Key Developments: Repros Therapeutics Inc (RPRX.PH)

RPRX.PH on Philadelphia Stock Exchange

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27 Mar 2015
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Latest Key Developments (Source: Significant Developments)

Repros Therapeutics Inc submits new drug application to FDA for Androxal
Monday, 2 Feb 2015 09:15am EST 

Repros Therapeutics Inc:Says it has electronically submitted New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Androxal, company's lead product candidate.Androxal is single isomer of clomiphene citrate and an orally active small molecule compound.Company is developing Androxal for treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function.Men with secondary hypogonadism exhibit low testosterone levels due to under stimulated testes but they are generally fertile.Androxal is designed to treat underlying mechanism, insufficient stimulation of the testes by pituitary, which causes secondary hypogonadism.Secondary hypogonadism due to being overweight or obese is single greatest cause of hypogonadism in general.Androxal is investigational product and has not been determined safe or efficacious.  Full Article

Repros Therapeutics Inc Updates Androxal global regulatory status
Monday, 29 Dec 2014 04:15pm EST 

Repros Therapeutics Inc:Updates the regulatory status for its drug, Androxal.Androxal is an oral therapy for the treatment of low testosterone due to secondary hypogonadism.Repros believes testosterone deficiency is linked to obesity in the majority of men that suffer from the disorder.In secondary hypogonadism associated with obesity, estrogen suppresses pituitary secretions of important hormones that are necessary for testosterone production by the testes.Androxal is an anti-estrogen and acts centrally to restore pituitary secretions and, thereby, restores normal testosterone production in the body.Company had a follow-up discussion with the Agency regarding the Environmental Assessment requirements for the NDA.FDA noted that commitment to perform the appropriate non-clinical experiments during the NDA review period would be considered sufficient for filing.Overall, the Company believes there are no refuse to file issues for its NDA.Lastly, the Company has engaged a European regulatory consultant, to convert the Company's Androxal NDA to a suitable dossier for EU filing.Based on the current schedule provided by the consultant, the Company believes that the dossier will be submitted in the EU in the first quarter of 2016.  Full Article

Repros Therapeutics Inc initiates two Phase 2B Uterine Fibroid Studies
Monday, 29 Dec 2014 04:15pm EST 

Repros Therapeutics Inc:Initiates two Phase 2B efficacy studies of Proellex in the treatment of uterine fibroids in women that experience heavy vaginal bleeding as a result of these benign tumors.Two studies both have the same FDA suggested endpoints but test two different routes of administration, oral and vaginal.Company had previously tested both routes using similar doses and found that Proellex exhibited significant effects on bleeding due to uterine fibroids with each route of administration.In addition to significant effects on bleeding due to Proellex administration, tumor size was significantly reduced.As a result of reduced tumor burden, bulk symptoms improved to the point where the majority of subjects reported to be symptom free using the Uterine Fibroid Symptom Quality of Life survey (UFSQoL).The UFSQoL is a validated survey that was used to approve uterine artery embolization and ultrasound focusing.  Full Article

Repros Therapeutics announces results from long-term study of Androxal(R) Exhibit positive safety profile
Tuesday, 21 Oct 2014 04:01pm EDT 

Repros Therapeutics Inc:Says results from a large, controlled, long-term safety study comparing Androxal to a placebo.No new safety signals were identified, including no evidence of negative effects on bone mineral density.Over 79 pct of the Androxal(®)-treated subjects had morning testosterone levels above 300 ng/dL after being treated for 12 months.  Full Article

Repros Therapeutics Inc 's Androxal achieves superiority in top line analysis for both co-primary endpoint and various secondary endpoints
Wednesday, 27 Aug 2014 08:11pm EDT 

Repros Therapeutics Inc:Reported top line results for first of two identical pivotal studies comparing Androxal to FDA approved topical gel (Androgel 1.62) and placebo.Says in this study, ZA-305, Androxal exhibited superiority in several assessments, particularly two co-primary endpoints: pct change from baseline in average sperm concentration and percent of subjects considered to be responders.Says responder is defined as an individual achieving 24 hour average testosterone in the normal range with associated average sperm concentration * 10 million/mL.Says multiple secondary endpoints also showed statistically significant differences between the Androxal and T gel groups.First primary efficacy endpoint was pct change from baseline in sperm concentration.Percent change from baseline was found to be unchanged from baseline for Androxal -treated subjects and those treated with Topical T experienced median 33 pct decrease from their baseline concentration.  Full Article

Repros Therapeutics Inc allowed to conduct phase 1 and 2 clinical studies of Low Dose Oral Proellex in treatment of Uterine Fibroids and Endometriosis
Monday, 17 Mar 2014 09:20am EDT 

Repros Therapeutics Inc:Receives guidance from FDA indicating that Repros may proceed to conduct Phase 1 and 2 studies of oral Proellex under two separate INDs for endometriosis and uterine fibroids, while remaining on partial clinical hold.FDA guidance provides that highest allowed dose will be 12 mg daily.Repros is conducting Phase 2 study for use of Proellex in severe endometriosis and plans to submit a Phase 2 protocol for the treatment of symptomatic fibroids.Regarding proposed uterine fibroid Phase 2 protocol, FDA provided guidance as to the appropriate inclusion and exclusion criteria for study subjects as well as the preferred efficacy endpoint.FDA preferred efficacy endpoint is reduction in excessive menstrual bleeding associated with uterine fibroids.FDA also noted preferred methodology to determine changes in bleeding.Repros will comply with FDA guidance as well as collecting additional efficacy outcomes such as tumor size and other symptomatic relief.  Full Article

Repros Therapeutics Inc Announces the Closing Of Public Offering of Common Stock
Tuesday, 25 Jun 2013 11:47am EDT 

Repros Therapeutics Inc announced that it has closed an underwritten public offering of 4,312,500 shares of its common stock at a public offering price of $19.00 per share, for net proceeds of approximately $76.5 million after deducting underwriting discounts and other estimated offering expenses. The Company intends to use the proceeds from this offering to progress the clinical development programs for Androxal and Proellex and for general administrative purposes. Our unaudited cash balance as of the date of this release, including the proceeds from this offering and after deducting estimated offering expenses, is approximately $87.5 million. The Company believes that our current liquidity will be sufficient to complete an NDA submission for both of its current clinical programs, with an anticipated NDA filing date for Androxal in mid-2014 and for Proellex in 2016. Additionally, these funds will allow us to maximize the commercial and strategic value for both programs. In connection with this offering, BofA Merrill Lynch acted as the sole book-running manager and Lazard Capital Markets LLC, Ladenburg Thalmann & Co. Inc. and Ascendiant Capital Markets, LLC acted as co-managers.  Full Article

Repros Therapeutics Inc Announces Pricing Of Public Offering Of Common Stock
Wednesday, 19 Jun 2013 07:35pm EDT 

Repros Therapeutics Inc announced the pricing of an underwritten public offering of 3,750,000 shares of its common stock at a public offering price of $19.00 per share, before underwriting discounts and other offering expenses. The gross proceeds from the sale of the shares, before underwriting discounts and other offering expenses, are expected to be $71.25 million. The offering is expected to close on June 25, 2013. Repros Therapeutics has also granted the underwriters a 30-day option to purchase up to 562,500 additional shares of common stock. All of the shares in the offering are to be sold by Repros Therapeutics Inc. In connection with this offering, BofA Merrill Lynch is acting as the sole book-running manager and Lazard Capital Markets LLC, Ladenburg Thalmann & Co. Inc. and Ascendiant Capital Markets, LLC are acting as co-managers.  Full Article

Repros Therapeutics Inc Proposed Public Offering of Common Stock
Monday, 17 Jun 2013 04:01pm EDT 

Repros Therapeutics Inc announced that it has commenced an underwritten public offering of up to 3,000,000 shares of its common stock. All of the shares in the offering are to be sold by Repros Therapeutics Inc. BofA Merrill Lynch is acting as the sole book-running manager for the offering and Lazard Capital Markets LLC, Ladenburg Thalmann & Co. Inc. and Ascendiant Capital Markets, LLC are acting as co-managers in the offering. Repros Therapeutics intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the number of shares sold. The offering is subject to market conditions which may delay or prevent the offering from being completed, or impact the actual size or terms of the offering.  Full Article

Repros Therapeutics Inc Announces That FDA Recommends Running Phase 2b Trial Of Proellex-V In Treatment of Severe Menstrual Bleeding Associated With Uterine Fibroids
Wednesday, 22 May 2013 08:00pm EDT 

Repros Therapeutics Inc announced it has met with the FDA regarding the clinical development of Proellex-V, the vaginally administered product, in the treatment of uterine fibroids. The FDA recommended that a Phase 2b study should be conducted as a prelude to the Phase 3 program. During the meeting, Repros and the FDA agreed that: The primary indication and label for Proellex-V should be treatment of severe menstrual bleeding associated with uterine fibroids. To this end, the Pictorial Blood Loss Assessment (PBAC) was identified as the key primary endpoint; If the Company proposes a label that includes a claim based on patient reported outcome (PRO), such as bulk symptoms or quality of life, the PRO must be validated before the start of Phase 3; and The FDA will review the protocol prior to study initiation. Repros believes one of the key benefits of Proellex-V is the relief of the bulk symptoms associated with uterine fibroids and that inclusion of such claims in the label will provide a significant marketing advantage. The study will start in the latter half of this year and results are expected in mid 2014. Additional discussions focused on the overall clinical and non-clinical program. The Company feels that many requirements have already been satisfied by completed studies using oral Proellex. The FDA acknowledged they would consider the information presented in white papers that Repros will prepare and cross-referenced submissions.  Full Article

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