Thu, Apr. 2, 9:13 AM
Thu, Apr. 2, 8:20 AM
- Thinly-traded micro cap Repros Therapeutics (NASDAQ:RPRX) is up 21% premarket on average volume in response to its announcement after the close yesterday that the FDA accepted its New Drug Application (NDA) for Androxal (enclomiphene citrate) for review.
- Previously: FDA accepts Repros' NDA for enclomiphene citrate (April 1)
Dec. 30, 2014, 8:58 AM
- Repros Therapeutics (NASDAQ:RPRX) is up 6% premarket on light volume. After yesterday's close, the company announced the initiation of two Proellex clinical trials and progress on its Androxal NDA.
- Previously: Repros initiates trials assessing Proellex in uterine fibroids (Dec. 29)
- Previously: Repros moving forward with Androxal NDA (Dec. 29)
Dec. 26, 2014, 10:50 AM
- The judge presiding over Dr. Harry Fisch's patent suit against Repros (NASDAQ:RPRX) has granted a summary judgment in Repros' favor, thereby ending the dispute.
- Fisch, an NYC urologist, had accused Repros CEO Joe Podolski of stealing the idea behind its Androxal testosterone drug during a face-to-face meeting.
Nov. 7, 2014, 12:52 PM
Nov. 7, 2014, 10:20 AM
- Nano cap Repros Therapeutics (RPRX +39.2%) is up in early trading on above average volume in response to the company's report on its meeting with the FDA regarding its planned NDA submission for Androxal (isomer of clomiphene citrate).
- The agency did identify any additional clinical trials that would needed for the NDA filing, but did state that additional safety studies would be required in the future (post approval - Phase 4). The company believes it has the information and data it needs for the filing and does not expect to meet with the FDA again prior to making the submission.
- Today's up move provides a respite for longs. Shares have been in a down trend for over a year since the high of $29.79 in late September 2013. Prices bottomed at $5.92 on October 21 after investors sold heavily in response the the FDA downgrading the meeting to Type C guidance.
- Previously: Repros gets roughed up after FDA downgrades meeting
Nov. 7, 2014, 9:14 AM
- Gainers: MITK +29%. RMTI +27%. RPRX +24%. SHLD +22%. CNET +15%. NETE +11%. PGNX +10%. ZNGA +9%. APT +9%. KING +9%. KING +9%. KGC +8%. TKMR +7%. AGIO +7%. BEBE +5%.
- Losers: SLXP -35%. MDRX -20%. CTIC -19%. ICPT -19%. UBNT -17%. ANF -13%. ANET -11%. ORBC -10%. AVNR -7%. FSLR -7%. PLNR -6%. NDLS -6%. RIG -5%. DVA -5%. NADL -5%.
Oct. 22, 2014, 9:19 AM| 1 Comment
Oct. 17, 2014, 12:52 PM
Oct. 17, 2014, 11:16 AM
- Investors slap Nano cap Repros Therapeutics (RPRX -34.3%) on a 3x surge in volume after its announcement that the FDA has downgraded its November session with the company to a Type C guidance meeting from Type B pre-NDA meeting regarding Androxal (clomiphene citrate). The agency's action is based on its preliminary review of the firm's briefing document. It found that there is not sufficient clinical information for a Type B pre-NDA meeting. Repros believes the change of status is due to the absence of the one-year DEXA safety study and the Drug-Drug Interaction Study, both of which were unavailable at the time it submitted the briefing document to the regulator.
- What this means is that the company's planned Androxal NDA submission for late 2014 will be delayed.
Oct. 17, 2014, 9:20 AM
Sep. 26, 2014, 12:45 PM
Sep. 26, 2014, 9:14 AM
Sep. 26, 2014, 8:09 AM
- Shares of Repros Therapeutics (NASDAQ:RPRX) are up 12% premarket on good volume in response to its report of positive results for oral Androxal (clomiphene citrate) (NYSE:ABBV) versus topical Androgel (testosterone gel) in a Phase 3 trial.
- In the study, ZA-304, Androxal met its co-primary efficacy endpoints while demonstrating results consistent with an earlier trial. Androxal was superior to Androgel in the percent change from baseline in average sperm concentration and percent of subjects considered to be responders. A responder is defined as a person achieving a 24-hour average testosterone in the normal range with associated average sperm concentration of 10 million/mL.
- The 129-patient study group was randomized into three cohorts, Androxal (41), Androgel (43) and placebo (45).
- The first primary efficacy endpoint was the percent change from baseline in sperm concentration. The median decrease in the Androxal cohort was 1% (stated as unchanged) compared to a median decrease of 71% in the Androgel cohort. The results were statistically significant compared to baseline and Androgel.
- The second primary efficacy endpoint was a comparison of the proportion of responders. The Androxal cohort demonstrated a success rate of 61% (25/41) compared to 16% (7/43) for Androgel. Again, the results were statistically significant.
- The company has a pre-IND meeting scheduled with the FDA for mid-November. It expects to file by year end. If approved, it will be the first drug therapy specifically targeting secondary hypogonadism.
Sep. 24, 2014, 10:52 AM
- Lipocine's (LPCN +40.8%) oral testosterone replacement therapy candidate, LPCN 1021, achieves its primary efficacy endpoint in a Phase 3 clinical trial.
- The FDA guidelines for primary efficacy success stipulate a minimum of 75% of trial subjects on active treatment achieve a serum testosterone concentration within the normal range of 300-1140 ng/dL and the lower bound of the 95% CI (confidence interval) must be greater than 65%.
- In the Phase 3 study, 88% of LPCN 1021-treated patients achieved testosterone levels in the normal range with a lower bound CI of 82%.
- LPCN 1021's safety profile was acceptable as well. Three percent of the subjects reported a serious adverse event, though none were drug-related. All drug-related adverse events were mild or moderate. The safety extension phase of the trial is ongoing.
- One aspect of the value proposition of oral TRT therapy is the elimination of the risk of inadvertent testosterone transfer associated with transdermal gels (before the gel dries).
- Related tickers: (LLY +0.6%)(ABBV +1.1%)(RPRX +8.1%)(AUXL -0.2%)(TEVA +0.4%)
Sep. 18, 2014, 12:45 PM
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