Venaxis, Inc.
 (APPY)

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  • Jan. 29, 2015, 1:12 PM
    • Thinly-traded nano cap Venaxis (APPY -72.4%) craters in response to the FDA's rejection of its 510(k) filing for its APPY1 blood test which is used to identify patients at risk for appendicitis. The agency determined that the product does not meet the criteria for substantial equivalence based on the data in the application. The company will review all the issues cited in the FDA's response and evaluate its options.
    • APPY1 is CE Mark-approved in Europe.
    • Previously: Venaxis files for FDA authorization of appendicitis test (March 31, 2014)
    | Jan. 29, 2015, 1:12 PM | 7 Comments
  • Jan. 29, 2015, 12:47 PM
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  • Jan. 29, 2015, 9:12 AM
    | Jan. 29, 2015, 9:12 AM | 2 Comments
  • Apr. 3, 2014, 12:45 PM
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  • Apr. 3, 2014, 9:09 AM
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  • Mar. 31, 2014, 9:13 AM
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  • Mar. 13, 2014, 12:48 PM
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  • Mar. 13, 2014, 9:17 AM
    | Mar. 13, 2014, 9:17 AM
  • Mar. 13, 2014, 7:41 AM
    • Venaxis' (APPY) APPY1 Test for identifying patients who are at low risk of appendicitis performed well in a pivotal trial, with sensitivity and negative predictive value results surpassing those in a pilot study.
    • Venaxis believes that the data is enough to receive FDA approval, and the company intends to file a 510(k) application in the next few weeks.
    • Shares surge 29% premarket. (PR)
    | Mar. 13, 2014, 7:41 AM | 4 Comments
  • Nov. 25, 2013, 2:52 PM
    • Shares of Venaxis (APPY +12%) are notably higher on the session.
    • Apparently helping the cause are analysts at Craig-Hallum, who are reportedly out with a $4 price target on the shares, representing upside of just under 141% from Friday's close.
    | Nov. 25, 2013, 2:52 PM | 1 Comment
  • Oct. 23, 2013, 9:29 AM
    • Venaxis (APPY) shares plunge 9.8% pre-market after it files a shelf to sell up to $20M in common stock. (S-3)
    • If carried out in full, the issuance would dilute shares outstanding by ~48%.
    | Oct. 23, 2013, 9:29 AM | 1 Comment
  • Sep. 26, 2013, 12:47 PM
    | Sep. 26, 2013, 12:47 PM
  • Jul. 15, 2013, 8:40 AM

    Venaxis (APPY) says the external Data & Safety Monitoring Board created for the trial of the company's APPY1 Test has recommended continuing the study based on two futility analyses that were carried out on 579 patients. The trial will enroll a total of 2,000 patients for the APPY1 Test, which identifies patients who are at low risk of appendicitis. Shares are -5.1%, possibly because Venaxis expects to complete recruitment by the end of 2013 rather than in August, as previously forecast, and file for FDA clearance in Q1 2014. (PR)

    | Jul. 15, 2013, 8:40 AM
  • May 24, 2013, 11:52 AM

    Venaxis (APPY -5%) slips today after pricing its 10M shares and related warrants to purchase 3.5M shares at a combined public price of $1.25 per share with an exercise price of $1.36. The offering is expected to close on May 30. Venaxis should realize approximately $11.1M in net proceeds from the sale, for which it intends to use primarily for funding of further clinical development and seeking FDA clearance for APPY1, as well as for initial commercialization of the drug in the U.S. and the E.U.

    | May 24, 2013, 11:52 AM
  • May 24, 2013, 9:10 AM
    Premarket gainers: BLOX +17%. IOC +15%. YGE +13%. P +11%. MRVL +5%.
    Losers: DF -52%. SHLD -16%. AVEO -15%. RSOL -13%. TITN -11%. APPY -7%. ANF -7%. CRM -5%.
    | May 24, 2013, 9:10 AM | 2 Comments
  • Mar. 26, 2013, 8:09 PM

    Venaxis Inc. (APPY) climbs in the post-trade session after providing an update on its clinical and commercial activities, reporting in its 10-K that it continues to enroll patients into its ongoing clinical study of APPY1, and it anticipates completing the study and potentially filing with the FDA for regulatory clearance by year end. Read more on its Business Update Conference Call Here: Business Update Transcript. Shares +5% AH.

    | Mar. 26, 2013, 8:09 PM
Company Description
Venaxis Inc is engaged in the development and commercialization of products that address unmet diagnostic and therapeutic needs.