An investigation on behalf of investors in Repros Therapeutics Inc (NASDAQ:RPRX) shares was announced and NASDAQ:RPRX stockholders should contact the Shareholders Foundation at firstname.lastname@example.org
San Diego, CA -- (SBWIRE) -- 10/22/2014 -- An investigation on behalf of investors in Repros Therapeutics Inc (NASDAQ:RPRX) shares was announced concerning potential violations of Federal Securities Laws in connection certain statements over Androxal.
Investors who purchased shares of Repros Therapeutics Inc (NASDAQ:RPRX) shares, have certain options and should contact the Shareholders Foundation at email@example.com or call +1(858) 779 - 1554.
The investigation by a law firm concerns whether certain whether Repros Therapeutics Inc and certain of its officers and/or directors have violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
In September 2013 Repros Therapeutics Inc announced additional information confirming success for Study ZA-302, the second pivotal efficacy study for Androxal. Repros Therapeutics Inc said that the results of both pivotal studies, ZA-301 and ZA-302, have met the SPA co-primary endpoints as defined by the FDA.
In October 2013 Repros Therapeutics Inc announced it received FDA Guidance for the Androxal clinical program. Shares of Repros Therapeutics Inc (NASDAQ:RPRX) declined from over $28 per share in late Sept. 2013 to as low as $16.27 per share during Oct. 23, 2013.
On April 30, 2014, Repros Therapeutics Inc announced "that it has received guidance from the Food and Drug Administration (“FDA”) regarding primary endpoints for the two studies, ZA-304 and ZA-305 that Repros is currently conducting of Androxal (R) against a leading approved testosterone gel. The FDA stated that sperm concentration reductions should take into consideration recognized thresholds for fertility treatments, and also that the clinical significance of the degree of sperm concentration decline between the beginning and end of the treatment period is important, as it may represent an adverse effect on fertility, even if sperm concentration stays in the normal range."
On September 26, 2014, Repros Therapeutics Inc announced that it had been granted a Type B Pre-NDA meeting with the FDA in the first half of November, 2014. Repros Therapeutics Inc said that it would seek guidance during this Type B meeting on its planned New Drug Application (NDA) for Androxal for the treatment of secondary hypogonadism with preservation of testicular function. The press release also indicated that Repros believed that the NDA for Androxal® would be filed around the end of 2014.
However, on October 17, 2014, Repros Therapeutics Inc announced that there isn't enough clinical information to hold a planned pre-investigational NDA meeting in November and that Repros Therapeutics Inc will have a "type-C" guidance meeting with the FDA next month.
Shares of Repros Therapeutics Inc (NASDAQ:RPRX) declined to as low as $6.01 per share on October 17, 2014.
On October 20, 2014, NASDAQ:RPRX shares closed at $6.23 per share.
Those who purchased shares of Repros Therapeutics Inc have certain options and should contact the Shareholders Foundation.
Shareholders Foundation, Inc.
3111 Camino Del Rio North - Suite 423
92108 San Diego