07:00 , Sep 29, 2014 |  BC Week In Review  |  Clinical News

Enclomiphene: Phase III data

Top-line data from the double-blind, double-dummy, U.S. Phase III ZA-304 trial in 114 evaluable men with secondary hypogonadism showed that Androxal was superior to AndroGel 1.62% testosterone gel on the co-primary endpoints of the proportion...
07:00 , Sep 29, 2014 |  BC Week In Review  |  Clinical News

LPCN 1021: Phase III data

Top-line data from the efficacy population in the open-label, U.S. Phase III SOAR trial in 315 patients with hypogonadism showed that twice-daily oral LPCN 1021 met the primary endpoint of >=75% of patients on active...
02:44 , Sep 19, 2014 |  BC Extra  |  Company News

FDA panel rebuffs Clarus' testosterone

FDA's Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory committees voted against approval of Rextoro oral testosterone from Clarus Therapeutics Inc. (Northbrook, Ill.). The committees voted 18-3 that Rextoro's overall risk/benefit...
07:00 , Sep 1, 2014 |  BC Week In Review  |  Clinical News

Androxal enclomiphene: Phase III data

Top-line data from the double-blind, double-dummy, U.S. Phase III ZA-305 trial in 117 evaluable men with secondary hypogonadism showed that Androxal was superior to AndroGel 1.62% testosterone gel on the co-primary endpoints of the proportion...
07:00 , Sep 1, 2014 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Alkermes plc (NASDAQ:ALKS) gained $1.49 to $44.73 last week after submitting an NDA to FDA for aripiprazole lauroxil to treat schizophrenia. The product is a once-monthly, injectable formulation of aripiprazole that uses Alkermes' LinkeRx technology....
01:18 , Aug 29, 2014 |  BC Extra  |  Clinical News

Repros jumps on Phase III Androxal data

Repros Therapeutics Inc. (NASDAQ:RPRX) jumped $3.37 (19%) to $21.58 on Thursday after reporting data from the Phase III ZA-305 trial of Androxal enclomiphene to treat secondary hypogonadism. In the trial, 65.9% of patients receiving Androxal...
07:00 , May 19, 2014 |  BC Week In Review  |  Clinical News

Androxal enclomiphene: Phase III amended

Repros amended the identical, double-blind, placebo-controlled, U.S. Phase III ZA-304 and ZA-305 trials to include co-primary endpoints that compare semen concentration outcome for 12.5 or 25 mg oral Androxal for 16 weeks vs. AndroGel 1.62%...
07:00 , May 12, 2014 |  BC Week In Review  |  Clinical News

LPCN 1021: Completed Phase III enrollment

Lipocine completed enrollment of 315 patients with low testosterone (<300 ng/dL) in the open-label, U.S. Phase III SOAR trial comparing twice-daily oral LPCN 1021 vs. once-daily AndroGel 1.62% testosterone gel for 52 weeks. Patients are...
07:00 , Apr 21, 2014 |  BC Week In Review  |  Clinical News

Androxal enclomiphene: Completed Phase III enrollment

Repros completed enrollment of 120 patients in the double-blind, placebo-controlled, U.S. Phase III ZA-305 trial comparing 12.5 or 25 mg oral Androxal vs. AndroGel 1.62% testosterone gel for 16 weeks. The company said it expects...
08:00 , Mar 3, 2014 |  BC Week In Review  |  Clinical News

Androxal enclomiphene: Additional Phase III data

Additional data from the 6-month, open-label, dose-escalation, U.S. Phase III ZA-300 trial in 499 patients showed that oral Androxal significantly reduced mean testosterone levels at week 26 by 286.6 ng/dL at the 12.5 mg dose...