UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) September 22, 2014
Repros Therapeutics Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 001-15281 | 76-0233274 |
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
| 2408 Timberloch Place, Suite B-7 The Woodlands, Texas |
77380 |
| (Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code: (281) 719-3400
________________________________________________________________________________
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01. Regulation FD Disclosure.
On September 22, 2014 the Registrant issued a press release, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
Exhibit 99.1. Press release dated September 22, 2014
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Repros Therapeutics Inc.
(Registrant) |
||
| September 22, 2014
(Date) |
/s/ KATHI ANDERSON
Kathi Anderson CFO |
| Exhibit Index | ||
| 99.1 | Press release dated September 22, 2014 | |
EXHIBIT 99.1
THE WOODLANDS, Texas, Sept. 22, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that the conclusions of the FDA Advisory Panel that met on Wednesday, September 17, 2014, to discuss the appropriate population suited to testosterone replacement therapy (TRT), were not directly applicable to Androxal®, the Company's leading drug designed for the treatment of secondary hypogonadism, since Androxal® is not a form of testosterone. The FDA panelists voted to recommend that testosterone replacement class label should be revised, narrowing the treatment option to those with indications such as testes, pituitary or hypothalamus impairment, and excluding age-related hypogonadism, which the panel considered as a normal sign of aging.
The Company believes that for the majority of hypogonadal men in the general population suffering from secondary hypogonadism, as described in the European Male Aging Study (Tajar et al JECM 2010), their condition is neither idiopathic nor age-related, but is typically associated with obesity. These men typically have functional but under-stimulated testes due to suppressed gonadotropins. The Company believes that Androxal® can restore normal function in the hypothalamic-pituitary-testes (HPT) axis. By raising endogenous testosterone through the use of Androxal®, the Company believes this disorder can potentially be reversed in conjunction with diet and exercise to induce weight loss. The Company further believes that proper diagnosis is imperative before considering treatment. Androxal® is currently the only drug in Phase 3 development to treat secondary hypogonadism.
Dr. Frederick Wu, Professor of Medicine and Endocrinology, University of Manchester, Manchester, United Kingdom, and Principal Investigator on the European Male Aging Study, commented, "Although T replacement is a well-accepted indication for the treatment of patients with classical (pathological and irreversible) primary or secondary hypogonadism, there is currently no approved therapy of the much more common (functional and potentially reversible) secondary hypogonadism associated with obesity, irrespective of age. In the majority of these men, traditional T treatment is not only inappropriate because of further suppression of gonadotropins, but indeed may be counterproductive, particularly in those still seeking fertility."
Joseph S. Podolski, President and CEO of Repros Therapeutics, will be presenting at the Biocentury's Newsmakers in the Biotech Industry in New York City on Friday, September 26, 2014 at 1:30 PM (ET).
A live and archived webcast of the presentation will be available on the "Events" section of the Company's website, http://www.reprosrx.com.
About Repros Therapeutics Inc. ®
Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company's actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as "may," "will," "expect," "anticipate," "continue," "estimate," "project," "intend," "believe," "plan," "seek," "could," "can," "should" or similar expressions. These statements are based on assumptions that the Company has made in light of the Company's experience in the industry, as well as the Company's perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to planned clinical studies and the timing and nature of the results thereof, the impact of the studies on the Androxal® label and the commercial potential of Androxal® and the timing of the Company's expected filing of an NDA for Androxal®. Such statements are based on current expectations that involve a number of known and unknown risks, uncertainties and other factors that may cause actual events to be materially different from those expressed or implied by such forward-looking statements, including the ability to have success in the clinical development of the Company's technologies, the reliability of interim results to predict final study outcomes, the ability to protect the Company's intellectual property rights and such other risks as are identified in the Company's most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please visit the Company's website at http://www.reprosrx.com.
CONTACT: Investor Relations:
Thomas Hoffmann
The Trout Group
(646) 378-2931
thoffmann@troutgroup.com