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Tobira Therapeutics, Inc. (TBRA)

- NASDAQ
  • Mon, Jun. 8, 1:57 PM
    • Thinly traded micro cap Tobira Therapeutics (TBRA +20.7%) heads north in response to its announcement that enrollment in its Phase 2b trial, called CENTAUR, assessing cenicriviroc (CVC) in patients with non-alcoholic steatohepatitis (NASH) is now complete. The primary endpoint is a two-point improvement in NAFLD Activity Score without progression of fibrosis (scarring). Top-line results are expected in mid-2016.
    • NASH or fatty liver disease affects as many as 5% of adult Americans.
    • CVC is a dual inhibitor of proteins called CCR2 and CCR5 that play key roles in inflammation and fibrosis.
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  • Aug. 25, 2014, 8:52 AM
    • Shares of nano cap Regado Biosciences (NASDAQ:RGDO) plunge 43% premarket on moderately high volume after it announced the permanent termination of patient enrollment in its Phase 3 clinical trial of Revolixys Kit evaluating its safety and efficacy versus bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention.
    • The company based its decision on the recommendation of the Data and Safety Monitoring Board (DSMD) after it completed its analysis of the results from the first 3,250 patients in the trial. The DSMD found that the level of serious allergic adverse events associated with Revolixys was to too high to recommend proceeding.
    • Regado initiated a voluntary halt to patient enrollment in July after the FDA implemented a clinical hold based on the unacceptably high incidence of severe allergic reactions.
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  • Jul. 3, 2014, 7:27 AM
    • Shares of Regado BioSciences (RGDO) are down 38% premarket on light volume in response to its disclosure of an unplanned review of data from the Phase 3 clinical trial of its antithrombotic drug system, Revolixys Kit (previously known as REG1) by The Data Safety Monitoring Board (DSMB). The board will focus its attention on serious adverse events related to allergic reactions. Patient enrollment will cease until the DSMB completes its analysis and communicates its recommendations.
    • Regado will hold a conference call this morning to address the issue.
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  • Jul. 2, 2014, 7:00 PM
    • Regado (RGDO) states the Data Safety Monitoring Board "has initiated an unplanned review of data" for its Regulate-PCI Phase 3 trial.
    • Patient enrolllment  has been paused while the DSMB conducts a review focused on "serious adverse events related to allergic reactions." Its recommendations are expected in the next 8 weeks.
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  • Mar. 10, 2014, 9:11 AM
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  • Sep. 17, 2013, 10:08 AM
    • Regado Biosciences (RGDO +18%) adds to Monday's analyst coverage-fueled gains.
    • Earlier today, the company announced the enrollment of the first subject in a Phase 3 trial of REG1 in "patients undergoing percutaneous coronary intervention electively or for the treatment of unstable angina or non-ST elevated myocardial infarction." (PR)
    • Make no mistake, this is a big deal for RGDO, which priced its IPO at $4 last month after initially filing to sell shares at $14-16 — "If I knew why we missed we'd have hit the target goal," CEO David Mazzo tells FierceBiotech.
    • The IPO did give the company enough money (when combined with an earlier funding round) to get REG1 to an interim analysis, John Carroll says. From there, the hope is that "wary investors will jump into the game in a big way."
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  • Sep. 16, 2013, 9:09 AM
    • Recently-public Regado Biosciences (RGDO) trades 8.7% higher premarket on a bevy of bullish calls.
    • Cowen initiates coverage at Outperform.
    • Canaccord starts the shares at Buy. Price target is $14.
    • BMO weighs in with an Outperform rating and a $12 price target.
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  • Aug. 22, 2013, 4:34 PM
    • Cardiovascular treatment company Regado Biosciences (RGDO) finish the day solidly higher on its market debut after earlier pricing its 10.7 million share IPO at $4.
    • The offering differed significantly from its original plans. In early May the company disclosed plans to sell around 5M shares at $14 to $16 each. That was later revised to 8.4 shares priced at $5.
    • Trading has been caught up in the afternoon-long trading halt for the Nasdaq exchange, with just over 223,000 shares changing hands through mid-day before trading was suspended.
    • The shares traded as high as $5.39 each soon after the stock opened, seldom trading much below $4.80 a share.
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Company Description
Tobira Therapeutics Inc is a clinical-stage biopharmaceutical company. It is engaged in the development & commercialization of novel treatments for liver & immuno-inflammatory diseases. Its product includes cenicriviroc & non-alcoholic steatohepatitis.
Sector: Healthcare
Industry: Biotechnology
Country: United States