Key Developments: Repros Therapeutics Inc (RPRX.PH)
15.86USD
23 May 2013
$0.29 (+1.86%)
$15.57
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$15.93
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Latest Key Developments (Source: Significant Developments)
Repros Therapeutics Inc Announces That FDA Recommends Running Phase 2b Trial Of Proellex-V In Treatment of Severe Menstrual Bleeding Associated With Uterine Fibroids
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
Repros Therapeutics Inc Provides Clinical Update For Androxal Phase 3 Program
Repros Therapeutics Inc announced that it has randomized the first subjects in ZA-301, the first of two pivotal studies. The study is being conducted at various US clinical sites. The second Phase 3 study, ZA-302, will begin enrollment at many of the same sites after the completion of enrollment in the ZA-301 study. The FDA has agreed that Repros may conduct both identical Phase 3 studies at the same clinical sites as long as the two studies have a distinct principal investigator. The Company has commenced an advertising campaign with the goal of increasing the enrollment rate into the Androxal Phase 3 program. The Company plans to provide an update in the fourth quarter of 2012, to project an estimated last patient last visit date for the first pivotal study and the estimated reporting date of top line results. The Company believes results from the first study could be available as early as the second quarter of 2013. The two identical pivotal studies are being conducted under a Special Protocol Assessment (SPA) granted by the FDA. The key features of the studies are: Primary efficacy endpoint; success is defined as at least 75% of Androxal-treated men must achieve 24 hour average testosterone >300 ng/dL at week 12 -- All men in active arm start dosing at 12.5 mg with up-titration to 25 mg at week 6 if morning T remains less than 300 ng/dL -- Primary efficacy to be determined on Intent-to-Treat Population Full Article
Repros Therapeutics Inc Announces Offering Of Unregistered Shares Of Common Stock In Amount Of $23.6 Million
Repros Therapeutics Inc announced that it entered into a purchase agreement with several institutional investors to sell an aggregate of 2,145,636 shares of common stock at $11 per share, in a private placement for gross proceeds of approximately $23.6 million, before deducting offering expenses. The proceeds will be used to fund the Company's Androxal and Proellex programs. Closing is expected to occur later. Full Article
FDA Accepts Repros Therapeutics Inc's Phase 3 Efficacy Protocol For Androxal
Repros Therapeutics Inc announced that it has reached agreement with the FDA for the design of the pivotal efficacy studies for Androxal for the treatment of secondary hypogonadism. The pivotal studies are being conducted under a Special Protocol Assessment and are expected to be initiated as soon as practicable. The two pivotal studies are identical. The key features of the studies are: 152 men randomized 3:1 active to placebo 12 week active dosing period Confirmed baseline morning testosterone levels <300 ng/dL determined on two separate days Confirmed baseline sperm concentrations >15,000,000 sperm/mL determined on two separate days separated by at least two days Primary efficacy endpoint; at least 75% of men achieve 24 hour average testosterone >300 ng/dL at week 12 (comparison to baseline for active arm only) All men in active arm start at 12.5 mg with up-titration to 25 mg at week six if morning T <300 ng/dL Primary efficacy to be determined on Intent-to-Treat Population Primary safety endpoint; comparison of active and placebo arm with respect to the percent of men that exhibit a 50% reduction in sperm counts between two assessments at baseline and two assessments at the end of the active dosing period. The active arm should be non-inferior to placebo. Depending on study enrollment and the completion of other studies, the Company believes it may be able to submit an NDA around the end of 2013. Full Article
Repros Therapeutics Inc Updates Special Protocol Assessment Documentation For Pivotal Studies For Androxal
Repros Therapeutics Inc announced it has modified the pivotal protocol following additional FDA input post the May 9 meeting. The revision included additional secondary endpoints specifying the number of men in the study that exhibit a single time point of testosterone concentration greater than 1500, 1800 and 2500 ng/dL. It is common to experience such high excursions for approved topical products. No subject in an Androxal study has ever exhibited a concentration greater than 1500 ng/dL and the maximum levels achieved are approximately 1100 ng/dL. This level occurs rarely and only in men administered the higher (25 mg) dose. The pivotal studies are designed to titrate men to greater than 450 ng/dL by first starting on the 12.5 mg dose. The Company believes 60% of men will achieve the 450 ng/dL up-titration threshold on the 12.5 mg dose resulting in 40% of men up-titrating to the 25 mg dose. The difference in Androxal response as compared to the topical products is related to the mechanism of action of the Repros drug. Androxal stimulates endogenous production of testosterone. Normal maximum testosterone production can reach a concentration of around 1040 ng/dL. Full Article
Repros Therapeutics Inc Announces Closing Of Registered Direct Offering Of Approximately $11.1 Million
Repros Therapeutics Inc. announced that they have closed a registered direct offering to sell an aggregate of 2,463,537 shares of common stock for gross proceeds of approximately $11.1 million, before deducting placement agent's fees and estimated offering expenses. Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Thalmann Financial Services Inc., acted as the exclusive placement agent for the transaction. Full Article
Repros Therapeutics Inc Announces Registered Direct Offering Of Approximately $11.1 Million
Repros Therapeutics Inc announced that it has entered into definitive agreements with certain institutional investors, including certain existing shareholders, to sell an aggregate of 2,463,538 shares of common stock, par value $0.001 per share (Common Stock) in a registered direct offering for gross proceeds of approximately $11.1 million, before deducting placement agent's fees and estimated offering expenses. The investors have agreed to purchase the shares of Common Stock for a price of $4.50 per share. The Common Stock described above is being offered pursuant to a shelf registration statement on Form S-3, as amended (File No. 333-163648), which was declared effective by the United States Securities and Exchange Commission (SEC) on January 8, 2010. The Company anticipates that the net proceeds from the offering will be used for working capital and general corporate purposes, including continuing clinical trials for Androxal and Proellex. The closing of this offering is expected to occur on or about January 31, 2012. Full Article
Repros Therapeutics Inc Announces IND For Proellex-V Accepted By FDA
Repros Therapeutics Inc announced that its Investigational New Drug Application (IND) for Proellex-V, or vaginally delivered Proellex, has been accepted by the FDA. The indication identified in the new IND is for the use of Proellex-V for the purpose of fibroid size reduction and symptom elimination with the goal of avoiding surgery. Full Article
Repros Therapeutics Inc Provides Result For End Of Dosing Analysis On Phase 2 Clinical Study Of Androxal
Repros Therapeutics Inc provided results for the end of dosing analysis on its Phase 2 clinical study of Androxal in hypogonadal men with type 2 diabetes. Many men with secondary hypogonadism also have type 2 diabetes. A total of 108 men completed the three month dosing period and were the basis for this analysis. The study was conducted at 19 clinical sites in the US. A total of 119 men were enrolled in the study and satisfied the requirement of one visit in which efficacy measures could be assessed and are included in the intent to treat population. Outcomes for the completer and intent to treat populations were similar. At baseline, mean morning testosterone levels for the three groups were; placebo (238 ng/dl), 12.5 mg Androxal (244 ng/dl) and 25 mg Androxal (246 ng/dl). There was no statistical difference between the groups in testosterone at baseline. At the end of the 3 month dosing period mean morning testosterone levels were placebo (231 ng/dl), 12.5 mg Androxal (445 ng/dl) and 25 mg Androxal (455 ng/dl). A comparison of either the 12.5 mg or 25 mg dose of Androxal to placebo showed them to be statistically different (p< 0.0001). There was no statistical difference between the two active arms. Full Article
Interim Analysis of Repros Therapeutics Inc.Study of Androxal in Men With Type 2 Diabetes Yields Statistically Significant and Clinically Relevant Reductions in HbA1c
Repros Therapeutics Inc provided unaudited top line results for an interim analysis it has performed on its Phase 2 clinical study of Androxal(R) in hypogonadal men with type 2 diabetes. Many men with secondary hypogonadism are also type 2 diabetic. 61 men have completed the three month dosing period and were the basis for this interim analysis. The study is being conducted at 19 clinical sites in the US. Enrollment of 110-120 subjects is expected to be completed by the end of August. Top line results for the full study should be available around year end 2011. The study is designed to include secondary hypogonadal men, ages 20 to 80, who have been previously diagnosed with type 2 diabetes for at least six months, as defined by American Diabetes Association criteria. The men must also have been receiving a stable dose of any of several oral hypoglycemic agents as prescribed by their personal physician. The protocol calls for a three month treatment regimen. The study is designed to assess various factors indicative of glycemic control following the treatment with blinded placebo, 12.5 or 25 mg Androxal. Included in the assessment are changes from baseline to end of active dosing in HbA1c (glycosylated hemoglobin) and fasting plasma glucose. Levels of HbA1c greater than or equal to 6.5% are considered indicative of poor glycemic control and used to determine whether an individual has diabetes. Men in the Androxal study were to have levels of HbA1c > 7.0% at baseline. Full Article
BRIEF-Repros Therapeutics jumps in premarket after testosterone drug hits main goals of study
NEW YORK, March 28 - Repros Therapeutics Inc : * Jumps 75.3 to $16 in premarket after testosterone drug hits main goals of study
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