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Stock Market & Financial Investment News

News For WHF;TSON;GALE;ALJ;ALDW From The Last 14 Days
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April 15, 2015
08:27 EDTALJDelek, Alon USA deal should create additional value, says Cowen
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April 14, 2015
18:30 EDTALJOn The Fly: After Hours Movers
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17:16 EDTALJDelek US to acquire 48% ownership interest in Alon USA Energy
Delek US Holdings (DK) announced that it has entered into a definitive stock purchase agreement with Alon Israel Oil Company to acquire approximately 33.7M shares, or approximately 48% of the outstanding shares, of Alon USA Energy (ALJ) common stock owned by Alon Israel. Prior to commencing negotiations with Alon Israel, Delek US entered into a stockholder agreement with Alon USA. During the first year following the closing of this transaction, the agreement allows Delek US to acquire up to 49.99 percent of the outstanding shares of Alon USA at its discretion, with additional ownership above this threshold subject to approval of Alon USA’s board of directors. The stockholder agreement will expire on the first anniversary of the closing of this transaction, and Delek US will then have no further restrictions on ownership in Alon USA. The consideration to be paid by Delek US to acquire the Alon USA common stock will consist of the issuance of 6M shares of restricted Delek US common stock to Alon Israel, an unsecured $145M promissory note payable to Alon Israel maturing in January 2021 and $200M of cash that will be funded with a combination of cash on hand and borrowings on new or existing credit facilities. An additional 200,000 shares of Delek US common stock may be issued to Alon Israel under certain circumstances as outlined in the agreement. The approximate value of the transaction consideration is $572.4M based upon a closing price of $37.90 per share of Delek US common stock on April 14. The transaction is expected to close in the second half of May subject to customary governmental and other third party approvals.
07:26 EDTGALEGalena completes over-enrollment of NeuVax Phase 3 PRESENT clinical trial
Galena Biopharma announced the completion of enrollment in the NeuVax Phase 3 PRESENT, or Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment, clinical trial. NeuVax is a first-in-class, HER2-directed cancer immunotherapy under evaluation to prevent breast cancer recurrence after standard of care treatment in the adjuvant setting. As anticipated, Galena over-enrolled the trial by 7.7% with a total of 758 patients now in the intent-to-treat, or ITT, population. The protocol for the PRESENT trial, being conducted under an FDA approved Special Protocol Assessment, or SPA, called for 700 patients; and, the company expects this higher number of ITT patients will increase the confidence in both the timing and quality of the statistics and the final outcome of the trial. The primary endpoint is currently expected to be reached in 2018, after the last patient dosed reaches her 36th month of treatment, or a total of 141 events occur, whichever comes later.
April 9, 2015
17:46 EDTGALEGalena receives warning letter from FDA
Galena disclosed the following in a regulatory filing: "As previously reported by Galena Biopharma in its Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 5, following an inspection of our Portland, Oregon facility in November, the U.S. Food and Drug Administration issued a Form 483 Notice of Inspectional Observations noting deficiencies pertaining to post-marketing adverse drug experience reporting and current good manufacturing practices for Abstral and Zuplenz, our only approved products. We responded to the Form 483 Notice in a letter dated December 11, 2014. In conjunction with our response to the FDA, we initiated a number of programs and corrective actions to address the FDA's observations. On April 6, we received a Warning Letter from the FDA relating to certain of the matters originally identified in the Form 483 Notice. Specifically, the Warning Letter cites deficiencies in our response letter related to the adequacy of our written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences from all sources, and the failure to report each adverse drug experience not reported under 21 CFR 314.80(c)(1)(i) at quarterly intervals."
April 7, 2015
10:05 EDTALJOn The Fly: Analyst Downgrade Summary
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06:38 EDTALJAlon USA Energy downgraded to Neutral from Outperform at Credit Suisse
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