ: GEVO) this morning said it has received EPA approval for the pathway for isobutanol to be an advanced biofuel under the Renewable Fuel Standard Program (RFS). This development presents an opportunity for Gevo to achieve the 50% or greater greenhouse gas emissions reduction needed to claim the advanced D5 Renewable Identification Number (RIN). Gevo’s isobutanol currently generates D6 RINs, and with this approval, it could generate D5 RINs as well, which have historically had greater value in the marketplace. “We are pleased that there is now a route for advanced fuels that provides protein that contributes to the…

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TuesdayJan 17, 2017 12:15 pm

NetworkNewsBreaks – Celsion (NASDAQ: CLSN) Shares Hike on Positive Data from the OVATION Study

Shares of Celsion (NASDAQ: CLSN) are up 37% after the company reported positive data from the fourth cohort of patients in its phase Ib dose escalating clinical trial (the OVATION Study). The study combines GEN-1, the company's IL-12 gene-mediated immunotherapy, with the standard of care for the treatment of newly diagnosed patients with stage III and IV ovarian cancer who will undergo neoadjuvant chemotherapy followed by interval debulking surgery. The study has produced significant results, with no dose limiting toxicities and promising efficacy signals in this difficult to treat cancer. Celsion said it expects to report final data in Q2…

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TuesdayJan 17, 2017 9:17 am

NetworkNewsBreaks – Amyris, Inc. (NASDAQ: AMRS) Making Technological Breakthroughs under Guidance of Highly Experienced Management

Amyris (NASDAQ: AMRS) is one of the fastest growing industrial biotechnology companies among the 2,772 in the U.S today. The company's eight-person management team is comprised of hand-picked individuals with a proven ability to innovate and build companies in a number of industries. With over 30 years of experience as a tech entrepreneur and thought leader, president and CEO John Melo has led Amyris from technology development and industrial startup to product development and final commercialization. Thanks to the team's level of experience, Amyris has made outstanding technological breakthroughs, among these is the world's leading treatment for malaria, saving over…

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