Repros Therapeutics Inc (NASDAQ:RPRX) announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application for enclomiphene for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. A Complete Response Letter is a communication from theFDA that informs companies that an application cannot be approved in its present form.
In the letter, the FDA stated that, based on recent scientific developments, the design of enclomiphene Phase 3 studies is no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an additional Phase 3 study or studies to support approval in the target population. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase 3 program.
Repros plans to work with the FDA to determine an appropriate path forward to address these comments. “We are disappointed that the FDA has taken this position without the benefit of an advisory committee recommendation,” said Joseph Podolski, President and CEO of Repros. “We plan to work closely with the Agency to gain more information to determine the appropriate next steps regarding the enclomiphene application.” (Original Source)
Shares of Repros Therapeutics reacted to the news, dropping 31.11% to $1.65. RPRX has a 1-year high of $10.55 and a 1-year low of $1.18. The stock’s 50-day moving average is $3.48 and its 200-day moving average is $6.53.
On the ratings front, Repros has been the subject of a number of recent research reports. In a report issued on October 30, Brean Murray Carret analyst Jonathan Aschoff downgraded RPRX to Hold. Separately, on the same day, Ladenburg Thalmann’s Matthew Kaplan downgraded the stock to Hold .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jonathan Aschoff and Matthew Kaplan have a total average return of -0.5% and -2.2% respectively. Aschoff has a success rate of 44.6% and is ranked #2733 out of 3644 analysts, while Kaplan has a success rate of 42.1% and is ranked #2724.
Repros Therapeutics Inc is a development stage biopharmaceutical company. The Company is engaged in the development of new drugs to treat hormonal and reproductive system disorders.