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News Breaks
August 8, 2014
08:34 EDTBSTC, AUXLBioSpecifics announces initiation of Phase 2 clinical study of CCH
BioSpecifics (BSTC) announced that it has injected the first patient in its placebo-controlled Phase 2 clinical trial of CCH for the treatment of lipoma. The company expects to complete patient enrollment in this trial during the first quarter of 2015. The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of CCH for the treatment of lipoma. The primary endpoint of the Phase 2 clinical trial is the reduction in the measureable surface area of the target lipomas, as determined by caliper, at six months post injection. The secondary efficacy endpoints include responders at six months post injection who show a ≥50% decrease in lipoma surface area relative to baseline between CCH and placebo, the change in the length of the target lipoma, the relative change in lipoma surface area as measured by caliper at one month and three months, and the relative change in lipoma volume as measured by MRI. The study will also gather qualitative lipoma characteristics and an assessment of patient satisfaction through a questionnaire administered to each subject prior to injection and at each follow-up visit. BioSpecifics' strategic partner Auxilium (AUXL) has the option to license development and marketing rights to this indication based on a full analysis of the data from this Phase 2 clinical trial, which would transfer responsibility for the future development costs to Auxilium and trigger an opt-in payment and potential future milestone and royalty payments from Auxilium to BioSpecifics.
News For BSTC;AUXL From The Last 14 Days
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October 20, 2014
17:33 EDTAUXLAuxilium announces XIAFLEX approved for treatment of up to two DC joints
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October 16, 2014
08:41 EDTBSTCBioSpecifics' CCH shows positive preclinical results for uterine fibroid tumors
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October 13, 2014
06:41 EDTAUXLEndo upgraded to Hold from Sell at Cantor
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October 10, 2014
11:18 EDTAUXLOptions with decreasing implied volatility
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10:01 EDTAUXLOn The Fly: Analyst Downgrade Summary
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06:35 EDTAUXLAuxilium downgraded to Neutral from Buy at MKM Partners
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05:50 EDTAUXLEndo upgraded to Overweight from Neutral at Piper Jaffray
Piper Jaffray upgraded Endo (ENDP) to Overweight with an $84 price target citing an improved asset base following the takeover of Auxilium (AUXL).
05:47 EDTAUXLAuxilium downgraded to Neutral from Buy at Mizuho
Mizuho downgraded Auxilium (AUXL) to Neutral following the company's agreement to be acquired by Endo (ENDP). The firm expects shareholders to approve the deal and does not expect a competing bid.
October 9, 2014
09:20 EDTAUXLOn The Fly: Pre-market Movers
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09:00 EDTAUXLEndo says its not in position to give FY15
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08:49 EDTAUXLEndo sees low-double digit revenue growth with Auxilium portfolio
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08:37 EDTAUXLEndo expects Auxilium acquisition immediately accretive post close
Endo (ENDP) says the deal will provided expected annual run rate synergies of up to $175M by the first year after closing versus Auxilium's (AUXL trailing 12-month actuals as of June 30. Says synergies include Auxilium's $75M reduction in annual operating expenses previously announced. Says the deal is expected to "significantly'" enhance Endo's branded pharmaceutical business with the addition of Auxilium's men's health products and development portfolio. Says the agreement is designed to "accelerate growth" and maximize value of Auxilium's products by leveraging strengths of combined company. Says combined company will be "well positioned" to drive organic growth for branded pharmaceutical business. Says deal creates a "strong" margin profile and an enhanced near-and long-term revenue growth profile. Comments taken from the company's slide presentation regarding its combination with Auxilium.
07:49 EDTAUXLEndo and Auxilium host a joint conference call
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07:30 EDTAUXLQLT Inc. says re-engaging assessment of options after Auxilium deal ended
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06:52 EDTAUXLQLT Inc. merger with Auxilium terminated for superior proposal from Endo
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06:32 EDTAUXLEndo to acquire Auxilium in cash, stock transaction for approximately $2.6B
Endo (ENDP) and Auxilium Pharmaceuticals (AUXL) announced that they have entered into a definitive agreement under which Endo will acquire all of the outstanding shares of common stock of Auxilium for a per share consideration of $33.25 in a cash and stock transaction. The boards of both companies have unanimously approved the transaction, which is valued at $2.6B, including the repayment and assumption of debt. The transaction will include an election mechanism for Auxilium stockholders to elect cash and stock, all-stock or all-cash consideration, subject to proration in accordance with the terms of the definitive agreement. The per share consideration represents a premium of 55% to Auxilium's closing price on September 16, the day Endo made public its proposal for Auxilium. Subject to aggregate cash and equity consideration limits, Auxilium stockholders may elect one of three options with respect to transaction consideration: 100% equity which equates to 0.488 Endo shares per Auxilium share, 100% cash which equates to $33.25 per Auxilium share or a standard election of an equal mix of $16.625 in cash and 0.244 Endo shares per Auxilium share. The total cash consideration will not exceed 50% of the total equity value and the equity consideration will not exceed 75% of the total equity value. The transaction is expected to close in 1H15 and is subject to the approval of Auxilium's stockholders, regulatory approval in the U.S. and certain other jurisdictions, and other customary closing conditions.
06:31 EDTAUXLEndo to acquire Auxilium in cash, stock transaction for approximately $2.6B
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