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Tue, Jan. 26, 7:38 PM
- Venaxis (NASDAQ:APPY) intends to merge with privately held Indian genomics firm Strand Life Sciences Private Limited. Assuming 100% participation from Strand shareholders, Strand will own 68% of the combined company, Strand Life Sciences, and Venaxis shareholders will own 32%.
- To comply with certain long-term holding period requirements under Indian tax law, the transaction will be completed in two closings. The first will happen after the Venaxis shareholders approve the deal, the receipt of all other approvals and the satisfaction of closing conditions. The second will occur about six months later. At each closing, Venaxis will enter into resale registration rights agreements with the Strand shareholders participating in the closing.
- Venaxis will continue its efforts to secure a partner to advance the development and commercialization of its appendicitis portfolio.
- Strand Executive Chairman Dr. Vijay Chandrou will serve as Executive Chairman of the combined firm with Venaxis' chief Steve Lundy serving as CEO and Jeff McGonegal as CFO.
- Management will host a conference call tomorrow morning at 8:30 am ET to discuss the deal.
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, 12:47 PM
Jan. 29, 2015, 9:12 AM
Apr. 3, 2014, 12:45 PM
Apr. 3, 2014, 9:12 AM
Apr. 3, 2014, 9:09 AM
Apr. 2, 2014, 4:21 PM
Mar. 31, 2014, 9:44 AM
- Venaxis (APPY +1.6%) has filed for FDA 510(k) approval of its APPY1 Test for identifying patients who are at low risk of appendicitis.
- The submission comes after APPY1 performed well in a pivotal trial, with sensitivity and negative predictive value results surpassing those in a pilot study. (PR)
Mar. 31, 2014, 9:13 AM
Mar. 13, 2014, 12:48 PM
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)
Nov. 25, 2013, 2:52 PM
Oct. 23, 2013, 9:29 AM
Sep. 26, 2013, 12:47 PM
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