Investigation Overview
October 21, 2014 (Update) - 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.
May 12, 2014 (Shareholders Foundation) - An investigation on behalf of investors in Repros Therapeutics Inc (NASDAQ:RPRX) shares was announced over potential breaches of fiduciary duties by certain officers and directors at Repros Therapeutics Inc.
The investigation by a law firm concerns whether certain Repros Therapeutics officers and directors breached their fiduciary duties and caused damage to the company and its shareholders.
Repros Therapeutics Inc (NASDAQ:RPRX) reported that its Net Loss increased from $4.77 million in 2010 to $18.17 million in 2012.
Shares of Repros Therapeutics Inc (NASDAQ:RPRX) grew from $2.76 per share in early 2011 to as high as $28.35 per share on September 20, 2013.
On September 18, 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.
However, then on October 22, 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.
Then 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.'
Shares of Repros Therapeutics Inc (NASDAQ:RPRX) closed on May 12, 2014, at $15.90 per share.