Repros Therapeutics Inc. (RPRX) - NASDAQ
  • Fri, Jun. 24, 11:00 AM
    | Fri, Jun. 24, 11:00 AM
  • Thu, Jun. 2, 12:59 PM
    • Nano cap Repros Therapeutics (RPRX +21.9%) is up on increased volume in response to its announcement of positive interim results from a Phase 2 clinical trial assessing lead product candidate enclomiphene citrate for the treatment of men with low testosterone due to secondary hypogonadism (SH).
    • The study is evaluating two doses of enclomiphene citrate (12.5 mg and 25 mg) in conjunction with diet and exercise in obese men with SH. Participants have been provided a commercially available prepared diet along with enrollment in a health club with a personal trainer. They were asked to attend the health club at least three times per week. Six-month data on the changes in anatomical measurements (e.g., lean body mass, BMI, waist circumference), biochemical markers and quality of life should be available in late Q3.
    • During the following six-month period, men will continue with enclomiphene or placebo but will no longer be provided with the commercial diet. Exercise with the trainer will continue. The same metrics will be assessed again at the end of the period. During the last three months of the study, men will no longer be treated with enclomiphene, but will continue in the health club, although without the help of a trainer.
    • Interim three-month data are encouraging. All groups lost weight, but the enclomiphene arm experienced a significant increase in testosterone. The placebo group showed an average decrease in testosterone of 3.2% from baseline (221 ng/dL) to month 3 (214 ng/dL). The enclomiphene arms showed an average increase in testosterone of 88.2% (212 ng/dL versus 399 ng/dL). The difference was highly statistically significant (p<0.0001). Enclomiphene's effect on the other metrics is important, though, because the FDA's criteria for approval includes the proof of a clinical benefit other than (in addition to) increasing testosterone.
    • In December 2015, the company received a CRL from the FDA citing the need for an additional clinical trial based on new scientific developments that undermined the ability of the company's Phase 3 studies to show clinical benefit.
    • Previously: Repros receives CRL from FDA regarding enclomiphene citrate NDA; shares slump 33% (Dec. 1, 2015)
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  • Tue, Apr. 12, 5:05 PM
    • Thinly traded nano cap Repros Therapeutics (NASDAQ:RPRX) jumps 30% after hours on robust volume in response to its announcement of successful results in a Phase 2b clinical trial assessing Proellex's ability to reduce excessive menstrual bleeding in women with uterine fibroids (UF). Excessive bleeding, greater than 80 mL during menses (normal is ~35 mL), is a key symptom of UF.
    • The three-arm study evaluated 6 mg and 12 mg doses of Proellex and placebo, administered vaginally, in 13, 15 and 14 women, respectively, for 18 weeks. At baseline, average blood loss per menstrual cycle per arm was 255 mL, 274 mL and 238 mL, respectively.
    • 52% of Proellex-treated subjects experienced a cessation of menses with no evidence of dose effect compared to zero for placebo (p=0.0011). Proellex also demonstrated superiority over placebo in two additional metrics: PBAC (Pictorial Blood Assessment Chart) with 100% reduction in scores in the test groups compared to a 25.4% reduction for placebo (p=0.0033) and volume reduction in fibroids measured by MRI which showed an 18% reduction in the Proellex cohorts versus an increase in size for placebo (p=0.0437).
    • Proellex was generally well-tolerated. Women in both test groups maintained levels of estradiol consistent with bone preservation.
    • Study participants are currently being treated for a second 18-week period. Results should be available within the next five months.
    • Once the mid-stage vaginal and oral studies are completed, the company intends to schedule an end-of-Phase 2 meeting with the FDA to discuss the data and clarify the parameters for advancement to Phase 3. According to clinicaltrials.gov, the estimated completion dates for both studies is December of this year.
    • Proellex (telapristone acetate) is a small molecule compound that selectively blocks the progesterone receptor.
    | Tue, Apr. 12, 5:05 PM | 3 Comments
  • Dec. 1, 2015, 1:10 PM
    | Dec. 1, 2015, 1:10 PM | 1 Comment
  • Dec. 1, 2015, 11:27 AM
    • The FDA issues a Complete Response Letter (CRL) to Repros Therapeutics (RPRX -33%) in response to its New Drug Application (NDA) seeking approval of enclomiphene citrate for the treatment of men with low testosterone due to secondary hypogonadism, a condition caused by insufficient stimulation of the testes by the pituitary gland.
    • In the letter, the agency states, based on scientific developments, that the design of the Phase 3 studies supporting the NDA is no longer adequate to show clinical benefit and the company will need to conduct an additional study to support approval in the target population. It also includes concerns about study entry criteria, titration and bioanalytical method validation in the Phase 3 program.
    • The company intends to work with the regulator to clarify a path forward that will address all its concerns. CEO Joe Podolski says, "We are disappointed that the FDA has taken this position without the benefit of an advisory committee recommendation. We plan to work closely with the agency to gain more information to determine the appropriate next steps regarding the enclomiphene application."
    • Shares are down on more than triple normal volume.
    • Previously: FDA action date approaches for Repros' Androxal (Nov. 27)
    | Dec. 1, 2015, 11:27 AM | 1 Comment
Company Description
Repros Therapeutics, Inc. is a development stage company. The company operates as a biopharmaceutical company, which focuses on the development of new drugs to treat hormonal and reproductive system disorders. Its current product pipeline consists of Enclomiphene and Proellex. The company was... More
Sector: Healthcare
Industry: Biotechnology
Country: United States