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News Breaks
August 8, 2014
08:34 EDTAUXL, BSTCBioSpecifics 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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November 21, 2014
08:35 EDTAUXL, BSTCBioSpecifics announces new data on XIAFLEX for Peyronie's Disease
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November 20, 2014
07:09 EDTAUXLAuxilium presents STENDRA data at SMSNA meeting
Auxilium Pharmaceuticals announced that data were presented regarding the use of STENDRA tablets for the treatment of erectile dysfunction at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America held in Miami from November 20-23. A post-hoc analysis of data from a placebo-controlled, Phase 4 study of STENDRA evaluated men who had at least one attempt at intercourse within approximately 15 minutes of taking the medication. The STENDRA 100 and 200mg doses demonstrated statistically significant improvement in onset of erectogenic effect at approximately 15 minutes compared to placebo, with a mean per-patient proportion of sexual attempts that resulted in at least one successful intercourse within approximately 15 minutes after dosing of 73.3% and 71.5%, respectively. Results of a study examining the proportion of men with ED who reported successful intercourse within the first three doses of STENDRA showed more than 60% of patients reported successful intercourse within the first three doses of STENDRA. This compares to about 40% with placebo. A higher percentage, or 75% for STENDRA vs. 56% for placebo, also reported success after any dose.
07:07 EDTAUXLAuxilium presents XIAFLEX for Peyronie's Disease data
Auxilium Pharmaceuticals announced presentations of data from new studies, as well as new analyses of data from the Phase 2 and the pivotal Phase 3 IMPRESS trials evaluating XIAFLEX for the treatment of Peyronie's disease, at the 20th Annual Fall Scientific Meeting of the Sexual Medicine Society of North America held in Miami from November 20-23. Data were presented providing further evidence that PD bother is clinically significant and may be a useful measure in clinical practice when treating PD. Data were also presented suggesting that improvements in PD bother are correlated with improvements in penile curvature deformity.
November 19, 2014
07:33 EDTAUXLEndo, Auxilium receive early termination of HSR waiting period for deal
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November 18, 2014
07:02 EDTAUXLAntares Pharma names James Fickenscher as SVP, CFO
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