RPRX
Repros Therapeutics Inc.NASDAQ
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  • Today, 12:50 PM
    | Today, 12:50 PM | 2 Comments
  • Today, 8:04 AM
    • In a panel meeting yesterday, the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 16 - 5 that the achievement of testosterone improvement will maintaining evidence of spermatogenesis is not sufficient to demonstrate clinical benefit in patients with obesity-related hypogonadism. Panel members suggested that an additional symptoms-related endpoint should be measured.
    • Repros Therapeutics (NASDAQ:RPRX) expects its ongoing diet-and-exercise study to provide useful information toward the development of such an assessment tool. After the study is completed, it plans to meet with the FDA to discuss the design of a pivotal Phase 3 trial that incorporates the committee's advice.
    • The company's lead product candidate is enclomiphene citrate for the treatment of secondary hypogonadism. It received a CRL in December 2015 in response to its original marketing application. Its regulatory filing in Europe is currently under review.
    | Today, 8:04 AM | 4 Comments
  • Wed, Nov. 16, 9:17 AM
    | Wed, Nov. 16, 9:17 AM
  • Tue, Nov. 15, 9:17 AM
    | Tue, Nov. 15, 9:17 AM | 8 Comments
  • Mon, Nov. 14, 5:04 PM
    • Thinly traded nano cap Repros Therapeutics (NASDAQ:RPRX) is up 16% after hours on increased volume in response to its announcement of positive results from two Phase 2 studies assessing oral and vaginal delivery of Proellex (telapristone acetate) for the treatment of uterine fibroids.
    • Both studies enrolled women with confirmed fibroids at baseline and experiencing more than 80 mL of blood loss during menses. Participants were administered both 6 mg and 12 mg doses, by either route for 18 weeks followed by a treatment-free phase to allow for menses. After menses occurred, a second 18-week course of treatment was conducted.
    • At the end of the second course of treatment, 92.9% of subjects treated with oral Proellex achieved amenorrhea (absence of menstruation) while only 50% of the vaginally treated group did. In the orally administered group, 100% of subjects receiving the 12 mg dose achieved amenorrhea while 88.9% of the 6 mg group stopped menses.
    • The company intends to advance orally administered Proellex to Phase 3 development.
    • Proellex is a small molecule compound that selectively blocks the progesterone receptor.
    | Mon, Nov. 14, 5:04 PM
  • Tue, Nov. 8, 5:08 PM
    • Repros Therapeutics (NASDAQ:RPRX): Q3 EPS of -$0.17 beats by $0.01.
    • Revenue of $10K (+900.0% Y/Y)
    • Press Release
    | Tue, Nov. 8, 5:08 PM
  • Wed, Oct. 5, 11:55 AM
    • The European Medicines Agency accepts for review Repros Therapeutics' (RPRX +4.3%) Marketing Authorization Application (MAA) seeking approval of enclomiphene citrate for the treatment of secondary hypogonadism.
    • The maximum time limit for an opinion to be issued by the advisory Committee for Medicinal Products for Human Use (CHMP) is 210 days. If positive, a final decision from the European Commission is announced ~60 days later.
    • Its U.S. application was rejected by the FDA in December 2015 citing the need for more supporting data, i.e., a new Phase 3 study will be needed to support the filing.
    • Previously: Repros receives CRL from FDA regarding enclomiphene citrate NDA; shares slump 33% (Dec. 1, 2015)
    | Wed, Oct. 5, 11:55 AM
  • Thu, Sep. 8, 11:00 AM
    | Thu, Sep. 8, 11:00 AM
  • Thu, Sep. 8, 9:23 AM
    | Thu, Sep. 8, 9:23 AM
  • Wed, Sep. 7, 4:47 PM
    • Thinly traded nano cap Repros Therapeutics (NASDAQ:RPRX) is up 42% after hours on on increased volume in response to its announcement of positive results from a Phase 2 study assessing Proellex (telapristone acetate) for the treatment of premenopausal women with pelvic pain associated with endometriosis.
    • The 60-subject, double-blind, placebo-controlled study randomized participants to receive either 6 or 12 mg of Proellex or placebo for 18 weeks followed by an Off Drug Interval. The primary endpoint was the change from baseline in pelvic pain as measured by a scale called Biberoglu and Behrman Symptom Score (BBSS) over the treatment period.
    • 70% of the patients treated with Proellex became amenorrheic, which was associated with a substantial reduction in pain and analgesic use. Responses were similar between the two doses of Proellex so the reported results are pooled.
    • The median percent change from baseline in BBSS score related to menstrual pain was a reduction of 85.4% compared to -37.5% for placebo (p=0.0008). Reductions in non-menstrual pain were also observed but they were similar between the treatment groups.
    • Patients receiving Proellex showed a 56% reduction in total analgesic pill count compared to baseline versus a 30% reduction for placebo (p=0.0521). For non-prescription meds, the reductions were 74% and 11%, respectively (p=0.0423). The drug was generally well-tolerated.
    • Proellex is a small molecule compound that selectively blocks the progesterone receptor.
    • The company intends to advance Proellex to Phase 3 development.
    | Wed, Sep. 7, 4:47 PM
  • Tue, Aug. 9, 11:00 AM
    | Tue, Aug. 9, 11:00 AM
  • Tue, Aug. 9, 9:28 AM
    • Repros Therapeutics (NASDAQ:RPRX): Q2 EPS of -$0.18 beats by $0.02.
    • Revenue of $15K vs. $1K in 2Q15
    • Press Release
    | Tue, Aug. 9, 9:28 AM
  • Wed, Jul. 20, 11:00 AM
    | Wed, Jul. 20, 11:00 AM | 1 Comment
  • 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)
    | Thu, Jun. 2, 12:59 PM
  • Thu, Jun. 2, 12:45 PM
    | Thu, Jun. 2, 12:45 PM